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) | 1.15 [0.92, 1.43] | | < 1 | | 86% | 10 studies (10/-) | 11.4 % | low | low | high | crucial | - |
deaths (OS) (extension) | 1.36 [0.90, 2.06] | | < 1 | | 96% | 5 studies (5/-) | 7.1 % | low | serious | high | important | - |
MFS | 0.75 [0.65, 0.87] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | low | not evaluable | high | important | - |
MFS (extension) | 0.76 [0.64, 0.90] | | < 1 | | 0% | 1 study (1/-) | 99.9 % | NA | not evaluable | | important | - |
progression or deaths (PFS) | 1.77 [1.45, 2.16] | | < 1 | | 66% | 6 studies (6/-) | 0.0 % | low | not evaluable | high | important | - |
RFS (extension) | 0.73 [0.65, 0.83] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | low | not evaluable | high | important | - |
RFS/DFS | 0.72 [0.62, 0.82] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | low | not evaluable | high | important | - |
DCR | 0.84 [0.61, 1.16] | | > 1 | | 0% | 1 study (1/-) | 14.4 % | NA | not evaluable | | non important | - |
objective responses (ORR) | 0.43 [0.21, 0.87] | | > 1 | | 93% | 8 studies (8/-) | 1.0 % | low | not evaluable | high | non important | - |
safety endpoints 00 |
AE (any grade) | 1.21 [0.28, 5.25] | | < 1 | | 86% | 4 studies (4/-) | 40.2 % | low | not evaluable | high | non important | - |
AE (grade 3-4) | 0.42 [0.16, 1.10] | | < 1 | | 96% | 4 studies (4/-) | 96.2 % | low | not evaluable | high | non important | - |
TRAE (any grade) | 0.83 [0.35, 1.95] | | < 1 | | 97% | 10 studies (10/-) | 66.7 % | low | low | high | non important | - |
TRAE (grade 3-4) | 0.89 [0.40, 1.94] | | < 1 | | 97% | 10 studies (10/-) | 61.9 % | low | low | high | non important | - |
TRAE leading to death (grade 5) | 0.83 [0.28, 2.46] | | < 1 | | 0% | 7 studies (7/-) | 63.0 % | low | not evaluable | high | non important | - |
TRAE leading to discontinuation (any grade) | 0.77 [0.24, 2.42] | | < 1 | | 98% | 8 studies (8/-) | 67.5 % | low | not evaluable | high | non important | - |
TRAE leading to discontinuation (grade 3-4) | 0.40 [0.17, 0.98] | | < 1 | | 91% | 7 studies (7/-) | 97.8 % | low | not evaluable | high | non important | - |
TRAE (grade 3-4) endpoints 00 |
Adrenal insufficiency TRAE (grade 3-4) | 0.59 [0.24, 1.50] | | < 1 | | 0% | 7 studies (7/-) | 86.5 % | low | not evaluable | high | non important | - |
Colitis TRAE (grade 3-4) | 2.35 [1.02, 5.42] | | < 1 | | 82% | 9 studies (9/-) | 2.2 % | low | serious | high | non important | - |
Diarrhoea TRAE (grade 3-4) | 1.28 [0.62, 2.67] | | < 1 | | 84% | 10 studies (10/-) | 25.2 % | low | critical | high | non important | - |
Endocrine disorders TRAE (grade 3-4) | 2.98 [0.56, 15.74] | | < 1 | | 83% | 5 studies (5/-) | 10.0 % | low | not evaluable | high | non important | - |
Eye disorders TRAE (grade 3-4) | 2.01 [0.07, 60.22] | | < 1 | | 0% | 1 study (1/-) | 34.5 % | NA | not evaluable | | non important | - |
Febrile neutropenia TRAE (grade 3-4) | 0.25 [0.01, 5.57] | | < 1 | | 0% | 1 study (1/-) | 80.6 % | NA | not evaluable | | non important | - |
Gastrointestinal disorders TRAE (grade 3-4) | 1.28 [0.31, 5.21] | | < 1 | | 94% | 6 studies (6/-) | 36.7 % | low | not evaluable | high | non important | - |
