| Outcome |
Relative effect 95%CI |
LoD |
Trt. better when |
|
I2 |
k (RCT/OBS)
|
Bayesian probability
|
Overall ROB
|
Publication bias |
Degree of certainty |
Endpoint importance |
Published MA |
efficacy endpoints 00 |
| deaths (OS) | 0.62 [0.53, 0.73] | | < 1 | | 0% | 3 studies (3/-) | 100.0 % | low | not evaluable | high | crucial | - |
| deaths (OS) (extension) | 0.66 [0.42, 1.04] | | < 1 | | 89% | 2 studies (2/-) | 96.4 % | low | not evaluable | high | important | - |
| PFS (extension) | 0.50 [0.31, 0.83] | | < 1 | | 91% | 3 studies (3/-) | 99.7 % | low | not evaluable | high | important | - |
| progression or deaths (PFS) | 0.51 [0.32, 0.80] | | < 1 | | 83% | 3 studies (3/-) | 99.8 % | low | not evaluable | high | important | - |
| RFS/DFS | 0.30 [0.17, 0.52] | | < 1 | | 23% | 2 studies (2/-) | 100.0 % | low | not evaluable | high | important | - |
| objective responses (ORR) | 5.33 [1.47, 19.35] | | > 1 | | 95% | 3 studies (3/-) | 99.4 % | low | not evaluable | high | non important | - |
| objective responses (ORR) (extension) | 6.41 [4.99, 8.23] | | > 1 | | 0% | 3 studies (3/-) | 100.0 % | low | not evaluable | high | non important | - |
safety endpoints 00 |
| AE leading to death (grade 5) | 0.97 [0.06, 15.73] | | < 1 | | 0% | 2 studies (2/-) | 50.8 % | low | not evaluable | high | non important | - |
| AE leading to treatment discontinuation (any grade) | 18.39 [5.56, 60.77] | | < 1 | | 47% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| AE leading to treatment discontinuation (grade 3-4) | 19.58 [4.47, 85.82] | | < 1 | | 45% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| SAE (any grade) | 4.08 [2.31, 7.19] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| SAE (grade 3-4) | 5.29 [2.15, 13.00] | | < 1 | | 53% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| STRAE (any grade) | 12.43 [2.18, 70.81] | | < 1 | | 76% | 2 studies (2/-) | 0.2 % | low | not evaluable | high | non important | - |
| STRAE (grade 3-4) | 14.97 [0.88, 254.99] | | < 1 | | 74% | 2 studies (2/-) | 3.2 % | low | not evaluable | high | non important | - |
| TRAE (any grade) | 3.82 [1.82, 8.04] | | < 1 | | 62% | 5 studies (5/-) | 0.0 % | low | not evaluable | high | non important | - |
| TRAE (grade 3-4) | 5.53 [3.48, 8.78] | | < 1 | | 68% | 5 studies (5/-) | 0.0 % | low | not evaluable | high | non important | - |
| TRAE leading to death (grade 5) | 0.98 [0.14, 7.02] | | < 1 | | 0% | 4 studies (4/-) | 50.6 % | low | not evaluable | high | non important | - |
| TRAE leading to discontinuation (any grade) | 5.94 [3.54, 9.94] | | < 1 | | 65% | 5 studies (5/-) | 0.0 % | low | serious | high | non important | - |
| TRAE leading to discontinuation (grade 3-4) | 5.35 [2.83, 10.13] | | < 1 | | 71% | 5 studies (5/-) | 0.0 % | low | serious | high | non important | - |
TRAE (grade 3-4) endpoints 00 |
| Abdominal pain TRAE (grade 3-4) | 0.67 [0.16, 2.88] | | < 1 | | 0% | 5 studies (5/-) | 70.3 % | low | not evaluable | high | non important | - |
| Acute kidney injury TRAE (grade 3-4) | 1.96 [0.18, 21.95] | | < 1 | | 0% | 2 studies (2/-) | 29.4 % | low | not evaluable | high | non important | - |
| Adrenal insufficiency TRAE (grade 3-4) | 2.06 [0.70, 6.03] | | < 1 | | 6% | 5 studies (5/-) | 9.5 % | low | not evaluable | high | non important | - |
| Alopecia TRAE (grade 3-4) | 0.97 [0.06, 15.73] | | < 1 | | 0% | 2 studies (2/-) | 50.8 % | low | not evaluable | high | non important | - |
| Anaemia TRAE (grade 3-4) | 1.96 [0.18, 21.95] | | < 1 | | 0% | 2 studies (2/-) | 29.4 % | low | not evaluable | high | non important | - |
| Arthralgia TRAE (grade 3-4) | 1.15 [0.28, 4.66] | | < 1 | | 0% | 5 studies (5/-) | 42.4 % | low | not evaluable | high | non important | - |
| Asthenia TRAE (grade 3-4) | 0.63 [0.12, 3.30] | | < 1 | | 0% | 3 studies (3/-) | 70.6 % | low | not evaluable | high | non important | - |
| Blood and lymphatic system disorders TRAE (grade 3-4) | 1.44 [0.11, 19.02] | | < 1 | | 0% | 2 studies (2/-) | 39.2 % | low | not evaluable | high | non important | - |
| Blood creatinine increased TRAE (grade 3-4) | 0.93 [0.02, 47.58] | | < 1 | | 0% | 1 study (1/-) | 51.5 % | NA | not evaluable | | non important | - |
| Chills TRAE (grade 3-4) | 0.77 [0.08, 7.49] | | < 1 | | 0% | 3 studies (3/-) | 58.8 % | low | not evaluable | high | non important | - |
| Colitis TRAE (grade 3-4) | 3.27 [1.09, 9.81] | | < 1 | | 66% | 5 studies (5/-) | 1.7 % | low | not evaluable | high | non important | - |
| Constipation TRAE (grade 3-4) | 0.98 [0.03, 29.71] | | < 1 | | 0% | 1 study (1/-) | 50.5 % | NA | not evaluable | | non important | - |
| Cough TRAE (grade 3-4) | 0.61 [0.10, 3.79] | | < 1 | | 0% | 4 studies (4/-) | 70.2 % | low | not evaluable | high | non important | - |
| Decreased appetite TRAE (grade 3-4) | 2.53 [0.63, 10.18] | | < 1 | | 0% | 5 studies (5/-) | 9.6 % | low | not evaluable | high | non important | - |
| Diabetes TRAE (grade 3-4) | 0.65 [0.05, 8.65] | | < 1 | | 0% | 2 studies (2/-) | 62.5 % | low | not evaluable | high | non important | - |
| Diarrhoea TRAE (grade 3-4) | 1.92 [1.24, 2.97] | | < 1 | | 1% | 5 studies (5/-) | 0.2 % | low | not evaluable | high | non important | - |
| Dizziness TRAE (grade 3-4) | 0.97 [0.06, 15.73] | | < 1 | | 0% | 2 studies (2/-) | 50.8 % | low | not evaluable | high | non important | - |
| Dry skin TRAE (grade 3-4) | 0.98 [0.14, 7.02] | | < 1 | | 0% | 4 studies (4/-) | 50.6 % | low | not evaluable | high | non important | - |
| Dysgeusia TRAE (grade 3-4) | 0.97 [0.06, 15.73] | | < 1 | | 0% | 2 studies (2/-) | 50.8 % | low | not evaluable | high | non important | - |
| Dyspepsia TRAE (grade 3-4) | 0.97 [0.06, 15.73] | | < 1 | | 0% | 2 studies (2/-) | 50.8 % | low | not evaluable | high | non important | - |
| Dyspnoea TRAE (grade 3-4) | 2.65 [0.68, 10.29] | | < 1 | | 0% | 5 studies (5/-) | 8.0 % | low | not evaluable | high | non important | - |
| Ear and labyrinth disorders TRAE (grade 3-4) | 0.97 [0.06, 15.73] | | < 1 | | 0% | 2 studies (2/-) | 50.8 % | low | not evaluable | high | non important | - |
| Endocrine disorders TRAE (grade 3-4) | 2.81 [0.83, 9.50] | | < 1 | | 1% | 3 studies (3/-) | 4.8 % | low | not evaluable | high | non important | - |
| Eye disorders TRAE (grade 3-4) | 1.96 [0.18, 21.95] | | < 1 | | 0% | 2 studies (2/-) | 29.4 % | low | not evaluable | high | non important | - |
| Fatigue TRAE (grade 3-4) | 3.95 [1.75, 8.96] | | < 1 | | 0% | 5 studies (5/-) | 0.0 % | low | not evaluable | high | non important | - |
| Gastritis TRAE (grade 3-4) | 4.00 [0.44, 36.34] | | < 1 | | 0% | 2 studies (2/-) | 11.1 % | low | not evaluable | high | non important | - |
| Gastrointestinal disorders TRAE (grade 3-4) | 4.34 [1.30, 14.54] | | < 1 | | 27% | 3 studies (3/-) | 0.9 % | low | not evaluable | high | non important | - |
| General disorders and administration site conditions TRAE (grade 3-4) | 4.00 [0.44, 36.34] | | < 1 | | 0% | 2 studies (2/-) | 11.1 % | low | not evaluable | high | non important | - |
| Headache TRAE (grade 3-4) | 1.91 [0.47, 7.78] | | < 1 | | 0% | 5 studies (5/-) | 18.3 % | low | not evaluable | high | non important | - |
| Hepatitis TRAE (grade 3-4) | 5.40 [1.81, 16.16] | | < 1 | | 0% | 5 studies (5/-) | 0.1 % | low | not evaluable | high | non important | - |
| Hepatobiliary disorders TRAE (grade 3-4) | 11.06 [3.24, 37.77] | | < 1 | | 0% | 3 studies (3/-) | 0.0 % | low | not evaluable | high | non important | - |
| Hypertension TRAE (grade 3-4) | 0.97 [0.06, 15.73] | | < 1 | | 0% | 2 studies (2/-) | 50.8 % | low | not evaluable | high | non important | - |
| Hyperthyroidism TRAE (grade 3-4) | 4.40 [1.08, 17.93] | | < 1 | | 0% | 5 studies (5/-) | 2.0 % | low | serious | high | non important | - |
| Hypophysitis TRAE (grade 3-4) | 1.08 [0.44, 2.63] | | < 1 | | 0% | 5 studies (5/-) | 43.3 % | low | not evaluable | high | non important | - |
| Hypothyroidism TRAE (grade 3-4) | 1.21 [0.23, 6.30] | | < 1 | | 0% | 5 studies (5/-) | 41.1 % | low | serious | high | non important | - |
| Increase AST TRAE (grade 3-4) | 6.32 [3.05, 13.07] | | < 1 | | 0% | 5 studies (5/-) | 0.0 % | low | not evaluable | high | non important | - |
| Increased ALT TRAE (grade 3-4) | 6.82 [3.74, 12.43] | | < 1 | | 0% | 5 studies (5/-) | 0.0 % | low | not evaluable | high | non important | - |
| Increased lipase level TRAE (grade 3-4) | 2.85 [1.89, 4.31] | | < 1 | | 0% | 5 studies (5/-) | 0.0 % | low | not evaluable | high | non important | - |
| Infusion-related reactions TRAE (grade 3-4) | 0.97 [0.06, 15.73] | | < 1 | | 0% | 2 studies (2/-) | 50.8 % | low | not evaluable | high | non important | - |
| Leucopenia TRAE (grade 3-4) | 0.97 [0.06, 15.73] | | < 1 | | 0% | 2 studies (2/-) | 50.8 % | low | not evaluable | high | non important | - |
| Maculopapular rash TRAE (grade 3-4) | 3.31 [1.15, 9.56] | | < 1 | | 0% | 5 studies (5/-) | 1.4 % | low | not evaluable | high | non important | - |
| Metabolism and nutrition disorders TRAE (grade 3-4) | 1.30 [0.15, 11.32] | | < 1 | | 0% | 2 studies (2/-) | 40.7 % | low | not evaluable | high | non important | - |
| Musculoskeletal and connective tissue disorders TRAE (grade 3-4) | 0.31 [0.03, 3.39] | | < 1 | | 0% | 2 studies (2/-) | 83.0 % | low | not evaluable | high | non important | - |
| Myalgia TRAE (grade 3-4) | 0.89 [0.19, 4.08] | | < 1 | | 0% | 5 studies (5/-) | 56.0 % | low | not evaluable | high | non important | - |
| Myositis TRAE (grade 3-4) | 0.97 [0.06, 15.73] | | < 1 | | 0% | 2 studies (2/-) | 50.8 % | low | not evaluable | high | non important | - |
| Nausea TRAE (grade 3-4) | 2.56 [0.82, 7.94] | | < 1 | | 0% | 5 studies (5/-) | 5.2 % | low | not evaluable | high | non important | - |
