| 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) | 0.83 [0.66, 1.04] | | < 1 | | 61% | 2 studies (2/-) | 95.1 % | some concern | not evaluable | moderate | crucial | - |
| deaths (OS) (extension) | 0.70 [0.57, 0.85] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
| PFS (extension) | 0.96 [0.79, 1.16] | | < 1 | | 0% | 1 study (1/-) | 66.1 % | NA | not evaluable | | important | - |
| progression or deaths (PFS) | 1.15 [0.84, 1.58] | | < 1 | | 82% | 2 studies (2/-) | 18.9 % | some concern | not evaluable | moderate | important | - |
| DOR | 4.66 [1.83, 11.87] | | < 1 | | 0% | 1 study (1/-) | 0.1 % | NA | not evaluable | | non important | - |
| objective responses (ORR) | 1.04 [0.27, 3.95] | | > 1 | | 95% | 2 studies (2/-) | 52.4 % | some concern | not evaluable | moderate | non important | - |
| objective responses (ORR) (extension) | 2.16 [1.34, 3.48] | | > 1 | | 0% | 1 study (1/-) | 99.9 % | NA | not evaluable | | non important | - |
safety endpoints 00 |
| AE (any grade) | 0.28 [0.10, 0.75] | | < 1 | | 0% | 1 study (1/-) | 99.4 % | NA | not evaluable | | non important | - |
| AE (grade 3-4) | 0.61 [0.43, 0.86] | | < 1 | | 0% | 1 study (1/-) | 99.7 % | NA | not evaluable | | non important | - |
| AE (grade 3-5) | 0.38 [0.26, 0.54] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
| AE leading to death (grade 5) | 2.43 [1.13, 5.25] | | < 1 | | 41% | 2 studies (2/-) | 1.2 % | some concern | not evaluable | moderate | non important | - |
| AE leading to treatment discontinuation (any grade) | 0.77 [0.55, 1.07] | | < 1 | | 0% | 2 studies (2/-) | 93.8 % | some concern | not evaluable | moderate | non important | - |
| AE leading to treatment discontinuation (grade 3-4) | 0.85 [0.44, 1.65] | | < 1 | | 0% | 1 study (1/-) | 68.1 % | NA | not evaluable | | non important | - |
| STRAE (any grade) | 0.39 [0.26, 0.59] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
| TRAE (any grade) | 0.12 [0.05, 0.25] | | < 1 | | 75% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
| TRAE (grade 3-4) | 0.12 [0.05, 0.28] | | < 1 | | 88% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
| TRAE leading to death (grade 5) | 1.01 [0.32, 3.16] | | < 1 | | 0% | 2 studies (2/-) | 49.1 % | some concern | not evaluable | moderate | non important | - |
| TRAE leading to discontinuation (any grade) | 0.48 [0.25, 0.93] | | < 1 | | 0% | 1 study (1/-) | 98.5 % | NA | not evaluable | | non important | - |
TRAE (grade 3-4) endpoints 00 |
| Adrenal insufficiency TRAE (grade 3-4) | 1.53 [0.12, 19.99] | | < 1 | | 0% | 2 studies (2/-) | 37.4 % | some concern | not evaluable | moderate | non important | - |
| Alopecia TRAE (grade 3-4) | 0.24 [0.01, 5.31] | | < 1 | | 0% | 1 study (1/-) | 81.5 % | NA | not evaluable | | non important | - |
| Anaemia TRAE (grade 3-4) | 0.04 [0.01, 0.12] | | < 1 | | 44% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
| Asthenia TRAE (grade 3-4) | 0.13 [0.03, 0.56] | | < 1 | | 0% | 2 studies (2/-) | 99.7 % | some concern | not evaluable | moderate | non important | - |
| Colitis TRAE (grade 3-4) | 4.97 [0.85, 29.26] | | < 1 | | 0% | 2 studies (2/-) | 3.9 % | some concern | not evaluable | moderate | non important | - |
| Constipation TRAE (grade 3-4) | 0.31 [0.02, 5.57] | | < 1 | | 64% | 2 studies (2/-) | 78.4 % | some concern | not evaluable | moderate | non important | - |
| Decreased appetite TRAE (grade 3-4) | 0.27 [0.04, 1.67] | | < 1 | | 0% | 2 studies (2/-) | 91.9 % | some concern | not evaluable | moderate | non important | - |
