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 [0.59, 0.86] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | crucial | - |
deaths (OS) (extension) | 0.68 [0.53, 0.87] | | < 1 | | 0% | 1 study (1/-) | 99.9 % | NA | not evaluable | | important | - |
PFS (extension) | 0.61 [0.50, 0.75] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
progression or deaths (PFS) | 0.54 [0.46, 0.64] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | important | - |
objective responses (ORR) | 5.09 [2.33, 11.13] | | > 1 | | 68% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
safety endpoints 00 |
STRAE (any grade) | 0.63 [0.39, 1.03] | | < 1 | | 0% | 1 study (1/-) | 96.8 % | NA | not evaluable | | non important | - |
STRAE (grade 3-4) | 0.92 [0.02, 46.74] | | < 1 | | 0% | 1 study (1/-) | 51.5 % | NA | not evaluable | | non important | - |
TRAE (any grade) | 0.97 [0.64, 1.46] | | < 1 | | 40% | 2 studies (2/-) | 56.6 % | some concern | not evaluable | moderate | non important | - |
TRAE (grade 3-4) | 0.68 [0.46, 1.02] | | < 1 | | 29% | 2 studies (2/-) | 96.8 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to death (grade 5) | 1.40 [0.11, 18.31] | | < 1 | | 0% | 2 studies (2/-) | 39.9 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to discontinuation (any grade) | 1.35 [0.84, 2.17] | | < 1 | | 0% | 2 studies (2/-) | 11.0 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to discontinuation (grade 3-4) | 2.50 [0.82, 7.64] | | < 1 | | 0% | 2 studies (2/-) | 5.4 % | some concern | not evaluable | moderate | non important | - |
TRAE (grade 3-4) endpoints 00 |
Abdominal pain TRAE (grade 3-4) | 0.92 [0.02, 46.74] | | < 1 | | 0% | 1 study (1/-) | 51.5 % | NA | not evaluable | | non important | - |
Alopecia TRAE (grade 3-4) | 0.94 [0.06, 15.07] | | < 1 | | 0% | 2 studies (2/-) | 51.7 % | some concern | not evaluable | moderate | non important | - |
Anaemia TRAE (grade 3-4) | 0.13 [0.01, 1.12] | | < 1 | | 0% | 2 studies (2/-) | 96.8 % | some concern | not evaluable | moderate | non important | - |
Arthralgia TRAE (grade 3-4) | 0.94 [0.10, 9.13] | | < 1 | | 0% | 2 studies (2/-) | 52.0 % | some concern | not evaluable | moderate | non important | - |
Asthenia TRAE (grade 3-4) | 0.51 [0.06, 4.02] | | < 1 | | 0% | 2 studies (2/-) | 73.9 % | some concern | not evaluable | moderate | non important | - |
Chills TRAE (grade 3-4) | 0.92 [0.02, 46.74] | | < 1 | | 0% | 1 study (1/-) | 51.5 % | NA | not evaluable | | non important | - |
Colitis TRAE (grade 3-4) | 0.76 [0.10, 5.79] | | < 1 | | 66% | 2 studies (2/-) | 60.3 % | some concern | not evaluable | moderate | non important | - |
Constipation TRAE (grade 3-4) | 0.94 [0.06, 15.07] | | < 1 | | 0% | 2 studies (2/-) | 51.7 % | some concern | not evaluable | moderate | non important | - |
Cough TRAE (grade 3-4) | 0.92 [0.02, 46.74] | | < 1 | | 0% | 1 study (1/-) | 51.5 % | NA | not evaluable | | non important | - |
Decreased appetite TRAE (grade 3-4) | 0.94 [0.06, 15.07] | | < 1 | | 0% | 2 studies (2/-) | 51.7 % | some concern | not evaluable | moderate | non important | - |
Diabetes TRAE (grade 3-4) | 1.85 [0.06, 55.43] | | < 1 | | 0% | 1 study (1/-) | 36.3 % | NA | not evaluable | | non important | - |
Diarrhoea TRAE (grade 3-4) | 0.67 [0.21, 2.15] | | < 1 | | 24% | 2 studies (2/-) | 74.7 % | some concern | not evaluable | moderate | non important | - |
Dry skin TRAE (grade 3-4) | 0.94 [0.06, 15.07] | | < 1 | | 0% | 2 studies (2/-) | 51.7 % | some concern | not evaluable | moderate | non important | - |
Dyspnoea TRAE (grade 3-4) | 0.92 [0.06, 14.85] | | < 1 | | 0% | 1 study (1/-) | 52.2 % | NA | not evaluable | | non important | - |
Fatigue TRAE (grade 3-4) | 0.45 [0.12, 1.77] | | < 1 | | 32% | 2 studies (2/-) | 87.1 % | some concern | not evaluable | moderate | non important | - |
Headache TRAE (grade 3-4) | 0.92 [0.02, 46.74] | | < 1 | | 0% | 1 study (1/-) | 51.5 % | NA | not evaluable | | non important | - |
Hepatitis TRAE (grade 3-4) | 4.40 [0.75, 25.82] | | < 1 | | 0% | 2 studies (2/-) | 5.1 % | some concern | not evaluable | moderate | non important | - |
Hyperthyroidism TRAE (grade 3-4) | 0.63 [0.05, 8.23] | | < 1 | | 0% | 2 studies (2/-) | 63.7 % | some concern | not evaluable | moderate | non important | - |
Hypophysitis TRAE (grade 3-4) | 0.56 [0.07, 4.37] | | < 1 | | 0% | 2 studies (2/-) | 70.8 % | some concern | not evaluable | moderate | non important | - |
Hypothyroidism TRAE (grade 3-4) | 0.94 [0.06, 15.07] | | < 1 | | 0% | 2 studies (2/-) | 51.7 % | some concern | not evaluable | moderate | non important | - |
Increase AST TRAE (grade 3-4) | 0.46 [0.04, 5.11] | | < 1 | | 0% | 1 study (1/-) | 73.5 % | NA | not evaluable | | non important | - |
Increased ALT TRAE (grade 3-4) | 0.46 [0.04, 5.11] | | < 1 | | 0% | 1 study (1/-) | 73.5 % | NA | not evaluable | | non important | - |
Leucopenia TRAE (grade 3-4) | 0.07 [0.00, 1.17] | | < 1 | | 0% | 1 study (1/-) | 96.7 % | NA | not evaluable | | non important | - |
Maculopapular rash TRAE (grade 3-4) | 1.24 [0.14, 10.63] | | < 1 | | 0% | 2 studies (2/-) | 42.4 % | some concern | not evaluable | moderate | non important | - |
Myalgia TRAE (grade 3-4) | 0.47 [0.04, 5.19] | | < 1 | | 0% | 2 studies (2/-) | 73.0 % | some concern | not evaluable | moderate | non important | - |
Myositis TRAE (grade 3-4) | 0.92 [0.02, 46.74] | | < 1 | | 0% | 1 study (1/-) | 51.5 % | NA | not evaluable | | non important | - |
Nausea TRAE (grade 3-4) | 0.33 [0.05, 2.22] | | < 1 | | 0% | 2 studies (2/-) | 87.3 % | some concern | not evaluable | moderate | non important | - |
Nephritis TRAE (grade 3-4) | 0.46 [0.02, 13.80] | | < 1 | | 0% | 1 study (1/-) | 67.0 % | NA | not evaluable | | non important | - |
Neutropenia TRAE (grade 3-4) | 0.18 [0.02, 1.90] | | < 1 | | 0% | 2 studies (2/-) | 92.1 % | some concern | not evaluable | moderate | non important | - |
Pancreatitis TRAE (grade 3-4) | 1.92 [0.06, 57.48] | | < 1 | | 0% | 1 study (1/-) | 35.6 % | NA | not evaluable | | non important | - |
Paraesthesia TRAE (grade 3-4) | 0.63 [0.05, 8.23] | | < 1 | | 0% | 2 studies (2/-) | 63.7 % | some concern | not evaluable | moderate | non important | - |
Peripheral neuropathy TRAE (grade 3-4) | 0.24 [0.01, 5.29] | | < 1 | | 0% | 1 study (1/-) | 81.5 % | NA | not evaluable | | non important | - |
Pneumonitis TRAE (grade 3-4) | 2.16 [0.28, 16.57] | | < 1 | | 0% | 2 studies (2/-) | 23.1 % | some concern | not evaluable | moderate | non important | - |
Pruritic rash TRAE (grade 3-4) | 0.92 [0.02, 46.74] | | < 1 | | 0% | 1 study (1/-) | 51.5 % | NA | not evaluable | | non important | - |
Pruritus TRAE (grade 3-4) | 0.94 [0.06, 15.07] | | < 1 | | 0% | 2 studies (2/-) | 51.7 % | some concern | not evaluable | moderate | non important | - |
Pyrexia TRAE (grade 3-4) | 0.92 [0.02, 46.74] | | < 1 | | 0% | 1 study (1/-) | 51.5 % | NA | not evaluable | | non important | - |
Rash TRAE (grade 3-4) | 0.94 [0.06, 15.07] | | < 1 | | 0% | 2 studies (2/-) | 51.7 % | some concern | not evaluable | moderate | non important | - |
Thrombocytopenia TRAE (grade 3-4) | 0.23 [0.03, 2.12] | | < 1 | | 0% | 1 study (1/-) | 90.0 % | NA | not evaluable | | non important | - |
Uveitis TRAE (grade 3-4) | 1.40 [0.11, 18.31] | | < 1 | | 0% | 2 studies (2/-) | 39.9 % | some concern | not evaluable | moderate | non important | - |
Vitiligo TRAE (grade 3-4) | 0.96 [0.02, 48.41] | | < 1 | | 0% | 1 study (1/-) | 50.9 % | NA | not evaluable | | non important | - |
Vomiting TRAE (grade 3-4) | 0.33 [0.05, 2.22] | | < 1 | | 0% | 2 studies (2/-) | 87.3 % | some concern | not evaluable | moderate | non important | - |
Weight decreased TRAE (grade 3-4) | 0.46 [0.02, 13.80] | | < 1 | | 0% | 1 study (1/-) | 67.0 % | NA | not evaluable | | non important | - |