All patients
Age < 65y (younger) Age > 65y BRAF mutant BRAF wild type ECOG 0 ECOG 1 Gender, female Gender, male LDH > ULN LDH ≤ULN PD-L1 < 1% PD-L1 > 1% stage IIIa stage IIIb stage IIIc
Top evidence (RCT only, high risk of bias excluded)
Best available evidence (possibly low or very low)
All RCTs
All studies (RCT+OBS)
metastatic/adv melanoma (mML), pembrolizumab alone vs. all, meta-analysis of study results Outcome TE 95% CI n k I2 ROB Pub. bias deaths (OS)detailed results IMspire-170, 2020 (REV) 0.94 [0.62; 1.44]
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]
0.75 [0.66 ; 0.85 ] IMspire-170, 2020 (REV), KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 5 3% 2,277 moderate not evaluable deaths (OS) (extension)detailed results KEYNOTE-006 (2 week), 2015 0.68 [0.53; 0.87]
KEYNOTE-006 (3 week), 2015 0.68 [0.53; 0.87]
0.68 [0.57 ; 0.81 ] KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 2 0% 1,112 moderate not evaluable MFSdetailed results KEYNOTE 054 (all population), 2018 0.53 [0.37; 0.76]
0.53 [0.37 ; 0.76 ] KEYNOTE 054 (all population), 2018 1 0% 1,019 NA not evaluable PFS (extension)detailed results KEYNOTE-006 (2 week), 2015 0.61 [0.50; 0.75]
KEYNOTE-006 (3 week), 2015 0.61 [0.50; 0.75]
0.61 [0.53 ; 0.70 ] KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 2 0% 1,112 moderate not evaluable progression or deaths (PFS)detailed results IMspire-170, 2020 (REV) 0.87 [0.67; 1.14]
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]
0.60 [0.51 ; 0.71 ] IMspire-170, 2020 (REV), KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 5 60% 2,277 moderate not evaluable RFS (extension)detailed results KEYNOTE 054 (all population), 2018 0.59 [0.49; 0.71]
KEYNOTE 054 (PDL1>1%), 2018 0.57 [0.43; 0.75]
0.58 [0.50 ; 0.68 ] KEYNOTE 054 (all population), 2018, KEYNOTE 054 (PDL1>1%), 2018 2 0% 1,872 low not evaluable RFS/DFSdetailed results KEYNOTE 054 (all population), 2018 0.57 [0.43; 0.75]
KEYNOTE 054 (PDL1>1%), 2018 0.54 [0.42; 0.69]
0.55 [0.46 ; 0.66 ] KEYNOTE 054 (all population), 2018, KEYNOTE 054 (PDL1>1%), 2018 2 0% 1,872 low not evaluable DCRdetailed results IMspire-170, 2020 (REV) 1.09 [0.75; 1.59]
1.09 [0.75 ; 1.59 ] IMspire-170, 2020 (REV) 1 0% 446 NA not evaluable DMFSdetailed results KEYNOTE 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%), 2018 2 0% 1,872 low not evaluable objective responses (ORR)detailed results IMspire-170, 2020 (REV) 1.30 [0.85; 1.99]
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]
3.69 [2.00 ; 6.80 ] IMspire-170, 2020 (REV), KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 5 85% 2,277 moderate not evaluable AE (any grade)detailed results IMspire-170, 2020 (REV) 0.07 [0.02; 0.30]
KEYNOTE 054 (all population), 2018 1.51 [0.96; 2.38]
0.35 [0.02 ; 7.12 ] IMspire-170, 2020 (REV), KEYNOTE 054 (all population), 2018 2 94% 1,447 low not evaluable AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 0.25 [0.17; 0.37]
KEYNOTE 054 (all population), 2018 2.03 [1.52; 2.73]
0.71 [0.09 ; 5.61 ] IMspire-170, 2020 (REV), KEYNOTE 054 (all population), 2018 2 99% 1,447 low not evaluable AE leading to death (grade 5)detailed results IMspire-170, 2020 (REV) 0.72 [0.23; 2.31]
0.72 [0.23 ; 2.31 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable STRAE (any grade)detailed results KEYNOTE-006 (2 week), 2015 0.67 [0.41; 1.09]
KEYNOTE-006 (3 week), 2015 0.63 [0.39; 1.03]
0.65 [0.46 ; 0.92 ] KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 2 0% 1,067 moderate not evaluable STRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58]
KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74]
0.92 [0.06 ; 14.79 ] KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 2 0% 1,067 moderate not evaluable TRAE (any grade)detailed results 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]
1.11 [0.73 ; 1.69 ] 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 5 81% 2,777 moderate serious TRAE (grade 3-4)detailed results 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]
0.95 [0.44 ; 2.06 ] 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 5 92% 2,777 moderate not evaluable TRAE leading to death (grade 5)detailed results 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]
1.51 [0.30 ; 7.49 ] 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 5 0% 2,777 moderate serious TRAE leading to discontinuation (any grade)detailed results 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]
1.05 [0.74 ; 1.50 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 4 0% 1,766 moderate not evaluable TRAE leading to discontinuation (grade 3-4)detailed results 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]
1.92 [0.84 ; 4.37 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 4 0% 1,766 moderate not evaluable Abdominal pain TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58]
KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74]
