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) | 0.76 [0.64, 0.89] | | < 1 | | 0% | 2 studies (2/-) | 99.9 % | low | not evaluable | high | crucial | - |
deaths (OS) (extension) | 0.76 [0.60, 0.96] | | < 1 | | 0% | 1 study (1/-) | 99.0 % | NA | not evaluable | | important | - |
PFS (extension) | 0.77 [0.63, 0.95] | | < 1 | | 0% | 1 study (1/-) | 99.4 % | NA | not evaluable | | important | - |
progression or deaths (PFS) | 0.76 [0.65, 0.88] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | low | not evaluable | high | important | - |
objective responses (ORR) | 1.12 [0.64, 1.97] | | > 1 | | 75% | 2 studies (2/-) | 65.2 % | low | not evaluable | high | non important | - |
objective responses (ORR) (extension) | 0.84 [0.56, 1.25] | | > 1 | | 0% | 1 study (1/-) | 19.5 % | NA | not evaluable | | non important | - |
safety endpoints 00 |
AE (any grade) | 14.63 [0.82, 259.59] | | < 1 | | 0% | 1 study (1/-) | 3.5 % | NA | not evaluable | | non important | - |
AE (grade 3-4) | 1.14 [0.85, 1.54] | | < 1 | | 0% | 2 studies (2/-) | 19.2 % | low | not evaluable | high | non important | - |
AE leading to death (grade 5) | 0.71 [0.20, 2.53] | | < 1 | | 69% | 2 studies (2/-) | 70.0 % | low | not evaluable | high | non important | - |
AE leading to treatment discontinuation (any grade) | 3.02 [1.77, 5.15] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
SAE (any grade) | 1.12 [0.74, 1.70] | | < 1 | | 0% | 1 study (1/-) | 29.0 % | NA | not evaluable | | non important | - |
STRAE (any grade) | 1.26 [0.78, 2.06] | | < 1 | | 0% | 1 study (1/-) | 17.4 % | NA | not evaluable | | non important | - |
TRAE (any grade) | 1.72 [0.89, 3.32] | | < 1 | | 0% | 2 studies (2/-) | 5.3 % | low | not evaluable | high | non important | - |
TRAE (grade 3-4) | 1.07 [0.81, 1.41] | | < 1 | | 0% | 2 studies (2/-) | 31.4 % | low | not evaluable | high | non important | - |
TRAE leading to death (grade 5) | 1.00 [0.39, 2.54] | | < 1 | | 0% | 2 studies (2/-) | 50.3 % | low | not evaluable | high | non important | - |
TRAE (grade 3-4) endpoints 00 |
Acute kidney injury TRAE (grade 3-4) | 3.99 [0.18, 89.04] | | < 1 | | 0% | 1 study (1/-) | 19.4 % | NA | not evaluable | | non important | - |
Adrenal insufficiency TRAE (grade 3-4) | 2.35 [0.21, 26.79] | | < 1 | | 0% | 2 studies (2/-) | 24.8 % | low | not evaluable | high | non important | - |
Alopecia TRAE (grade 3-4) | 0.67 [0.05, 8.74] | | < 1 | | 0% | 2 studies (2/-) | 61.9 % | low | not evaluable | high | non important | - |
Anaemia TRAE (grade 3-4) | 1.13 [0.76, 1.68] | | < 1 | | 0% | 2 studies (2/-) | 28.0 % | low | not evaluable | high | non important | - |
Asthenia TRAE (grade 3-4) | 0.49 [0.12, 2.00] | | < 1 | | 0% | 1 study (1/-) | 83.8 % | NA | not evaluable | | non important | - |
Colitis TRAE (grade 3-4) | 1.11 [0.15, 8.06] | | < 1 | | 7% | 2 studies (2/-) | 46.0 % | low | not evaluable | high | non important | - |
Constipation TRAE (grade 3-4) | 0.64 [0.06, 6.33] | | < 1 | | 0% | 2 studies (2/-) | 64.8 % | low | not evaluable | high | non important | - |
Decreased appetite TRAE (grade 3-4) | 0.68 [0.02, 20.43] | | < 1 | | 61% | 2 studies (2/-) | 58.8 % | low | not evaluable | high | non important | - |
