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 [0.67, 0.87] | | < 1 | | 9% | 6 studies (6/-) | 100.0 % | some concern | not evaluable | moderate | crucial | - |
deaths (OS) (extension) | 0.68 [0.57, 0.81] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | important | - |
MFS | 0.53 [0.37, 0.76] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
PFS (extension) | 0.61 [0.53, 0.70] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | important | - |
progression or deaths (PFS) | 0.64 [0.51, 0.81] | | < 1 | | 80% | 6 studies (6/-) | 100.0 % | some concern | not evaluable | moderate | important | - |
RFS (extension) | 0.59 [0.49, 0.71] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
RFS/DFS | 0.57 [0.43, 0.75] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
DMFS | 0.60 [0.49, 0.73] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
DOR | 0.41 [0.20, 0.83] | | < 1 | | 0% | 1 study (1/-) | 99.3 % | NA | not evaluable | | non important | - |
objective responses (ORR) | 2.63 [1.19, 5.81] | | > 1 | | 92% | 6 studies (6/-) | 99.2 % | some concern | not evaluable | moderate | non important | - |
safety endpoints 00 |
AE (any grade) | 3.41 [0.70, 16.68] | | < 1 | | 76% | 3 studies (3/-) | 6.6 % | low | not evaluable | high | non important | - |
AE (grade 3-4) | 2.72 [1.67, 4.43] | | < 1 | | 73% | 3 studies (3/-) | 0.0 % | low | not evaluable | high | non important | - |
AE leading to death (grade 5) | 1.58 [0.53, 4.71] | | < 1 | | 0% | 2 studies (2/-) | 20.5 % | some concern | not evaluable | moderate | non important | - |
AE leading to treatment discontinuation (any grade) | 2.58 [1.16, 5.75] | | < 1 | | 0% | 1 study (1/-) | 1.0 % | NA | not evaluable | | non important | - |
STRAE (any grade) | 0.65 [0.46, 0.92] | | < 1 | | 0% | 2 studies (2/-) | 99.3 % | some concern | not evaluable | moderate | non important | - |
STRAE (grade 3-4) | 0.92 [0.06, 14.79] | | < 1 | | 0% | 2 studies (2/-) | 52.3 % | some concern | not evaluable | moderate | non important | - |
TRAE (any grade) | 1.12 [0.75, 1.67] | | < 1 | | 77% | 6 studies (6/-) | 28.8 % | some concern | not evaluable | moderate | non important | - |
TRAE (grade 3-4) | 1.17 [0.56, 2.45] | | < 1 | | 92% | 6 studies (6/-) | 33.9 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to death (grade 5) | 1.59 [0.37, 6.78] | | < 1 | | 0% | 6 studies (6/-) | 26.6 % | some concern | serious | moderate | non important | - |
TRAE leading to discontinuation (any grade) | 1.25 [0.81, 1.94] | | < 1 | | 42% | 5 studies (5/-) | 16.0 % | some concern | not evaluable | moderate | non important | - |
TRAE leading to discontinuation (grade 3-4) | 1.92 [0.84, 4.37] | | < 1 | | 0% | 4 studies (4/-) | 6.1 % | some concern | not evaluable | moderate | non important | - |
TRAE (grade 3-4) endpoints 00 |
Abdominal pain TRAE (grade 3-4) | 0.92 [0.06, 14.79] | | < 1 | | 0% | 2 studies (2/-) | 52.3 % | some concern | not evaluable | moderate | non important | - |
Adrenal insufficiency TRAE (grade 3-4) | 1.97 [0.07, 58.99] | | < 1 | | 0% | 1 study (1/-) | 34.9 % | NA | not evaluable | | non important | - |
Alopecia TRAE (grade 3-4) | 0.94 [0.13, 6.69] | | < 1 | | 0% | 4 studies (4/-) | 52.5 % | some concern | not evaluable | moderate | non important | - |
Anaemia TRAE (grade 3-4) | 0.25 [0.05, 1.30] | | < 1 | | 36% | 4 studies (4/-) | 95.0 % | some concern | not evaluable | moderate | non important | - |
Arthralgia TRAE (grade 3-4) | 1.42 [0.35, 5.86] | | < 1 | | 0% | 5 studies (5/-) | 31.2 % | some concern | not evaluable | moderate | non important | - |