0.92 [0.06 ; 14.79 ] KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 2 0% 1,067 moderate not evaluable Adrenal insufficiency TRAE (grade 3-4)detailed results KEYNOTE 054 (all population), 2018 1.97 [0.07; 58.99]
1.97 [0.07 ; 58.99 ] KEYNOTE 054 (all population), 2018 1 0% 1,011 NA not evaluable Alopecia TRAE (grade 3-4)detailed results 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]
0.94 [0.13 ; 6.69 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 4 0% 1,766 moderate not evaluable Anaemia TRAE (grade 3-4)detailed results 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]
0.25 [0.05 ; 1.30 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 4 36% 1,766 moderate not evaluable Arthralgia TRAE (grade 3-4)detailed results 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]
1.42 [0.35 ; 5.86 ] 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 5 0% 2,777 moderate not evaluable Asthenia TRAE (grade 3-4)detailed results 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]
0.57 [0.15 ; 2.25 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 4 0% 1,766 moderate not evaluable Chills TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58]
KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74]
0.92 [0.06 ; 14.79 ] KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 2 0% 1,067 moderate not evaluable Colitis TRAE (grade 3-4)detailed results 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]
0.81 [0.21 ; 3.18 ] 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 5 71% 2,777 moderate not evaluable Constipation TRAE (grade 3-4)detailed results 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]
0.94 [0.13 ; 6.69 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 4 0% 1,766 moderate not evaluable Cough TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58]
KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74]
0.92 [0.06 ; 14.79 ] KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 2 0% 1,067 moderate not evaluable Decreased appetite TRAE (grade 3-4)detailed results 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]
0.94 [0.13 ; 6.69 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 4 0% 1,766 moderate not evaluable Diabetes TRAE (grade 3-4)detailed results KEYNOTE 054 (all population), 2018 9.95 [0.54; 182.62]
KEYNOTE-006 (3 week), 2015 1.85 [0.06; 55.43]
4.89 [0.54 ; 44.56 ] KEYNOTE 054 (all population), 2018, KEYNOTE-006 (3 week), 2015 2 0% 1,544 low not evaluable Diarrhoea TRAE (grade 3-4)detailed results 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]
0.79 [0.42 ; 1.51 ] 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 5 0% 2,777 moderate not evaluable Dry skin TRAE (grade 3-4)detailed results 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]
0.94 [0.13 ; 6.69 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 4 0% 1,766 moderate not evaluable Dyspnoea TRAE (grade 3-4)detailed results 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]
0.94 [0.15 ; 5.79 ] KEYNOTE 054 (all population), 2018, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 3 0% 2,078 moderate not evaluable Endocrine disorders TRAE (grade 3-4) detailed results KEYNOTE 054 (all population), 2018 18.05 [1.04; 312.27]
18.05 [1.04 ; 312.27 ] KEYNOTE 054 (all population), 2018 1 0% 1,011 NA not evaluable Fatigue TRAE (grade 3-4)detailed results 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]
0.35 [0.15 ; 0.82 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 4 0% 1,766 moderate not evaluable Gastrointestinal disorders TRAE (grade 3-4) detailed results KEYNOTE 054 (all population), 2018 5.01 [1.09; 22.98]
5.01 [1.09 ; 22.98 ] KEYNOTE 054 (all population), 2018 1 0% 1,011 NA not evaluable Headache TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58]
KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74]
0.92 [0.06 ; 14.79 ] KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 2 0% 1,067 moderate not evaluable Hepatitis TRAE (grade 3-4)detailed results 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]
3.97 [1.30 ; 12.10 ] 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 5 0% 2,777 moderate not evaluable Hyperthyroidism TRAE (grade 3-4)detailed results 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]
0.81 [0.16 ; 4.03 ] 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 5 0% 2,777 moderate not evaluable Hypophysitis TRAE (grade 3-4)detailed results 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]
0.94 [0.24 ; 3.66 ] 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 5 0% 2,777 moderate not evaluable Hypothyroidism TRAE (grade 3-4)detailed results 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]
1.13 [0.21 ; 6.16 ] 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 5 0% 2,777 moderate serious Increase AST TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 0.23 [0.01; 5.10]
KEYNOTE-006 (3 week), 2015 0.46 [0.04; 5.11]