Guillain-Barré syndrome TRAE (grade 3-4) | 0.25 [0.01, 5.57] | | < 1 | | 0% | 1 study (1/-) | 80.6 % | NA | not evaluable | | non important | - |
Hepatitis TRAE (grade 3-4) | 0.37 [0.15, 0.90] | | < 1 | | 0% | 8 studies (8/-) | 98.5 % | low | not evaluable | high | non important | - |
Hepatobiliary disorders TRAE (grade 3-4) | 0.53 [0.04, 7.00] | | < 1 | | 87% | 5 studies (5/-) | 68.2 % | low | not evaluable | high | non important | - |
Hypersensitivity TRAE (grade 3-4) | 0.51 [0.04, 5.72] | | < 1 | | 14% | 2 studies (2/-) | 70.8 % | low | not evaluable | high | non important | - |
Hypophysitis TRAE (grade 3-4) | 1.67 [0.72, 3.91] | | < 1 | | 50% | 10 studies (10/-) | 11.8 % | low | critical | high | non important | - |
Hypothyroidism TRAE (grade 3-4) | 0.77 [0.25, 2.38] | | < 1 | | 0% | 9 studies (9/-) | 67.7 % | low | serious | high | non important | - |
Increase AST TRAE (grade 3-4) | 0.33 [0.13, 0.85] | | < 1 | | 36% | 9 studies (9/-) | 98.9 % | low | serious | high | non important | - |
Increased ALT TRAE (grade 3-4) | 0.38 [0.17, 0.85] | | < 1 | | 44% | 9 studies (9/-) | 99.1 % | low | not evaluable | high | non important | - |
Increased lipase level TRAE (grade 3-4) | 0.48 [0.26, 0.88] | | < 1 | | 19% | 4 studies (4/-) | 99.1 % | low | not evaluable | high | non important | - |
Infusion-related reactions TRAE (grade 3-4) | 0.25 [0.01, 5.57] | | < 1 | | 0% | 1 study (1/-) | 80.6 % | NA | not evaluable | | non important | - |
Maculopapular rash TRAE (grade 3-4) | 0.35 [0.12, 0.98] | | < 1 | | 0% | 7 studies (7/-) | 97.7 % | low | not evaluable | high | non important | - |
Nervous system disorders TRAE (grade 3-4) | 1.54 [0.01, 206.07] | | < 1 | | 83% | 2 studies (2/-) | 43.4 % | low | not evaluable | high | non important | - |
Pancreatitis TRAE (grade 3-4) | 0.50 [0.02, 15.01] | | < 1 | | 0% | 1 study (1/-) | 65.2 % | NA | not evaluable | | non important | - |
Pancytopenia TRAE (grade 3-4) | 0.50 [0.02, 15.01] | | < 1 | | 0% | 1 study (1/-) | 65.2 % | NA | not evaluable | | non important | - |
Pericarditis TRAE (grade 3-4) | 0.50 [0.02, 15.01] | | < 1 | | 0% | 1 study (1/-) | 65.2 % | NA | not evaluable | | non important | - |
Peripheral neuropathy TRAE (grade 3-4) | 0.25 [0.01, 5.57] | | < 1 | | 0% | 1 study (1/-) | 80.6 % | NA | not evaluable | | non important | - |
Pneumonitis TRAE (grade 3-4) | 0.64 [0.21, 1.92] | | < 1 | | 0% | 6 studies (6/-) | 78.8 % | low | not evaluable | high | non important | - |
Polymyalgia Rheumatica TRAE (grade 3-4) | 2.01 [0.07, 60.22] | | < 1 | | 0% | 1 study (1/-) | 34.5 % | NA | not evaluable | | non important | - |
Pruritic rash TRAE (grade 3-4) | 1.33 [0.28, 6.35] | | < 1 | | 0% | 6 studies (6/-) | 35.9 % | low | not evaluable | high | non important | - |
Pruritus TRAE (grade 3-4) | 0.57 [0.22, 1.47] | | < 1 | | 0% | 9 studies (9/-) | 87.9 % | low | not evaluable | high | non important | - |
Rash TRAE (grade 3-4) | 0.64 [0.34, 1.22] | | < 1 | | 10% | 10 studies (10/-) | 91.0 % | low | low | high | non important | - |
Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) | 0.27 [0.06, 1.25] | | < 1 | | 0% | 3 studies (3/-) | 95.3 % | low | not evaluable | high | non important | - |
