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 [0.64, 1.09] | | < 1 | | 73% | 3 studies (3/-) | 91.2 % | some concern | not evaluable | moderate | crucial | - |
deaths (OS) (extension) | 0.72 [0.57, 0.92] | | < 1 | | 67% | 2 studies (2/-) | 99.5 % | some concern | not evaluable | moderate | important | - |
PFS (extension) | 0.73 [0.35, 1.51] | | < 1 | | 96% | 2 studies (2/-) | 80.1 % | some concern | not evaluable | moderate | important | - |
progression or deaths (PFS) | 0.85 [0.58, 1.24] | | < 1 | | 91% | 3 studies (3/-) | 80.3 % | some concern | not evaluable | moderate | important | - |
objective responses (ORR) | 1.24 [0.85, 1.82] | | > 1 | | 73% | 3 studies (3/-) | 86.6 % | some concern | not evaluable | moderate | non important | - |
objective responses (ORR) (extension) | 1.35 [0.75, 2.44] | | > 1 | | 80% | 2 studies (2/-) | 84.1 % | some concern | not evaluable | moderate | non important | - |
safety endpoints 00 |
STRAE (any grade) | 1.05 [0.60, 1.82] | | < 1 | | 0% | 1 study (1/-) | 43.5 % | NA | not evaluable | | non important | - |
STRAE (grade 3-4) | 0.97 [0.55, 1.72] | | < 1 | | 0% | 1 study (1/-) | 54.4 % | NA | not evaluable | | non important | - |
TRAE (any grade) | 0.22 [0.14, 0.34] | | < 1 | | 44% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
TRAE (grade 3-4) | 0.30 [0.24, 0.38] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to death (grade 5) | 0.81 [0.39, 1.66] | | < 1 | | 0% | 2 studies (2/-) | 71.9 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to discontinuation (any grade) | 0.88 [0.62, 1.24] | | < 1 | | 0% | 2 studies (2/-) | 76.5 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to discontinuation (grade 3-4) | 1.05 [0.71, 1.55] | | < 1 | | 0% | 2 studies (2/-) | 41.1 % | some concern | not evaluable | moderate | non important | - |
TRAE (grade 3-4) endpoints 00 |
Adrenal insufficiency TRAE (grade 3-4) | 3.88 [0.17, 86.15] | | < 1 | | 0% | 1 study (1/-) | 19.9 % | NA | not evaluable | | non important | - |
Alopecia TRAE (grade 3-4) | 0.07 [0.00, 1.21] | | < 1 | | 0% | 1 study (1/-) | 96.5 % | NA | not evaluable | | non important | - |
Anaemia TRAE (grade 3-4) | 0.06 [0.03, 0.12] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
Arthralgia TRAE (grade 3-4) | 0.97 [0.02, 48.81] | | < 1 | | 0% | 1 study (1/-) | 50.7 % | NA | not evaluable | | non important | - |
Asthenia TRAE (grade 3-4) | 0.29 [0.08, 1.05] | | < 1 | | 0% | 1 study (1/-) | 97.0 % | NA | not evaluable | | non important | - |
Blood creatinine increased TRAE (grade 3-4) | 0.49 [0.02, 14.58] | | < 1 | | 0% | 1 study (1/-) | 65.9 % | NA | not evaluable | | non important | - |
Colitis TRAE (grade 3-4) | 3.90 [0.65, 23.43] | | < 1 | | 0% | 2 studies (2/-) | 6.9 % | some concern | not evaluable | moderate | non important | - |
Constipation TRAE (grade 3-4) | 0.97 [0.06, 15.56] | | < 1 | | 0% | 2 studies (2/-) | 50.8 % | some concern | not evaluable | moderate | non important | - |
Decreased appetite TRAE (grade 3-4) | 0.44 [0.16, 1.24] | | < 1 | | 0% | 2 studies (2/-) | 93.8 % | some concern | not evaluable | moderate | non important | - |
Diabetes TRAE (grade 3-4) | 1.95 [0.07, 58.69] | | < 1 | | 0% | 1 study (1/-) | 35.2 % | NA | not evaluable | | non important | - |
Diarrhoea TRAE (grade 3-4) | 3.57 [0.98, 13.00] | | < 1 | | 0% | 2 studies (2/-) | 2.7 % | some concern | not evaluable | moderate | non important | - |
Dysgeusia TRAE (grade 3-4) | 0.97 [0.02, 49.41] | | < 1 | | 0% | 1 study (1/-) | 50.5 % | NA | not evaluable | | non important | - |
Fatigue TRAE (grade 3-4) | 0.37 [0.13, 1.04] | | < 1 | | 0% | 2 studies (2/-) | 97.0 % | some concern | not evaluable | moderate | non important | - |
