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) | 0.62 [0.53, 0.73] | | < 1 | | 0% | 3 studies (3/-) | 100.0 % | low | not evaluable | high | crucial | - |
deaths (OS) (extension) | 0.66 [0.42, 1.04] | | < 1 | | 89% | 2 studies (2/-) | 96.4 % | low | not evaluable | high | important | - |
PFS (extension) | 0.50 [0.31, 0.83] | | < 1 | | 91% | 3 studies (3/-) | 99.7 % | low | not evaluable | high | important | - |
progression or deaths (PFS) | 0.51 [0.32, 0.80] | | < 1 | | 83% | 3 studies (3/-) | 99.8 % | low | not evaluable | high | important | - |
objective responses (ORR) | 5.33 [1.47, 19.35] | | > 1 | | 95% | 3 studies (3/-) | 99.4 % | low | not evaluable | high | non important | - |
objective responses (ORR) (extension) | 6.41 [4.99, 8.23] | | > 1 | | 0% | 3 studies (3/-) | 100.0 % | low | not evaluable | high | non important | - |
safety endpoints 00 |
TRAE (any grade) | 2.72 [1.34, 5.52] | | < 1 | | 56% | 3 studies (3/-) | 0.3 % | low | not evaluable | high | non important | - |
TRAE (grade 3-4) | 4.24 [3.36, 5.33] | | < 1 | | 0% | 3 studies (3/-) | 0.0 % | low | not evaluable | high | non important | - |
TRAE leading to death (grade 5) | 1.00 [0.06, 15.97] | | < 1 | | 0% | 2 studies (2/-) | 50.1 % | low | not evaluable | high | non important | - |
TRAE leading to discontinuation (any grade) | 4.36 [3.35, 5.68] | | < 1 | | 0% | 3 studies (3/-) | 0.0 % | low | not evaluable | high | non important | - |
TRAE leading to discontinuation (grade 3-4) | 3.73 [2.37, 5.86] | | < 1 | | 50% | 3 studies (3/-) | 0.0 % | low | not evaluable | high | non important | - |
TRAE (grade 3-4) endpoints 00 |
Abdominal pain TRAE (grade 3-4) | 0.59 [0.11, 3.22] | | < 1 | | 0% | 3 studies (3/-) | 72.9 % | low | not evaluable | high | non important | - |
Adrenal insufficiency TRAE (grade 3-4) | 1.87 [0.34, 10.33] | | < 1 | | 53% | 3 studies (3/-) | 23.8 % | low | not evaluable | high | non important | - |
Arthralgia TRAE (grade 3-4) | 1.89 [0.34, 10.48] | | < 1 | | 0% | 3 studies (3/-) | 23.3 % | low | not evaluable | high | non important | - |
Asthenia TRAE (grade 3-4) | 0.63 [0.12, 3.30] | | < 1 | | 0% | 3 studies (3/-) | 70.6 % | low | not evaluable | high | non important | - |
Chills TRAE (grade 3-4) | 0.49 [0.01, 24.92] | | < 1 | | 0% | 1 study (1/-) | 63.7 % | NA | not evaluable | | non important | - |
Colitis TRAE (grade 3-4) | 2.87 [0.75, 11.03] | | < 1 | | 81% | 3 studies (3/-) | 6.3 % | low | not evaluable | high | non important | - |
Constipation TRAE (grade 3-4) | 0.98 [0.03, 29.71] | | < 1 | | 0% | 1 study (1/-) | 50.5 % | NA | not evaluable | | non important | - |
Cough TRAE (grade 3-4) | 0.42 [0.04, 4.83] | | < 1 | | 0% | 2 studies (2/-) | 75.4 % | low | not evaluable | high | non important | - |
Decreased appetite TRAE (grade 3-4) | 3.48 [0.70, 17.36] | | < 1 | | 0% | 3 studies (3/-) | 6.5 % | low | not evaluable | high | non important | - |
Diarrhoea TRAE (grade 3-4) | 1.91 [1.01, 3.63] | | < 1 | | 48% | 3 studies (3/-) | 2.4 % | low | not evaluable | high | non important | - |
Dry skin TRAE (grade 3-4) | 1.00 [0.06, 15.97] | | < 1 | | 0% | 2 studies (2/-) | 50.1 % | low | not evaluable | high | non important | - |
Dyspnoea TRAE (grade 3-4) | 3.62 [0.77, 17.10] | | < 1 | | 0% | 3 studies (3/-) | 5.2 % | low | not evaluable | high | non important | - |
Endocrine disorders TRAE (grade 3-4) | 1.24 [0.23, 6.63] | | < 1 | | 0% | 1 study (1/-) | 40.3 % | NA | not evaluable | | non important | - |
Fatigue TRAE (grade 3-4) | 4.52 [1.92, 10.63] | | < 1 | | 0% | 3 studies (3/-) | 0.0 % | low | not evaluable | high | non important | - |
Gastrointestinal disorders TRAE (grade 3-4) | 2.22 [0.77, 6.34] | | < 1 | | 0% | 1 study (1/-) | 6.9 % | NA | not evaluable | | non important | - |
Headache TRAE (grade 3-4) | 2.41 [0.48, 12.22] | | < 1 | | 0% | 3 studies (3/-) | 14.5 % | low | not evaluable | high | non important | - |
Hepatitis TRAE (grade 3-4) | 6.87 [1.26, 37.62] | | < 1 | | 0% | 3 studies (3/-) | 1.3 % | low | not evaluable | high | non important | - |
Hepatobiliary disorders TRAE (grade 3-4) | 15.93 [0.93, 273.74] | | < 1 | | 0% | 1 study (1/-) | 3.0 % | NA | not evaluable | | non important | - |
Hyperthyroidism TRAE (grade 3-4) | 3.42 [0.53, 22.13] | | < 1 | | 0% | 3 studies (3/-) | 9.9 % | low | not evaluable | high | non important | - |
Hypophysitis TRAE (grade 3-4) | 1.19 [0.38, 3.72] | | < 1 | | 24% | 3 studies (3/-) | 38.0 % | low | not evaluable | high | non important | - |
Hypothyroidism TRAE (grade 3-4) | 1.36 [0.18, 10.58] | | < 1 | | 0% | 3 studies (3/-) | 38.5 % | low | not evaluable | high | non important | - |
Increase AST TRAE (grade 3-4) | 7.83 [3.20, 19.16] | | < 1 | | 0% | 3 studies (3/-) | 0.0 % | low | not evaluable | high | non important | - |
Increased ALT TRAE (grade 3-4) | 6.62 [3.31, 13.26] | | < 1 | | 0% | 3 studies (3/-) | 0.0 % | low | not evaluable | high | non important | - |
Increased lipase level TRAE (grade 3-4) | 2.85 [1.81, 4.50] | | < 1 | | 0% | 3 studies (3/-) | 0.0 % | low | not evaluable | high | non important | - |
Maculopapular rash TRAE (grade 3-4) | 3.75 [1.15, 12.21] | | < 1 | | 0% | 3 studies (3/-) | 1.4 % | low | not evaluable | high | non important | - |
Myalgia TRAE (grade 3-4) | 1.05 [0.16, 6.91] | | < 1 | | 0% | 3 studies (3/-) | 48.1 % | low | not evaluable | high | non important | - |
Nausea TRAE (grade 3-4) | 3.01 [0.62, 14.55] | | < 1 | | 29% | 3 studies (3/-) | 8.6 % | low | not evaluable | high | non important | - |
Pneumonitis TRAE (grade 3-4) | 2.14 [0.56, 8.15] | | < 1 | | 0% | 3 studies (3/-) | 13.3 % | low | not evaluable | high | non important | - |
Pruritic rash TRAE (grade 3-4) | 0.79 [0.08, 7.59] | | < 1 | | 0% | 3 studies (3/-) | 58.2 % | low | not evaluable | high | non important | - |
Pruritus TRAE (grade 3-4) | 4.52 [1.14, 17.86] | | < 1 | | 0% | 3 studies (3/-) | 1.6 % | low | not evaluable | high | non important | - |
Pyrexia TRAE (grade 3-4) | 2.70 [0.54, 13.50] | | < 1 | | 0% | 3 studies (3/-) | 11.4 % | low | not evaluable | high | non important | - |
Rash TRAE (grade 3-4) | 3.05 [1.22, 7.65] | | < 1 | | 1% | 3 studies (3/-) | 0.9 % | low | not evaluable | high | non important | - |
Renal and urinary disorders TRAE (grade 3-4) | 0.98 [0.03, 29.71] | | < 1 | | 0% | 1 study (1/-) | 50.5 % | NA | not evaluable | | non important | - |
Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) | 1.48 [0.15, 14.67] | | < 1 | | 0% | 1 study (1/-) | 36.9 % | NA | not evaluable | | non important | - |
Skin and subcutaneous tissue disorders TRAE (grade 3-4) | 9.64 [0.55, 170.02] | | < 1 | | 0% | 1 study (1/-) | 6.3 % | NA | not evaluable | | non important | - |
Thyroiditis TRAE (grade 3-4) | 2.00 [0.18, 22.08] | | < 1 | | 0% | 2 studies (2/-) | 28.8 % | low | not evaluable | high | non important | - |
Vitiligo TRAE (grade 3-4) | 0.61 [0.07, 5.24] | | < 1 | | 0% | 3 studies (3/-) | 67.3 % | low | not evaluable | high | non important | - |
Vomiting TRAE (grade 3-4) | 5.19 [1.33, 20.26] | | < 1 | | 0% | 3 studies (3/-) | 0.9 % | low | not evaluable | high | non important | - |
Weight decreased TRAE (grade 3-4) | 0.67 [0.05, 8.74] | | < 1 | | 0% | 2 studies (2/-) | 61.9 % | low | not evaluable | high | non important | - |