| 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 |
| MFS | 0.53 [0.37, 0.76] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
| RFS (extension) | 0.59 [0.49, 0.71] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
| RFS/DFS | 0.57 [0.45, 0.72] | | < 1 | | 0% | 2 studies (2/-) | 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) | 1.51 [0.96, 2.38] | | < 1 | | 0% | 1 study (1/-) | 3.8 % | NA | not evaluable | | non important | - |
| AE (grade 3-4) | 2.03 [1.52, 2.73] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
| AE leading to death (grade 5) | 0.93 [0.02, 47.58] | | < 1 | | 0% | 1 study (1/-) | 51.5 % | NA | not evaluable | | non important | - |
| AE leading to treatment discontinuation (any grade) | 3.57 [0.71, 18.07] | | < 1 | | 0% | 1 study (1/-) | 6.2 % | NA | not evaluable | | non important | - |
| AE leading to treatment discontinuation (grade 3-4) | 4.90 [0.55, 43.46] | | < 1 | | 0% | 1 study (1/-) | 7.8 % | NA | not evaluable | | non important | - |
| SAE (any grade) | 1.27 [0.56, 2.87] | | < 1 | | 0% | 1 study (1/-) | 28.6 % | NA | not evaluable | | non important | - |
| SAE (grade 3-4) | 2.51 [0.94, 6.74] | | < 1 | | 0% | 1 study (1/-) | 3.4 % | NA | not evaluable | | non important | - |
| STRAE (any grade) | 6.13 [1.29, 29.17] | | < 1 | | 0% | 1 study (1/-) | 1.2 % | NA | not evaluable | | non important | - |
| STRAE (grade 3-4) | 19.34 [1.09, 342.95] | | < 1 | | 0% | 1 study (1/-) | 2.3 % | NA | not evaluable | | non important | - |
| TRAE (any grade) | 5.78 [4.15, 8.04] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| TRAE (grade 3-4) | 8.94 [3.72, 21.51] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| TRAE leading to death (grade 5) | 1.43 [0.11, 18.73] | | < 1 | | 0% | 2 studies (2/-) | 39.4 % | low | not evaluable | high | non important | - |
| TRAE leading to discontinuation (any grade) | 7.29 [0.86, 61.51] | | < 1 | | 0% | 1 study (1/-) | 3.5 % | NA | not evaluable | | non important | - |
| TRAE leading to discontinuation (grade 3-4) | 9.90 [0.53, 186.01] | | < 1 | | 0% | 1 study (1/-) | 6.5 % | NA | not evaluable | | non important | - |
TRAE (grade 3-4) endpoints 00 |
| Abdominal pain TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Acute kidney injury TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Adrenal insufficiency TRAE (grade 3-4) | 1.42 [0.11, 18.58] | | < 1 | | 0% | 2 studies (2/-) | 39.6 % | low | not evaluable | high | non important | - |
| Alopecia TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Anaemia TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Arthralgia TRAE (grade 3-4) | 4.76 [0.55, 41.38] | | < 1 | | 0% | 2 studies (2/-) | 8.0 % | low | not evaluable | high | non important | - |
| Blood and lymphatic system disorders TRAE (grade 3-4) | 5.72 [0.28, 116.99] | | < 1 | | 0% | 1 study (1/-) | 13.2 % | NA | not evaluable | | non important | - |
| Blood creatinine increased TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Chills TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Colitis TRAE (grade 3-4) | 5.57 [0.73, 42.20] | | < 1 | | 11% | 2 studies (2/-) | 4.9 % | low | not evaluable | high | non important | - |
| Cough TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Decreased appetite TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Diabetes TRAE (grade 3-4) | 4.89 [0.53, 44.80] | | < 1 | | 0% | 2 studies (2/-) | 8.1 % | low | not evaluable | high | non important | - |
| Diarrhoea TRAE (grade 3-4) | 1.39 [0.35, 5.50] | | < 1 | | 0% | 2 studies (2/-) | 32.0 % | low | not evaluable | high | non important | - |
| Dizziness TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Dry skin TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Dysgeusia TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Dyspepsia TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Dyspnoea TRAE (grade 3-4) | 1.42 [0.11, 18.58] | | < 1 | | 0% | 2 studies (2/-) | 39.6 % | low | not evaluable | high | non important | - |
| Endocrine disorders TRAE (grade 3-4) | 7.05 [0.78, 63.89] | | < 1 | | 1% | 2 studies (2/-) | 4.2 % | low | not evaluable | high | non important | - |
| Eye disorders TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Fatigue TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Gastritis TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Gastrointestinal disorders TRAE (grade 3-4) | 4.24 [1.06, 17.05] | | < 1 | | 0% | 2 studies (2/-) | 2.1 % | low | not evaluable | high | non important | - |
