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) | 0.68 [0.49, 0.95] | | < 1 | | 0% | 1 study (1/-) | 98.9 % | NA | not evaluable | | crucial | - |
deaths (OS) (extension) | 0.71 [0.59, 0.86] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
PFS (extension) | 0.85 [0.73, 0.98] | | < 1 | | 0% | 1 study (1/-) | 98.5 % | NA | not evaluable | | important | - |
progression or deaths (PFS) | 0.98 [0.79, 1.22] | | < 1 | | 0% | 1 study (1/-) | 57.1 % | NA | not evaluable | | important | - |
objective responses (ORR) | 1.35 [1.05, 1.73] | | > 1 | | 0% | 1 study (1/-) | 99.1 % | NA | not evaluable | | non important | - |
objective responses (ORR) (extension) | 1.36 [1.06, 1.74] | | > 1 | | 0% | 1 study (1/-) | 99.3 % | NA | not evaluable | | non important | - |
safety endpoints 00 |
TRAE (any grade) | 0.41 [0.22, 0.76] | | < 1 | | 0% | 1 study (1/-) | 99.7 % | NA | not evaluable | | non important | - |
TRAE (grade 3-4) | 0.49 [0.39, 0.63] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
TRAE leading to death (grade 5) | 1.97 [0.59, 6.58] | | < 1 | | 0% | 1 study (1/-) | 13.6 % | NA | not evaluable | | non important | - |
TRAE leading to discontinuation (any grade) | 1.98 [1.42, 2.74] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
TRAE (grade 3-4) endpoints 00 |
Acute kidney injury TRAE (grade 3-4) | 1.31 [0.29, 5.86] | | < 1 | | 0% | 1 study (1/-) | 36.4 % | NA | not evaluable | | non important | - |
Adrenal insufficiency TRAE (grade 3-4) | 21.94 [1.29, 374.25] | | < 1 | | 0% | 1 study (1/-) | 1.7 % | NA | not evaluable | | non important | - |
Anaemia TRAE (grade 3-4) | 0.08 [0.02, 0.35] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
Asthenia TRAE (grade 3-4) | 0.75 [0.33, 1.72] | | < 1 | | 0% | 1 study (1/-) | 75.3 % | NA | not evaluable | | non important | - |
Blister TRAE (grade 3-4) | 0.16 [0.01, 3.25] | | < 1 | | 0% | 1 study (1/-) | 88.0 % | NA | not evaluable | | non important | - |
Blood creatinine increased TRAE (grade 3-4) | 0.49 [0.04, 5.40] | | < 1 | | 0% | 1 study (1/-) | 71.9 % | NA | not evaluable | | non important | - |
Colitis TRAE (grade 3-4) | 21.94 [1.29, 374.25] | | < 1 | | 0% | 1 study (1/-) | 1.7 % | NA | not evaluable | | non important | - |
Decreased appetite TRAE (grade 3-4) | 1.14 [0.38, 3.42] | | < 1 | | 0% | 1 study (1/-) | 40.6 % | NA | not evaluable | | non important | - |
Diabetes TRAE (grade 3-4) | 11.86 [0.66, 212.80] | | < 1 | | 0% | 1 study (1/-) | 4.8 % | NA | not evaluable | | non important | - |
Diarrhoea TRAE (grade 3-4) | 0.65 [0.37, 1.14] | | < 1 | | 0% | 1 study (1/-) | 93.2 % | NA | not evaluable | | non important | - |
Dysgeusia TRAE (grade 3-4) | 0.49 [0.02, 14.59] | | < 1 | | 0% | 1 study (1/-) | 65.8 % | NA | not evaluable | | non important | - |
Dyspepsia TRAE (grade 3-4) | 0.98 [0.02, 49.38] | | < 1 | | 0% | 1 study (1/-) | 50.4 % | NA | not evaluable | | non important | - |
Eczema TRAE (grade 3-4) | 0.98 [0.02, 49.38] | | < 1 | | 0% | 1 study (1/-) | 50.4 % | NA | not evaluable | | non important | - |
Endocrine disorders TRAE (grade 3-4) | 39.87 [5.45, 291.45] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
Erythema TRAE (grade 3-4) | 0.98 [0.02, 49.38] | | < 1 | | 0% | 1 study (1/-) | 50.4 % | NA | not evaluable | | non important | - |
Fatigue TRAE (grade 3-4) | 0.44 [0.26, 0.72] | | < 1 | | 0% | 1 study (1/-) | 99.9 % | NA | not evaluable | | non important | - |
Gastrointestinal disorders TRAE (grade 3-4) | 0.84 [0.50, 1.43] | | < 1 | | 0% | 1 study (1/-) | 73.4 % | NA | not evaluable | | non important | - |