Skin and subcutaneous tissue disorders TRAE (grade 3-4) | 0.80 [0.21, 3.02] | | < 1 | | 71% | 6 studies (6/-) | 63.1 % | low | not evaluable | high | non important | - |
Thyroiditis TRAE (grade 3-4) | 0.61 [0.08, 4.71] | | < 1 | | 0% | 3 studies (3/-) | 68.3 % | low | not evaluable | high | non important | - |
Uveitis TRAE (grade 3-4) | 1.39 [0.16, 11.91] | | < 1 | | 0% | 3 studies (3/-) | 38.3 % | some concern | not evaluable | moderate | non important | - |
Vitiligo TRAE (grade 3-4) | 1.18 [0.22, 6.46] | | < 1 | | 0% | 5 studies (5/-) | 42.5 % | low | not evaluable | high | non important | - |
AE (grade 3-4) endpoints 00 |
Abdominal pain AE (grade 3-4) | 0.21 [0.03, 1.36] | | < 1 | | 77% | 3 studies (3/-) | 94.8 % | low | not evaluable | high | non important | - |
Anaemia AE (grade 3-4) | 0.61 [0.20, 1.81] | | < 1 | | 43% | 2 studies (2/-) | 81.5 % | low | not evaluable | high | non important | - |
Colitis AE (grade 3-4) | 6.26 [2.61, 15.03] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
Constipation AE (grade 3-4) | 2.99 [0.80, 11.14] | | < 1 | | 0% | 2 studies (2/-) | 5.2 % | low | not evaluable | high | non important | - |
Cough AE (grade 3-4) | 0.20 [0.01, 6.38] | | < 1 | | 69% | 3 studies (3/-) | 81.4 % | low | not evaluable | high | non important | - |
Decreased appetite AE (grade 3-4) | 0.34 [0.07, 1.59] | | < 1 | | 56% | 3 studies (3/-) | 91.4 % | low | not evaluable | high | non important | - |
Diarrhoea AE (grade 3-4) | 1.01 [0.20, 5.07] | | < 1 | | 89% | 3 studies (3/-) | 49.7 % | low | not evaluable | high | non important | - |
Dyspnoea AE (grade 3-4) | 0.95 [0.43, 2.08] | | < 1 | | 0% | 2 studies (2/-) | 55.5 % | low | not evaluable | high | non important | - |
Fatigue AE (grade 3-4) | 0.53 [0.04, 6.96] | | < 1 | | 96% | 3 studies (3/-) | 68.2 % | low | not evaluable | high | non important | - |
Headache AE (grade 3-4) | 0.42 [0.03, 6.30] | | < 1 | | 92% | 3 studies (3/-) | 73.3 % | low | not evaluable | high | non important | - |
Hypophysitis AE (grade 3-4) | 11.01 [2.57, 47.24] | | < 1 | | 0% | 1 study (1/-) | 0.1 % | NA | not evaluable | | non important | - |
Hypothyroidism AE (grade 3-4) | 0.14 [0.02, 1.16] | | < 1 | | 0% | 1 study (1/-) | 96.5 % | NA | not evaluable | | non important | - |
Increase AST AE (grade 3-4) | 0.80 [0.45, 1.45] | | < 1 | | 0% | 1 study (1/-) | 76.6 % | NA | not evaluable | | non important | - |
Increased ALT AE (grade 3-4) | 0.97 [0.55, 1.70] | | < 1 | | 0% | 1 study (1/-) | 54.8 % | NA | not evaluable | | non important | - |
Nausea AE (grade 3-4) | 0.26 [0.02, 4.55] | | < 1 | | 89% | 3 studies (3/-) | 81.8 % | low | not evaluable | high | non important | - |
Pruritus AE (grade 3-4) | 0.14 [0.07, 0.26] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
Pyrexia AE (grade 3-4) | 0.24 [0.10, 0.58] | | < 1 | | 0% | 3 studies (3/-) | 99.9 % | low | not evaluable | high | non important | - |
Rash AE (grade 3-4) | 0.06 [0.03, 0.15] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
Vomiting AE (grade 3-4) | 0.44 [0.07, 2.85] | | < 1 | | 79% | 3 studies (3/-) | 80.5 % | low | not evaluable | high | non important | - |
Weight decreased AE (grade 3-4) | 0.02 [0.00, 0.16] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |