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) | 0.78 [0.70, 0.86] | | < 1 | | 34% | 7 studies (7/-) | 100.0 % | some concern | not evaluable | moderate | crucial | - |
deaths (OS) (extension) | 0.53 [0.22, 1.23] | | < 1 | | 77% | 2 studies (2/-) | 93.0 % | some concern | not evaluable | moderate | important | - |
PFS (extension) | 0.69 [0.44, 1.07] | | < 1 | | 46% | 2 studies (2/-) | 95.2 % | some concern | not evaluable | moderate | important | - |
progression or deaths (PFS) | 0.91 [0.80, 1.04] | | < 1 | | 66% | 7 studies (7/-) | 92.3 % | some concern | not evaluable | moderate | important | - |
objective responses (ORR) | 1.64 [1.23, 2.19] | | > 1 | | 55% | 7 studies (7/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
objective responses (ORR) (extension) | 1.63 [0.19, 14.17] | | > 1 | | 91% | 2 studies (2/-) | 67.1 % | some concern | not evaluable | moderate | non important | - |
safety endpoints 00 |
AE (any grade) | 0.50 [0.26, 0.95] | | < 1 | | 66% | 3 studies (3/-) | 98.2 % | some concern | not evaluable | moderate | non important | - |
AE (grade 3-4) | 0.50 [0.42, 0.59] | | < 1 | | 0% | 3 studies (3/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
AE leading to death (grade 5) | 0.80 [0.40, 1.57] | | < 1 | | 0% | 2 studies (2/-) | 74.6 % | some concern | not evaluable | moderate | non important | - |
AE leading to treatment discontinuation (any grade) | 0.45 [0.24, 0.87] | | < 1 | | 66% | 2 studies (2/-) | 99.2 % | some concern | not evaluable | moderate | non important | - |
SAE (any grade) | 1.05 [0.64, 1.73] | | < 1 | | 0% | 1 study (1/-) | 42.1 % | NA | not evaluable | | non important | - |
SAE (grade 3-4) | 0.34 [0.03, 3.42] | | < 1 | | 93% | 2 studies (2/-) | 81.8 % | some concern | not evaluable | moderate | non important | - |
STRAE (any grade) | 0.37 [0.27, 0.52] | | < 1 | | 30% | 4 studies (4/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
STRAE (grade 3-4) | 0.29 [0.19, 0.45] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
TRAE (any grade) | 0.29 [0.24, 0.35] | | < 1 | | 0% | 5 studies (5/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
TRAE (grade 3-4) | 0.14 [0.10, 0.20] | | < 1 | | 75% | 6 studies (6/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to death (grade 5) | 0.30 [0.13, 0.69] | | < 1 | | 0% | 5 studies (5/-) | 99.8 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to discontinuation (any grade) | 0.35 [0.17, 0.71] | | < 1 | | 64% | 4 studies (4/-) | 99.8 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to discontinuation (grade 3-4) | 0.52 [0.16, 1.64] | | < 1 | | 44% | 2 studies (2/-) | 86.8 % | some concern | not evaluable | moderate | non important | - |
TRAE (grade 3-4) endpoints 00 |
Abdominal pain TRAE (grade 3-4) | 0.49 [0.02, 14.75] | | < 1 | | 0% | 1 study (1/-) | 65.7 % | NA | not evaluable | | non important | - |
Acute kidney injury TRAE (grade 3-4) | 0.74 [0.08, 7.10] | | < 1 | | 0% | 3 studies (3/-) | 60.3 % | some concern | not evaluable | moderate | non important | - |
Adrenal insufficiency TRAE (grade 3-4) | 1.86 [0.06, 55.60] | | < 1 | | 0% | 1 study (1/-) | 36.2 % | NA | not evaluable | | non important | - |
