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 [0.73, 0.94] | | < 1 | | 0% | 4 studies (4/-) | 99.9 % | some concern | not evaluable | moderate | crucial | - |
deaths (OS) (extension) | 0.71 [0.45, 1.12] | | < 1 | | 0% | 1 study (1/-) | 92.9 % | NA | not evaluable | | important | - |
PFS (extension) | 0.54 [0.35, 0.83] | | < 1 | | 0% | 1 study (1/-) | 99.7 % | NA | not evaluable | | important | - |
progression or deaths (PFS) | 0.68 [0.61, 0.76] | | < 1 | | 0% | 4 studies (4/-) | 100.0 % | some concern | not evaluable | moderate | important | - |
DOR | 2.27 [1.44, 3.57] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | some concern | not evaluable | moderate | non important | - |
objective responses (ORR) | 1.89 [1.30, 2.75] | | > 1 | | 59% | 3 studies (3/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
objective responses (ORR) (extension) | 2.80 [1.34, 5.83] | | > 1 | | 0% | 1 study (1/-) | 99.7 % | NA | not evaluable | | non important | - |
safety endpoints 00 |
AE (any grade) | 5.12 [1.11, 23.56] | | < 1 | | 0% | 1 study (1/-) | 1.8 % | NA | not evaluable | | non important | - |
AE (grade 3-4) | 1.37 [0.98, 1.90] | | < 1 | | 0% | 1 study (1/-) | 3.3 % | NA | not evaluable | | non important | - |
AE leading to death (grade 5) | 2.59 [1.36, 4.92] | | < 1 | | 0% | 1 study (1/-) | 0.2 % | NA | not evaluable | | non important | - |
AE leading to treatment discontinuation (any grade) | 2.09 [1.45, 3.02] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
SAE (any grade) | 2.28 [1.66, 3.14] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
STRAE (any grade) | 2.17 [1.56, 3.01] | | < 1 | | 0% | 3 studies (3/-) | 0.0 % | some concern | not evaluable | moderate | non important | - |
STRAE (grade 3-4) | 2.83 [1.13, 7.06] | | < 1 | | 45% | 2 studies (2/-) | 1.3 % | some concern | not evaluable | moderate | non important | - |
TRAE (any grade) | 2.03 [1.08, 3.81] | | < 1 | | 50% | 3 studies (3/-) | 1.4 % | some concern | not evaluable | moderate | non important | - |
TRAE (grade 3-4) | 1.85 [1.41, 2.42] | | < 1 | | 13% | 3 studies (3/-) | 0.0 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to death (grade 5) | 1.48 [0.49, 4.46] | | < 1 | | 0% | 3 studies (3/-) | 24.5 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to discontinuation (any grade) | 0.86 [0.50, 1.46] | | < 1 | | 0% | 2 studies (2/-) | 71.4 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to discontinuation (grade 3-4) | 1.35 [0.29, 6.37] | | < 1 | | 51% | 2 studies (2/-) | 35.2 % | some concern | not evaluable | moderate | non important | - |
TRAE (grade 3-4) endpoints 00 |
Acute kidney injury TRAE (grade 3-4) | 4.32 [0.19, 97.73] | | < 1 | | 0% | 1 study (1/-) | 18.2 % | NA | not evaluable | | non important | - |
Adrenal insufficiency TRAE (grade 3-4) | 2.00 [0.07, 59.91] | | < 1 | | 0% | 1 study (1/-) | 34.7 % | NA | not evaluable | | non important | - |
Alopecia TRAE (grade 3-4) | 1.03 [0.06, 16.50] | | < 1 | | 0% | 2 studies (2/-) | 49.3 % | some concern | not evaluable | moderate | non important | - |
Anaemia TRAE (grade 3-4) | 1.12 [0.83, 1.52] | | < 1 | | 0% | 3 studies (3/-) | 22.1 % | some concern | not evaluable | moderate | non important | - |
Arthralgia TRAE (grade 3-4) | 1.00 [0.02, 50.55] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
Asthenia TRAE (grade 3-4) | 0.80 [0.31, 2.05] | | < 1 | | 0% | 2 studies (2/-) | 67.7 % | some concern | not evaluable | moderate | non important | - |
Blood creatinine increased TRAE (grade 3-4) | 1.05 [0.02, 53.86] | | < 1 | | 0% | 1 study (1/-) | 49.0 % | NA | not evaluable | | non important | - |
Colitis TRAE (grade 3-4) | 8.08 [0.43, 153.53] | | < 1 | | 0% | 1 study (1/-) | 8.4 % | NA | not evaluable | | non important | - |
Constipation TRAE (grade 3-4) | 0.47 [0.06, 3.37] | | < 1 | | 0% | 3 studies (3/-) | 77.4 % | some concern | not evaluable | moderate | non important | - |
Decreased appetite TRAE (grade 3-4) | 2.25 [0.86, 5.84] | | < 1 | | 0% | 3 studies (3/-) | 4.9 % | some concern | not evaluable | moderate | non important | - |
Diabetes TRAE (grade 3-4) | 6.05 [0.30, 121.16] | | < 1 | | 0% | 1 study (1/-) | 12.2 % | NA | not evaluable | | non important | - |
Diarrhoea TRAE (grade 3-4) | 1.28 [0.55, 2.99] | | < 1 | | 0% | 3 studies (3/-) | 28.4 % | some concern | not evaluable | moderate | non important | - |
Dizziness TRAE (grade 3-4) | 1.05 [0.02, 53.86] | | < 1 | | 0% | 1 study (1/-) | 49.0 % | NA | not evaluable | | non important | - |