| Diabetes TRAE (grade 3-4) | 2.27 [0.08, 67.88] | | < 1 | | 0% | 1 study (1/-) | 32.1 % | NA | not evaluable | | non important | - |
| Diarrhoea TRAE (grade 3-4) | 1.07 [0.37, 3.10] | | < 1 | | 0% | 2 studies (2/-) | 45.3 % | some concern | not evaluable | moderate | non important | - |
| Fatigue TRAE (grade 3-4) | 0.36 [0.15, 0.87] | | < 1 | | 0% | 2 studies (2/-) | 98.8 % | some concern | not evaluable | moderate | non important | - |
| Hepatitis TRAE (grade 3-4) | 2.27 [0.08, 67.88] | | < 1 | | 0% | 1 study (1/-) | 32.1 % | NA | not evaluable | | non important | - |
| Hyperthyroidism TRAE (grade 3-4) | 1.04 [0.07, 16.70] | | < 1 | | 0% | 2 studies (2/-) | 48.9 % | some concern | not evaluable | moderate | non important | - |
| Hypophysitis TRAE (grade 3-4) | 2.27 [0.08, 67.88] | | < 1 | | 0% | 1 study (1/-) | 32.1 % | NA | not evaluable | | non important | - |
| Hypothyroidism TRAE (grade 3-4) | 2.27 [0.08, 67.88] | | < 1 | | 0% | 1 study (1/-) | 32.1 % | NA | not evaluable | | non important | - |
| Infusion-related reactions TRAE (grade 3-4) | 0.96 [0.02, 48.49] | | < 1 | | 0% | 1 study (1/-) | 50.8 % | NA | not evaluable | | non important | - |
| Leucopenia TRAE (grade 3-4) | 0.01 [0.00, 0.13] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
| Myocarditis TRAE (grade 3-4) | 1.13 [0.02, 57.26] | | < 1 | | 0% | 1 study (1/-) | 47.6 % | NA | not evaluable | | non important | - |
| Myositis TRAE (grade 3-4) | 0.69 [0.05, 9.04] | | < 1 | | 0% | 2 studies (2/-) | 61.0 % | some concern | not evaluable | moderate | non important | - |
| Nausea TRAE (grade 3-4) | 0.26 [0.07, 0.94] | | < 1 | | 0% | 2 studies (2/-) | 98.0 % | some concern | not evaluable | moderate | non important | - |
| Nephritis TRAE (grade 3-4) | 3.03 [0.31, 29.97] | | < 1 | | 0% | 2 studies (2/-) | 17.3 % | some concern | not evaluable | moderate | non important | - |
| Neutropenia TRAE (grade 3-4) | 0.01 [0.00, 0.05] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
| Pancreatitis TRAE (grade 3-4) | 4.55 [0.20, 101.37] | | < 1 | | 0% | 1 study (1/-) | 17.2 % | NA | not evaluable | | non important | - |
| Peripheral neuropathy TRAE (grade 3-4) | 0.24 [0.01, 5.31] | | < 1 | | 0% | 1 study (1/-) | 81.5 % | NA | not evaluable | | non important | - |
| Pneumonitis TRAE (grade 3-4) | 6.02 [1.04, 34.78] | | < 1 | | 0% | 2 studies (2/-) | 2.3 % | some concern | not evaluable | moderate | non important | - |
| Pruritus TRAE (grade 3-4) | 0.69 [0.05, 9.04] | | < 1 | | 0% | 2 studies (2/-) | 61.0 % | some concern | not evaluable | moderate | non important | - |
| Rash TRAE (grade 3-4) | 0.57 [0.02, 16.92] | | < 1 | | 0% | 1 study (1/-) | 62.7 % | NA | not evaluable | | non important | - |
| Sarcoidosis TRAE (grade 3-4) | 1.13 [0.02, 57.26] | | < 1 | | 0% | 1 study (1/-) | 47.6 % | NA | not evaluable | | non important | - |
| Severe skin reaction TRAE (grade 3-4) | 0.66 [0.15, 2.90] | | < 1 | | 0% | 2 studies (2/-) | 71.0 % | some concern | not evaluable | moderate | non important | - |
| Thrombocytopenia TRAE (grade 3-4) | 0.02 [0.00, 0.13] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
| Thyroiditis TRAE (grade 3-4) | 1.57 [0.12, 20.47] | | < 1 | | 0% | 2 studies (2/-) | 36.7 % | some concern | not evaluable | moderate | non important | - |
| Vomiting TRAE (grade 3-4) | 0.14 [0.02, 1.12] | | < 1 | | 0% | 1 study (1/-) | 96.8 % | NA | not evaluable | | non important | - |