Asthenia TRAE (grade 3-4) | 0.57 [0.15, 2.25] | | < 1 | | 0% | 4 studies (4/-) | 78.8 % | some concern | not evaluable | moderate | non important | - |
Chills TRAE (grade 3-4) | 0.92 [0.06, 14.79] | | < 1 | | 0% | 2 studies (2/-) | 52.3 % | some concern | not evaluable | moderate | non important | - |
Colitis TRAE (grade 3-4) | 0.81 [0.21, 3.18] | | < 1 | | 71% | 5 studies (5/-) | 61.6 % | some concern | not evaluable | moderate | non important | - |
Constipation TRAE (grade 3-4) | 0.94 [0.13, 6.69] | | < 1 | | 0% | 4 studies (4/-) | 52.5 % | some concern | not evaluable | moderate | non important | - |
Cough TRAE (grade 3-4) | 0.92 [0.06, 14.79] | | < 1 | | 0% | 2 studies (2/-) | 52.3 % | some concern | not evaluable | moderate | non important | - |
Decreased appetite TRAE (grade 3-4) | 0.94 [0.13, 6.69] | | < 1 | | 0% | 4 studies (4/-) | 52.5 % | some concern | not evaluable | moderate | non important | - |
Diabetes TRAE (grade 3-4) | 4.89 [0.54, 44.56] | | < 1 | | 0% | 2 studies (2/-) | 8.1 % | low | not evaluable | high | non important | - |
Diarrhoea TRAE (grade 3-4) | 0.79 [0.42, 1.51] | | < 1 | | 0% | 5 studies (5/-) | 75.9 % | some concern | not evaluable | moderate | non important | - |
Dry skin TRAE (grade 3-4) | 0.94 [0.13, 6.69] | | < 1 | | 0% | 4 studies (4/-) | 52.5 % | some concern | not evaluable | moderate | non important | - |
Dyspnoea TRAE (grade 3-4) | 0.94 [0.15, 5.79] | | < 1 | | 0% | 3 studies (3/-) | 52.6 % | some concern | not evaluable | moderate | non important | - |
Endocrine disorders TRAE (grade 3-4) | 18.05 [1.04, 312.27] | | < 1 | | 0% | 1 study (1/-) | 2.4 % | NA | not evaluable | | non important | - |
Fatigue TRAE (grade 3-4) | 0.35 [0.15, 0.82] | | < 1 | | 0% | 4 studies (4/-) | 99.2 % | some concern | not evaluable | moderate | non important | - |
Gastrointestinal disorders TRAE (grade 3-4) | 5.01 [1.09, 22.98] | | < 1 | | 0% | 1 study (1/-) | 1.9 % | NA | not evaluable | | non important | - |
Headache TRAE (grade 3-4) | 0.92 [0.06, 14.79] | | < 1 | | 0% | 2 studies (2/-) | 52.3 % | some concern | not evaluable | moderate | non important | - |
Hepatitis TRAE (grade 3-4) | 3.97 [1.30, 12.10] | | < 1 | | 0% | 5 studies (5/-) | 0.8 % | some concern | not evaluable | moderate | non important | - |
Hyperthyroidism TRAE (grade 3-4) | 0.81 [0.16, 4.03] | | < 1 | | 0% | 5 studies (5/-) | 60.0 % | some concern | not evaluable | moderate | non important | - |
Hypophysitis TRAE (grade 3-4) | 0.94 [0.24, 3.66] | | < 1 | | 0% | 5 studies (5/-) | 53.7 % | some concern | not evaluable | moderate | non important | - |
Hypothyroidism TRAE (grade 3-4) | 1.13 [0.21, 6.16] | | < 1 | | 0% | 5 studies (5/-) | 44.5 % | some concern | serious | moderate | non important | - |
Increase AST TRAE (grade 3-4) | 0.35 [0.05, 2.37] | | < 1 | | 0% | 2 studies (2/-) | 85.7 % | some concern | not evaluable | moderate | non important | - |
Increased ALT TRAE (grade 3-4) | 0.35 [0.05, 2.37] | | < 1 | | 0% | 2 studies (2/-) | 85.7 % | some concern | not evaluable | moderate | non important | - |
Leucopenia TRAE (grade 3-4) | 0.07 [0.01, 0.50] | | < 1 | | 0% | 2 studies (2/-) | 99.5 % | some concern | not evaluable | moderate | non important | - |
Maculopapular rash TRAE (grade 3-4) | 1.09 [0.22, 5.44] | | < 1 | | 0% | 4 studies (4/-) | 45.6 % | some concern | not evaluable | moderate | non important | - |
Myalgia TRAE (grade 3-4) | 0.94 [0.22, 4.02] | | < 1 | | 0% | 4 studies (4/-) | 53.2 % | some concern | not evaluable | moderate | non important | - |
