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) | 0.84 [0.74, 0.96] | | < 1 | | 24% | 3 studies (3/-) | 99.6 % | 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) | 1.01 [0.74, 1.39] | | < 1 | | 89% | 3 studies (3/-) | 47.6 % | 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) | 1.17 [0.53, 2.59] | | > 1 | | 93% | 3 studies (3/-) | 64.8 % | 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) | 0.76 [0.19, 3.00] | | < 1 | | 96% | 2 studies (2/-) | 65.4 % | some concern | not evaluable | moderate | non important | - |
AE leading to death (grade 5) | 2.88 [1.73, 4.78] | | < 1 | | 16% | 3 studies (3/-) | 0.0 % | some concern | not evaluable | moderate | non important | - |
AE leading to treatment discontinuation (any grade) | 1.05 [0.52, 2.14] | | < 1 | | 87% | 3 studies (3/-) | 44.5 % | 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) | 0.68 [0.23, 1.96] | | < 1 | | 94% | 2 studies (2/-) | 76.3 % | some concern | not evaluable | moderate | 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) | 0.26 [0.05, 1.37] | | < 1 | | 98% | 3 studies (3/-) | 94.3 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to death (grade 5) | 1.00 [0.38, 2.69] | | < 1 | | 0% | 3 studies (3/-) | 49.6 % | 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) | 1.68 [0.22, 13.01] | | < 1 | | 0% | 3 studies (3/-) | 31.2 % | 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) | 0.11 [0.01, 1.60] | | < 1 | | 96% | 3 studies (3/-) | 94.5 % | some concern | not evaluable | moderate | non important | - |
Asthenia TRAE (grade 3-4) | 0.32 [0.07, 1.52] | | < 1 | | 62% | 3 studies (3/-) | 92.3 % | some concern | not evaluable | moderate | non important | - |
Colitis TRAE (grade 3-4) | 3.59 [0.86, 14.94] | | < 1 | | 0% | 3 studies (3/-) | 4.0 % | some concern | not evaluable | moderate | non important | - |
Constipation TRAE (grade 3-4) | 0.33 [0.05, 1.99] | | < 1 | | 31% | 3 studies (3/-) | 88.6 % | some concern | not evaluable | moderate | non important | - |
Decreased appetite TRAE (grade 3-4) | 0.29 [0.07, 1.20] | | < 1 | | 0% | 3 studies (3/-) | 95.5 % | some concern | not evaluable | moderate | non important | - |
Diabetes TRAE (grade 3-4) | 2.11 [0.19, 23.33] | | < 1 | | 0% | 2 studies (2/-) | 27.3 % | some concern | not evaluable | moderate | non important | - |
Diarrhoea TRAE (grade 3-4) | 1.20 [0.55, 2.63] | | < 1 | | 0% | 3 studies (3/-) | 32.4 % | some concern | not evaluable | moderate | non important | - |
Fatigue TRAE (grade 3-4) | 0.53 [0.26, 1.06] | | < 1 | | 12% | 3 studies (3/-) | 96.3 % | some concern | not evaluable | moderate | non important | - |
Hepatitis TRAE (grade 3-4) | 2.11 [0.19, 23.33] | | < 1 | | 0% | 2 studies (2/-) | 27.3 % | some concern | not evaluable | moderate | non important | - |
Hyperthyroidism TRAE (grade 3-4) | 1.34 [0.16, 11.51] | | < 1 | | 0% | 3 studies (3/-) | 39.5 % | some concern | not evaluable | moderate | non important | - |
Hypophysitis TRAE (grade 3-4) | 3.89 [0.41, 36.85] | | < 1 | | 0% | 2 studies (2/-) | 12.0 % | some concern | not evaluable | moderate | non important | - |
Hypothyroidism TRAE (grade 3-4) | 3.06 [0.31, 30.30] | | < 1 | | 0% | 2 studies (2/-) | 17.1 % | some concern | not evaluable | moderate | 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) | 0.09 [0.00, 7.03] | | < 1 | | 89% | 2 studies (2/-) | 85.4 % | some concern | not evaluable | moderate | non important | - |
Myocarditis TRAE (grade 3-4) | 1.55 [0.12, 20.23] | | < 1 | | 0% | 2 studies (2/-) | 37.0 % | some concern | not evaluable | moderate | non important | - |
Myositis TRAE (grade 3-4) | 0.77 [0.09, 6.59] | | < 1 | | 0% | 3 studies (3/-) | 59.4 % | some concern | not evaluable | moderate | non important | - |
Nausea TRAE (grade 3-4) | 0.54 [0.24, 1.19] | | < 1 | | 0% | 3 studies (3/-) | 93.6 % | some concern | not evaluable | moderate | non important | - |
Nephritis TRAE (grade 3-4) | 2.65 [0.40, 17.69] | | < 1 | | 0% | 3 studies (3/-) | 15.9 % | some concern | not evaluable | moderate | non important | - |
Neutropenia TRAE (grade 3-4) | 0.04 [0.00, 2.29] | | < 1 | | 91% | 3 studies (3/-) | 93.6 % | some concern | not evaluable | moderate | non important | - |
Pancreatitis TRAE (grade 3-4) | 4.23 [0.47, 37.98] | | < 1 | | 0% | 2 studies (2/-) | 10.0 % | some concern | not evaluable | moderate | 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) | 4.61 [1.15, 18.48] | | < 1 | | 0% | 3 studies (3/-) | 1.6 % | some concern | not evaluable | moderate | non important | - |
Pruritus TRAE (grade 3-4) | 1.72 [0.24, 12.08] | | < 1 | | 0% | 3 studies (3/-) | 29.4 % | some concern | not evaluable | moderate | non important | - |
Rash TRAE (grade 3-4) | 2.23 [0.35, 14.10] | | < 1 | | 0% | 2 studies (2/-) | 19.8 % | some concern | not evaluable | moderate | non important | - |
Sarcoidosis TRAE (grade 3-4) | 1.05 [0.07, 16.88] | | < 1 | | 0% | 2 studies (2/-) | 48.5 % | some concern | not evaluable | moderate | non important | - |
Severe skin reaction TRAE (grade 3-4) | 1.36 [0.32, 5.68] | | < 1 | | 41% | 3 studies (3/-) | 33.8 % | some concern | not evaluable | moderate | non important | - |
Thrombocytopenia TRAE (grade 3-4) | 0.14 [0.00, 5.55] | | < 1 | | 92% | 2 studies (2/-) | 84.9 % | some concern | not evaluable | moderate | non important | - |
Thyroiditis TRAE (grade 3-4) | 1.36 [0.16, 11.68] | | < 1 | | 0% | 3 studies (3/-) | 39.0 % | some concern | not evaluable | moderate | non important | - |
Vomiting TRAE (grade 3-4) | 0.49 [0.07, 3.55] | | < 1 | | 68% | 2 studies (2/-) | 76.1 % | some concern | not evaluable | moderate | 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 | - |