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) | 0.80 [0.71, 0.89] | | < 1 | | 0% | 3 studies (3/-) | 100.0 % | some concern | not evaluable | moderate | crucial | - |
deaths (OS) (extension) | 0.76 [0.53, 1.08] | | < 1 | | 0% | 1 study (1/-) | 93.7 % | NA | not evaluable | | important | - |
PFS (extension) | 0.72 [0.60, 0.86] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
progression or deaths (PFS) | 0.89 [0.78, 1.03] | | < 1 | | 43% | 3 studies (3/-) | 93.9 % | some concern | not evaluable | moderate | important | - |
objective responses (ORR) | 1.03 [0.82, 1.30] | | > 1 | | 0% | 3 studies (3/-) | 60.9 % | some concern | not evaluable | moderate | non important | - |
objective responses (ORR) (extension) | 1.68 [0.94, 3.01] | | > 1 | | 0% | 1 study (1/-) | 95.9 % | NA | not evaluable | | non important | - |
safety endpoints 00 |
AE (any grade) | 0.62 [0.42, 0.93] | | < 1 | | 0% | 3 studies (3/-) | 99.0 % | some concern | not evaluable | moderate | non important | - |
AE (grade 3-4) | 0.49 [0.39, 0.60] | | < 1 | | 22% | 3 studies (3/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
AE leading to death (grade 5) | 0.84 [0.49, 1.43] | | < 1 | | 0% | 3 studies (3/-) | 74.0 % | some concern | not evaluable | moderate | non important | - |
AE leading to treatment discontinuation (any grade) | 0.43 [0.27, 0.68] | | < 1 | | 60% | 3 studies (3/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
SAE (any grade) | 1.01 [0.75, 1.36] | | < 1 | | 0% | 2 studies (2/-) | 46.9 % | some concern | not evaluable | moderate | non important | - |
SAE (grade 3-4) | 1.03 [0.80, 1.31] | | < 1 | | 0% | 1 study (1/-) | 42.1 % | NA | not evaluable | | non important | - |
STRAE (any grade) | 0.50 [0.29, 0.85] | | < 1 | | 0% | 1 study (1/-) | 99.5 % | NA | not evaluable | | non important | - |
TRAE (any grade) | 0.28 [0.23, 0.35] | | < 1 | | 0% | 3 studies (3/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
TRAE (grade 3-4) | 0.22 [0.17, 0.27] | | < 1 | | 0% | 3 studies (3/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to death (grade 5) | 0.38 [0.07, 1.97] | | < 1 | | 0% | 3 studies (3/-) | 87.5 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to discontinuation (any grade) | 0.07 [0.02, 0.29] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
TRAE (grade 3-4) endpoints 00 |
Colitis TRAE (grade 3-4) | 3.70 [0.17, 82.36] | | < 1 | | 0% | 1 study (1/-) | 20.7 % | NA | not evaluable | | non important | - |
Hepatitis TRAE (grade 3-4) | 11.47 [1.48, 88.87] | | < 1 | | 0% | 1 study (1/-) | 1.0 % | NA | not evaluable | | non important | - |
Hyperthyroidism TRAE (grade 3-4) | 0.92 [0.02, 46.51] | | < 1 | | 0% | 1 study (1/-) | 51.6 % | NA | not evaluable | | non important | - |
Hypothyroidism TRAE (grade 3-4) | 0.92 [0.02, 46.51] | | < 1 | | 0% | 1 study (1/-) | 51.6 % | NA | not evaluable | | non important | - |
Infusion-related reactions TRAE (grade 3-4) | 0.92 [0.02, 46.51] | | < 1 | | 0% | 1 study (1/-) | 51.6 % | NA | not evaluable | | non important | - |
Pneumonitis TRAE (grade 3-4) | 3.70 [0.17, 82.36] | | < 1 | | 0% | 1 study (1/-) | 20.7 % | NA | not evaluable | | non important | - |
Rash TRAE (grade 3-4) | 1.38 [0.23, 8.34] | | < 1 | | 0% | 1 study (1/-) | 36.2 % | NA | not evaluable | | non important | - |
AE (grade 3-4) endpoints 00 |
Alopecia AE (grade 3-4) | 0.47 [0.02, 14.16] | | < 1 | | 0% | 1 study (1/-) | 66.4 % | NA | not evaluable | | non important | - |
Anaemia AE (grade 3-4) | 0.18 [0.04, 0.86] | | < 1 | | 87% | 2 studies (2/-) | 98.4 % | some concern | not evaluable | moderate | non important | - |
Arthralgia AE (grade 3-4) | 2.86 [0.30, 27.54] | | < 1 | | 0% | 1 study (1/-) | 18.4 % | NA | not evaluable | | non important | - |
Asthenia AE (grade 3-4) | 0.52 [0.24, 1.14] | | < 1 | | 0% | 2 studies (2/-) | 94.9 % | some concern | not evaluable | moderate | non important | - |
Back pain AE (grade 3-4) | 1.67 [0.49, 5.73] | | < 1 | | 0% | 1 study (1/-) | 20.8 % | NA | not evaluable | | non important | - |
Constipation AE (grade 3-4) | 1.55 [0.37, 6.54] | | < 1 | | 0% | 2 studies (2/-) | 27.6 % | some concern | not evaluable | moderate | non important | - |
Cough AE (grade 3-4) | 1.88 [0.26, 13.39] | | < 1 | | 0% | 2 studies (2/-) | 26.5 % | some concern | not evaluable | moderate | non important | - |
Decreased appetite AE (grade 3-4) | 0.63 [0.04, 9.82] | | < 1 | | 62% | 2 studies (2/-) | 62.7 % | some concern | not evaluable | moderate | non important | - |
Diarrhoea AE (grade 3-4) | 0.32 [0.11, 0.95] | | < 1 | | 0% | 2 studies (2/-) | 97.9 % | some concern | not evaluable | moderate | non important | - |
Dysgeusia AE (grade 3-4) | 0.95 [0.02, 47.91] | | < 1 | | 0% | 1 study (1/-) | 51.0 % | NA | not evaluable | | non important | - |
Dyspnoea AE (grade 3-4) | 1.09 [0.53, 2.23] | | < 1 | | 0% | 2 studies (2/-) | 40.7 % | some concern | not evaluable | moderate | non important | - |
Fatigue AE (grade 3-4) | 0.62 [0.34, 1.12] | | < 1 | | 0% | 2 studies (2/-) | 94.4 % | some concern | not evaluable | moderate | non important | - |
Febrile neutropenia AE (grade 3-4) | 0.02 [0.00, 0.11] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
Hypertension AE (grade 3-4) | 0.61 [0.10, 3.68] | | < 1 | | 0% | 1 study (1/-) | 70.4 % | NA | not evaluable | | non important | - |
Increase AST AE (grade 3-4) | 4.66 [0.54, 40.17] | | < 1 | | 0% | 1 study (1/-) | 8.2 % | NA | not evaluable | | non important | - |
Increased ALT AE (grade 3-4) | 4.66 [0.54, 40.17] | | < 1 | | 0% | 1 study (1/-) | 8.2 % | NA | not evaluable | | non important | - |
Leucopenia AE (grade 3-4) | 0.23 [0.03, 2.05] | | < 1 | | 0% | 1 study (1/-) | 90.5 % | NA | not evaluable | | non important | - |
Myalgia AE (grade 3-4) | 0.24 [0.03, 2.12] | | < 1 | | 0% | 1 study (1/-) | 90.0 % | NA | not evaluable | | non important | - |
Nausea AE (grade 3-4) | 0.65 [0.06, 6.44] | | < 1 | | 65% | 2 studies (2/-) | 64.4 % | some concern | not evaluable | moderate | non important | - |
Neutropenia AE (grade 3-4) | 0.03 [0.01, 0.08] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
Pancytopenia (AE grade 3-4) | 0.46 [0.04, 5.08] | | < 1 | | 0% | 1 study (1/-) | 73.6 % | NA | not evaluable | | non important | - |
Peripheral neuropathy AE (grade 3-4) | 0.07 [0.00, 1.18] | | < 1 | | 0% | 1 study (1/-) | 96.6 % | NA | not evaluable | | non important | - |
Peripheral oedema AE (grade 3-4) | 0.32 [0.03, 3.04] | | < 1 | | 0% | 1 study (1/-) | 83.9 % | NA | not evaluable | | non important | - |
Pneumonia AE (grade 3-4) | 0.71 [0.26, 1.93] | | < 1 | | 0% | 1 study (1/-) | 75.0 % | NA | not evaluable | | non important | - |
Pyrexia AE (grade 3-4) | 0.71 [0.08, 6.09] | | < 1 | | 0% | 2 studies (2/-) | 62.2 % | some concern | not evaluable | moderate | non important | - |
Sepsis AE (grade 3-4) | 0.46 [0.04, 5.08] | | < 1 | | 0% | 1 study (1/-) | 73.6 % | NA | not evaluable | | non important | - |
Stomatitis AE (grade 3-4) | 0.08 [0.01, 0.66] | | < 1 | | 0% | 1 study (1/-) | 99.1 % | NA | not evaluable | | non important | - |
Thrombocytopenia AE (grade 3-4) | 0.05 [0.01, 0.34] | | < 1 | | 0% | 1 study (1/-) | 99.9 % | NA | not evaluable | | non important | - |
Vomiting AE (grade 3-4) | 0.47 [0.12, 1.88] | | < 1 | | 0% | 2 studies (2/-) | 85.8 % | some concern | not evaluable | moderate | non important | - |