| 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) | 0.65 [0.53, 0.80] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | crucial | - |
| deaths (OS) (extension) | 0.83 [0.67, 1.03] | | < 1 | | 0% | 1 study (1/-) | 95.5 % | NA | not evaluable | | important | - |
| PFS (extension) | 0.79 [0.65, 0.97] | | < 1 | | 0% | 1 study (1/-) | 98.9 % | NA | not evaluable | | important | - |
| progression or deaths (PFS) | 0.74 [0.60, 0.92] | | < 1 | | 0% | 1 study (1/-) | 99.7 % | NA | not evaluable | | important | - |
| RFS/DFS | 0.40 [0.20, 0.79] | | < 1 | | 0% | 1 study (1/-) | 99.6 % | NA | not evaluable | | important | - |
| objective responses (ORR) | 1.76 [1.28, 2.41] | | > 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
| objective responses (ORR) (extension) | 5.96 [4.16, 8.54] | | > 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | 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) | 3.76 [2.07, 6.82] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| TRAE (grade 3-4) | 5.05 [3.67, 6.95] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| TRAE leading to death (grade 5) | 1.01 [0.06, 16.25] | | < 1 | | 0% | 2 studies (2/-) | 49.7 % | low | not evaluable | high | non important | - |
| TRAE leading to discontinuation (any grade) | 6.60 [2.96, 14.68] | | < 1 | | 61% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| TRAE leading to discontinuation (grade 3-4) | 6.58 [3.16, 13.70] | | < 1 | | 46% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
TRAE (grade 3-4) endpoints 00 |
| Abdominal pain TRAE (grade 3-4) | 1.50 [0.11, 19.66] | | < 1 | | 0% | 2 studies (2/-) | 38.0 % | 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) | 2.83 [0.66, 12.13] | | < 1 | | 0% | 2 studies (2/-) | 8.1 % | 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) | 0.90 [0.12, 6.61] | | < 1 | | 8% | 2 studies (2/-) | 54.0 % | low | not evaluable | high | non important | - |
| Asthenia TRAE (grade 3-4) | 1.00 [0.06, 16.06] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | 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) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Colitis TRAE (grade 3-4) | 8.88 [2.90, 27.22] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| Cough TRAE (grade 3-4) | 0.43 [0.04, 4.88] | | < 1 | | 0% | 2 studies (2/-) | 75.2 % | low | not evaluable | high | non important | - |
| Decreased appetite TRAE (grade 3-4) | 3.85 [0.36, 40.67] | | < 1 | | 0% | 2 studies (2/-) | 13.3 % | 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) | 3.17 [1.51, 6.63] | | < 1 | | 0% | 2 studies (2/-) | 0.1 % | 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) | 1.01 [0.06, 16.25] | | < 1 | | 0% | 2 studies (2/-) | 49.7 % | 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) | 2.30 [0.32, 16.44] | | < 1 | | 0% | 2 studies (2/-) | 20.4 % | 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) | 5.50 [0.62, 48.70] | | < 1 | | 0% | 1 study (1/-) | 6.4 % | NA | not evaluable | | 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) | 3.90 [1.17, 13.00] | | < 1 | | 0% | 2 studies (2/-) | 1.4 % | 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) | 9.36 [1.13, 77.61] | | < 1 | | 0% | 1 study (1/-) | 2.0 % | NA | not evaluable | | 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) | 2.38 [0.21, 27.18] | | < 1 | | 0% | 2 studies (2/-) | 24.5 % | low | not evaluable | high | non important | - |
| Hepatitis TRAE (grade 3-4) | 4.34 [1.03, 18.18] | | < 1 | | 0% | 2 studies (2/-) | 2.3 % | low | not evaluable | high | non important | - |
| Hepatobiliary disorders TRAE (grade 3-4) | 7.53 [1.60, 35.49] | | < 1 | | 0% | 1 study (1/-) | 0.5 % | NA | not evaluable | | 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) | 6.22 [0.74, 52.20] | | < 1 | | 0% | 2 studies (2/-) | 4.7 % | low | not evaluable | high | non important | - |
| Hypophysitis TRAE (grade 3-4) | 2.38 [0.28, 19.85] | | < 1 | | 20% | 2 studies (2/-) | 21.3 % | low | not evaluable | high | non important | - |
| Hypothyroidism TRAE (grade 3-4) | 1.50 [0.11, 19.66] | | < 1 | | 0% | 2 studies (2/-) | 38.0 % | low | not evaluable | high | non important | - |
| Increase AST TRAE (grade 3-4) | 4.70 [1.88, 11.77] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| Increased ALT TRAE (grade 3-4) | 6.51 [2.85, 14.89] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| Increased lipase level TRAE (grade 3-4) | 2.67 [1.49, 4.79] | | < 1 | | 0% | 2 studies (2/-) | 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) | 2.83 [0.66, 12.13] | | < 1 | | 0% | 2 studies (2/-) | 8.1 % | 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) | 0.76 [0.09, 6.57] | | < 1 | | 0% | 2 studies (2/-) | 59.7 % | 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) | 5.45 [0.45, 65.95] | | < 1 | | 11% | 2 studies (2/-) | 9.3 % | 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) | 2.30 [0.32, 16.44] | | < 1 | | 0% | 2 studies (2/-) | 20.4 % | low | not evaluable | high | non important | - |
| Pruritic rash TRAE (grade 3-4) | 1.00 [0.02, 50.56] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
| Pruritus TRAE (grade 3-4) | 4.08 [0.63, 26.40] | | < 1 | | 0% | 2 studies (2/-) | 7.1 % | low | not evaluable | high | non important | - |
| Pyrexia TRAE (grade 3-4) | 4.10 [0.45, 37.05] | | < 1 | | 0% | 2 studies (2/-) | 10.6 % | low | not evaluable | high | non important | - |
| Rash TRAE (grade 3-4) | 10.30 [1.31, 80.93] | | < 1 | | 0% | 1 study (1/-) | 1.4 % | NA | not evaluable | | non important | - |
| Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) | 1.02 [0.02, 52.25] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | 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) | 3.17 [0.32, 31.48] | | < 1 | | 0% | 1 study (1/-) | 16.4 % | NA | not evaluable | | 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) | 1.50 [0.11, 19.66] | | < 1 | | 0% | 2 studies (2/-) | 38.0 % | 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) | 0.68 [0.05, 8.87] | | < 1 | | 0% | 2 studies (2/-) | 61.6 % | low | not evaluable | high | non important | - |
| Vomiting TRAE (grade 3-4) | 4.64 [0.73, 29.59] | | < 1 | | 0% | 2 studies (2/-) | 5.3 % | low | not evaluable | high | non important | - |
| Weight decreased TRAE (grade 3-4) | 1.01 [0.06, 16.25] | | < 1 | | 0% | 2 studies (2/-) | 49.7 % | low | not evaluable | high | non important | - |