Diabetes TRAE (grade 3-4) | 1.48 [0.11, 19.35] | | < 1 | | 0% | 2 studies (2/-) | 38.3 % | low | not evaluable | high | non important | - |
Diarrhoea TRAE (grade 3-4) | 2.19 [0.65, 7.31] | | < 1 | | 0% | 2 studies (2/-) | 10.2 % | low | not evaluable | high | non important | - |
Fatigue TRAE (grade 3-4) | 3.50 [0.72, 17.02] | | < 1 | | 0% | 2 studies (2/-) | 6.1 % | low | not evaluable | high | non important | - |
Febrile neutropenia TRAE (grade 3-4) | 0.48 [0.18, 1.30] | | < 1 | | 0% | 1 study (1/-) | 92.5 % | NA | not evaluable | | non important | - |
Guillain-Barré syndrome TRAE (grade 3-4) | 1.98 [0.07, 59.51] | | < 1 | | 0% | 1 study (1/-) | 34.9 % | NA | not evaluable | | non important | - |
Hepatitis TRAE (grade 3-4) | 6.04 [0.72, 50.41] | | < 1 | | 0% | 2 studies (2/-) | 4.9 % | low | not evaluable | high | non important | - |
Hyperthyroidism TRAE (grade 3-4) | 1.48 [0.11, 19.35] | | < 1 | | 0% | 2 studies (2/-) | 38.3 % | low | not evaluable | high | non important | - |
Hypophysitis TRAE (grade 3-4) | 0.99 [0.06, 15.96] | | < 1 | | 0% | 2 studies (2/-) | 50.1 % | low | not evaluable | high | non important | - |
Hypothyroidism TRAE (grade 3-4) | 0.99 [0.06, 15.96] | | < 1 | | 0% | 2 studies (2/-) | 50.1 % | low | not evaluable | high | non important | - |
Infusion-related reactions TRAE (grade 3-4) | 4.02 [0.45, 36.30] | | < 1 | | 0% | 1 study (1/-) | 10.9 % | NA | not evaluable | | non important | - |
Leucopenia TRAE (grade 3-4) | 1.26 [0.76, 2.11] | | < 1 | | 0% | 2 studies (2/-) | 18.5 % | low | not evaluable | high | non important | - |
Myocarditis TRAE (grade 3-4) | 1.00 [0.02, 50.62] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
Myositis TRAE (grade 3-4) | 2.00 [0.07, 60.06] | | < 1 | | 0% | 1 study (1/-) | 34.6 % | NA | not evaluable | | non important | - |
Nausea TRAE (grade 3-4) | 1.00 [0.20, 4.97] | | < 1 | | 0% | 2 studies (2/-) | 50.2 % | low | not evaluable | high | non important | - |
Nephritis TRAE (grade 3-4) | 1.99 [0.18, 22.08] | | < 1 | | 0% | 2 studies (2/-) | 28.8 % | low | not evaluable | high | non important | - |
Neutropenia TRAE (grade 3-4) | 0.98 [0.73, 1.32] | | < 1 | | 0% | 2 studies (2/-) | 54.4 % | low | not evaluable | high | non important | - |
Pancreatitis TRAE (grade 3-4) | 0.79 [0.11, 5.62] | | < 1 | | 0% | 2 studies (2/-) | 59.4 % | low | not evaluable | high | non important | - |
Pancytopenia TRAE (grade 3-4) | 0.33 [0.03, 3.17] | | < 1 | | 0% | 1 study (1/-) | 83.1 % | NA | not evaluable | | non important | - |
Peripheral neuropathy TRAE (grade 3-4) | 3.99 [0.18, 89.04] | | < 1 | | 0% | 1 study (1/-) | 19.4 % | NA | not evaluable | | non important | - |
Pneumonia TRAE (grade 3-4) | 6.02 [0.30, 120.88] | | < 1 | | 0% | 1 study (1/-) | 12.3 % | NA | not evaluable | | non important | - |
Pneumonitis TRAE (grade 3-4) | 1.46 [0.13, 16.80] | | < 1 | | 39% | 2 studies (2/-) | 38.0 % | low | not evaluable | high | non important | - |
Rash TRAE (grade 3-4) | 8.06 [0.42, 153.52] | | < 1 | | 0% | 1 study (1/-) | 8.5 % | NA | not evaluable | | non important | - |
Severe skin reaction TRAE (grade 3-4) | 3.81 [0.36, 40.15] | | < 1 | | 0% | 2 studies (2/-) | 13.5 % | low | not evaluable | high | non important | - |