Alopecia TRAE (grade 3-4) | 0.65 [0.10, 4.29] | | < 1 | | 0% | 4 studies (4/-) | 67.2 % | some concern | not evaluable | moderate | non important | - |
Anaemia TRAE (grade 3-4) | 0.10 [0.03, 0.34] | | < 1 | | 0% | 4 studies (4/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
Arthralgia TRAE (grade 3-4) | 0.72 [0.08, 6.15] | | < 1 | | 0% | 3 studies (3/-) | 61.9 % | some concern | not evaluable | moderate | non important | - |
Asthenia TRAE (grade 3-4) | 0.10 [0.03, 0.36] | | < 1 | | 0% | 3 studies (3/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
Blood creatinine increased TRAE (grade 3-4) | 0.66 [0.04, 10.53] | | < 1 | | 0% | 2 studies (2/-) | 61.6 % | some concern | not evaluable | moderate | non important | - |
Colitis TRAE (grade 3-4) | 1.74 [0.24, 12.56] | | < 1 | | 0% | 3 studies (3/-) | 29.3 % | some concern | not evaluable | moderate | non important | - |
Constipation TRAE (grade 3-4) | 0.40 [0.04, 4.62] | | < 1 | | 0% | 2 studies (2/-) | 76.5 % | some concern | not evaluable | moderate | non important | - |
Decreased appetite TRAE (grade 3-4) | 0.25 [0.05, 1.16] | | < 1 | | 0% | 4 studies (4/-) | 96.2 % | some concern | not evaluable | moderate | non important | - |
Diabetes TRAE (grade 3-4) | 0.66 [0.04, 10.53] | | < 1 | | 0% | 2 studies (2/-) | 61.6 % | some concern | not evaluable | moderate | non important | - |
Diarrhoea TRAE (grade 3-4) | 0.38 [0.11, 1.34] | | < 1 | | 0% | 4 studies (4/-) | 93.4 % | some concern | not evaluable | moderate | non important | - |
Dizziness TRAE (grade 3-4) | 0.98 [0.02, 50.00] | | < 1 | | 0% | 1 study (1/-) | 50.3 % | NA | not evaluable | | non important | - |
Dysgeusia TRAE (grade 3-4) | 0.93 [0.02, 47.22] | | < 1 | | 0% | 1 study (1/-) | 51.3 % | NA | not evaluable | | non important | - |
Dyspnoea TRAE (grade 3-4) | 0.46 [0.04, 5.13] | | < 1 | | 0% | 1 study (1/-) | 73.3 % | NA | not evaluable | | non important | - |
Eczema TRAE (grade 3-4) | 0.66 [0.04, 10.53] | | < 1 | | 0% | 2 studies (2/-) | 61.6 % | some concern | not evaluable | moderate | non important | - |
Endocrine disorders TRAE (grade 3-4) | 0.46 [0.01, 23.40] | | < 1 | | 0% | 1 study (1/-) | 64.7 % | NA | not evaluable | | non important | - |
Erythema TRAE (grade 3-4) | 0.66 [0.04, 10.53] | | < 1 | | 0% | 2 studies (2/-) | 61.6 % | some concern | not evaluable | moderate | non important | - |
Fatigue TRAE (grade 3-4) | 0.18 [0.08, 0.39] | | < 1 | | 0% | 4 studies (4/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
Febrile neutropenia TRAE (grade 3-4) | 0.02 [0.00, 0.09] | | < 1 | | 0% | 3 studies (3/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
Gastrointestinal disorders TRAE (grade 3-4) | 0.93 [0.03, 27.74] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
Headache TRAE (grade 3-4) | 0.46 [0.02, 13.86] | | < 1 | | 0% | 1 study (1/-) | 66.9 % | NA | not evaluable | | non important | - |
Hepatobiliary disorders TRAE (grade 3-4) | 1.39 [0.14, 13.49] | | < 1 | | 0% | 1 study (1/-) | 38.8 % | NA | not evaluable | | non important | - |