0.35 [0.05 ; 2.37 ] KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 2 0% 1,067 moderate not evaluable Increased ALT TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 0.23 [0.01; 5.10]
KEYNOTE-006 (3 week), 2015 0.46 [0.04; 5.11]
0.35 [0.05 ; 2.37 ] KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 2 0% 1,067 moderate not evaluable Leucopenia TRAE (grade 3-4)detailed results KEYNOTE-002 (10 mg/kg), 2015 0.07 [0.00; 1.17]
KEYNOTE-002 (2 mg/kg), 2015 0.07 [0.00; 1.17]
0.07 [0.01 ; 0.50 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 2 0% 699 moderate not evaluable Maculopapular rash TRAE (grade 3-4)detailed results 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]
1.09 [0.22 ; 5.44 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 4 0% 1,766 moderate not evaluable Myalgia TRAE (grade 3-4)detailed results 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]
0.94 [0.22 ; 4.02 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 4 0% 1,766 moderate not evaluable Myocarditis TRAE (grade 3-4)detailed results KEYNOTE 054 (all population), 2018 1.97 [0.07; 58.99]
1.97 [0.07 ; 58.99 ] KEYNOTE 054 (all population), 2018 1 0% 1,011 NA not evaluable Myositis TRAE (grade 3-4)detailed results 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]
0.94 [0.10 ; 9.08 ] KEYNOTE 054 (all population), 2018, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 3 0% 2,078 moderate not evaluable Nausea TRAE (grade 3-4)detailed results 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]
0.34 [0.08 ; 1.37 ] 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 5 0% 2,777 moderate not evaluable Nephritis TRAE (grade 3-4)detailed results KEYNOTE 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), 2015 3 0% 2,078 moderate not evaluable Neutropenia TRAE (grade 3-4)detailed results 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]
0.18 [0.04 ; 0.96 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 4 0% 1,766 moderate not evaluable Pancreatitis TRAE (grade 3-4)detailed results 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]
1.20 [0.18 ; 7.92 ] KEYNOTE 054 (all population), 2018, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 3 0% 1,710 moderate not evaluable Paraesthesia TRAE (grade 3-4)detailed results 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]
0.63 [0.10 ; 3.88 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 4 0% 1,766 moderate not evaluable Peripheral neuropathy TRAE (grade 3-4)detailed results KEYNOTE-002 (10 mg/kg), 2015 0.24 [0.01; 5.29]
KEYNOTE-002 (2 mg/kg), 2015 0.24 [0.01; 5.32]
0.24 [0.03 ; 2.13 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 2 0% 699 moderate not evaluable Pneumonitis TRAE (grade 3-4)detailed results 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]
2.19 [0.55 ; 8.64 ] 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 5 0% 2,777 moderate not evaluable Pruritic rash TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58]
KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74]
0.92 [0.06 ; 14.79 ] KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 2 0% 1,067 moderate not evaluable Pruritus TRAE (grade 3-4)detailed results 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]
0.95 [0.16 ; 5.49 ] 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 5 0% 2,777 moderate not evaluable Pyrexia TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 0.92 [0.02; 46.58]
KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74]
0.92 [0.06 ; 14.79 ] KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 2 0% 1,067 moderate not evaluable Rash TRAE (grade 3-4)detailed results 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]
1.13 [0.21 ; 6.19 ] 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 5 0% 2,777 moderate serious Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) detailed results KEYNOTE 054 (all population), 2018 7.94 [0.42; 150.67]
7.94 [0.42 ; 150.67 ] KEYNOTE 054 (all population), 2018 1 0% 1,011 NA not evaluable Sarcoidosis TRAE (grade 3-4)detailed results KEYNOTE 054 (all population), 2018 0.99 [0.02; 49.80]
0.99 [0.02 ; 49.80 ] KEYNOTE 054 (all population), 2018 1 0% 1,011 NA not evaluable Severe skin reaction TRAE (grade 3-4)detailed results KEYNOTE 054 (all population), 2018 5.95 [0.30; 119.02]
5.95 [0.30 ; 119.02 ] KEYNOTE 054 (all population), 2018 1 0% 1,011 NA not evaluable Skin and subcutaneous tissue disorders TRAE (grade 3-4) detailed results KEYNOTE 054 (all population), 2018 1.97 [0.07; 58.99]
1.97 [0.07 ; 58.99 ] KEYNOTE 054 (all population), 2018 1 0% 1,011 NA not evaluable Thrombocytopenia TRAE (grade 3-4)detailed results KEYNOTE-002 (10 mg/kg), 2015 0.23 [0.03; 2.12]
KEYNOTE-002 (2 mg/kg), 2015 0.12 [0.01; 2.24]
0.18 [0.03 ; 1.07 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 2 0% 699 moderate not evaluable Thyroiditis TRAE (grade 3-4)detailed results KEYNOTE 054 (all population), 2018 0.99 [0.02; 49.80]