Thrombocytopenia TRAE (grade 3-4) | 1.25 [0.80, 1.94] | | < 1 | | 0% | 2 studies (2/-) | 16.2 % | low | not evaluable | high | non important | - |
Uveitis TRAE (grade 3-4) | 2.00 [0.07, 60.06] | | < 1 | | 0% | 1 study (1/-) | 34.6 % | NA | not evaluable | | non important | - |
Vomiting TRAE (grade 3-4) | 0.66 [0.18, 2.36] | | < 1 | | 0% | 2 studies (2/-) | 73.8 % | low | not evaluable | high | non important | - |
AE (grade 3-4) endpoints 00 |
Alopecia AE (grade 3-4) | 0.50 [0.02, 14.95] | | < 1 | | 0% | 1 study (1/-) | 65.4 % | NA | not evaluable | | non important | - |
Anaemia AE (grade 3-4) | 1.03 [0.62, 1.73] | | < 1 | | 0% | 1 study (1/-) | 44.8 % | NA | not evaluable | | non important | - |
Asthenia AE (grade 3-4) | 0.72 [0.28, 1.82] | | < 1 | | 0% | 1 study (1/-) | 75.8 % | NA | not evaluable | | non important | - |
Back pain AE (grade 3-4) | 2.00 [0.07, 60.06] | | < 1 | | 0% | 1 study (1/-) | 34.6 % | NA | not evaluable | | non important | - |
Constipation AE (grade 3-4) | 0.50 [0.04, 5.53] | | < 1 | | 0% | 1 study (1/-) | 71.4 % | NA | not evaluable | | non important | - |
Cough AE (grade 3-4) | 0.50 [0.04, 5.53] | | < 1 | | 0% | 1 study (1/-) | 71.4 % | NA | not evaluable | | non important | - |
Decreased appetite AE (grade 3-4) | 0.25 [0.03, 2.22] | | < 1 | | 0% | 1 study (1/-) | 89.2 % | NA | not evaluable | | non important | - |
Diarrhoea AE (grade 3-4) | 1.00 [0.32, 3.15] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
Dizziness AE (grade 3-4) | 1.00 [0.02, 50.62] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
Dyspnoea AE (grade 3-4) | 0.75 [0.17, 3.37] | | < 1 | | 0% | 1 study (1/-) | 64.7 % | NA | not evaluable | | non important | - |
Fatigue AE (grade 3-4) | 1.51 [0.42, 5.44] | | < 1 | | 0% | 1 study (1/-) | 26.3 % | NA | not evaluable | | non important | - |
Headache AE (grade 3-4) | 0.50 [0.02, 14.95] | | < 1 | | 0% | 1 study (1/-) | 65.4 % | NA | not evaluable | | non important | - |
Hypothyroidism AE (grade 3-4) | 1.00 [0.02, 50.62] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
Leucopenia AE (grade 3-4) | 1.27 [0.69, 2.33] | | < 1 | | 0% | 1 study (1/-) | 22.1 % | NA | not evaluable | | non important | - |
Nausea AE (grade 3-4) | 0.66 [0.11, 4.01] | | < 1 | | 0% | 1 study (1/-) | 67.2 % | NA | not evaluable | | non important | - |
Neutropenia AE (grade 3-4) | 1.12 [0.77, 1.63] | | < 1 | | 0% | 1 study (1/-) | 28.3 % | NA | not evaluable | | non important | - |
Peripheral oedema AE (grade 3-4) | 1.00 [0.02, 50.62] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
Pneumonia AE (grade 3-4) | 1.54 [0.67, 3.50] | | < 1 | | 0% | 1 study (1/-) | 15.3 % | NA | not evaluable | | non important | - |
Pruritus AE (grade 3-4) | 1.00 [0.02, 50.62] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
Pyrexia AE (grade 3-4) | 1.00 [0.06, 16.09] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
Rash AE (grade 3-4) | 6.07 [0.30, 121.85] | | < 1 | | 0% | 1 study (1/-) | 12.2 % | NA | not evaluable | | non important | - |
Thrombocytopenia AE (grade 3-4) | 1.28 [0.73, 2.25] | | < 1 | | 0% | 1 study (1/-) | 19.6 % | NA | not evaluable | | non important | - |
Vomiting AE (grade 3-4) | 0.50 [0.09, 2.73] | | < 1 | | 0% | 1 study (1/-) | 78.9 % | NA | not evaluable | | non important | - |