Myocarditis TRAE (grade 3-4) | 1.97 [0.07, 58.99] | | < 1 | | 0% | 1 study (1/-) | 34.9 % | NA | not evaluable | | non important | - |
Myositis TRAE (grade 3-4) | 0.94 [0.10, 9.08] | | < 1 | | 0% | 3 studies (3/-) | 52.0 % | some concern | not evaluable | moderate | non important | - |
Nausea TRAE (grade 3-4) | 0.34 [0.08, 1.37] | | < 1 | | 0% | 5 studies (5/-) | 93.5 % | some concern | not evaluable | moderate | non important | - |
Nephritis TRAE (grade 3-4) | 1.03 [0.15, 6.90] | | < 1 | | 0% | 3 studies (3/-) | 48.7 % | some concern | not evaluable | moderate | non important | - |
Neutropenia TRAE (grade 3-4) | 0.18 [0.04, 0.96] | | < 1 | | 0% | 4 studies (4/-) | 97.7 % | some concern | not evaluable | moderate | non important | - |
Pancreatitis TRAE (grade 3-4) | 1.20 [0.18, 7.92] | | < 1 | | 0% | 3 studies (3/-) | 42.4 % | some concern | not evaluable | moderate | non important | - |
Paraesthesia TRAE (grade 3-4) | 0.63 [0.10, 3.88] | | < 1 | | 0% | 4 studies (4/-) | 69.0 % | some concern | not evaluable | moderate | non important | - |
Peripheral neuropathy TRAE (grade 3-4) | 0.24 [0.03, 2.13] | | < 1 | | 0% | 2 studies (2/-) | 89.9 % | some concern | not evaluable | moderate | non important | - |
Pneumonitis TRAE (grade 3-4) | 2.19 [0.55, 8.64] | | < 1 | | 0% | 5 studies (5/-) | 13.3 % | some concern | not evaluable | moderate | non important | - |
Pruritic rash TRAE (grade 3-4) | 0.92 [0.06, 14.79] | | < 1 | | 0% | 2 studies (2/-) | 52.3 % | some concern | not evaluable | moderate | non important | - |
Pruritus TRAE (grade 3-4) | 0.95 [0.16, 5.49] | | < 1 | | 0% | 5 studies (5/-) | 52.3 % | some concern | not evaluable | moderate | non important | - |
Pyrexia TRAE (grade 3-4) | 0.92 [0.06, 14.79] | | < 1 | | 0% | 2 studies (2/-) | 52.3 % | some concern | not evaluable | moderate | non important | - |
Rash TRAE (grade 3-4) | 1.13 [0.21, 6.19] | | < 1 | | 0% | 5 studies (5/-) | 44.3 % | some concern | serious | moderate | non important | - |
Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) | 7.94 [0.42, 150.67] | | < 1 | | 0% | 1 study (1/-) | 8.6 % | NA | not evaluable | | non important | - |
Sarcoidosis TRAE (grade 3-4) | 0.99 [0.02, 49.80] | | < 1 | | 0% | 1 study (1/-) | 50.3 % | NA | not evaluable | | non important | - |
Severe skin reaction TRAE (grade 3-4) | 5.95 [0.30, 119.02] | | < 1 | | 0% | 1 study (1/-) | 12.5 % | NA | not evaluable | | non important | - |
Skin and subcutaneous tissue disorders TRAE (grade 3-4) | 1.97 [0.07, 58.99] | | < 1 | | 0% | 1 study (1/-) | 34.9 % | NA | not evaluable | | non important | - |
Thrombocytopenia TRAE (grade 3-4) | 0.18 [0.03, 1.07] | | < 1 | | 0% | 2 studies (2/-) | 97.0 % | some concern | not evaluable | moderate | non important | - |
Thyroiditis TRAE (grade 3-4) | 0.99 [0.02, 49.80] | | < 1 | | 0% | 1 study (1/-) | 50.3 % | NA | not evaluable | | non important | - |
Uveitis TRAE (grade 3-4) | 1.13 [0.21, 6.18] | | < 1 | | 0% | 5 studies (5/-) | 44.4 % | some concern | serious | moderate | non important | - |
Vitiligo TRAE (grade 3-4) | 0.97 [0.10, 9.32] | | < 1 | | 0% | 3 studies (3/-) | 51.1 % | some concern | not evaluable | moderate | non important | - |
Vomiting TRAE (grade 3-4) | 0.38 [0.10, 1.43] | | < 1 | | 0% | 4 studies (4/-) | 92.4 % | some concern | not evaluable | moderate | non important | - |
Weight decreased TRAE (grade 3-4) | 0.46 [0.04, 5.09] | | < 1 | | 0% | 2 studies (2/-) | 73.5 % | some concern | not evaluable | moderate | non important | - |