| General disorders and administration site conditions TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Headache TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Hepatitis TRAE (grade 3-4) | 5.75 [1.01, 32.84] | | < 1 | | 0% | 2 studies (2/-) | 2.5 % | low | not evaluable | high | non important | - |
| Hepatobiliary disorders TRAE (grade 3-4) | 3.74 [0.16, 84.94] | | < 1 | | 0% | 1 study (1/-) | 20.7 % | NA | not evaluable | | non important | - |
| Hypertension TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Hyperthyroidism TRAE (grade 3-4) | 1.42 [0.11, 18.58] | | < 1 | | 0% | 2 studies (2/-) | 39.6 % | low | not evaluable | high | non important | - |
| Hypophysitis TRAE (grade 3-4) | 3.57 [0.38, 33.94] | | < 1 | | 0% | 2 studies (2/-) | 13.6 % | low | not evaluable | high | non important | - |
| Hypothyroidism TRAE (grade 3-4) | 0.95 [0.06, 15.26] | | < 1 | | 0% | 2 studies (2/-) | 51.5 % | low | not evaluable | high | non important | - |
| Increase AST TRAE (grade 3-4) | 5.72 [0.28, 116.99] | | < 1 | | 0% | 1 study (1/-) | 13.2 % | NA | not evaluable | | non important | - |
| Increased ALT TRAE (grade 3-4) | 5.72 [0.28, 116.99] | | < 1 | | 0% | 1 study (1/-) | 13.2 % | NA | not evaluable | | non important | - |
| Increased lipase level TRAE (grade 3-4) | 0.91 [0.17, 4.70] | | < 1 | | 0% | 1 study (1/-) | 54.7 % | NA | not evaluable | | non important | - |
| Infusion-related reactions TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Leucopenia TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Maculopapular rash TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Metabolism and nutrition disorders TRAE (grade 3-4) | 1.84 [0.06, 55.93] | | < 1 | | 0% | 1 study (1/-) | 36.6 % | NA | not evaluable | | non important | - |
| Musculoskeletal and connective tissue disorders TRAE (grade 3-4) | 5.72 [0.28, 116.99] | | < 1 | | 0% | 1 study (1/-) | 13.2 % | NA | not evaluable | | non important | - |
| Myalgia TRAE (grade 3-4) | 1.84 [0.06, 55.93] | | < 1 | | 0% | 1 study (1/-) | 36.6 % | NA | not evaluable | | 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) | 0.95 [0.06, 15.26] | | < 1 | | 0% | 2 studies (2/-) | 51.5 % | low | not evaluable | high | non important | - |
| Nausea TRAE (grade 3-4) | 0.95 [0.06, 15.26] | | < 1 | | 0% | 2 studies (2/-) | 51.5 % | 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) | 3.74 [0.16, 84.94] | | < 1 | | 0% | 1 study (1/-) | 20.7 % | NA | not evaluable | | non important | - |
| Neutropenia TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Pancreatitis TRAE (grade 3-4) | 0.96 [0.10, 9.28] | | < 1 | | 0% | 2 studies (2/-) | 51.4 % | low | not evaluable | high | non important | - |
| Paraesthesia TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Peripheral neuropathy TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Pneumonitis TRAE (grade 3-4) | 3.66 [0.35, 38.61] | | < 1 | | 0% | 2 studies (2/-) | 14.2 % | low | not evaluable | high | non important | - |
| Pruritus TRAE (grade 3-4) | 0.95 [0.06, 15.26] | | < 1 | | 0% | 2 studies (2/-) | 51.5 % | low | not evaluable | high | non important | - |
| Pyrexia TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Rash TRAE (grade 3-4) | 1.97 [0.07, 58.99] | | < 1 | | 0% | 1 study (1/-) | 34.9 % | NA | not evaluable | | non important | - |
| Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) | 3.66 [0.35, 38.61] | | < 1 | | 0% | 2 studies (2/-) | 14.2 % | low | not evaluable | high | non important | - |
| Sarcoidosis TRAE (grade 3-4) | 0.95 [0.06, 15.26] | | < 1 | | 0% | 2 studies (2/-) | 51.5 % | 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) | 1.90 [0.17, 21.18] | | < 1 | | 0% | 2 studies (2/-) | 30.1 % | low | not evaluable | high | non important | - |
| Stomatitis TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Thrombocytopenia TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Thyroiditis TRAE (grade 3-4) | 0.95 [0.06, 15.26] | | < 1 | | 0% | 2 studies (2/-) | 51.5 % | low | not evaluable | high | non important | - |
| Uveitis TRAE (grade 3-4) | 0.95 [0.06, 15.26] | | < 1 | | 0% | 2 studies (2/-) | 51.5 % | low | not evaluable | high | non important | - |
| Vitiligo TRAE (grade 3-4) | 0.95 [0.06, 15.26] | | < 1 | | 0% | 2 studies (2/-) | 51.5 % | low | not evaluable | high | non important | - |
| Vomiting TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
| Weight decreased TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