Hypersensitivity TRAE (grade 3-4) | 0.44 [0.06, 3.38] | | < 1 | | 0% | 3 studies (3/-) | 78.6 % | some concern | not evaluable | moderate | non important | - |
Hypertension TRAE (grade 3-4) | 1.86 [0.17, 20.62] | | < 1 | | 0% | 1 study (1/-) | 30.8 % | NA | not evaluable | | non important | - |
Hyperthyroidism TRAE (grade 3-4) | 0.66 [0.04, 10.53] | | < 1 | | 0% | 2 studies (2/-) | 61.6 % | some concern | not evaluable | moderate | non important | - |
Hypothyroidism TRAE (grade 3-4) | 1.00 [0.12, 8.54] | | < 1 | | 0% | 3 studies (3/-) | 50.1 % | some concern | not evaluable | moderate | non important | - |
Increase AST TRAE (grade 3-4) | 0.81 [0.09, 6.95] | | < 1 | | 0% | 2 studies (2/-) | 57.6 % | some concern | not evaluable | moderate | non important | - |
Increased ALT TRAE (grade 3-4) | 0.91 [0.16, 5.34] | | < 1 | | 0% | 3 studies (3/-) | 54.1 % | some concern | not evaluable | moderate | non important | - |
Increased lacrimation (TRAE grade 3-4) | 0.93 [0.02, 47.22] | | < 1 | | 0% | 1 study (1/-) | 51.3 % | NA | not evaluable | | non important | - |
Increased lipase level TRAE (grade 3-4) | 3.74 [0.42, 33.65] | | < 1 | | 0% | 1 study (1/-) | 12.1 % | NA | not evaluable | | non important | - |
Infusion-related reactions TRAE (grade 3-4) | 1.93 [0.34, 10.91] | | < 1 | | 7% | 3 studies (3/-) | 22.9 % | some concern | not evaluable | moderate | non important | - |
Leucopenia TRAE (grade 3-4) | 0.05 [0.01, 0.16] | | < 1 | | 0% | 4 studies (4/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
Maculopapular rash TRAE (grade 3-4) | 0.66 [0.04, 10.53] | | < 1 | | 0% | 2 studies (2/-) | 61.6 % | some concern | not evaluable | moderate | non important | - |
Mucosal inflammation TRAE (grade 3-4) | 0.17 [0.03, 1.05] | | < 1 | | 0% | 3 studies (3/-) | 97.1 % | some concern | not evaluable | moderate | non important | - |
Myalgia TRAE (grade 3-4) | 0.55 [0.08, 3.90] | | < 1 | | 0% | 3 studies (3/-) | 72.3 % | some concern | not evaluable | moderate | non important | - |
Myocarditis TRAE (grade 3-4) | 0.93 [0.02, 46.93] | | < 1 | | 0% | 1 study (1/-) | 51.4 % | NA | not evaluable | | non important | - |
Nausea TRAE (grade 3-4) | 0.46 [0.11, 1.95] | | < 1 | | 0% | 3 studies (3/-) | 85.5 % | some concern | not evaluable | moderate | non important | - |
Neutropenia TRAE (grade 3-4) | 0.02 [0.01, 0.05] | | < 1 | | 0% | 4 studies (4/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) | 0.63 [0.05, 8.17] | | < 1 | | 0% | 2 studies (2/-) | 63.9 % | some concern | not evaluable | moderate | non important | - |
Paraesthesia TRAE (grade 3-4) | 0.96 [0.06, 15.39] | | < 1 | | 0% | 2 studies (2/-) | 51.2 % | some concern | not evaluable | moderate | non important | - |
Peripheral neuropathy TRAE (grade 3-4) | 0.16 [0.03, 0.88] | | < 1 | | 0% | 3 studies (3/-) | 98.2 % | some concern | not evaluable | moderate | non important | - |
Peripheral oedema TRAE (grade 3-4) | 0.35 [0.05, 2.46] | | < 1 | | 0% | 3 studies (3/-) | 85.3 % | some concern | not evaluable | moderate | non important | - |
Peripheral sensory neuropathy TRAE (grade 3-4) | 0.46 [0.02, 13.86] | | < 1 | | 0% | 1 study (1/-) | 66.9 % | NA | not evaluable | | non important | - |
Pneumonia TRAE (grade 3-4) | 0.09 [0.00, 1.68] | | < 1 | | 0% | 1 study (1/-) | 94.4 % | NA | not evaluable | | non important | - |
Pneumonitis TRAE (grade 3-4) | 2.82 [0.77, 10.37] | | < 1 | | 0% | 4 studies (4/-) | 6.0 % | some concern | not evaluable | moderate | non important | - |
Pruritic rash TRAE (grade 3-4) | 0.93 [0.02, 47.22] | | < 1 | | 0% | 1 study (1/-) | 51.3 % | NA | not evaluable | | non important | - |
Pruritus generalised TRAE (grade 3-4) | 0.66 [0.04, 10.53] | | < 1 | | 0% | 2 studies (2/-) | 61.6 % | some concern | not evaluable | moderate | non important | - |
Pruritus TRAE (grade 3-4) | 0.66 [0.04, 10.53] | | < 1 | | 0% | 2 studies (2/-) | 61.6 % | some concern | not evaluable | moderate | non important | - |
Pyrexia TRAE (grade 3-4) | 0.72 [0.08, 6.19] | | < 1 | | 0% | 3 studies (3/-) | 61.7 % | some concern | not evaluable | moderate | non important | - |
Rash TRAE (grade 3-4) | 1.08 [0.17, 6.66] | | < 1 | | 0% | 3 studies (3/-) | 46.9 % | some concern | not evaluable | moderate | non important | - |
Renal and urinary disorders TRAE (grade 3-4) | 0.46 [0.01, 23.40] | | < 1 | | 0% | 1 study (1/-) | 64.7 % | NA | not evaluable | | non important | - |
Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) | 6.60 [0.37, 116.99] | | < 1 | | 0% | 1 study (1/-) | 10.2 % | NA | not evaluable | | non important | - |
Sepsis TRAE (grade 3-4) | 0.23 [0.01, 5.14] | | < 1 | | 0% | 1 study (1/-) | 82.0 % | NA | not evaluable | | non important | - |
Skin and subcutaneous tissue disorders TRAE (grade 3-4) | 2.79 [0.14, 56.11] | | < 1 | | 0% | 1 study (1/-) | 25.4 % | NA | not evaluable | | non important | - |
Skin exfoliation TRAE (grade 3-4) | 0.93 [0.02, 47.22] | | < 1 | | 0% | 1 study (1/-) | 51.3 % | NA | not evaluable | | non important | - |
Stomatitis TRAE (grade 3-4) | 0.19 [0.02, 1.62] | | < 1 | | 0% | 2 studies (2/-) | 93.5 % | some concern | not evaluable | moderate | non important | - |
Thyroiditis TRAE (grade 3-4) | 0.66 [0.04, 10.53] | | < 1 | | 0% | 2 studies (2/-) | 61.6 % | some concern | not evaluable | moderate | non important | - |
Urticaria TRAE (grade 3-4) | 0.93 [0.02, 47.22] | | < 1 | | 0% | 1 study (1/-) | 51.3 % | NA | not evaluable | | non important | - |
Vitiligo TRAE (grade 3-4) | 0.46 [0.01, 23.40] | | < 1 | | 0% | 1 study (1/-) | 64.7 % | NA | not evaluable | | non important | - |
Vomiting TRAE (grade 3-4) | 0.35 [0.05, 2.48] | | < 1 | | 0% | 3 studies (3/-) | 85.2 % | some concern | not evaluable | moderate | non important | - |
Weight decreased TRAE (grade 3-4) | 0.93 [0.06, 14.90] | | < 1 | | 0% | 1 study (1/-) | 52.1 % | NA | not evaluable | | non important | - |
AE (grade 3-4) endpoints 00 |
Abdominal pain AE (grade 3-4) | 0.15 [0.01, 3.09] | | < 1 | | 0% | 1 study (1/-) | 88.6 % | NA | not evaluable | | non important | - |
Alopecia AE (grade 3-4) | 0.63 [0.05, 8.27] | | < 1 | | 0% | 2 studies (2/-) | 63.5 % | some concern | not evaluable | moderate | non important | - |
Anaemia AE (grade 3-4) | 0.39 [0.22, 0.67] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |