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 |
MFS | 0.53 [0.37, 0.76] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | 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 | - |
safety endpoints 00 |
AE (any grade) | 1.51 [0.96, 2.38] | | < 1 | | 0% | 1 study (1/-) | 3.8 % | NA | not evaluable | | non important | - |
AE (grade 3-4) | 2.03 [1.52, 2.73] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
TRAE (any grade) | 6.05 [4.24, 8.63] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
TRAE (grade 3-4) | 12.66 [3.87, 41.39] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
TRAE leading to death (grade 5) | 1.97 [0.07, 58.99] | | < 1 | | 0% | 1 study (1/-) | 34.9 % | NA | not evaluable | | non important | - |
TRAE (grade 3-4) endpoints 00 |
Adrenal insufficiency TRAE (grade 3-4) | 1.97 [0.07, 58.99] | | < 1 | | 0% | 1 study (1/-) | 34.9 % | NA | not evaluable | | non important | - |
Arthralgia TRAE (grade 3-4) | 5.95 [0.30, 119.02] | | < 1 | | 0% | 1 study (1/-) | 12.5 % | NA | not evaluable | | non important | - |
Colitis TRAE (grade 3-4) | 10.04 [1.28, 78.73] | | < 1 | | 0% | 1 study (1/-) | 1.5 % | NA | not evaluable | | non important | - |
Diabetes TRAE (grade 3-4) | 9.95 [0.54, 182.62] | | < 1 | | 0% | 1 study (1/-) | 6.3 % | NA | not evaluable | | non important | - |
Diarrhoea TRAE (grade 3-4) | 1.32 [0.29, 5.92] | | < 1 | | 0% | 1 study (1/-) | 36.0 % | NA | not evaluable | | non important | - |
Dyspnoea TRAE (grade 3-4) | 1.97 [0.07, 58.99] | | < 1 | | 0% | 1 study (1/-) | 34.9 % | NA | not evaluable | | 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 | - |
Gastrointestinal disorders TRAE (grade 3-4) | 5.01 [1.09, 22.98] | | < 1 | | 0% | 1 study (1/-) | 1.9 % | NA | not evaluable | | non important | - |
Hepatitis TRAE (grade 3-4) | 6.99 [0.86, 56.99] | | < 1 | | 0% | 1 study (1/-) | 3.6 % | NA | not evaluable | | non important | - |
Hyperthyroidism TRAE (grade 3-4) | 1.97 [0.07, 58.99] | | < 1 | | 0% | 1 study (1/-) | 34.9 % | NA | not evaluable | | non important | - |
Hypophysitis TRAE (grade 3-4) | 5.95 [0.30, 119.02] | | < 1 | | 0% | 1 study (1/-) | 12.5 % | NA | not evaluable | | non important | - |
Hypothyroidism TRAE (grade 3-4) | 0.99 [0.02, 49.80] | | < 1 | | 0% | 1 study (1/-) | 50.3 % | NA | not evaluable | | 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) | 0.99 [0.02, 49.80] | | < 1 | | 0% | 1 study (1/-) | 50.3 % | NA | not evaluable | | non important | - |
Nausea TRAE (grade 3-4) | 0.99 [0.02, 49.80] | | < 1 | | 0% | 1 study (1/-) | 50.3 % | NA | not evaluable | | non important | - |
Nephritis TRAE (grade 3-4) | 3.96 [0.18, 87.96] | | < 1 | | 0% | 1 study (1/-) | 19.5 % | NA | not evaluable | | non important | - |
Pancreatitis TRAE (grade 3-4) | 0.99 [0.06, 15.81] | | < 1 | | 0% | 1 study (1/-) | 50.4 % | NA | not evaluable | | non important | - |
Pneumonitis TRAE (grade 3-4) | 7.94 [0.42, 150.67] | | < 1 | | 0% | 1 study (1/-) | 8.6 % | NA | not evaluable | | non important | - |
Pruritus TRAE (grade 3-4) | 0.99 [0.02, 49.80] | | < 1 | | 0% | 1 study (1/-) | 50.3 % | NA | not evaluable | | non important | - |
Rash TRAE (grade 3-4) | 1.97 [0.07, 58.99] | | < 1 | | 0% | 1 study (1/-) | 34.9 % | NA | not evaluable | | 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 | - |
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) | 0.99 [0.02, 49.80] | | < 1 | | 0% | 1 study (1/-) | 50.3 % | NA | not evaluable | | non important | - |
Vitiligo TRAE (grade 3-4) | 0.99 [0.02, 49.80] | | < 1 | | 0% | 1 study (1/-) | 50.3 % | NA | not evaluable | | non important | - |