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) | 0.49 [0.38, 0.64] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | crucial | - |
deaths (OS) (extension) | 0.56 [0.45, 0.70] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
PFS (extension) | 0.48 [0.40, 0.58] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
progression or deaths (PFS) | 0.52 [0.43, 0.63] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
objective responses (ORR) | 3.88 [2.61, 5.79] | | > 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
objective responses (ORR) (extension) | 3.84 [2.58, 5.70] | | > 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
safety endpoints 00 |
AE (any grade) | 4.04 [0.36, 44.82] | | < 1 | | 0% | 1 study (1/-) | 13.0 % | NA | not evaluable | | non important | - |
AE (grade 3-4) | 1.03 [0.73, 1.45] | | < 1 | | 0% | 1 study (1/-) | 44.4 % | NA | not evaluable | | non important | - |
AE leading to death (grade 5) | 1.13 [0.56, 2.28] | | < 1 | | 0% | 1 study (1/-) | 36.6 % | NA | not evaluable | | non important | - |
AE leading to treatment discontinuation (any grade) | 2.19 [1.31, 3.65] | | < 1 | | 0% | 1 study (1/-) | 0.1 % | NA | not evaluable | | non important | - |
AE leading to treatment discontinuation (grade 3-4) | 2.04 [1.16, 3.59] | | < 1 | | 0% | 1 study (1/-) | 0.7 % | NA | not evaluable | | non important | - |
TRAE (grade 3-4) endpoints 00 |
Adrenal insufficiency TRAE (grade 3-4) | 0.50 [0.03, 8.00] | | < 1 | | 0% | 1 study (1/-) | 68.7 % | NA | not evaluable | | non important | - |
Colitis TRAE (grade 3-4) | 3.01 [0.15, 60.33] | | < 1 | | 0% | 1 study (1/-) | 23.8 % | NA | not evaluable | | non important | - |
Diabetes TRAE (grade 3-4) | 1.00 [0.03, 29.86] | | < 1 | | 0% | 1 study (1/-) | 50.1 % | NA | not evaluable | | non important | - |
Hepatitis TRAE (grade 3-4) | 4.02 [0.21, 76.41] | | < 1 | | 0% | 1 study (1/-) | 18.0 % | NA | not evaluable | | non important | - |
Hyperthyroidism TRAE (grade 3-4) | 0.50 [0.01, 25.20] | | < 1 | | 0% | 1 study (1/-) | 63.4 % | NA | not evaluable | | non important | - |
Hypophysitis TRAE (grade 3-4) | 0.50 [0.01, 25.20] | | < 1 | | 0% | 1 study (1/-) | 63.4 % | NA | not evaluable | | non important | - |
Hypothyroidism TRAE (grade 3-4) | 2.00 [0.09, 44.56] | | < 1 | | 0% | 1 study (1/-) | 33.3 % | NA | not evaluable | | non important | - |
Infusion-related reactions TRAE (grade 3-4) | 1.00 [0.03, 29.86] | | < 1 | | 0% | 1 study (1/-) | 50.1 % | NA | not evaluable | | non important | - |
Myositis TRAE (grade 3-4) | 0.50 [0.01, 25.20] | | < 1 | | 0% | 1 study (1/-) | 63.4 % | NA | not evaluable | | non important | - |
Nephritis TRAE (grade 3-4) | 6.06 [0.34, 109.04] | | < 1 | | 0% | 1 study (1/-) | 11.3 % | NA | not evaluable | | non important | - |
Pancreatitis TRAE (grade 3-4) | 2.00 [0.09, 44.56] | | < 1 | | 0% | 1 study (1/-) | 33.3 % | NA | not evaluable | | non important | - |
Pneumonitis TRAE (grade 3-4) | 1.00 [0.30, 3.35] | | < 1 | | 0% | 1 study (1/-) | 50.2 % | NA | not evaluable | | non important | - |
Severe skin reaction TRAE (grade 3-4) | 1.00 [0.30, 3.35] | | < 1 | | 0% | 1 study (1/-) | 50.2 % | NA | not evaluable | | non important | - |
Thyroiditis TRAE (grade 3-4) | 0.50 [0.01, 25.20] | | < 1 | | 0% | 1 study (1/-) | 63.4 % | NA | not evaluable | | non important | - |
AE (grade 3-4) endpoints 00 |
Anaemia AE (grade 3-4) | 1.07 [0.67, 1.71] | | < 1 | | 0% | 1 study (1/-) | 38.2 % | NA | not evaluable | | non important | - |
Asthenia AE (grade 3-4) | 1.83 [0.78, 4.31] | | < 1 | | 0% | 1 study (1/-) | 8.3 % | NA | not evaluable | | non important | - |
Constipation AE (grade 3-4) | 2.00 [0.22, 18.06] | | < 1 | | 0% | 1 study (1/-) | 26.9 % | NA | not evaluable | | non important | - |
Cough AE (grade 3-4) | 0.50 [0.01, 25.20] | | < 1 | | 0% | 1 study (1/-) | 63.4 % | NA | not evaluable | | non important | - |
Decreased appetite AE (grade 3-4) | 3.02 [0.36, 25.28] | | < 1 | | 0% | 1 study (1/-) | 15.5 % | NA | not evaluable | | non important | - |
Diarrhoea AE (grade 3-4) | 1.79 [0.71, 4.50] | | < 1 | | 0% | 1 study (1/-) | 10.9 % | NA | not evaluable | | non important | - |
Dyspnoea AE (grade 3-4) | 0.67 [0.30, 1.48] | | < 1 | | 0% | 1 study (1/-) | 83.9 % | NA | not evaluable | | non important | - |
Fatigue AE (grade 3-4) | 2.37 [0.89, 6.34] | | < 1 | | 0% | 1 study (1/-) | 4.3 % | NA | not evaluable | | non important | - |
Lacrimation increased AE (grade 3-4) | 0.50 [0.01, 25.20] | | < 1 | | 0% | 1 study (1/-) | 63.4 % | NA | not evaluable | | non important | - |
Nausea AE (grade 3-4) | 1.00 [0.40, 2.51] | | < 1 | | 0% | 1 study (1/-) | 50.2 % | NA | not evaluable | | non important | - |
Neutropenia AE (grade 3-4) | 1.39 [0.84, 2.30] | | < 1 | | 0% | 1 study (1/-) | 9.9 % | NA | not evaluable | | non important | - |
Peripheral oedema AE (grade 3-4) | 1.00 [0.03, 29.86] | | < 1 | | 0% | 1 study (1/-) | 50.1 % | NA | not evaluable | | non important | - |
Pyrexia AE (grade 3-4) | 1.00 [0.03, 29.86] | | < 1 | | 0% | 1 study (1/-) | 50.1 % | NA | not evaluable | | non important | - |
Rash AE (grade 3-4) | 1.17 [0.30, 4.56] | | < 1 | | 0% | 1 study (1/-) | 41.3 % | NA | not evaluable | | non important | - |
Thrombocytopenia AE (grade 3-4) | 1.15 [0.60, 2.21] | | < 1 | | 0% | 1 study (1/-) | 33.5 % | NA | not evaluable | | non important | - |
Vomiting AE (grade 3-4) | 1.26 [0.48, 3.29] | | < 1 | | 0% | 1 study (1/-) | 32.1 % | NA | not evaluable | | non important | - |