AE (grade 3-4) endpoints 00 |
| Abdominal pain AE (grade 3-4) | 0.40 [0.10, 1.58] | | < 1 | | 0% | 1 study (1/-) | 90.3 % | NA | not evaluable | | non important | - |
| Acute kidney injury AE (grade 3-4) | 2.27 [0.58, 8.88] | | < 1 | | 0% | 1 study (1/-) | 12.0 % | NA | not evaluable | | non important | - |
| Alopecia AE (grade 3-4) | 0.16 [0.01, 3.17] | | < 1 | | 0% | 1 study (1/-) | 88.3 % | NA | not evaluable | | non important | - |
| Anaemia AE (grade 3-4) | 0.65 [0.37, 1.16] | | < 1 | | 0% | 1 study (1/-) | 92.8 % | NA | not evaluable | | non important | - |
| Arthralgia AE (grade 3-4) | 0.16 [0.01, 3.17] | | < 1 | | 0% | 1 study (1/-) | 88.3 % | NA | not evaluable | | non important | - |
| Asthenia AE (grade 3-4) | 0.14 [0.03, 0.63] | | < 1 | | 0% | 1 study (1/-) | 99.5 % | NA | not evaluable | | non important | - |
| Back pain AE (grade 3-4) | 1.92 [0.17, 21.35] | | < 1 | | 0% | 1 study (1/-) | 29.8 % | NA | not evaluable | | non important | - |
| Blood and lymphatic system disorders AE (grade 3-4) | 0.24 [0.15, 0.40] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
| Blood creatinine increased AE (grade 3-4) | 1.92 [0.17, 21.35] | | < 1 | | 0% | 1 study (1/-) | 29.8 % | NA | not evaluable | | non important | - |
| Cardiac disorders AE (grade 3-4) | 0.72 [0.16, 3.23] | | < 1 | | 0% | 1 study (1/-) | 66.8 % | NA | not evaluable | | non important | - |
| Constipation AE (grade 3-4) | 0.35 [0.09, 1.34] | | < 1 | | 0% | 1 study (1/-) | 93.6 % | NA | not evaluable | | non important | - |
| Cough AE (grade 3-4) | 1.92 [0.06, 57.51] | | < 1 | | 0% | 1 study (1/-) | 35.5 % | NA | not evaluable | | non important | - |
| Decreased appetite AE (grade 3-4) | 3.28 [0.89, 12.06] | | < 1 | | 0% | 1 study (1/-) | 3.7 % | NA | not evaluable | | non important | - |
| Diarrhoea AE (grade 3-4) | 0.96 [0.24, 3.87] | | < 1 | | 0% | 1 study (1/-) | 52.4 % | NA | not evaluable | | non important | - |
| Dizziness AE (grade 3-4) | 0.48 [0.02, 14.32] | | < 1 | | 0% | 1 study (1/-) | 66.2 % | NA | not evaluable | | non important | - |
| Dry skin AE (grade 3-4) | 0.96 [0.02, 48.49] | | < 1 | | 0% | 1 study (1/-) | 50.8 % | NA | not evaluable | | non important | - |
| Dysgeusia AE (grade 3-4) | 0.96 [0.02, 48.49] | | < 1 | | 0% | 1 study (1/-) | 50.8 % | NA | not evaluable | | non important | - |
| Dyspnoea AE (grade 3-4) | 1.61 [0.38, 6.80] | | < 1 | | 0% | 1 study (1/-) | 25.9 % | NA | not evaluable | | non important | - |
| Endocrine disorders AE (grade 3-4) | 5.81 [0.29, 116.49] | | < 1 | | 0% | 1 study (1/-) | 12.8 % | NA | not evaluable | | non important | - |
| Eye disorders AE (grade 3-4) | 3.86 [0.17, 85.92] | | < 1 | | 0% | 1 study (1/-) | 20.0 % | NA | not evaluable | | non important | - |
| Fatigue AE (grade 3-4) | 0.63 [0.28, 1.42] | | < 1 | | 0% | 1 study (1/-) | 86.9 % | NA | not evaluable | | non important | - |
| Febrile neutropenia AE (grade 3-4) | 0.02 [0.00, 0.39] | | < 1 | | 0% | 1 study (1/-) | 99.5 % | NA | not evaluable | | non important | - |
| Gastrointestinal disorders AE (grade 3-4) | 0.42 [0.24, 0.75] | | < 1 | | 0% | 1 study (1/-) | 99.9 % | NA | not evaluable | | non important | - |
| General disorders and administration site conditions AE (grade 3-4) | 0.49 [0.28, 0.86] | | < 1 | | 0% | 1 study (1/-) | 99.4 % | NA | not evaluable | | non important | - |
| Headache AE (grade 3-4) | 1.92 [0.06, 57.51] | | < 1 | | 0% | 1 study (1/-) | 35.5 % | NA | not evaluable | | non important | - |
| Hypothyroidism AE (grade 3-4) | 0.96 [0.02, 48.49] | | < 1 | | 0% | 1 study (1/-) | 50.8 % | NA | not evaluable | | non important | - |
| Increase AST AE (grade 3-4) | 11.75 [0.65, 211.40] | | < 1 | | 0% | 1 study (1/-) | 4.9 % | NA | not evaluable | | non important | - |
| Increased ALT AE (grade 3-4) | 5.81 [0.29, 116.49] | | < 1 | | 0% | 1 study (1/-) | 12.8 % | NA | not evaluable | | non important | - |
| Infections and infestations AE (grade 3-4) | 1.22 [0.72, 2.06] | | < 1 | | 0% | 1 study (1/-) | 22.8 % | NA | not evaluable | | non important | - |
| Injury, poisoning and procedure AE (grade 3-4) | 1.45 [0.40, 5.19] | | < 1 | | 0% | 1 study (1/-) | 28.5 % | NA | not evaluable | | non important | - |
| Investigations AE (grade 3-4) | 0.46 [0.26, 0.79] | | < 1 | | 0% | 1 study (1/-) | 99.7 % | NA | not evaluable | | non important | - |
| Metabolism and nutrition disorders AE (grade 3-4) | 1.07 [0.62, 1.84] | | < 1 | | 0% | 1 study (1/-) | 40.4 % | NA | not evaluable | | non important | - |
| Mucosal inflammation AE (grade 3-4) | 0.24 [0.03, 2.13] | | < 1 | | 0% | 1 study (1/-) | 89.9 % | NA | not evaluable | | non important | - |
| Musculoskeletal and connective tissue disorders AE (grade 3-4) | 1.36 [0.59, 3.12] | | < 1 | | 0% | 1 study (1/-) | 23.4 % | NA | not evaluable | | non important | - |
| Myalgia AE (grade 3-4) | 1.92 [0.06, 57.51] | | < 1 | | 0% | 1 study (1/-) | 35.5 % | NA | not evaluable | | non important | - |
| Nausea AE (grade 3-4) | 0.72 [0.16, 3.23] | | < 1 | | 0% | 1 study (1/-) | 66.8 % | NA | not evaluable | | non important | - |
| Nervous system disorders AE (grade 3-4) | 0.27 [0.10, 0.74] | | < 1 | | 0% | 1 study (1/-) | 99.5 % | NA | not evaluable | | non important | - |
| Neutropenia AE (grade 3-4) | 0.01 [0.00, 0.18] | | < 1 | | 0% | 1 study (1/-) | 99.9 % | NA | not evaluable | | non important | - |
| Peripheral neuropathy AE (grade 3-4) | 0.24 [0.01, 5.31] | | < 1 | | 0% | 1 study (1/-) | 81.5 % | NA | not evaluable | | non important | - |
| Peripheral oedema AE (grade 3-4) | 0.24 [0.01, 5.31] | | < 1 | | 0% | 1 study (1/-) | 81.5 % | NA | not evaluable | | non important | - |
| Pruritus AE (grade 3-4) | 0.48 [0.02, 14.32] | | < 1 | | 0% | 1 study (1/-) | 66.2 % | NA | not evaluable | | non important | - |
| Pyrexia AE (grade 3-4) | 0.64 [0.11, 3.84] | | < 1 | | 0% | 1 study (1/-) | 68.8 % | NA | not evaluable | | non important | - |
| Rash AE (grade 3-4) | 1.92 [0.06, 57.51] | | < 1 | | 0% | 1 study (1/-) | 35.5 % | NA | not evaluable | | non important | - |
| Renal and urinary disorders AE (grade 3-4) | 2.77 [1.31, 5.84] | | < 1 | | 0% | 1 study (1/-) | 0.4 % | NA | not evaluable | | non important | - |
| Respiratory, thoracic and mediastinal disorders AE (grade 3-4) | 1.63 [0.70, 3.80] | | < 1 | | 0% | 1 study (1/-) | 12.8 % | NA | not evaluable | | non important | - |
| Skin and subcutaneous tissue disorders AE (grade 3-4) | 0.16 [0.02, 1.31] | | < 1 | | 0% | 1 study (1/-) | 95.6 % | NA | not evaluable | | non important | - |
| Stomatitis AE (grade 3-4) | 0.96 [0.06, 15.41] | | < 1 | | 0% | 1 study (1/-) | 51.2 % | NA | not evaluable | | non important | - |
| Vascular disorders AE (grade 3-4) | 2.71 [0.85, 8.61] | | < 1 | | 0% | 1 study (1/-) | 4.6 % | NA | not evaluable | | non important | - |
| Vomiting AE (grade 3-4) | 0.96 [0.06, 15.41] | | < 1 | | 0% | 1 study (1/-) | 51.2 % | NA | not evaluable | | non important | - |
