studies

metastatic/adv melanoma (mML), immune chekpoint inhibitors vs. all, meta-analysis of study results

OutcomeTE95% CInkI2ROBPub. bias deaths (OS)detailed resultsA3671009, 2013 0.88 [0.75; 1.04] Ascierto (ipi 10 vs 3 mg/kg), 2017 0.84 [0.71; 1.00] CA184-024, 2011 0.72 [0.59; 0.87] CheckMate 066, 2015 0.42 [0.25; 0.72] CheckMate 066 DUPLICATE, 2015 0.36 [0.24; 0.55] CheckMate 067 (N vs I ; all population), 2015 0.63 [0.48; 0.82] CheckMate 067 (NI vs I ; all population), 2015 0.55 [0.42; 0.72] CheckMate 067 (NI vs N) EXPLORATORY, 2015 0.65 [0.53; 0.80] CheckMate 069 (all population), 2015 0.74 [0.43; 1.27] CheckMate 069 (BRAF mutant) EXPLORATORY, 2015 1.44 [0.46; 4.49] CheckMate 238, 2017 0.87 [0.66; 1.14] EORTC 18071, 2015 0.72 [0.58; 0.89] IMspire-150 (BRAF mutant), 2020 0.85 [0.65; 1.12] IMspire-170, 2020 1.06 [0.69; 1.62] KEYNOTE-002 (10 mg/kg), 2015 0.74 [0.57; 0.96] KEYNOTE-002 (2 mg/kg), 2015 0.86 [0.67; 1.10] KEYNOTE-006 (2 week), 2015 0.63 [0.47; 0.84] KEYNOTE-006 (3 week), 2015 0.69 [0.52; 0.91] KEYNOTE-022, 2019 0.76 [0.41; 1.40] MDX010 Ipi plus gp100 vs gp100, 2010 0.68 [0.55; 0.85] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 1.04 [0.83; 1.30] MDX010 Ipi vs gp100, 2010 0.66 [0.51; 0.86] 0.73[0.67; 0.80]A3671009, 2013, Ascierto (ipi 10 vs 3 mg/kg), 2017, CA184-024, 2011, CheckMate 066, 2015, CheckMate 066 DUPLICATE, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 069 (BRAF mutant) EXPLORATORY, 2015, CheckMate 238, 2017, EORTC 18071, 2015, IMspire-150 (BRAF mutant), 2020, IMspire-170, 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015, KEYNOTE-022, 2019, MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010, MDX010 Ipi vs gp100, 20102257%10,905lowlow deaths (OS) (extension)detailed resultsCA184-024, 2011 0.69 [0.57; 0.84] CheckMate 066, 2015 0.46 [0.36; 0.59] CheckMate 067 (N vs I ; all population), 2015 0.63 [0.52; 0.76] CheckMate 067 (NI vs I ; all population), 2015 0.52 [0.42; 0.64] CheckMate 067 (NI vs N) EXPLORATORY, 2015 0.83 [0.67; 1.03] EORTC 18071, 2015 0.73 [0.64; 0.83] KEYNOTE-006 (2 week), 2015 0.68 [0.53; 0.87] KEYNOTE-006 (3 week), 2015 0.68 [0.53; 0.87] 0.65[0.57; 0.73]CA184-024, 2011, CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, EORTC 18071, 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015866%4,371lownot evaluable MFSdetailed resultsCheckMate 238, 2017 0.73 [0.56; 0.96] EORTC 18071, 2015 0.76 [0.63; 0.91] KEYNOTE 054 (all population), 2018 0.53 [0.37; 0.76] 0.70[0.58; 0.84]CheckMate 238, 2017, EORTC 18071, 2015, KEYNOTE 054 (all population), 2018336%2,705lownot evaluable MFS (extension)detailed resultsEORTC 18071, 2015 0.76 [0.64; 0.90] 0.76[0.64; 0.90]EORTC 18071, 201510%951NAnot evaluable PFS (extension)detailed resultsCheckMate 066, 2015 0.42 [0.33; 0.53] CheckMate 067 (N vs I ; all population), 2015 0.53 [0.44; 0.64] CheckMate 067 (NI vs I ; all population), 2015 0.42 [0.35; 0.51] CheckMate 067 (NI vs N) EXPLORATORY, 2015 0.79 [0.65; 0.97] CheckMate 069 (all population), 2015 0.36 [0.23; 0.57] CheckMate 069 (BRAF mutant) EXPLORATORY, 2015 0.47 [0.10; 2.27] KEYNOTE-006 (2 week), 2015 0.61 [0.50; 0.75] KEYNOTE-006 (3 week), 2015 0.61 [0.50; 0.75] 0.53[0.44; 0.64]CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 069 (BRAF mutant) EXPLORATORY, 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015877%3,595lownot evaluable progression or deaths (PFS)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 0.89 [0.66; 1.21] CA184-024, 2011 0.76 [0.63; 0.92] CheckMate 066, 2015 0.43 [0.34; 0.55] CheckMate 066 DUPLICATE, 2015 0.43 [0.34; 0.55] CheckMate 067 (N vs I ; all population), 2015 0.57 [0.43; 0.76] CheckMate 067 (NI vs I ; all population), 2015 0.42 [0.31; 0.57] CheckMate 067 (NI vs N) EXPLORATORY, 2015 0.74 [0.60; 0.92] CheckMate 069 (all population), 2015 0.38 [0.23; 0.63] CheckMate 069 (BRAF mutant) EXPLORATORY, 2015 0.38 [0.15; 0.98] CheckMate 069 (BRAF wild type), 2015 0.40 [0.23; 0.69] IMspire-150 (BRAF mutant), 2020 0.78 [0.63; 0.97] IMspire-170, 2020 1.15 [0.88; 1.50] KEYNOTE-002 (10 mg/kg), 2015 0.50 [0.39; 0.64] KEYNOTE-002 (2 mg/kg), 2015 0.57 [0.45; 0.73] KEYNOTE-006 (2 week), 2015 0.58 [0.46; 0.73] KEYNOTE-006 (3 week), 2015 0.58 [0.47; 0.72] KEYNOTE-022, 2019 0.66 [0.40; 1.08] 0.59[0.51; 0.68]Ascierto (ipi 10 vs 3 mg/kg), 2017, CA184-024, 2011, CheckMate 066, 2015, CheckMate 066 DUPLICATE, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 069 (BRAF mutant) EXPLORATORY, 2015, CheckMate 069 (BRAF wild type), 2015, IMspire-150 (BRAF mutant), 2020, IMspire-170, 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015, KEYNOTE-022, 20191778%7,150lowlow RFS (extension)detailed resultsCheckMate 238, 2017 0.71 [0.59; 0.85] EORTC 18071, 2015 0.75 [0.63; 0.89] KEYNOTE 054 (all population), 2018 0.56 [0.47; 0.67] KEYNOTE 054 (PDL1>1%), 2018 0.57 [0.43; 0.75] 0.65[0.56; 0.76]CheckMate 238, 2017, EORTC 18071, 2015, KEYNOTE 054 (all population), 2018, KEYNOTE 054 (PDL1>1%), 2018457%3,729lownot evaluable RFS/DFSdetailed resultsCheckMate 238, 2017 0.65 [0.51; 0.83] EORTC 18071, 2015 0.75 [0.63; 0.89] IMMUNED (N vs P ; all population), 2020 0.56 [0.33; 0.95] IMMUNED (NI vs N) EXPLORATORY, 2020 0.40 [0.20; 0.79] IMMUNED (NI vs P ; all population), 2020 0.23 [0.12; 0.45] KEYNOTE 054 (all population), 2018 0.57 [0.43; 0.75] KEYNOTE 054 (PDL1>1%), 2018 0.54 [0.42; 0.69] 0.56[0.46; 0.69]CheckMate 238, 2017, EORTC 18071, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE 054 (all population), 2018, KEYNOTE 054 (PDL1>1%), 2018764%4,063lowserious DCRdetailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 1.19 [0.86; 1.63] CA184-024, 2011 1.15 [0.79; 1.68] IMspire-170, 2020 0.91 [0.63; 1.32] 1.09[0.89; 1.33]Ascierto (ipi 10 vs 3 mg/kg), 2017, CA184-024, 2011, IMspire-170, 202030%1,675lownot evaluable DMFSdetailed resultsKEYNOTE 054 (all population), 2018 0.60 [0.49; 0.73] KEYNOTE 054 (PDL1>1%), 2018 0.60 [0.49; 0.73] 0.60[0.52; 0.69]KEYNOTE 054 (all population), 2018, KEYNOTE 054 (PDL1>1%), 201820%1,872lownot evaluable DORdetailed resultsKEYNOTE-022, 2019 0.41 [0.20; 0.83] MDX010 Ipi plus gp100 vs gp100, 2010 0.68 [0.55; 0.85] 0.59[0.38; 0.92]KEYNOTE-022, 2019, MDX010 Ipi plus gp100 vs gp100, 2010245%106lownot evaluable DOR (extension)detailed resultsCheckMate 066, 2015 3.45 [1.46; 8.18] 3.45[1.46; 8.18]CheckMate 066, 201510%120NAnot evaluable objective responses (ORR)detailed resultsA3671009, 2013 1.14 [0.69; 1.88] Ascierto (ipi 10 vs 3 mg/kg), 2017 1.31 [0.86; 2.00] CA184-024, 2011 1.56 [0.91; 2.65] CheckMate 066, 2015 4.06 [2.52; 6.54] CheckMate 066 DUPLICATE, 2015 4.06 [2.52; 6.54] CheckMate 067 (N vs I ; all population), 2015 3.40 [2.02; 5.72] CheckMate 067 (NI vs I ; all population), 2015 6.11 [3.59; 10.39] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1.76 [1.28; 2.41] CheckMate 069 (all population), 2015 15.08 [8.07; 28.17] CheckMate 069 (BRAF mutant) EXPLORATORY, 2015 9.82 [0.45; 212.91] CheckMate 069 (BRAF wild type), 2015 12.96 [3.47; 48.38] IMspire-150 (BRAF mutant), 2020 1.19 [0.83; 1.71] IMspire-170, 2020 0.77 [0.50; 1.17] KEYNOTE-002 (10 mg/kg), 2015 8.16 [3.74; 17.80] KEYNOTE-002 (2 mg/kg), 2015 6.11 [2.77; 13.47] KEYNOTE-006 (2 week), 2015 3.77 [2.43; 5.86] KEYNOTE-006 (3 week), 2015 3.63 [2.34; 5.65] KEYNOTE-022, 2019 0.68 [0.32; 1.47] MDX010 Ipi plus gp100 vs gp100, 2010 4.06 [0.94; 17.43] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 0.49 [0.25; 0.97] MDX010 Ipi vs gp100, 2010 8.24 [1.85; 36.76] 2.76[1.90; 4.02]A3671009, 2013, Ascierto (ipi 10 vs 3 mg/kg), 2017, CA184-024, 2011, CheckMate 066, 2015, CheckMate 066 DUPLICATE, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 069 (BRAF mutant) EXPLORATORY, 2015, CheckMate 069 (BRAF wild type), 2015, IMspire-150 (BRAF mutant), 2020, IMspire-170, 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015, KEYNOTE-022, 2019, MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010, MDX010 Ipi vs gp100, 20102189%9,157lowlow objective responses (ORR) (extension)detailed resultsCheckMate 066, 2015 4.50 [2.79; 7.25] CheckMate 067 (N vs I ; all population), 2015 3.54 [2.46; 5.10] CheckMate 067 (NI vs I ; all population), 2015 6.35 [4.38; 9.21] CheckMate 067 (NI vs N) EXPLORATORY, 2015 5.96 [4.16; 8.54] CheckMate 069 (all population), 2015 12.20 [4.41; 33.76] CheckMate 069 (BRAF mutant) EXPLORATORY, 2015 9.80 [0.45; 211.42] CheckMate 069 (BRAF wild type), 2015 13.00 [3.48; 48.60] 5.54[4.14; 7.40]CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 069 (BRAF mutant) EXPLORATORY, 2015, CheckMate 069 (BRAF wild type), 2015745%2,592lownot evaluable AE (any grade)detailed resultsA3671009, 2013 2.22 [1.12; 4.38] CA184-024, 2011 5.17 [1.48; 18.09] CheckMate 066, 2015 0.78 [0.34; 1.76] CheckMate 238, 2017 0.49 [0.20; 1.23] EORTC 18071, 2015 7.53 [3.17; 17.90] IMspire-170, 2020 14.27 [3.34; 61.03] KEYNOTE 054 (all population), 2018 1.51 [0.96; 2.38] KEYNOTE-022, 2019 2.03 [0.18; 23.06] MDX010 Ipi plus gp100 vs gp100, 2010 1.95 [0.54; 7.01] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 1.96 [0.55; 7.07] MDX010 Ipi vs gp100, 2010 0.99 [0.24; 4.05] 2.07[1.19; 3.60]A3671009, 2013, CA184-024, 2011, CheckMate 066, 2015, CheckMate 238, 2017, EORTC 18071, 2015, IMspire-170, 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-022, 2019, MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010, MDX010 Ipi vs gp100, 20101171%6,256lowlow AE (grade 3-4)detailed resultsA3671009, 2013 1.84 [1.35; 2.52] CA184-024, 2011 3.39 [2.34; 4.94] CheckMate 066, 2015 0.84 [0.56; 1.25] CheckMate 238, 2017 0.28 [0.21; 0.37] EORTC 18071, 2015 0.11 [0.08; 0.17] IMspire-170, 2020 4.03 [2.70; 6.00] KEYNOTE 054 (all population), 2018 2.03 [1.52; 2.73] KEYNOTE-022, 2019 2.44 [1.17; 5.12] MDX010 Ipi plus gp100 vs gp100, 2010 0.94 [0.63; 1.40] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 0.99 [0.66; 1.47] MDX010 Ipi vs gp100, 2010 0.95 [0.59; 1.55] 1.10[0.56; 2.13]A3671009, 2013, CA184-024, 2011, CheckMate 066, 2015, CheckMate 238, 2017, EORTC 18071, 2015, IMspire-170, 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-022, 2019, MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010, MDX010 Ipi vs gp100, 20101197%6,256lowlow AE leading to death (grade 5)detailed resultsA3671009, 2013 1.71 [0.85; 3.45] CA184-024, 2011 1.02 [0.02; 51.42] CheckMate 066, 2015 1.00 [0.02; 50.40] IMMUNED (N vs P ; all population), 2020 0.93 [0.02; 47.58] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] IMspire-150 (BRAF mutant), 2020 1.23 [0.42; 3.56] IMspire-170, 2020 1.39 [0.43; 4.44] KEYNOTE-022, 2019 4.10 [0.18; 92.93] 1.50[0.91; 2.46]A3671009, 2013, CA184-024, 2011, CheckMate 066, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, IMspire-150 (BRAF mutant), 2020, IMspire-170, 2020, KEYNOTE-022, 201990%2,943moderatenot evaluable AE leading to treatment discontinuation (any grade)detailed resultsA3671009, 2013 97.13 [5.95; 1585.40] CheckMate 066, 2015 0.55 [0.28; 1.10] CheckMate 238, 2017 0.15 [0.10; 0.21] IMMUNED (N vs P ; all population), 2020 3.57 [0.71; 18.07] IMMUNED (NI vs N) EXPLORATORY, 2020 11.33 [4.34; 29.62] IMMUNED (NI vs P ; all population), 2020 39.67 [8.72; 180.45] IMspire-150 (BRAF mutant), 2020 0.78 [0.47; 1.29] KEYNOTE-022, 2019 2.58 [1.16; 5.75] 2.81[0.77; 10.28]A3671009, 2013, CheckMate 066, 2015, CheckMate 238, 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, IMspire-150 (BRAF mutant), 2020, KEYNOTE-022, 2019895%2,914lowserious AE leading to treatment discontinuation (grade 3-4)detailed resultsCheckMate 066, 2015 0.61 [0.29; 1.28] CheckMate 238, 2017 0.11 [0.07; 0.18] IMMUNED (N vs P ; all population), 2020 4.90 [0.55; 43.46] IMMUNED (NI vs N) EXPLORATORY, 2020 11.38 [3.94; 32.84] IMMUNED (NI vs P ; all population), 2020 55.77 [7.19; 432.80] 2.55[0.30; 21.54]CheckMate 066, 2015, CheckMate 238, 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020596%1,640lowserious SAE (any grade)detailed resultsA3671009, 2013 3.19 [2.19; 4.65] CheckMate 066, 2015 0.73 [0.49; 1.10] IMMUNED (N vs P ; all population), 2020 1.27 [0.56; 2.87] IMMUNED (NI vs N) EXPLORATORY, 2020 3.69 [1.68; 8.08] IMMUNED (NI vs P ; all population), 2020 4.55 [2.00; 10.32] 2.14[0.98; 4.66]A3671009, 2013, CheckMate 066, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020589%1,378lownot evaluable SAE (grade 3-4)detailed resultsCheckMate 066, 2015 0.74 [0.47; 1.17] IMMUNED (N vs P ; all population), 2020 2.51 [0.94; 6.74] IMMUNED (NI vs N) EXPLORATORY, 2020 3.48 [1.58; 7.66] IMMUNED (NI vs P ; all population), 2020 8.75 [3.35; 22.86] 2.63[0.83; 8.34]CheckMate 066, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020489%735lownot evaluable STRAE (any grade)detailed resultsCheckMate 066, 2015 1.06 [0.54; 2.07] IMMUNED (N vs P ; all population), 2020 6.13 [1.29; 29.17] IMMUNED (NI vs N) EXPLORATORY, 2020 5.69 [2.43; 13.31] IMMUNED (NI vs P ; all population), 2020 34.09 [7.51; 154.62] IMspire-150 (BRAF mutant), 2020 1.24 [0.85; 1.81] KEYNOTE-006 (2 week), 2015 0.67 [0.41; 1.09] KEYNOTE-006 (3 week), 2015 0.63 [0.39; 1.03] 1.97[0.97; 3.98]CheckMate 066, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, IMspire-150 (BRAF mutant), 2020, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015788%2,312lowserious STRAE (grade 3-4)detailed resultsCheckMate 066, 2015 0.99 [0.44; 2.27] IMMUNED (N vs P ; all population), 2020 19.34 [1.09; 342.95] IMMUNED (NI vs N) EXPLORATORY, 2020 4.68 [1.93; 11.38] IMMUNED (NI vs P ; all population), 2020 90.55 [5.31; 1542.75] KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] 4.03[1.07; 15.21]CheckMate 066, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015667%1,802lownot evaluable TRAE (any grade)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 2.40 [1.76; 3.28] CA184-024, 2011 5.64 [3.80; 8.35] CheckMate 066, 2015 0.93 [0.60; 1.46] CheckMate 067 (N vs I ; all population), 2015 1.01 [0.64; 1.59] CheckMate 067 (NI vs I ; all population), 2015 3.70 [1.95; 7.04] CheckMate 067 (NI vs N) EXPLORATORY, 2015 3.58 [1.88; 6.81] CheckMate 069 (all population), 2015 0.75 [0.19; 2.97] CheckMate 238, 2017 0.25 [0.15; 0.43] EORTC 18071, 2015 14.40 [10.07; 20.60] IMMUNED (N vs P ; all population), 2020 4.29 [1.74; 10.57] IMMUNED (NI vs N) EXPLORATORY, 2020 5.07 [1.04; 24.68] IMMUNED (NI vs P ; all population), 2020 21.77 [4.78; 99.11] IMspire-150 (BRAF mutant), 2020 0.82 [0.11; 5.85] KEYNOTE 054 (all population), 2018 1.79 [1.36; 2.37] KEYNOTE-002 (10 mg/kg), 2015 0.76 [0.45; 1.26] KEYNOTE-002 (2 mg/kg), 2015 0.56 [0.34; 0.93] KEYNOTE-006 (2 week), 2015 1.62 [1.07; 2.46] KEYNOTE-006 (3 week), 2015 1.16 [0.78; 1.72] KEYNOTE-022, 2019 1.36 [0.29; 6.34] MDX010 Ipi plus gp100 vs gp100, 2010 2.17 [1.28; 3.67] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 1.99 [1.17; 3.41] MDX010 Ipi vs gp100, 2010 1.09 [0.60; 1.98] 1.87[1.22; 2.86]Ascierto (ipi 10 vs 3 mg/kg), 2017, CA184-024, 2011, CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, EORTC 18071, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, IMspire-150 (BRAF mutant), 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015, KEYNOTE-022, 