| 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 | 0.40 [0.20, 0.79] | | < 1 | | 0% | 1 study (1/-) | 99.6 % | NA | not evaluable | | 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) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| AE leading to treatment discontinuation (any grade) | 11.33 [4.34, 29.62] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
| AE leading to treatment discontinuation (grade 3-4) | 11.38 [3.94, 32.84] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
| SAE (any grade) | 3.69 [1.68, 8.08] | | < 1 | | 0% | 1 study (1/-) | 0.1 % | NA | not evaluable | | non important | - |
| SAE (grade 3-4) | 3.48 [1.58, 7.66] | | < 1 | | 0% | 1 study (1/-) | 0.1 % | NA | not evaluable | | non important | - |
| STRAE (any grade) | 5.69 [2.43, 13.31] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
| STRAE (grade 3-4) | 4.68 [1.93, 11.38] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
| TRAE (any grade) | 3.01 [1.67, 5.43] | | < 1 | | 39% | 4 studies (4/-) | 0.0 % | low | not evaluable | high | non important | - |
| TRAE (grade 3-4) | 4.37 [3.50, 5.46] | | < 1 | | 0% | 4 studies (4/-) | 0.0 % | low | not evaluable | high | non important | - |
| TRAE leading to death (grade 5) | 1.00 [0.10, 9.70] | | < 1 | | 0% | 3 studies (3/-) | 49.9 % | low | not evaluable | high | non important | - |
| TRAE leading to discontinuation (any grade) | 4.79 [3.49, 6.58] | | < 1 | | 25% | 4 studies (4/-) | 0.0 % | low | not evaluable | high | non important | - |
| TRAE leading to discontinuation (grade 3-4) | 4.49 [2.64, 7.66] | | < 1 | | 64% | 4 studies (4/-) | 0.0 % | low | not evaluable | high | non important | - |
TRAE (grade 3-4) endpoints 00 |
| Abdominal pain TRAE (grade 3-4) | 0.64 [0.13, 3.06] | | < 1 | | 0% | 4 studies (4/-) | 71.1 % | low | not evaluable | high | non important | - |
| Acute kidney injury TRAE (grade 3-4) | 2.06 [0.07, 62.55] | | < 1 | | 0% | 1 study (1/-) | 34.2 % | NA | not evaluable | | non important | - |
| Adrenal insufficiency TRAE (grade 3-4) | 1.97 [0.52, 7.51] | | < 1 | | 30% | 4 studies (4/-) | 16.1 % | low | not evaluable | high | non important | - |
| Alopecia TRAE (grade 3-4) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Anaemia TRAE (grade 3-4) | 2.06 [0.07, 62.55] | | < 1 | | 0% | 1 study (1/-) | 34.2 % | NA | not evaluable | | non important | - |
| Arthralgia TRAE (grade 3-4) | 1.18 [0.26, 5.31] | | < 1 | | 0% | 4 studies (4/-) | 41.4 % | 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) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Chills TRAE (grade 3-4) | 0.70 [0.04, 11.39] | | < 1 | | 0% | 2 studies (2/-) | 59.7 % | low | not evaluable | high | non important | - |
| Colitis TRAE (grade 3-4) | 3.12 [0.93, 10.46] | | < 1 | | 74% | 4 studies (4/-) | 3.3 % | 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) | 0.54 [0.07, 4.28] | | < 1 | | 0% | 3 studies (3/-) | 71.9 % | low | not evaluable | high | non important | - |
| Decreased appetite TRAE (grade 3-4) | 2.92 [0.66, 12.93] | | < 1 | | 0% | 4 studies (4/-) | 8.0 % | low | not evaluable | high | non important | - |
| Diabetes TRAE (grade 3-4) | 0.50 [0.02, 15.35] | | < 1 | | 0% | 1 study (1/-) | 65.1 % | NA | not evaluable | | non important | - |
| Diarrhoea TRAE (grade 3-4) | 1.89 [1.09, 3.27] | | < 1 | | 25% | 4 studies (4/-) | 1.2 % | low | not evaluable | high | non important | - |
| Dizziness TRAE (grade 3-4) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Dry skin TRAE (grade 3-4) | 1.00 [0.10, 9.70] | | < 1 | | 0% | 3 studies (3/-) | 49.9 % | low | not evaluable | high | non important | - |
| Dysgeusia TRAE (grade 3-4) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Dyspepsia TRAE (grade 3-4) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Dyspnoea TRAE (grade 3-4) | 3.06 [0.72, 12.94] | | < 1 | | 0% | 4 studies (4/-) | 6.5 % | low | not evaluable | high | non important | - |
| Ear and labyrinth disorders TRAE (grade 3-4) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Endocrine disorders TRAE (grade 3-4) | 2.20 [0.53, 9.16] | | < 1 | | 12% | 2 studies (2/-) | 13.9 % | low | not evaluable | high | non important | - |
| Eye disorders TRAE (grade 3-4) | 2.06 [0.07, 62.55] | | < 1 | | 0% | 1 study (1/-) | 34.2 % | NA | not evaluable | | non important | - |
| Fatigue TRAE (grade 3-4) | 4.22 [1.83, 9.74] | | < 1 | | 0% | 4 studies (4/-) | 0.0 % | low | not evaluable | high | non important | - |
| Gastritis TRAE (grade 3-4) | 4.19 [0.18, 95.03] | | < 1 | | 0% | 1 study (1/-) | 18.7 % | NA | not evaluable | | non important | - |
| Gastrointestinal disorders TRAE (grade 3-4) | 3.36 [0.93, 12.09] | | < 1 | | 30% | 2 studies (2/-) | 3.2 % | low | not evaluable | high | non important | - |
| General disorders and administration site conditions TRAE (grade 3-4) | 4.19 [0.18, 95.03] | | < 1 | | 0% | 1 study (1/-) | 18.7 % | NA | not evaluable | | non important | - |
| Headache TRAE (grade 3-4) | 2.13 [0.47, 9.54] | | < 1 | | 0% | 4 studies (4/-) | 16.3 % | low | not evaluable | high | non important | - |
| Hepatitis TRAE (grade 3-4) | 4.71 [1.44, 15.37] | | < 1 | | 0% | 4 studies (4/-) | 0.5 % | low | not evaluable | high | non important | - |
| Hepatobiliary disorders TRAE (grade 3-4) | 8.94 [2.29, 34.87] | | < 1 | | 0% | 2 studies (2/-) | 0.1 % | low | not evaluable | high | non important | - |
| Hypertension TRAE (grade 3-4) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Hyperthyroidism TRAE (grade 3-4) | 4.07 [0.83, 19.91] | | < 1 | | 0% | 4 studies (4/-) | 4.2 % | low | not evaluable | high | non important | - |
| Hypophysitis TRAE (grade 3-4) | 1.09 [0.44, 2.72] | | < 1 | | 0% | 4 studies (4/-) | 42.8 % | low | not evaluable | high | non important | - |
| Hypothyroidism TRAE (grade 3-4) | 1.28 [0.21, 7.89] | | < 1 | | 0% | 4 studies (4/-) | 39.6 % | low | not evaluable | high | non important | - |
| Increase AST TRAE (grade 3-4) | 5.90 [2.78, 12.52] | | < 1 | | 0% | 4 studies (4/-) | 0.0 % | low | not evaluable | high | non important | - |
| Increased ALT TRAE (grade 3-4) | 6.35 [3.44, 11.74] | | < 1 | | 0% | 4 studies (4/-) | 0.0 % | low | not evaluable | high | non important | - |
| Increased lipase level TRAE (grade 3-4) | 2.87 [1.86, 4.42] | | < 1 | | 0% | 4 studies (4/-) | 0.0 % | low | not evaluable | high | non important | - |
| Infusion-related reactions TRAE (grade 3-4) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Leucopenia TRAE (grade 3-4) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Maculopapular rash TRAE (grade 3-4) | 3.52 [1.15, 10.73] | | < 1 | | 0% | 4 studies (4/-) | 1.4 % | low | not evaluable | high | non important | - |
| Metabolism and nutrition disorders TRAE (grade 3-4) | 1.02 [0.06, 16.70] | | < 1 | | 0% | 1 study (1/-) | 49.5 % | NA | not evaluable | | non important | - |
| Musculoskeletal and connective tissue disorders TRAE (grade 3-4) | 0.16 [0.01, 3.31] | | < 1 | | 0% | 1 study (1/-) | 87.9 % | NA | not evaluable | | non important | - |
| Myalgia TRAE (grade 3-4) | 0.88 [0.17, 4.61] | | < 1 | | 0% | 4 studies (4/-) | 55.8 % | low | not evaluable | high | non important | - |
| Myositis TRAE (grade 3-4) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Nausea TRAE (grade 3-4) | 2.78 [0.83, 9.38] | | < 1 | | 3% | 4 studies (4/-) | 5.0 % | low | not evaluable | high | non important | - |
| Nervous system disorders TRAE (grade 3-4) | 0.50 [0.04, 5.68] | | < 1 | | 0% | 1 study (1/-) | 71.0 % | NA | not evaluable | | non important | - |
| Neutropenia TRAE (grade 3-4) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Pancreatitis TRAE (grade 3-4) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Paraesthesia TRAE (grade 3-4) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Peripheral neuropathy TRAE (grade 3-4) | 2.06 [0.07, 62.55] | | < 1 | | 0% | 1 study (1/-) | 34.2 % | NA | not evaluable | | non important | - |
| Pneumonitis TRAE (grade 3-4) | 1.98 [0.56, 7.03] | | < 1 | | 0% | 4 studies (4/-) | 14.6 % | 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) | 3.85 [1.05, 14.07] | | < 1 | | 0% | 4 studies (4/-) | 2.1 % | low | not evaluable | high | non important | - |
| Pyrexia TRAE (grade 3-4) | 2.96 [0.71, 12.38] | | < 1 | | 0% | 4 studies (4/-) | 6.9 % | low | not evaluable | 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) | 1.35 [0.19, 9.77] | | < 1 | | 0% | 2 studies (2/-) | 38.4 % | low | not evaluable | high | non important | - |
| Sarcoidosis TRAE (grade 3-4) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Skin and subcutaneous tissue disorders TRAE (grade 3-4) | 4.89 [0.81, 29.38] | | < 1 | | 0% | 2 studies (2/-) | 4.2 % | low | not evaluable | high | non important | - |
| Stomatitis TRAE (grade 3-4) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Thrombocytopenia TRAE (grade 3-4) | 2.06 [0.07, 62.55] | | < 1 | | 0% | 1 study (1/-) | 34.2 % | NA | not evaluable | | non important | - |
| Thyroiditis TRAE (grade 3-4) | 1.66 [0.21, 12.94] | | < 1 | | 0% | 3 studies (3/-) | 31.4 % | low | not evaluable | high | non important | - |
| Uveitis TRAE (grade 3-4) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Vitiligo TRAE (grade 3-4) | 0.69 [0.10, 4.53] | | < 1 | | 0% | 4 studies (4/-) | 65.2 % | low | not evaluable | high | non important | - |
| Vomiting TRAE (grade 3-4) | 4.36 [1.20, 15.79] | | < 1 | | 0% | 4 studies (4/-) | 1.3 % | low | not evaluable | high | non important | - |
| Weight decreased TRAE (grade 3-4) | 0.76 [0.09, 6.53] | | < 1 | | 0% | 3 studies (3/-) | 59.9 % | low | not evaluable | high | non important | - |
