| 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) | 0.72 [0.58, 0.89] | | < 1 | | 0% | 1 study (1/-) | 99.9 % | NA | not evaluable | | crucial | - |
| deaths (OS) (extension) | 0.73 [0.64, 0.83] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
| MFS | 0.66 [0.46, 0.93] | | < 1 | | 67% | 2 studies (2/-) | 99.1 % | low | not evaluable | high | important | - |
| MFS (extension) | 0.76 [0.64, 0.90] | | < 1 | | 0% | 1 study (1/-) | 99.9 % | NA | not evaluable | | important | - |
| RFS (extension) | 0.65 [0.49, 0.87] | | < 1 | | 81% | 2 studies (2/-) | 99.8 % | low | not evaluable | high | important | - |
| RFS/DFS | 0.54 [0.37, 0.77] | | < 1 | | 78% | 4 studies (4/-) | 100.0 % | low | not evaluable | high | important | - |
| DMFS | 0.60 [0.49, 0.73] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
safety endpoints 00 |
| AE (any grade) | 3.23 [0.67, 15.56] | | < 1 | | 90% | 2 studies (2/-) | 7.3 % | low | not evaluable | high | non important | - |
| AE (grade 3-4) | 0.48 [0.03, 8.11] | | < 1 | | 99% | 2 studies (2/-) | 69.1 % | low | not evaluable | high | non important | - |
| AE leading to death (grade 5) | 0.93 [0.06, 15.01] | | < 1 | | 0% | 2 studies (2/-) | 52.1 % | low | not evaluable | high | non important | - |
| AE leading to treatment discontinuation (any grade) | 12.12 [1.15, 128.21] | | < 1 | | 78% | 2 studies (2/-) | 2.0 % | low | not evaluable | high | non important | - |
| AE leading to treatment discontinuation (grade 3-4) | 17.04 [1.57, 184.53] | | < 1 | | 61% | 2 studies (2/-) | 1.0 % | low | not evaluable | high | non important | - |
| SAE (any grade) | 2.40 [0.69, 8.40] | | < 1 | | 79% | 2 studies (2/-) | 8.6 % | low | not evaluable | high | non important | - |
| SAE (grade 3-4) | 4.71 [1.39, 15.99] | | < 1 | | 68% | 2 studies (2/-) | 0.7 % | low | not evaluable | high | non important | - |
| STRAE (any grade) | 14.61 [2.72, 78.57] | | < 1 | | 58% | 2 studies (2/-) | 0.1 % | low | not evaluable | high | non important | - |
| STRAE (grade 3-4) | 42.30 [5.62, 318.55] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| TRAE (any grade) | 8.76 [4.52, 17.01] | | < 1 | | 80% | 4 studies (4/-) | 0.0 % | low | not evaluable | high | non important | - |
| TRAE (grade 3-4) | 17.87 [8.78, 36.39] | | < 1 | | 46% | 4 studies (4/-) | 0.0 % | low | not evaluable | high | non important | - |
| TRAE leading to death (grade 5) | 2.63 [0.47, 14.86] | | < 1 | | 0% | 4 studies (4/-) | 13.8 % | low | not evaluable | high | non important | - |
| TRAE leading to discontinuation (any grade) | 22.32 [9.86, 50.54] | | < 1 | | 23% | 3 studies (3/-) | 0.0 % | low | not evaluable | high | non important | - |
| TRAE leading to discontinuation (grade 3-4) | 34.42 [3.18, 372.75] | | < 1 | | 27% | 2 studies (2/-) | 0.2 % | low | not evaluable | high | non important | - |
TRAE (grade 3-4) endpoints 00 |
| Abdominal pain TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Acute kidney injury TRAE (grade 3-4) | 1.37 [0.10, 18.13] | | < 1 | | 0% | 2 studies (2/-) | 40.6 % | low | not evaluable | high | non important | - |
| Adrenal insufficiency TRAE (grade 3-4) | 1.57 [0.20, 12.24] | | < 1 | | 0% | 3 studies (3/-) | 33.5 % | low | not evaluable | high | non important | - |
| Alopecia TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Anaemia TRAE (grade 3-4) | 1.37 [0.10, 18.13] | | < 1 | | 0% | 2 studies (2/-) | 40.6 % | low | not evaluable | high | non important | - |
| Arthralgia TRAE (grade 3-4) | 3.26 [0.49, 21.69] | | < 1 | | 0% | 3 studies (3/-) | 11.2 % | low | not evaluable | high | non important | - |
| Blood and lymphatic system disorders TRAE (grade 3-4) | 3.50 [0.36, 33.64] | | < 1 | | 0% | 2 studies (2/-) | 14.0 % | low | not evaluable | high | non important | - |
| Blood creatinine increased TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Chills TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Colitis TRAE (grade 3-4) | 11.79 [3.23, 43.04] | | < 1 | | 8% | 4 studies (4/-) | 0.0 % | low | not evaluable | high | non important | - |
| Cough TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Decreased appetite TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Diabetes TRAE (grade 3-4) | 3.28 [0.48, 22.60] | | < 1 | | 0% | 3 studies (3/-) | 11.5 % | low | not evaluable | high | non important | - |
| Diarrhoea TRAE (grade 3-4) | 3.97 [0.63, 25.09] | | < 1 | | 66% | 4 studies (4/-) | 7.2 % | low | not evaluable | high | non important | - |
| Dizziness TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Dry skin TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Dysgeusia TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Dyspepsia TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Dyspnoea TRAE (grade 3-4) | 1.25 [0.14, 10.76] | | < 1 | | 0% | 3 studies (3/-) | 42.0 % | low | not evaluable | high | non important | - |
| Ear and labyrinth disorders TRAE (grade 3-4) | 0.93 [0.02, 47.58] | | < 1 | | 0% | 1 study (1/-) | 51.5 % | NA | not evaluable | | non important | - |
| Endocrine disorders TRAE (grade 3-4) | 16.68 [4.47, 62.16] | | < 1 | | 0% | 4 studies (4/-) | 0.0 % | low | not evaluable | high | non important | - |
| Eye disorders TRAE (grade 3-4) | 1.37 [0.10, 18.13] | | < 1 | | 0% | 2 studies (2/-) | 40.6 % | low | not evaluable | high | non important | - |
| Fatigue TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Gastritis TRAE (grade 3-4) | 2.19 [0.19, 25.33] | | < 1 | | 0% | 2 studies (2/-) | 26.6 % | low | not evaluable | high | non important | - |
| Gastrointestinal disorders TRAE (grade 3-4) | 11.22 [4.04, 31.14] | | < 1 | | 24% | 4 studies (4/-) | 0.0 % | low | not evaluable | high | non important | - |
| General disorders and administration site conditions TRAE (grade 3-4) | 2.19 [0.19, 25.33] | | < 1 | | 0% | 2 studies (2/-) | 26.6 % | low | not evaluable | high | non important | - |
| Headache TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Hepatitis TRAE (grade 3-4) | 7.04 [1.58, 31.38] | | < 1 | | 0% | 3 studies (3/-) | 0.5 % | low | not evaluable | high | non important | - |
| Hepatobiliary disorders TRAE (grade 3-4) | 26.18 [5.91, 115.97] | | < 1 | | 5% | 3 studies (3/-) | 0.0 % | low | not evaluable | high | non important | - |
| Hypertension TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Hyperthyroidism TRAE (grade 3-4) | 2.57 [0.36, 18.21] | | < 1 | | 0% | 3 studies (3/-) | 17.4 % | low | not evaluable | high | non important | - |
| Hypophysitis TRAE (grade 3-4) | 6.32 [1.18, 33.82] | | < 1 | | 8% | 4 studies (4/-) | 1.6 % | low | not evaluable | high | non important | - |
| Hypothyroidism TRAE (grade 3-4) | 0.94 [0.10, 9.11] | | < 1 | | 0% | 3 studies (3/-) | 52.1 % | low | not evaluable | high | non important | - |
| Increase AST TRAE (grade 3-4) | 10.16 [1.26, 81.81] | | < 1 | | 0% | 2 studies (2/-) | 1.5 % | low | not evaluable | high | non important | - |
| Increased ALT TRAE (grade 3-4) | 14.02 [1.76, 111.54] | | < 1 | | 0% | 2 studies (2/-) | 0.7 % | low | not evaluable | high | non important | - |
| Increased lipase level TRAE (grade 3-4) | 1.72 [0.60, 4.99] | | < 1 | | 0% | 2 studies (2/-) | 15.8 % | low | not evaluable | high | non important | - |
| Infusion-related reactions TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Leucopenia TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Maculopapular rash TRAE (grade 3-4) | 1.37 [0.10, 18.13] | | < 1 | | 0% | 2 studies (2/-) | 40.6 % | low | not evaluable | high | non important | - |
| Metabolism and nutrition disorders TRAE (grade 3-4) | 1.85 [0.17, 20.75] | | < 1 | | 0% | 2 studies (2/-) | 31.0 % | low | not evaluable | high | non important | - |
| Musculoskeletal and connective tissue disorders TRAE (grade 3-4) | 2.92 [0.27, 32.01] | | < 1 | | 0% | 2 studies (2/-) | 19.2 % | low | not evaluable | high | non important | - |
| Myalgia TRAE (grade 3-4) | 1.37 [0.10, 18.08] | | < 1 | | 0% | 2 studies (2/-) | 40.7 % | low | not evaluable | high | non important | - |
| Myocarditis TRAE (grade 3-4) | 1.97 [0.07, 58.99] | | < 1 | | 0% | 1 study (1/-) | 34.9 % | NA | not evaluable | | non important | - |
| Myositis TRAE (grade 3-4) | 0.94 [0.10, 9.11] | | < 1 | | 0% | 3 studies (3/-) | 52.1 % | low | not evaluable | high | non important | - |
| Nausea TRAE (grade 3-4) | 0.94 [0.10, 9.11] | | < 1 | | 0% | 3 studies (3/-) | 52.1 % | low | not evaluable | high | non important | - |
| Nephritis TRAE (grade 3-4) | 3.96 [0.18, 87.96] | | < 1 | | 0% | 1 study (1/-) | 19.5 % | NA | not evaluable | | non important | - |
| Nervous system disorders TRAE (grade 3-4) | 5.81 [0.97, 34.87] | | < 1 | | 0% | 3 studies (3/-) | 2.8 % | low | not evaluable | high | non important | - |
| Neutropenia TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Pancreatitis TRAE (grade 3-4) | 0.95 [0.13, 6.79] | | < 1 | | 0% | 3 studies (3/-) | 52.0 % | low | not evaluable | high | non important | - |
| Paraesthesia TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Peripheral neuropathy TRAE (grade 3-4) | 1.37 [0.10, 18.13] | | < 1 | | 0% | 2 studies (2/-) | 40.6 % | low | not evaluable | high | non important | - |
| Pneumonitis TRAE (grade 3-4) | 2.55 [0.34, 19.24] | | < 1 | | 0% | 3 studies (3/-) | 18.4 % | low | not evaluable | high | non important | - |
| Pruritus TRAE (grade 3-4) | 0.94 [0.10, 9.11] | | < 1 | | 0% | 3 studies (3/-) | 52.1 % | low | not evaluable | high | non important | - |
| Pyrexia TRAE (grade 3-4) | 2.19 [0.19, 25.33] | | < 1 | | 0% | 2 studies (2/-) | 26.6 % | low | not evaluable | high | non important | - |
| Rash TRAE (grade 3-4) | 5.08 [0.56, 46.30] | | < 1 | | 0% | 2 studies (2/-) | 7.6 % | low | not evaluable | high | non important | - |
| Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) | 2.55 [0.34, 19.24] | | < 1 | | 0% | 3 studies (3/-) | 18.4 % | low | not evaluable | high | non important | - |
| Sarcoidosis TRAE (grade 3-4) | 0.94 [0.10, 9.11] | | < 1 | | 0% | 3 studies (3/-) | 52.1 % | low | not evaluable | high | non important | - |
| Severe skin reaction TRAE (grade 3-4) | 5.95 [0.30, 119.02] | | < 1 | | 0% | 1 study (1/-) | 12.5 % | NA | not evaluable | | non important | - |
| Skin and subcutaneous tissue disorders TRAE (grade 3-4) | 6.71 [1.40, 32.05] | | < 1 | | 0% | 4 studies (4/-) | 0.9 % | low | not evaluable | high | non important | - |
| Stomatitis TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Thrombocytopenia TRAE (grade 3-4) | 1.37 [0.10, 18.13] | | < 1 | | 0% | 2 studies (2/-) | 40.6 % | low | not evaluable | high | non important | - |
| Thyroiditis TRAE (grade 3-4) | 0.94 [0.10, 9.11] | | < 1 | | 0% | 3 studies (3/-) | 52.1 % | low | not evaluable | high | non important | - |
| Uveitis TRAE (grade 3-4) | 0.94 [0.10, 9.11] | | < 1 | | 0% | 3 studies (3/-) | 52.1 % | low | not evaluable | high | non important | - |
| Vitiligo TRAE (grade 3-4) | 0.94 [0.10, 9.11] | | < 1 | | 0% | 3 studies (3/-) | 52.1 % | low | not evaluable | high | non important | - |
| Vomiting TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
| Weight decreased TRAE (grade 3-4) | 0.92 [0.06, 14.87] | | < 1 | | 0% | 2 studies (2/-) | 52.4 % | low | not evaluable | high | non important | - |
AE (grade 3-4) endpoints 00 |
| Abdominal pain AE (grade 3-4) | 0.04 [0.01, 0.17] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
| Colitis AE (grade 3-4) | 6.26 [2.61, 15.03] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
| Cough AE (grade 3-4) | 0.01 [0.00, 0.15] | | < 1 | | 0% | 1 study (1/-) | 99.9 % | NA | not evaluable | | non important | - |
| Decreased appetite AE (grade 3-4) | 0.06 [0.01, 0.46] | | < 1 | | 0% | 1 study (1/-) | 99.6 % | NA | not evaluable | | non important | - |
| Diarrhoea AE (grade 3-4) | 0.26 [0.18, 0.37] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
| Fatigue AE (grade 3-4) | 0.05 [0.03, 0.10] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
| Headache AE (grade 3-4) | 0.04 [0.01, 0.11] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
| Hypophysitis AE (grade 3-4) | 11.01 [2.57, 47.24] | | < 1 | | 0% | 1 study (1/-) | 0.1 % | NA | not evaluable | | non important | - |
| Hypothyroidism AE (grade 3-4) | 0.14 [0.02, 1.16] | | < 1 | | 0% | 1 study (1/-) | 96.5 % | NA | not evaluable | | non important | - |
| Increase AST AE (grade 3-4) | 0.80 [0.45, 1.45] | | < 1 | | 0% | 1 study (1/-) | 76.6 % | NA | not evaluable | | non important | - |
| Increased ALT AE (grade 3-4) | 0.97 [0.55, 1.70] | | < 1 | | 0% | 1 study (1/-) | 54.8 % | NA | not evaluable | | non important | - |
| Nausea AE (grade 3-4) | 0.01 [0.00, 0.07] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