0.99 [0.02 ; 49.80 ] KEYNOTE 054 (all population), 2018 1 0% 1,011 NA not evaluable Uveitis TRAE (grade 3-4)detailed results KEYNOTE 054 (all population), 2018 0.99 [0.02; 49.80]
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 0.92 [0.02; 46.58]
KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74]
1.13 [0.21 ; 6.18 ] 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 5 0% 2,777 moderate serious Vitiligo TRAE (grade 3-4)detailed results 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]
0.97 [0.10 ; 9.32 ] KEYNOTE 054 (all population), 2018, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 3 0% 1,710 moderate not evaluable Vomiting TRAE (grade 3-4)detailed results KEYNOTE-002 (10 mg/kg), 2015 0.23 [0.03; 2.12]
KEYNOTE-002 (2 mg/kg), 2015 0.24 [0.03; 2.13]
KEYNOTE-006 (2 week), 2015 1.84 [0.06; 55.23]
KEYNOTE-006 (3 week), 2015 0.92 [0.02; 46.74]
0.38 [0.10 ; 1.43 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 4 0% 1,766 moderate not evaluable Weight decreased TRAE (grade 3-4)detailed results KEYNOTE-006 (2 week), 2015 0.46 [0.02; 13.75]
KEYNOTE-006 (3 week), 2015 0.46 [0.02; 13.80]
0.46 [0.04 ; 5.09 ] KEYNOTE-006 (2 week), 2015, KEYNOTE-006 (3 week), 2015 2 0% 1,067 moderate not evaluable Abdominal pain AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 1.02 [0.14; 7.30]
1.02 [0.14 ; 7.30 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Anaemia AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 0.57 [0.17; 1.99]
0.57 [0.17 ; 1.99 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Arthralgia AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 1.02 [0.02; 51.57]
1.02 [0.02 ; 51.57 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Asthenia AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 0.57 [0.17; 1.99]
0.57 [0.17 ; 1.99 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Constipation AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 1.02 [0.02; 51.57]
1.02 [0.02 ; 51.57 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Decreased appetite AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 0.51 [0.02; 15.23]
0.51 [0.02 ; 15.23 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Dermatitis acneiform AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 0.04 [0.00; 0.75]
0.04 [0.00 ; 0.75 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Diarrhoea AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 0.23 [0.07; 0.68]
0.23 [0.07 ; 0.68 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Fatigue AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 0.61 [0.14; 2.57]
0.61 [0.14 ; 2.57 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Headache AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 0.51 [0.02; 15.23]
0.51 [0.02 ; 15.23 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Hypertension AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 0.57 [0.23; 1.38]
0.57 [0.23 ; 1.38 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Increase AST AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 0.33 [0.07; 1.67]
0.33 [0.07 ; 1.67 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Increased ALT AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 0.50 [0.12; 2.03]
0.50 [0.12 ; 2.03 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Increased Lipase Level AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 0.50 [0.15; 1.69]
0.50 [0.15 ; 1.69 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Nausea AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 0.10 [0.01; 1.84]
0.10 [0.01 ; 1.84 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Peripheral oedema AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 1.02 [0.06; 16.39]
1.02 [0.06 ; 16.39 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Pruritus AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 1.02 [0.02; 51.57]
1.02 [0.02 ; 51.57 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Pyrexia AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 0.17 [0.02; 1.39]
0.17 [0.02 ; 1.39 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Rash AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 0.13 [0.03; 0.57]
0.13 [0.03 ; 0.57 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Rash maculopapular AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 0.13 [0.01; 2.38]
0.13 [0.01 ; 2.38 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Sepsis AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 0.08 [0.00; 1.49]
0.08 [0.00 ; 1.49 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable Vomiting AE (grade 3-4)detailed results IMspire-170, 2020 (REV) 0.40 [0.08; 2.09]
0.40 [0.08 ; 2.09 ] IMspire-170, 2020 (REV) 1 0% 436 NA not evaluable 0.0 20.0 1.0 relative treatment effect www.metaEvidence.org 2024-06-14 21:58 +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
pathologies: 283,284,70,235,285,68,127,128,286,69,129
- treatments: 359,575,577,576,869
