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) | 0.82 [0.74, 0.91] | | < 1 | | 0% | 5 studies (5/-) | 100.0 % | 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) | 0.70 [0.63, 0.78] | | < 1 | | 23% | 6 studies (6/-) | 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) | 1.76 [1.35, 2.30] | | > 1 | | 57% | 5 studies (5/-) | 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) | 2.16 [1.72, 2.70] | | < 1 | | 0% | 5 studies (5/-) | 0.0 % | some concern | not evaluable | moderate | non important | - |
STRAE (grade 3-4) | 2.14 [1.60, 2.87] | | < 1 | | 0% | 4 studies (4/-) | 0.0 % | some concern | not evaluable | moderate | non important | - |
TRAE (any grade) | 1.37 [0.73, 2.60] | | < 1 | | 82% | 5 studies (5/-) | 16.5 % | some concern | not evaluable | moderate | non important | - |
TRAE (grade 3-4) | 1.44 [1.01, 2.06] | | < 1 | | 73% | 5 studies (5/-) | 2.3 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to death (grade 5) | 1.24 [0.54, 2.83] | | < 1 | | 0% | 4 studies (4/-) | 30.6 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to discontinuation (any grade) | 1.76 [0.82, 3.79] | | < 1 | | 81% | 4 studies (4/-) | 7.5 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to discontinuation (grade 3-4) | 2.50 [0.95, 6.59] | | < 1 | | 78% | 4 studies (4/-) | 3.2 % | 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) | 0.55 [0.24, 1.27] | | < 1 | | 85% | 5 studies (5/-) | 91.9 % | 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) | 0.97 [0.49, 1.94] | | < 1 | | 0% | 4 studies (4/-) | 53.4 % | 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) | 0.55 [0.11, 2.65] | | < 1 | | 0% | 5 studies (5/-) | 77.1 % | some concern | serious | moderate | non important | - |
Decreased appetite TRAE (grade 3-4) | 1.41 [0.67, 2.97] | | < 1 | | 1% | 5 studies (5/-) | 18.4 % | 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) | 1.57 [0.79, 3.15] | | < 1 | | 0% | 5 studies (5/-) | 10.0 % | 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) | 1.78 [0.98, 3.23] | | < 1 | | 0% | 5 studies (5/-) | 2.9 % | 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) | 1.97 [0.25, 15.63] | | < 1 | | 0% | 3 studies (3/-) | 26.1 % | 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) | 1.03 [0.42, 2.53] | | < 1 | | 24% | 5 studies (5/-) | 47.8 % | 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) | 0.53 [0.19, 1.45] | | < 1 | | 75% | 5 studies (5/-) | 89.1 % | 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) | 2.53 [0.45, 14.15] | | < 1 | | 0% | 4 studies (4/-) | 14.7 % | some concern | not evaluable | moderate | non important | - |
Rash TRAE (grade 3-4) | 4.17 [1.12, 15.51] | | < 1 | | 0% | 5 studies (5/-) | 1.7 % | 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) | 0.64 [0.17, 2.48] | | < 1 | | 49% | 5 studies (5/-) | 73.9 % | some concern | not evaluable | moderate | non important | - |