| Nervous system disorders TRAE (grade 3-4) | 0.78 [0.11, 5.64] | | < 1 | | 0% | 2 studies (2/-) | 59.7 % | low | not evaluable | high | non important | - |
| Neutropenia TRAE (grade 3-4) | 0.97 [0.06, 15.73] | | < 1 | | 0% | 2 studies (2/-) | 50.8 % | low | not evaluable | high | non important | - |
| Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) | 0.97 [0.06, 15.73] | | < 1 | | 0% | 2 studies (2/-) | 50.8 % | low | not evaluable | high | non important | - |
| Pancreatitis TRAE (grade 3-4) | 0.97 [0.06, 15.73] | | < 1 | | 0% | 2 studies (2/-) | 50.8 % | low | not evaluable | high | non important | - |
| Paraesthesia TRAE (grade 3-4) | 0.97 [0.06, 15.73] | | < 1 | | 0% | 2 studies (2/-) | 50.8 % | low | not evaluable | high | non important | - |
| Peripheral neuropathy TRAE (grade 3-4) | 1.96 [0.18, 21.95] | | < 1 | | 0% | 2 studies (2/-) | 29.4 % | low | not evaluable | high | non important | - |
| Pneumonitis TRAE (grade 3-4) | 1.84 [0.55, 6.16] | | < 1 | | 0% | 5 studies (5/-) | 16.0 % | low | not evaluable | high | non important | - |
| Pruritic rash TRAE (grade 3-4) | 0.79 [0.08, 7.59] | | < 1 | | 0% | 3 studies (3/-) | 58.2 % | low | not evaluable | high | non important | - |
| Pruritus TRAE (grade 3-4) | 3.35 [0.98, 11.47] | | < 1 | | 0% | 5 studies (5/-) | 2.8 % | low | serious | high | non important | - |
| Pyrexia TRAE (grade 3-4) | 3.10 [0.84, 11.36] | | < 1 | | 0% | 5 studies (5/-) | 4.5 % | low | serious | high | non important | - |
| Rash TRAE (grade 3-4) | 3.05 [1.22, 7.65] | | < 1 | | 1% | 3 studies (3/-) | 0.9 % | low | not evaluable | high | non important | - |
| Renal and urinary disorders TRAE (grade 3-4) | 0.98 [0.03, 29.71] | | < 1 | | 0% | 1 study (1/-) | 50.5 % | NA | not evaluable | | non important | - |
| Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) | 1.25 [0.21, 7.34] | | < 1 | | 0% | 3 studies (3/-) | 40.3 % | low | not evaluable | high | non important | - |
| Sarcoidosis TRAE (grade 3-4) | 0.97 [0.06, 15.73] | | < 1 | | 0% | 2 studies (2/-) | 50.8 % | low | not evaluable | high | non important | - |
| Skin and subcutaneous tissue disorders TRAE (grade 3-4) | 5.12 [1.10, 23.92] | | < 1 | | 0% | 3 studies (3/-) | 1.9 % | low | not evaluable | high | non important | - |
| Stomatitis TRAE (grade 3-4) | 0.97 [0.06, 15.73] | | < 1 | | 0% | 2 studies (2/-) | 50.8 % | low | not evaluable | high | non important | - |
| Thrombocytopenia TRAE (grade 3-4) | 1.96 [0.18, 21.95] | | < 1 | | 0% | 2 studies (2/-) | 29.4 % | low | not evaluable | high | non important | - |
| Thyroiditis TRAE (grade 3-4) | 1.47 [0.24, 9.05] | | < 1 | | 0% | 4 studies (4/-) | 34.0 % | low | not evaluable | high | non important | - |
| Uveitis TRAE (grade 3-4) | 0.97 [0.06, 15.73] | | < 1 | | 0% | 2 studies (2/-) | 50.8 % | low | not evaluable | high | non important | - |
| Vitiligo TRAE (grade 3-4) | 0.73 [0.13, 3.98] | | < 1 | | 0% | 5 studies (5/-) | 64.4 % | low | not evaluable | high | non important | - |
| Vomiting TRAE (grade 3-4) | 3.75 [1.10, 12.76] | | < 1 | | 0% | 5 studies (5/-) | 1.7 % | low | serious | high | non important | - |
| Weight decreased TRAE (grade 3-4) | 0.79 [0.12, 5.25] | | < 1 | | 0% | 4 studies (4/-) | 59.4 % | low | not evaluable | high | non important | - |