Hepatitis TRAE (grade 3-4) | 13.68 [0.77, 241.54] | | < 1 | | 0% | 1 study (1/-) | 3.9 % | NA | not evaluable | | non important | - |
Hyperthyroidism TRAE (grade 3-4) | 1.44 [0.11, 18.83] | | < 1 | | 0% | 2 studies (2/-) | 39.1 % | some concern | not evaluable | moderate | non important | - |
Hypophysitis TRAE (grade 3-4) | 3.62 [0.38, 34.25] | | < 1 | | 0% | 2 studies (2/-) | 13.3 % | some concern | not evaluable | moderate | non important | - |
Hypothyroidism TRAE (grade 3-4) | 1.44 [0.11, 18.83] | | < 1 | | 0% | 2 studies (2/-) | 39.1 % | some concern | not evaluable | moderate | non important | - |
Increase AST TRAE (grade 3-4) | 1.94 [0.35, 10.63] | | < 1 | | 0% | 1 study (1/-) | 22.3 % | NA | not evaluable | | non important | - |
Increased ALT TRAE (grade 3-4) | 1.75 [0.58, 5.26] | | < 1 | | 0% | 1 study (1/-) | 15.9 % | NA | not evaluable | | non important | - |
Infusion-related reactions TRAE (grade 3-4) | 0.24 [0.04, 1.55] | | < 1 | | 0% | 2 studies (2/-) | 93.2 % | some concern | not evaluable | moderate | non important | - |
Leucopenia TRAE (grade 3-4) | 0.05 [0.00, 0.82] | | < 1 | | 0% | 1 study (1/-) | 98.1 % | NA | not evaluable | | non important | - |
Myalgia TRAE (grade 3-4) | 1.94 [0.06, 57.80] | | < 1 | | 0% | 1 study (1/-) | 35.4 % | NA | not evaluable | | non important | - |
Myocarditis TRAE (grade 3-4) | 1.94 [0.06, 57.80] | | < 1 | | 0% | 1 study (1/-) | 35.4 % | NA | not evaluable | | non important | - |
Myositis TRAE (grade 3-4) | 0.97 [0.02, 49.41] | | < 1 | | 0% | 1 study (1/-) | 50.5 % | NA | not evaluable | | non important | - |
Nausea TRAE (grade 3-4) | 0.10 [0.01, 0.82] | | < 1 | | 0% | 2 studies (2/-) | 98.4 % | some concern | not evaluable | moderate | non important | - |
Nephritis TRAE (grade 3-4) | 1.94 [0.18, 21.52] | | < 1 | | 0% | 2 studies (2/-) | 29.5 % | some concern | not evaluable | moderate | non important | - |
Neutropenia TRAE (grade 3-4) | 0.02 [0.00, 0.10] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
Pancreatitis TRAE (grade 3-4) | 1.44 [0.11, 18.87] | | < 1 | | 0% | 2 studies (2/-) | 39.0 % | some concern | not evaluable | moderate | non important | - |
Peripheral neuropathy TRAE (grade 3-4) | 0.10 [0.01, 1.76] | | < 1 | | 0% | 1 study (1/-) | 94.1 % | NA | not evaluable | | non important | - |
Peripheral sensory neuropathy TRAE (grade 3-4) | 0.08 [0.00, 1.43] | | < 1 | | 0% | 1 study (1/-) | 95.5 % | NA | not evaluable | | non important | - |
Pneumonitis TRAE (grade 3-4) | 9.73 [1.92, 49.42] | | < 1 | | 16% | 2 studies (2/-) | 0.3 % | some concern | not evaluable | moderate | non important | - |
Pruritus TRAE (grade 3-4) | 3.88 [0.17, 86.15] | | < 1 | | 0% | 1 study (1/-) | 19.9 % | NA | not evaluable | | non important | - |
Pyrexia TRAE (grade 3-4) | 0.97 [0.02, 49.41] | | < 1 | | 0% | 1 study (1/-) | 50.5 % | NA | not evaluable | | non important | - |
Rash TRAE (grade 3-4) | 5.82 [0.29, 116.52] | | < 1 | | 0% | 1 study (1/-) | 12.7 % | NA | not evaluable | | non important | - |
Severe skin reaction TRAE (grade 3-4) | 11.23 [2.11, 59.83] | | < 1 | | 0% | 2 studies (2/-) | 0.2 % | some concern | not evaluable | moderate | non important | - |
Stomatitis TRAE (grade 3-4) | 0.41 [0.04, 4.70] | | < 1 | | 0% | 2 studies (2/-) | 76.1 % | some concern | not evaluable | moderate | non important | - |
Thrombocytopenia TRAE (grade 3-4) | 0.08 [0.02, 0.43] | | < 1 | | 0% | 2 studies (2/-) | 99.8 % | some concern | not evaluable | moderate | non important | - |
Thyroiditis TRAE (grade 3-4) | 0.97 [0.06, 15.56] | | < 1 | | 0% | 2 studies (2/-) | 50.8 % | some concern | not evaluable | moderate | non important | - |
Vomiting TRAE (grade 3-4) | 0.52 [0.07, 4.14] | | < 1 | | 0% | 2 studies (2/-) | 72.9 % | some concern | not evaluable | moderate | non important | - |