Dysgeusia TRAE (grade 3-4) | 1.05 [0.02, 53.86] | | < 1 | | 0% | 1 study (1/-) | 49.0 % | NA | not evaluable | | non important | - |
Fatigue TRAE (grade 3-4) | 2.08 [1.01, 4.27] | | < 1 | | 0% | 3 studies (3/-) | 2.3 % | some concern | not evaluable | moderate | non important | - |
Febrile neutropenia TRAE (grade 3-4) | 2.62 [1.11, 6.19] | | < 1 | | 0% | 2 studies (2/-) | 1.4 % | some concern | not evaluable | moderate | non important | - |
Guillain-Barré syndrome TRAE (grade 3-4) | 1.00 [0.02, 50.55] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
Hepatitis TRAE (grade 3-4) | 1.00 [0.06, 16.05] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
Hyperthyroidism TRAE (grade 3-4) | 1.52 [0.12, 19.92] | | < 1 | | 0% | 2 studies (2/-) | 37.6 % | some concern | not evaluable | moderate | non important | - |
Hypothyroidism TRAE (grade 3-4) | 2.40 [0.21, 27.49] | | < 1 | | 0% | 2 studies (2/-) | 24.2 % | some concern | not evaluable | moderate | non important | - |
Increase AST TRAE (grade 3-4) | 1.05 [0.06, 17.21] | | < 1 | | 0% | 1 study (1/-) | 48.6 % | NA | not evaluable | | non important | - |
Increased ALT TRAE (grade 3-4) | 1.05 [0.06, 17.21] | | < 1 | | 0% | 1 study (1/-) | 48.6 % | NA | not evaluable | | non important | - |
Increased lacrimation (TRAE grade 3-4) | 1.05 [0.02, 53.86] | | < 1 | | 0% | 1 study (1/-) | 49.0 % | NA | not evaluable | | non important | - |
Infusion-related reactions TRAE (grade 3-4) | 1.53 [0.12, 20.15] | | < 1 | | 0% | 2 studies (2/-) | 37.3 % | some concern | not evaluable | moderate | non important | - |
Leucopenia TRAE (grade 3-4) | 1.48 [0.74, 2.94] | | < 1 | | 0% | 2 studies (2/-) | 13.2 % | some concern | not evaluable | moderate | non important | - |
Myalgia TRAE (grade 3-4) | 1.00 [0.02, 50.55] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
Myositis TRAE (grade 3-4) | 1.00 [0.02, 50.55] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
Nausea TRAE (grade 3-4) | 1.58 [0.60, 4.19] | | < 1 | | 0% | 3 studies (3/-) | 18.0 % | some concern | not evaluable | moderate | non important | - |
Nephritis TRAE (grade 3-4) | 1.00 [0.02, 50.55] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
Neutropenia TRAE (grade 3-4) | 1.00 [0.73, 1.38] | | < 1 | | 0% | 3 studies (3/-) | 48.9 % | some concern | not evaluable | moderate | non important | - |
Pancreatitis TRAE (grade 3-4) | 2.00 [0.07, 59.91] | | < 1 | | 0% | 1 study (1/-) | 34.7 % | NA | not evaluable | | non important | - |
Pancytopenia TRAE (grade 3-4) | 0.52 [0.02, 15.84] | | < 1 | | 0% | 1 study (1/-) | 64.4 % | NA | not evaluable | | non important | - |
Peripheral neuropathy TRAE (grade 3-4) | 2.01 [0.37, 11.06] | | < 1 | | 0% | 1 study (1/-) | 21.2 % | NA | not evaluable | | non important | - |
Peripheral oedema TRAE (grade 3-4) | 1.05 [0.02, 53.86] | | < 1 | | 0% | 1 study (1/-) | 49.0 % | NA | not evaluable | | non important | - |
Peripheral sensory neuropathy TRAE (grade 3-4) | 4.04 [0.45, 36.31] | | < 1 | | 0% | 1 study (1/-) | 10.8 % | NA | not evaluable | | non important | - |
Pneumonia TRAE (grade 3-4) | 2.12 [0.07, 64.42] | | < 1 | | 0% | 1 study (1/-) | 33.5 % | NA | not evaluable | | non important | - |
Pneumonitis TRAE (grade 3-4) | 1.74 [0.46, 6.55] | | < 1 | | 0% | 2 studies (2/-) | 20.8 % | some concern | not evaluable | moderate | non important | - |
Pruritus TRAE (grade 3-4) | 1.06 [0.07, 17.04] | | < 1 | | 0% | 2 studies (2/-) | 48.4 % | some concern | not evaluable | moderate | non important | - |
Rash TRAE (grade 3-4) | 2.07 [0.38, 11.33] | | < 1 | | 0% | 3 studies (3/-) | 20.3 % | some concern | not evaluable | moderate | non important | - |
Sepsis TRAE (grade 3-4) | 2.12 [0.07, 64.42] | | < 1 | | 0% | 1 study (1/-) | 33.5 % | NA | not evaluable | | non important | - |
Severe skin reaction TRAE (grade 3-4) | 1.03 [0.11, 10.07] | | < 1 | | 0% | 2 studies (2/-) | 48.9 % | some concern | not evaluable | moderate | non important | - |
Stomatitis TRAE (grade 3-4) | 0.52 [0.02, 15.84] | | < 1 | | 0% | 1 study (1/-) | 64.4 % | NA | not evaluable | | non important | - |
Thrombocytopenia TRAE (grade 3-4) | 1.16 [0.69, 1.95] | | < 1 | | 0% | 2 studies (2/-) | 29.4 % | some concern | not evaluable | moderate | non important | - |
Vomiting TRAE (grade 3-4) | 1.83 [0.56, 5.97] | | < 1 | | 0% | 3 studies (3/-) | 15.7 % | some concern | not evaluable | moderate | non important | - |