Hepatobiliary disorders TRAE (grade 3-4) | 2.42 [1.41, 4.14] | | < 1 | | 0% | 1 study (1/-) | 0.1 % | NA | not evaluable | | non important | - |
Hypertension TRAE (grade 3-4) | 0.04 [0.01, 0.10] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
Hyperthyroidism TRAE (grade 3-4) | 3.92 [0.18, 87.20] | | < 1 | | 0% | 1 study (1/-) | 19.7 % | NA | not evaluable | | non important | - |
Hypophysitis TRAE (grade 3-4) | 30.14 [1.80, 505.79] | | < 1 | | 0% | 1 study (1/-) | 1.0 % | NA | not evaluable | | non important | - |
Hypothyroidism TRAE (grade 3-4) | 1.96 [0.18, 21.68] | | < 1 | | 0% | 1 study (1/-) | 29.3 % | NA | not evaluable | | non important | - |
Increase AST TRAE (grade 3-4) | 2.86 [1.20, 6.83] | | < 1 | | 0% | 1 study (1/-) | 0.9 % | NA | not evaluable | | non important | - |
Increased ALT TRAE (grade 3-4) | 3.15 [1.47, 6.75] | | < 1 | | 0% | 1 study (1/-) | 0.2 % | NA | not evaluable | | non important | - |
Increased lipase level TRAE (grade 3-4) | 1.61 [1.04, 2.49] | | < 1 | | 0% | 1 study (1/-) | 1.6 % | NA | not evaluable | | non important | - |
Maculopapular rash TRAE (grade 3-4) | 7.93 [0.99, 63.59] | | < 1 | | 0% | 1 study (1/-) | 2.6 % | NA | not evaluable | | non important | - |
Mucosal inflammation TRAE (grade 3-4) | 0.06 [0.01, 0.48] | | < 1 | | 0% | 1 study (1/-) | 99.6 % | NA | not evaluable | | non important | - |
Nausea TRAE (grade 3-4) | 1.12 [0.40, 3.11] | | < 1 | | 0% | 1 study (1/-) | 41.4 % | NA | not evaluable | | non important | - |
Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) | 0.02 [0.00, 0.13] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
Pruritic rash TRAE (grade 3-4) | 1.96 [0.07, 58.49] | | < 1 | | 0% | 1 study (1/-) | 35.1 % | NA | not evaluable | | non important | - |
Pruritus generalised TRAE (grade 3-4) | 0.98 [0.02, 49.38] | | < 1 | | 0% | 1 study (1/-) | 50.4 % | NA | not evaluable | | non important | - |
Pruritus TRAE (grade 3-4) | 5.90 [0.29, 117.97] | | < 1 | | 0% | 1 study (1/-) | 12.6 % | NA | not evaluable | | non important | - |
Rash TRAE (grade 3-4) | 17.88 [1.03, 309.26] | | < 1 | | 0% | 1 study (1/-) | 2.5 % | NA | not evaluable | | non important | - |
Renal and urinary disorders TRAE (grade 3-4) | 1.14 [0.38, 3.42] | | < 1 | | 0% | 1 study (1/-) | 40.6 % | NA | not evaluable | | non important | - |
Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) | 11.86 [0.66, 212.80] | | < 1 | | 0% | 1 study (1/-) | 4.8 % | NA | not evaluable | | non important | - |
Skin and subcutaneous tissue disorders TRAE (grade 3-4) | 0.36 [0.21, 0.60] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
Skin exfoliation TRAE (grade 3-4) | 0.98 [0.02, 49.38] | | < 1 | | 0% | 1 study (1/-) | 50.4 % | NA | not evaluable | | non important | - |
Skin hypopigmentation TRAE (grade 3-4) | 0.98 [0.02, 49.38] | | < 1 | | 0% | 1 study (1/-) | 50.4 % | NA | not evaluable | | non important | - |
Stomatitis TRAE (grade 3-4) | 0.03 [0.00, 0.57] | | < 1 | | 0% | 1 study (1/-) | 99.0 % | NA | not evaluable | | non important | - |
Thrombocytopenia TRAE (grade 3-4) | 0.02 [0.00, 0.34] | | < 1 | | 0% | 1 study (1/-) | 99.6 % | NA | not evaluable | | non important | - |
Thyroiditis TRAE (grade 3-4) | 1.96 [0.07, 58.49] | | < 1 | | 0% | 1 study (1/-) | 35.1 % | NA | not evaluable | | non important | - |
Urticaria TRAE (grade 3-4) | 1.96 [0.07, 58.49] | | < 1 | | 0% | 1 study (1/-) | 35.1 % | NA | not evaluable | | non important | - |
Vomiting TRAE (grade 3-4) | 0.39 [0.12, 1.24] | | < 1 | | 0% | 1 study (1/-) | 94.5 % | NA | not evaluable | | non important | - |