2019, MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010, MDX010 Ipi vs gp100, 20102293%10,517lowlow TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 2.70 [1.86; 3.92] CA184-024, 2011 11.25 [6.30; 20.10] CheckMate 066, 2015 0.62 [0.35; 1.08] CheckMate 067 (N vs I ; all population), 2015 0.71 [0.49; 1.03] CheckMate 067 (NI vs I ; all population), 2015 3.83 [2.74; 5.36] CheckMate 067 (NI vs N) EXPLORATORY, 2015 4.82 [3.41; 6.80] CheckMate 069 (all population), 2015 3.77 [1.71; 8.31] CheckMate 238, 2017 0.20 [0.14; 0.27] EORTC 18071, 2015 25.27 [14.14; 45.18] IMMUNED (N vs P ; all population), 2020 5.85 [1.58; 21.65] IMMUNED (NI vs N) EXPLORATORY, 2020 6.66 [2.91; 15.27] IMMUNED (NI vs P ; all population), 2020 39.00 [10.59; 143.61] IMspire-150 (BRAF mutant), 2020 1.41 [0.93; 2.12] KEYNOTE 054 (all population), 2018 4.93 [2.87; 8.48] KEYNOTE-002 (10 mg/kg), 2015 0.54 [0.32; 0.91] KEYNOTE-002 (2 mg/kg), 2015 0.44 [0.25; 0.76] KEYNOTE-006 (2 week), 2015 0.84 [0.54; 1.30] KEYNOTE-006 (3 week), 2015 0.82 [0.53; 1.28] KEYNOTE-022, 2019 3.60 [1.67; 7.74] MDX010 Ipi plus gp100 vs gp100, 2010 1.64 [0.90; 2.99] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 1.17 [0.68; 2.01] MDX010 Ipi vs gp100, 2010 1.41 [0.69; 2.88] 2.19[1.29; 3.72]Ascierto (ipi 10 vs 3 mg/kg), 2017, CA184-024, 2011, CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, EORTC 18071, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, IMspire-150 (BRAF mutant), 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015, KEYNOTE-022, 2019, MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010, MDX010 Ipi vs gp100, 20102296%10,517lowcritical TRAE leading to death (grade 5)detailed resultsA3671009, 2013 7.00 [0.86; 57.23] Ascierto (ipi 10 vs 3 mg/kg), 2017 2.00 [0.36; 10.99] CheckMate 067 (N vs I ; all population), 2015 0.99 [0.02; 50.24] CheckMate 067 (NI vs I ; all population), 2015 0.99 [0.02; 50.24] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1.00 [0.02; 50.56] CheckMate 238, 2017 0.25 [0.01; 5.55] EORTC 18071, 2015 10.16 [0.55; 186.52] IMMUNED (N vs P ; all population), 2020 0.93 [0.02; 47.58] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] KEYNOTE 054 (all population), 2018 1.97 [0.07; 58.99] KEYNOTE-002 (10 mg/kg), 2015 1.92 [0.06; 57.48] KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69] KEYNOTE-006 (2 week), 2015 1.84 [0.06; 55.23] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] KEYNOTE-022, 2019 2.02 [0.07; 61.28] MDX010 Ipi plus gp100 vs gp100, 2010 1.36 [0.28; 6.47] 1.74[0.87; 3.49]A3671009, 2013, Ascierto (ipi 10 vs 3 mg/kg), 2017, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 238, 2017, EORTC 18071, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015, KEYNOTE-022, 2019, MDX010 Ipi plus gp100 vs gp100, 2010170%8,853lowlow TRAE leading to discontinuation (any grade)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 1.97 [1.40; 2.78] CheckMate 067 (N vs I ; all population), 2015 0.72 [0.45; 1.13] CheckMate 067 (NI vs I ; all population), 2015 3.99 [2.72; 5.85] CheckMate 067 (NI vs N) EXPLORATORY, 2015 4.85 [3.25; 7.24] CheckMate 069 (all population), 2015 4.18 [1.76; 9.91] CheckMate 069 (BRAF wild type), 2015 3.39 [1.40; 8.19] CheckMate 238, 2017 0.12 [0.08; 0.17] EORTC 18071, 2015 21.35 [13.41; 33.97] IMMUNED (N vs P ; all population), 2020 7.29 [0.86; 61.51] IMMUNED (NI vs N) EXPLORATORY, 2020 11.33 [4.34; 29.62] IMMUNED (NI vs P ; all population), 2020 80.95 [10.39; 630.65] KEYNOTE-002 (10 mg/kg), 2015 1.65 [0.70; 3.87] KEYNOTE-002 (2 mg/kg), 2015 0.85 [0.32; 2.25] KEYNOTE-006 (2 week), 2015 0.74 [0.39; 1.40] KEYNOTE-006 (3 week), 2015 1.23 [0.69; 2.18] KEYNOTE-022, 2019 2.67 [1.18; 6.03] 2.63[1.23; 5.60]Ascierto (ipi 10 vs 3 mg/kg), 2017, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 069 (BRAF wild type), 2015, CheckMate 238, 2017, EORTC 18071, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015, KEYNOTE-022, 20191696%6,907lowlow TRAE leading to discontinuation (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 2.27 [1.53; 3.38] CheckMate 067 (N vs I ; all population), 2015 0.52 [0.31; 0.88] CheckMate 067 (NI vs I ; all population), 2015 2.72 [1.82; 4.06] CheckMate 067 (NI vs N) EXPLORATORY, 2015 5.10 [3.17; 8.19] CheckMate 069 (all population), 2015 4.14 [1.59; 10.74] CheckMate 238, 2017 0.09 [0.05; 0.15] IMMUNED (N vs P ; all population), 2020 9.90 [0.53; 186.01] IMMUNED (NI vs N) EXPLORATORY, 2020 11.38 [3.94; 32.84] IMMUNED (NI vs P ; all population), 2020 112.65 [6.61; 1919.31] KEYNOTE-002 (10 mg/kg), 2015 2.73 [0.85; 8.76] KEYNOTE-002 (2 mg/kg), 2015 1.46 [0.40; 5.25] KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] 2.30[0.95; 5.56]Ascierto (ipi 10 vs 3 mg/kg), 2017, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 20151394%5,735lowlow Abdominal pain TRAE (grade 3-4)detailed resultsCheckMate 066, 2015 1.00 [0.02; 50.40] CheckMate 067 (N vs I ; all population), 2015 0.25 [0.01; 5.50] CheckMate 067 (NI vs I ; all population), 2015 0.50 [0.04; 5.49] CheckMate 067 (NI vs N) EXPLORATORY, 2015 2.00 [0.07; 59.93] CheckMate 069 (all population), 2015 0.24 [0.01; 7.31] CheckMate 238, 2017 0.50 [0.02; 14.96] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] 0.64[0.23; 1.82]CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015110%4,721lowlow Acute kidney injury TRAE (grade 3-4)detailed resultsIMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 2.06 [0.07; 62.55] IMMUNED (NI vs P ; all population), 2020 1.87 [0.06; 56.97] 1.59[0.20; 12.46]IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 202030%324lownot evaluable Adrenal insufficiency TRAE (grade 3-4)detailed resultsA3671009, 2013 5.93 [0.30; 118.96] Ascierto (ipi 10 vs 3 mg/kg), 2017 1.99 [0.07; 59.56] CheckMate 067 (N vs I ; all population), 2015 1.99 [0.18; 22.10] CheckMate 067 (NI vs I ; all population), 2015 6.06 [0.73; 50.62] CheckMate 067 (NI vs N) EXPLORATORY, 2015 3.04 [0.61; 15.17] CheckMate 069 (all population), 2015 0.24 [0.02; 2.68] CheckMate 238, 2017 0.50 [0.09; 2.74] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 2.06 [0.07; 62.55] IMMUNED (NI vs P ; all population), 2020 1.87 [0.06; 56.97] KEYNOTE 054 (all population), 2018 1.97 [0.07; 58.99] MDX010 Ipi plus gp100 vs gp100, 2010 1.39 [0.06; 31.06] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 1.38 [0.06; 30.82] MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17] 1.58[0.79; 3.16]A3671009, 2013, Ascierto (ipi 10 vs 3 mg/kg), 2017, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE 054 (all population), 2018, MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010, MDX010 Ipi vs gp100, 2010140%6,910lowlow Alopecia TRAE (grade 3-4)detailed resultsCheckMate 066, 2015 1.00 [0.02; 50.40] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41] KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69] KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] 0.95[0.24; 3.81]CheckMate 066, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 201580%2,501moderatenot evaluable Anaemia TRAE (grade 3-4)detailed resultsCheckMate 066, 2015 1.00 [0.02; 50.40] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 2.06 [0.07; 62.55] IMMUNED (NI vs P ; all population), 2020 1.87 [0.06; 56.97] KEYNOTE-002 (10 mg/kg), 2015 0.05 [0.00; 0.88] KEYNOTE-002 (2 mg/kg), 2015 0.10 [0.01; 0.81] KEYNOTE-006 (2 week), 2015 1.85 [0.17; 20.50] KEYNOTE-006 (3 week), 2015 0.46 [0.02; 13.80] 0.45[0.15; 1.30]CheckMate 066, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 201584%2,501moderatenot evaluable Arthralgia TRAE (grade 3-4)detailed resultsCheckMate 066, 2015 1.00 [0.02; 50.40] CheckMate 067 (N vs I ; all population), 2015 1.99 [0.07; 59.55] CheckMate 067 (NI vs I ; all population), 2015 3.99 [0.18; 88.92] CheckMate 067 (NI vs N) EXPLORATORY, 2015 2.01 [0.18; 22.24] CheckMate 069 (all population), 2015 0.49 [0.01; 24.92] CheckMate 238, 2017 0.50 [0.05; 5.53] IMMUNED (N vs P ; all population), 2020 3.74 [0.16; 84.94] IMMUNED (NI vs N) EXPLORATORY, 2020 0.25 [0.01; 5.62] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] IMspire-150 (BRAF mutant), 2020 1.44 [0.48; 4.34] KEYNOTE 054 (all population), 2018 5.95 [0.30; 119.02] KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.06; 15.39] KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.06; 15.48] KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] 1.32[0.68; 2.56]CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, IMspire-150 (BRAF mutant), 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015150%6,942lowlow Asthenia TRAE (grade 3-4)detailed resultsCheckMate 066, 2015 0.50 [0.02; 14.88] CheckMate 067 (N vs I ; all population), 2015 0.50 [0.04; 5.49] CheckMate 067 (NI vs I ; all population), 2015 0.50 [0.04; 5.49] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1.00 [0.06; 16.06] CheckMate 069 (all population), 2015 0.49 [0.01; 24.92] CheckMate 238, 2017 0.25 [0.03; 2.24] IMspire-150 (BRAF mutant), 2020 2.47 [0.45; 13.60] KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.06; 15.39] KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.06; 15.48] KEYNOTE-006 (2 week), 2015 0.46 [0.04; 5.09] KEYNOTE-006 (3 week), 2015 0.23 [0.01; 5.12] 0.69[0.32; 1.49]CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015110%5,607lowlow Blood and lymphatic system disorders TRAE (grade 3-4)detailed resultsIMMUNED (N vs P ; all population), 2020 5.72 [0.28; 116.99] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 1.87 [0.06; 56.97] 2.58[0.36; 18.33]IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 202030%324lownot evaluable Blood creatinine increased TRAE (grade 3-4)detailed resultsIMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] IMspire-150 (BRAF mutant), 2020 0.61 [0.02; 18.27] 0.78[0.09; 6.72]IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs P ; all population), 2020, IMspire-150 (BRAF mutant), 202030%724lownot evaluable Chills TRAE (grade 3-4)detailed resultsCheckMate 069 (all population), 2015 0.49 [0.01; 24.92] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] 0.84[0.17; 4.19]CheckMate 069 (all population), 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 201560%1,531lownot evaluable Chorioretinopathy TRAE (grade 3-4)detailed resultsIMspire-150 (BRAF mutant), 2020 0.61 [0.02; 18.27] 0.61[0.02; 18.27]IMspire-150 (BRAF mutant), 202010%511NAnot evaluable Colitis TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 2.16 [0.96; 4.84] CA184-024, 2011 10.35 [0.56; 190.49] CheckMate 067 (N vs I ; all population), 2015 0.12 [0.03; 0.39] CheckMate 067 (NI vs I ; all population), 2015 1.08 [0.61; 1.93] CheckMate 067 (NI vs N) EXPLORATORY, 2015 9.36 [2.80; 31.26] CheckMate 069 (all population), 2015 2.94 [0.81; 10.66] EORTC 18071, 2015 39.14 [5.34; 286.74] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 6.40 [0.31; 130.93] IMMUNED (NI vs P ; all population), 2020 5.83 [0.28; 119.27] KEYNOTE 054 (all population), 2018 10.04 [1.28; 78.73] KEYNOTE-002 (10 mg/kg), 2015 2.90 [0.30; 28.13] KEYNOTE-002 (2 mg/kg), 2015 0.48 [0.02; 14.37] KEYNOTE-006 (2 week), 2015 0.19 [0.06; 0.58] KEYNOTE-006 (3 week), 2015 0.34 [0.14; 0.83] MDX010 Ipi plus gp100 vs gp100, 2010 8.58 [0.50; 146.20] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 0.58 [0.22; 1.50] MDX010 Ipi vs gp100, 2010 14.85 [0.83; 264.38] 1.90[0.91; 3.97]Ascierto (ipi 10 vs 3 mg/kg), 2017, CA184-024, 2011, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, EORTC 18071, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015, MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010, MDX010 Ipi vs gp100, 20101878%8,570lowlow Constipation TRAE (grade 3-4)detailed resultsCheckMate 066, 2015 1.00 [0.02; 50.40] CheckMate 069 (all population), 2015 0.98 [0.03; 29.71] KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41] KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69] KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] 0.96[0.20; 4.56]CheckMate 066, 2015, CheckMate 069 (all population), 2015, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 201560%2,317moderatenot evaluable Cough TRAE (grade 3-4)detailed resultsCheckMate 066, 2015 1.00 [0.02; 50.40] CheckMate 067 (N vs I ; all population), 2015 3.99 [0.18; 88.92] CheckMate 067 (NI vs I ; all population), 2015 0.99 [0.02; 50.24] CheckMate 067 (NI vs N) EXPLORATORY, 2015 0.25 [0.01; 5.54] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] 0.97[0.28; 3.31]CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 201590%3,676lownot evaluable Decreased appetite TRAE (grade 3-4)detailed resultsCheckMate 066, 2015 1.00 [0.02; 50.40] CheckMate 067 (N vs I ; all population), 2015 0.50 [0.02; 14.84] CheckMate 067 (NI vs I ; all population), 2015 4.01 [0.45; 36.11] CheckMate 067 (NI vs N) EXPLORATORY, 2015 8.09 [0.43; 153.69] CheckMate 069 (all population), 2015 0.49 [0.01; 24.92] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] IMspire-150 (BRAF mutant), 2020 0.30 [0.01; 6.77] KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41] KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69] KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] 1.28[0.49; 3.33]CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015130%5,026lowcritical Diabetes TRAE (grade 3-4)detailed resultsCheckMate 238, 2017 2.01 [0.07; 59.97] IMMUNED (N vs P ; all population), 2020 1.84 [0.06; 55.93] IMMUNED (NI vs N) EXPLORATORY, 2020 0.50 [0.02; 15.35] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] KEYNOTE 054 (all population), 2018 9.95 [0.54; 182.62] KEYNOTE-006 (3 week), 2015 1.85 [0.06; 55.43] 2.03[0.51; 8.05]CheckMate 238, 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-006 (3 week), 201560%2,773lowserious Diarrhoea TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 1.84 [1.05; 3.21] CA184-024, 2011 21.14 [1.23; 363.94] CheckMate 066, 2015 2.00 [0.18; 22.23] CheckMate 067 (N vs I ; all population), 2015 0.48 [0.21; 1.09] CheckMate 067 (NI vs I ; all population), 2015 1.66 [0.90; 3.06] CheckMate 067 (NI vs N) EXPLORATORY, 2015 3.45 [1.60; 7.41] CheckMate 069 (all population), 2015 0.98 [0.31; 3.04] CheckMate 238, 2017 0.15 [0.07; 0.34] EORTC 18071, 2015 25.54 [6.16; 105.87] IMMUNED (N vs P ; all population), 2020 1.84 [0.06; 55.93] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.06; 16.70] IMMUNED (NI vs P ; all population), 2020 1.87 [0.06; 56.97] IMspire-150 (BRAF mutant), 2020 0.53 [0.16; 1.76] KEYNOTE 054 (all population), 2018 1.32 [0.29; 5.92] KEYNOTE-002 (10 mg/kg), 2015 1.28 [0.28; 5.81] KEYNOTE-002 (2 mg/kg), 2015 0.16 [0.01; 3.17] KEYNOTE-006 (2 week), 2015 0.92 [0.32; 2.66] KEYNOTE-006 (3 week), 2015 0.39 [0.10; 1.52] MDX010 Ipi plus gp100 vs gp100, 2010 5.01 [0.65; 38.48] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 0.80 [0.30; 2.12] MDX010 Ipi vs gp100, 2010 6.29 [0.75; 52.98] 1.31[0.77; 2.23]Ascierto (ipi 10 vs 3 mg/kg), 2017, CA184-024, 2011, CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, EORTC 18071, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, IMspire-150 (BRAF mutant), 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015, MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010, MDX010 Ipi vs gp100, 20102173%10,397lowlow Dizziness TRAE (grade 3-4)detailed resultsIMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] 0.95[0.10; 9.23]IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 202030%324lownot evaluable Dry skin TRAE (grade 3-4)detailed resultsCheckMate 066, 2015 1.00 [0.02; 50.40] CheckMate 067 (N vs I ; all population), 2015 0.99 [0.02; 50.24] CheckMate 067 (NI vs I ; all population), 2015 1.37 [0.62; 3.04] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1.00 [0.02; 50.56] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] IMspire-150 (BRAF mutant), 2020 4.92 [0.22; 109.67] KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41] KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69] KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] 1.32[0.68; 2.53]CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015120%4,886lowlow Dysgeusia TRAE (grade 3-4)detailed resultsIMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] 0.95[0.10; 9.23]IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 202030%324lownot evaluable Dyspepsia TRAE (grade 3-4)detailed resultsIMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] 0.95[0.10; 9.23]IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 202030%324lownot evaluable Dyspnoea TRAE (grade 3-4)detailed resultsCheckMate 067 (N vs I ; all population), 2015 1.99 [0.07; 59.55] CheckMate 067 (NI vs I ; all population), 2015 6.01 [0.30; 120.48] CheckMate 067 (NI vs N) EXPLORATORY, 2015 3.02 [0.31; 29.19] CheckMate 069 (all population), 2015 3.00 [0.15; 61.17] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] KEYNOTE 054 (all population), 2018 1.97 [0.07; 58.99] KEYNOTE-006 (2 week), 2015 0.46 [0.02; 13.75] KEYNOTE-006 (3 week), 2015 0.92 [0.06; 14.85] 1.76[0.65; 4.80]CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015100%4,416lowlow Ear and labyrinth disorders TRAE (grade 3-4)detailed resultsIMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] 0.97[0.06; 15.73]IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 202020%217lownot evaluable Endocrine disorders TRAE (grade 3-4) detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 2.30 [0.99; 5.36] CheckMate 069 (all population), 2015 1.24 [0.23; 6.63] EORTC 18071, 2015 42.70 [5.84; 312.15] IMMUNED (N vs P ; all population), 2020 1.84 [0.06; 55.93] IMMUNED (NI vs N) EXPLORATORY, 2020 5.50 [0.62; 48.70] IMMUNED (NI vs P ; all population), 2020 10.10 [0.54; 189.78] KEYNOTE 054 (all population), 2018 18.05 [1.04; 312.27] MDX010 Ipi plus gp100 vs gp100, 2010 2.80 [0.15; 53.28] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 0.27 [0.07; 1.01] MDX010 Ipi vs gp100, 2010 10.44 [0.56; 193.00] 3.45[1.24; 9.62]Ascierto (ipi 10 vs 3 mg/kg), 2017, CheckMate 069 (all population), 2015, EORTC 18071, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE 054 (all population), 2018, MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010, MDX010 Ipi vs gp100, 20101062%4,432lowlow Erythema TRAE (grade 3-4)detailed resultsIMspire-150 (BRAF mutant), 2020 7.41 [0.37; 148.78] 7.41[0.37; 148.78]IMspire-150 (BRAF mutant), 202010%511NAnot evaluable Eye disorders TRAE (grade 3-4)detailed resultsA3671009, 2013 0.98 [0.02; 49.62] Ascierto (ipi 10 vs 3 mg/kg), 2017 0.50 [0.02; 14.85] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 2.06 [0.07; 62.55] IMMUNED (NI vs P ; all population), 2020 1.87 [0.06; 56.97] 1.13[0.23; 5.64]A3671009, 2013, Ascierto (ipi 10 vs 3 mg/kg), 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 202050%1,694lownot evaluable Fatigue TRAE (grade 3-4)detailed resultsCheckMate 066, 2015 0.25 [0.01; 5.51] CheckMate 067 (N vs I ; all population), 2015 0.99 [0.20; 4.96] CheckMate 067 (NI vs I ; all population), 2015 4.45 [1.26; 15.77] CheckMate 067 (NI vs N) EXPLORATORY, 2015 4.48 [1.26; 15.87] CheckMate 069 (all population), 2015 5.11 [0.27; 95.65] CheckMate 238, 2017 0.50 [0.09; 2.74] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] IMspire-150 (BRAF mutant), 2020 3.70 [0.38; 35.82] KEYNOTE-002 (10 mg/kg), 2015 0.23 [0.05; 1.10] KEYNOTE-002 (2 mg/kg), 2015 0.23 [0.05; 1.11] KEYNOTE-006 (2 week), 2015 0.30 [0.03; 2.95] KEYNOTE-006 (3 week), 2015 0.92 [0.18; 4.62] 1.01[0.50; 2.04]CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 20151442%5,931lowlow Febrile neutropenia TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 3.99 [0.18; 88.89] 3.99[0.18; 88.89]Ascierto (ipi 10 vs 3 mg/kg), 201710%726NAnot evaluable Gastritis TRAE (grade 3-4)detailed resultsIMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 4.19 [0.18; 95.03] IMMUNED (NI vs P ; all population), 2020 3.81 [0.17; 86.56] 2.81[0.41; 19.25]IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 202030%324lownot evaluable Gastrointestinal disorders TRAE (grade 3-4) detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 1.82 [1.14; 2.91] CheckMate 069 (all population), 2015 2.22 [0.77; 6.34] CheckMate 238, 2017 0.10 [0.05; 0.20] EORTC 18071, 2015 22.61 [8.20; 62.34] IMMUNED (N vs P ; all population), 2020 1.84 [0.06; 55.93] IMMUNED (NI vs N) EXPLORATORY, 2020 9.36 [1.13; 77.61] IMMUNED (NI vs P ; all population), 2020 17.19 [0.96; 307.68] KEYNOTE 054 (all population), 2018 5.01 [1.09; 22.98] MDX010 Ipi plus gp100 vs gp100, 2010 8.05 [1.07; 60.32] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 0.74 [0.34; 1.61] MDX010 Ipi vs gp100, 2010 10.83 [1.37; 85.84] 3.03[1.01; 9.08]Ascierto (ipi 10 vs 3 mg/kg), 2017, CheckMate 069 (all population), 2015, CheckMate 238, 2017, EORTC 18071, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE 054 (all population), 2018, MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010, MDX010 Ipi vs gp100, 20101190%5,337lowlow General disorders and administration site conditions TRAE (grade 3-4)detailed resultsIMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 4.19 [0.18; 95.03] IMMUNED (NI vs P ; all population), 2020 3.81 [0.17; 86.56] 2.81[0.41; 19.25]IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 202030%324lownot evaluable Guillain-Barré syndrome TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 3.99 [0.18; 88.89] 3.99[0.18; 88.89]Ascierto (ipi 10 vs 3 mg/kg), 201710%726NAnot evaluable Headache TRAE (grade 3-4)detailed resultsCheckMate 066, 2015 1.00 [0.02; 50.40] CheckMate 067 (N vs I ; all population), 2015 0.50 [0.02; 14.84] CheckMate 067 (NI vs I ; all population), 2015 1.99 [0.18; 22.10] CheckMate 067 (NI vs N) EXPLORATORY, 2015 4.02 [0.18; 89.49] CheckMate 069 (all population), 2015 1.98 [0.09; 44.77] CheckMate 238, 2017 0.14 [0.02; 1.15] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] 0.84[0.32; 2.19]CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015110%4,721lowlow Hepatitis TRAE (grade 3-4)detailed resultsA3671009, 2013 3.94 [0.18; 87.81] Ascierto (ipi 10 vs 3 mg/kg), 2017 2.51 [0.48; 13.01] CA184-024, 2011 6.16 [0.31; 123.62] CheckMate 067 (N vs I ; all population), 2015 0.99 [0.02; 50.24] CheckMate 067 (NI vs I ; all population), 2015 10.08 [0.55; 185.32] CheckMate 067 (NI vs N) EXPLORATORY, 2015 10.15 [0.55; 186.51] CheckMate 069 (all population), 2015 3.00 [0.15; 61.17] IMMUNED (N vs P ; all population), 2020 3.74 [0.16; 84.94] IMMUNED (NI vs N) EXPLORATORY, 2020 3.31 [0.64; 17.15] IMMUNED (NI vs P ; all population), 2020 12.37 [0.67; 227.41] KEYNOTE 054 (all population), 2018 6.99 [0.86; 56.99] KEYNOTE-002 (10 mg/kg), 2015 3.85 [0.17; 86.06] KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69] KEYNOTE-006 (2 week), 2015 2.78 [0.29; 26.92] KEYNOTE-006 (3 week), 2015 4.69 [0.54; 40.40] MDX010 Ipi plus gp100 vs gp100, 2010 0.69 [0.02; 20.81] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 0.69 [0.02; 20.65] MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17] 3.47[1.87; 6.43]A3671009, 2013, Ascierto (ipi 10 vs 3 mg/kg), 2017, CA184-024, 2011, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015, MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010, MDX010 Ipi vs gp100, 2010180%8,269lowlow Hepatobiliary disorders TRAE (grade 3-4) detailed resultsCheckMate 069 (all population), 2015 15.93 [0.93; 273.74] CheckMate 238, 2017 0.15 [0.07; 0.32] EORTC 18071, 2015 57.44 [7.90; 417.44] IMMUNED (N vs P ; all population), 2020 3.74 [0.16; 84.94] IMMUNED (NI vs N) EXPLORATORY, 2020 7.53 [1.60; 35.49] IMMUNED (NI vs P ; all population), 2020 28.19 [1.62; 491.24] MDX010 Ipi plus gp100 vs gp100, 2010 0.46 [0.10; 2.07] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 2.78 [0.15; 52.88] MDX010 Ipi vs gp100, 2010 0.16 [0.01; 3.32] 2.83[0.51; 15.67]CheckMate 069 (all population), 2015, CheckMate 238, 2017, EORTC 18071, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010, MDX010 Ipi vs gp100, 2010986%3,600lowserious Hypersensitivity TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 6.01 [0.30; 120.38] CheckMate 066, 2015 1.00 [0.02; 50.40] CheckMate 238, 2017 2.01 [0.07; 59.97] 2.68[0.38; 18.88]Ascierto (ipi 10 vs 3 mg/kg), 2017, CheckMate 066, 2015, CheckMate 238, 201730%2,042lownot evaluable Hypertension TRAE (grade 3-4)detailed resultsIMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] 0.95[0.10; 9.23]IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 202030%324lownot evaluable Hyperthyroidism TRAE (grade 3-4)detailed resultsCA184-024, 2011 1.02 [0.02; 51.42] CheckMate 066, 2015 2.00 [0.07; 59.80] CheckMate 067 (N vs I ; all population), 2015 0.99 [0.02; 50.24] CheckMate 067 (NI vs I ; all population), 2015 6.01 [0.30; 120.48] CheckMate 067 (NI vs N) EXPLORATORY, 2015 6.05 [0.30; 121.25] CheckMate 069 (all population), 2015 0.49 [0.01; 24.92] CheckMate 238, 2017 1.00 [0.06; 16.07] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 6.40 [0.31; 130.93] IMMUNED (NI vs P ; all population), 2020 5.83 [0.28; 119.27] IMspire-150 (BRAF mutant), 2020 4.92 [0.22; 109.67] KEYNOTE 054 (all population), 2018 1.97 [0.07; 58.99] KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41] KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69] KEYNOTE-006 (2 week), 2015 0.46 [0.02; 13.75] KEYNOTE-006 (3 week), 2015 0.46 [0.02; 13.80] 1.88[0.81; 4.36]CA184-024, 2011, CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, IMspire-150 (BRAF mutant), 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015160%7,440lowcritical Hypophysitis TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 1.43 [0.54; 3.81] CheckMate 067 (N vs I ; all population), 2015 0.20 [0.02; 1.69] CheckMate 067 (NI vs I ; all population), 2015 0.99 [0.28; 3.47] CheckMate 067 (NI vs N) EXPLORATORY, 2015 5.06 [0.59; 43.61] CheckMate 069 (all population), 2015 0.48 [0.07; 3.51] CheckMate 238, 2017 0.18 [0.04; 0.81] EORTC 18071, 2015 44.19 [2.67; 732.31] IMMUNED (N vs P ; all population), 2020 1.84 [0.06; 55.93] IMMUNED (NI vs N) EXPLORATORY, 2020 0.50 [0.02; 15.35] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] KEYNOTE 054 (all population), 2018 5.95 [0.30; 119.02] KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41] KEYNOTE-002 (2 mg/kg), 2015 1.93 [0.06; 57.80] KEYNOTE-006 (2 week), 2015 0.23 [0.01; 5.10] KEYNOTE-006 (3 week), 2015 0.46 [0.04; 5.11] MDX010 Ipi plus gp100 vs gp100, 2010 1.39 [0.06; 31.06] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 0.34 [0.05; 2.45] MDX010 Ipi vs gp100, 2010 4.08 [0.18; 91.29] 0.96[0.52; 1.76]Ascierto (ipi 10 vs 3 mg/kg), 2017, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, EORTC 18071, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015, MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010, MDX010 Ipi vs gp100, 20101824%8,977lowlow Hypothyroidism TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 1.99 [0.07; 59.56] CA184-024, 2011 1.02 [0.02; 51.42] CheckMate 066, 2015 1.00 [0.02; 50.40] CheckMate 067 (N vs I ; all population), 2015 0.99 [0.02; 50.24] CheckMate 067 (NI vs I ; all population), 2015 1.99 [0.07; 59.55] CheckMate 067 (NI vs N) EXPLORATORY, 2015 2.00 [0.07; 59.93] CheckMate 069 (all population), 2015 0.49 [0.01; 24.92] CheckMate 238, 2017 0.50 [0.05; 5.53] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] KEYNOTE 054 (all population), 2018 0.99 [0.02; 49.80] KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41] KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69] KEYNOTE-006 (2 week), 2015 1.84 [0.06; 55.23] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] MDX010 Ipi plus gp100 vs gp100, 2010 0.69 [0.02; 20.81] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 0.69 [0.02; 20.65] MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17] 0.99[0.43; 2.25]Ascierto (ipi 10 vs 3 mg/kg), 2017, CA184-024, 2011, CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015, MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010, MDX010 Ipi vs gp100, 2010190%8,941lowlow Increase AST TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 8.11 [1.01; 65.20] CA184-024, 2011 52.70 [7.19; 385.99] CheckMate 066, 2015 1.00 [0.06; 16.02] CheckMate 067 (N vs I ; all population), 2015 1.50 [0.25; 9.01] CheckMate 067 (NI vs I ; all population), 2015 9.98 [2.31; 43.24] CheckMate 067 (NI vs N) EXPLORATORY, 2015 6.68 [1.96; 22.80] CheckMate 069 (all population), 2015 7.32 [0.41; 131.94] CheckMate 238, 2017 0.10 [0.02; 0.44] IMMUNED (N vs P ; all population), 2020 5.72 [0.28; 116.99] IMMUNED (NI vs N) EXPLORATORY, 2020 3.01 [0.75; 12.00] IMMUNED (NI vs P ; all population), 2020 17.19 [0.96; 307.68] KEYNOTE-006 (2 week), 2015 0.23 [0.01; 5.10] KEYNOTE-006 (3 week), 2015 0.46 [0.04; 5.11] MDX010 Ipi plus gp100 vs gp100, 2010 0.17 [0.02; 1.91] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 0.69 [0.02; 20.65] MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17] 2.22[0.86; 5.74]Ascierto (ipi 10 vs 3 mg/kg), 2017, CA184-024, 2011, CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015, MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010, MDX010 Ipi vs gp100, 20101668%7,231lowlow Increased ALT TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 6.14 [1.36; 27.62] CA184-024, 2011 32.40 [7.79; 134.72] CheckMate 066, 2015 2.00 [0.18; 22.23] CheckMate 067 (N vs I ; all population), 2015 0.79 [0.21; 2.98] CheckMate 067 (NI vs I ; all population), 2015 5.78 [2.20; 15.21] CheckMate 067 (NI vs N) EXPLORATORY, 2015 7.29 [2.52; 21.10] CheckMate 069 (all population), 2015 10.83 [0.62; 189.76] CheckMate 238, 2017 0.18 [0.07; 0.48] IMMUNED (N vs P ; all population), 2020 5.72 [0.28; 116.99] IMMUNED (NI vs N) EXPLORATORY, 2020 5.47 [1.46; 20.45] IMMUNED (NI vs P ; all population), 2020 31.26 [1.80; 542.70] KEYNOTE-006 (2 week), 2015 0.23 [0.01; 5.10] KEYNOTE-006 (3 week), 2015 0.46 [0.04; 5.11] MDX010 Ipi plus gp100 vs gp100, 2010 1.39 [0.06; 31.06] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 1.38 [0.06; 30.82] MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17] 2.78[1.13; 6.89]Ascierto (ipi 10 vs 3 mg/kg), 2017, CA184-024, 2011, CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015, MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010, MDX010 Ipi vs gp100, 20101676%7,231lowlow Increased lipase level TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 1.99 [0.07; 59.56] CheckMate 067 (N vs I ; all population), 2015 1.17 [0.53; 2.56] CheckMate 067 (NI vs I ; all population), 2015 3.04 [1.54; 5.98] CheckMate 067 (NI vs N) EXPLORATORY, 2015 2.60 [1.37; 4.95] CheckMate 069 (all population), 2015 4.19 [0.51; 34.53] IMMUNED (N vs P ; all population), 2020 0.91 [0.17; 4.70] IMMUNED (NI vs N) EXPLORATORY, 2020 3.01 [0.75; 12.00] IMMUNED (NI vs P ; all population), 2020 2.72 [0.68; 10.90] IMspire-150 (BRAF mutant), 2020 0.99 [0.64; 1.52] 1.82[1.19; 2.78]Ascierto (ipi 10 vs 3 mg/kg), 2017, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, IMspire-150 (BRAF mutant), 2020942%3,575lownot evaluable Infusion-related reactions TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 3.99 [0.18; 88.89] CheckMate 066, 2015 1.00 [0.02; 50.40] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] 1.45[0.27; 7.62]Ascierto (ipi 10 vs 3 mg/kg), 2017, CheckMate 066, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 202050%1,461lowserious Leucopenia TRAE (grade 3-4)detailed resultsCheckMate 066, 2015 0.12 [0.01; 2.33] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] KEYNOTE-002 (10 mg/kg), 2015 0.07 [0.00; 1.17] KEYNOTE-002 (2 mg/kg), 2015 0.07 [0.00; 1.17] 0.19[0.05; 0.74]CheckMate 066, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 201560%1,434lowserious Maculopapular rash TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 1.99 [0.07; 59.56] CheckMate 066, 2015 2.00 [0.07; 59.80] CheckMate 067 (N vs I ; all population), 2015 1.99 [0.18; 22.10] CheckMate 067 (NI vs I ; all population), 2015 6.06 [0.73; 50.62] CheckMate 067 (NI vs N) EXPLORATORY, 2015 3.04 [0.61; 15.17] CheckMate 069 (all population), 2015 3.00 [0.15; 61.17] CheckMate 238, 2017 0.05 [0.00; 0.95] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 2.06 [0.07; 62.55] IMMUNED (NI vs P ; all population), 2020 1.87 [0.06; 56.97] IMspire-150 (BRAF mutant), 2020 1.36 [0.78; 2.37] KEYNOTE-002 (10 mg/kg), 2015 1.92 [0.06; 57.48] KEYNOTE-002 (2 mg/kg), 2015 1.93 [0.06; 57.80] KEYNOTE-006 (2 week), 2015 0.46 [0.02; 13.75] KEYNOTE-006 (3 week), 2015 0.92 [0.06; 14.85] 1.48[0.95; 2.30]Ascierto (ipi 10 vs 3 mg/kg), 2017, CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015150%6,657lowlow Metabolism and nutrition disorders TRAE (grade 3-4)detailed resultsIMMUNED (N vs P ; all population), 2020 1.84 [0.06; 55.93] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.06; 16.70] IMMUNED (NI vs P ; all population), 2020 1.87 [0.06; 56.97] 1.44[0.23; 8.93]IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 202030%324lownot evaluable Musculoskeletal and connective tissue disorders TRAE (grade 3-4)detailed resultsIMMUNED (N vs P ; all population), 2020 5.72 [0.28; 116.99] IMMUNED (NI vs N) EXPLORATORY, 2020 0.16 [0.01; 3.31] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] 0.95[0.11; 8.51]IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020325%324lownot evaluable Myalgia TRAE (grade 3-4)detailed resultsCheckMate 066, 2015 1.00 [0.02; 50.40] CheckMate 067 (N vs I ; all population), 2015 1.99 [0.07; 59.55] CheckMate 067 (NI vs I ; all population), 2015 1.99 [0.07; 59.55] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1.00 [0.06; 16.06] CheckMate 069 (all population), 2015 0.49 [0.01; 24.92] IMMUNED (N vs P ; all population), 2020 1.84 [0.06; 55.93] IMMUNED (NI vs N) EXPLORATORY, 2020 0.50 [0.02; 15.35] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] IMspire-150 (BRAF mutant), 2020 2.46 [0.22; 27.26] KEYNOTE-002 (10 mg/kg), 2015 0.48 [0.02; 14.29] KEYNOTE-002 (2 mg/kg), 2015 1.93 [0.17; 21.50] KEYNOTE-006 (2 week), 2015 0.92 [0.06; 14.80] KEYNOTE-006 (3 week), 2015 0.46 [0.02; 13.80] 1.15[0.48; 2.76]CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015130%5,026lowcritical Myocarditis TRAE (grade 3-4)detailed resultsKEYNOTE 054 (all population), 2018 1.97 [0.07; 58.99] 1.97[0.07; 58.99]KEYNOTE 054 (all population), 201810%1,011NAnot evaluable Myositis TRAE (grade 3-4)detailed resultsIMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] KEYNOTE 054 (all population), 2018 0.99 [0.02; 49.80] KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] 0.95[0.19; 4.71]IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 201560%2,402lownot evaluable Nausea TRAE (grade 3-4)detailed resultsCheckMate 066, 2015 1.00 [0.02; 50.40] CheckMate 067 (N vs I ; all population), 2015 0.25 [0.01; 5.50] CheckMate 067 (NI vs I ; all population), 2015 3.53 [0.73; 17.15] CheckMate 067 (NI vs N) EXPLORATORY, 2015 14.30 [0.81; 253.04] CheckMate 069 (all population), 2015 0.48 [0.03; 7.91] CheckMate 238, 2017 2.01 [0.07; 59.97] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] IMspire-150 (BRAF mutant), 2020 0.17 [0.02; 1.40] KEYNOTE 054 (all population), 2018 0.99 [0.02; 49.80] KEYNOTE-002 (10 mg/kg), 2015 0.23 [0.03; 2.12] KEYNOTE-002 (2 mg/kg), 2015 0.12 [0.01; 2.24] KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] 0.84[0.40; 1.76]CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, IMspire-150 (BRAF mutant), 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015150%6,942lowlow Nephritis TRAE (grade 3-4)detailed resultsKEYNOTE 054 (all population), 2018 3.96 [0.18; 87.96] KEYNOTE-006 (2 week), 2015 0.46 [0.02; 13.75] KEYNOTE-006 (3 week), 2015 0.46 [0.02; 13.80] 1.03[0.15; 6.90]KEYNOTE 054 (all population), 2018, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 201530%2,078moderatenot evaluable Nervous system disorders TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 8.03 [0.42; 152.51] EORTC 18071, 2015 18.45 [1.07; 319.15] IMMUNED (N vs P ; all population), 2020 3.74 [0.16; 84.94] IMMUNED (NI vs N) EXPLORATORY, 2020 0.50 [0.04; 5.68] IMMUNED (NI vs P ; all population), 2020 1.87 [0.06; 56.97] 3.11[0.83; 11.67]Ascierto (ipi 10 vs 3 mg/kg), 2017, EORTC 18071, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 202054%1,995lownot evaluable Neutropenia TRAE (grade 3-4)detailed resultsCheckMate 066, 2015 0.05 [0.00; 0.92] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] KEYNOTE-002 (10 mg/kg), 2015 0.08 [0.00; 1.39] KEYNOTE-002 (2 mg/kg), 2015 0.08 [0.00; 1.40] KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] 0.23[0.07; 0.79]CheckMate 066, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 201580%2,501moderateserious Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4)detailed resultsIMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] 0.95[0.10; 9.23]IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 202030%324lownot evaluable Pancreatitis TRAE (grade 3-4)detailed resultsA3671009, 2013 5.93 [0.30; 118.96] Ascierto (ipi 10 vs 3 mg/kg), 2017 1.99 [0.07; 59.56] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] KEYNOTE 054 (all population), 2018 0.99 [0.06; 15.81] KEYNOTE-002 (10 mg/kg), 2015 1.92 [0.06; 57.48] KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69] 1.56[0.46; 5.29]A3671009, 2013, Ascierto (ipi 10 vs 3 mg/kg), 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 201580%3,404lownot evaluable Pancytopenia TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 1.99 [0.07; 59.56] CheckMate 066, 2015 0.16 [0.01; 3.29] 0.50[0.04; 5.71]Ascierto (ipi 10 vs 3 mg/kg), 2017, CheckMate 066, 2015214%1,137lownot evaluable Paraesthesia TRAE (grade 3-4)detailed resultsCheckMate 066, 2015 1.00 [0.02; 50.40] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41] KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69] KEYNOTE-006 (2 week), 2015 0.46 [0.02; 13.75] KEYNOTE-006 (3 week), 2015 0.46 [0.02; 13.80] 0.77[0.20; 2.91]CheckMate 066, 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 201580%2,501moderateserious Pericarditis TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 1.99 [0.07; 59.56] 1.99[0.07; 59.56]Ascierto (ipi 10 vs 3 mg/kg), 201710%726NAnot evaluable Peripheral neuropathy TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 3.99 [0.18; 88.89] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 2.06 [0.07; 62.55] IMMUNED (NI vs P ; all population), 2020 1.87 [0.06; 56.97] KEYNOTE-002 (10 mg/kg), 2015 0.24 [0.01; 5.29] KEYNOTE-002 (2 mg/kg), 2015 0.24 [0.01; 5.32] 0.92[0.24; 3.56]Ascierto (ipi 10 vs 3 mg/kg), 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 201560%1,749lownot evaluable Peripheral oedema TRAE (grade 3-4)detailed resultsIMspire-150 (BRAF mutant), 2020 1.22 [0.02; 61.84] 1.22[0.02; 61.84]IMspire-150 (BRAF mutant), 202010%511NAnot evaluable Pneumonitis TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 8.03 [0.42; 152.51] CheckMate 067 (N vs I ; all population), 2015 0.99 [0.06; 15.96] CheckMate 067 (NI vs I ; all population), 2015 3.00 [0.31; 29.00] CheckMate 067 (NI vs N) EXPLORATORY, 2015 3.02 [0.31; 29.19] CheckMate 069 (all population), 2015 0.98 [0.09; 11.08] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] IMspire-150 (BRAF mutant), 2020 4.92 [0.22; 109.67] KEYNOTE 054 (all population), 2018 7.94 [0.42; 150.67] KEYNOTE-002 (10 mg/kg), 2015 5.81 [0.29; 116.90] KEYNOTE-002 (2 mg/kg), 2015 1.93 [0.06; 57.80] KEYNOTE-006 (2 week), 2015 0.46 [0.02; 13.75] KEYNOTE-006 (3 week), 2015 0.92 [0.06; 14.85] 2.13[0.97; 4.66]Ascierto (ipi 10 vs 3 mg/kg), 2017, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, IMspire-150 (BRAF mutant), 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015140%6,352lowlow Polymyalgia Rheumatica TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 0.50 [0.02; 14.85] 0.50[0.02; 14.85]Ascierto (ipi 10 vs 3 mg/kg), 201710%726NAnot evaluable Pruritic rash TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 0.50 [0.02; 14.85] CheckMate 067 (N vs I ; all population), 2015 0.99 [0.02; 50.24] CheckMate 067 (NI vs I ; all population), 2015 0.99 [0.02; 50.24] CheckMate 067 (NI vs N) EXPLORATORY, 2015 1.00 [0.02; 50.56] CheckMate 069 (all population), 2015 0.49 [0.01; 24.92] KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] 0.78[0.18; 3.32]Ascierto (ipi 10 vs 3 mg/kg), 2017, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 201570%3,807lownot evaluable Pruritus TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 0.99 [0.14; 7.10] CA184-024, 2011 10.35 [0.56; 190.49] CheckMate 066, 2015 2.00 [0.07; 59.80] CheckMate 067 (N vs I ; all population), 2015 0.99 [0.06; 15.96] CheckMate 067 (NI vs I ; all population), 2015 6.06 [0.73; 50.62] CheckMate 067 (NI vs N) EXPLORATORY, 2015 6.10 [0.73; 50.95] CheckMate 069 (all population), 2015 0.98 [0.03; 29.71] CheckMate 238, 2017 0.10 [0.01; 1.82] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 1.02 [0.02; 52.25] IMMUNED (NI vs P ; all population), 2020 0.93 [0.02; 47.58] IMspire-150 (BRAF mutant), 2020 2.46 [0.22; 27.26] KEYNOTE 054 (all population), 2018 0.99 [0.02; 49.80] KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41] KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69] KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] MDX010 Ipi plus gp100 vs gp100, 2010 0.69 [0.02; 20.81] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 0.69 [0.02; 20.65] MDX010 Ipi vs gp100, 2010 1.01 [0.02; 51.17] 1.53[0.78; 3.02]Ascierto (ipi 10 vs 3 mg/kg), 2017, CA184-024, 2011, CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, IMspire-150 (BRAF mutant), 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015, MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010, MDX010 Ipi vs gp100, 2010200%9,452lowcritical Pyrexia TRAE (grade 3-4)detailed resultsCheckMate 066, 2015 0.50 [0.02; 14.88] CheckMate 067 (N vs I ; all population), 2015 0.50 [0.02; 14.84] CheckMate 067 (NI vs I ; all population), 2015 1.99 [0.18; 22.10] CheckMate 067 (NI vs N) EXPLORATORY, 2015 4.02 [0.18; 89.49] CheckMate 069 (all population), 2015 3.00 [0.15; 61.17] CheckMate 238, 2017 0.25 [0.01; 5.55] IMMUNED (N vs P ; all population), 2020 0.91 [0.02; 46.72] IMMUNED (NI vs N) EXPLORATORY, 2020 4.19 [0.18; 95.03] IMMUNED (NI vs P ; all population), 2020 3.81 [0.17; 86.56] IMspire-150 (BRAF mutant), 2020 1.22 [0.24; 6.13] KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] 1.38[0.60; 3.16]CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, IMMUNED (N vs P ; all population), 2020, IMMUNED (NI vs N) EXPLORATORY, 2020, IMMUNED (NI vs P ; all population), 2020, IMspire-150 (BRAF mutant), 2020, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015120%5,232lowlow Rash TRAE (grade 3-4)detailed resultsAscierto (ipi 10 vs 3 mg/kg), 2017 2.51 [0.48; 13.01] CA184-024, 2011 6.16 [0.31; 123.62] CheckMate 066, 2015 2.00 [0.07; 59.80] CheckMate 067 (N vs I ; all population), 2015 0.20 [0.02; 1.69] CheckMate 067 (NI vs I ; all population), 2015 2.02 [0.68; 5.98] CheckMate 067 (NI vs N) EXPLORATORY, 2015 10.30 [1.31; 80.93] CheckMate 069 (all population), 2015 5.11 [0.27; 95.65] CheckMate 238, 2017 0.35 [0.13; 0.98] EORTC 18071, 2015 10.16 [0.55; 186.52] IMspire-150 (BRAF mutant), 2020 0.98 [0.53; 1.81] KEYNOTE 054 (all population), 2018 1.97 [0.07; 58.99] KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41] KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69] KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58] KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74] MDX010 Ipi plus gp100 vs gp100, 2010 3.51 [0.19; 64.62] MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010 1.73 [0.20; 14.97] MDX010 Ipi vs gp100, 2010 2.02 [0.07; 60.83] 1.33[0.82; 2.17]Ascierto (ipi 10 vs 3 mg/kg), 2017, CA184-024, 2011, CheckMate 066, 2015, CheckMate 067 (N vs I ; all population), 2015, CheckMate 067 (NI vs I ; all population), 2015, CheckMate 067 (NI vs N) EXPLORATORY, 2015, CheckMate 069 (all population), 2015, CheckMate 238, 2017, EORTC 18071, 2015, IMspire-150 (BRAF mutant), 2020, KEYNOTE 054 (all population), 2018, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015, MDX010 Ipi plus gp100 vs gp100, 2010, MDX010 Ipi plus gp100 vs Ipi (EXPLORATORY), 2010, MDX010 Ipi vs gp100, 20101813%10,073lowlow Renal and urinary disorders TRAE (grade 3-4) detailed resultsCheckMate 069 (all population), 2015 0.98 [0.03; 29.71] CheckMate 238, 2017 1.00 [0.02; 50.62] 0.99[0.08; 12.98]CheckMate 069 (all population), 2015, CheckMate 238, 201720%1,045lownot evaluable0.010.01.0relative treatment effectwww.metaEvidence.org2024-06-08 00:56 +02:00

TE: relative treatment effect (measured by a risk ratio, an odds ratio or an hazard ratio depending on what is reported in the papers); k: number of studies; n: total number of patients; ROB: risk of bias (ROB 2.0); Pub. bias: publication bias; OBS: observational studies; RCT: randomized clinical trials
studied treatment is better when TE > 1; studied treatment is better when TE < 1;

pathologies: 283,284,70,235,285,68,127,128,286,69,129 - treatments: 204,504,850,329,558,579,549,868,502,741,556,812,813,367,851,361,602,1070,671,865,744,696,1083,1281,1282,1283,1082,866,852,417,603,1051,876,853,1018,661,673,1049,1440,854,374,1073,953,672,1080,862,855,360,719,721,720,842,642,674,1085,863,503,847,982,359,575,577,576,869,1081,981,875,505,952,1021,1079,767,1071,1074,873,561,644,1251,1044,724,874,1043,1041,1042,940,1258,746,745,856,634,861,416,864,769,980,369,743

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