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) | 0.65 [0.53, 0.80] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | crucial | - |
deaths (OS) (extension) | 0.83 [0.67, 1.03] | | < 1 | | 0% | 1 study (1/-) | 95.5 % | NA | not evaluable | | important | - |
PFS (extension) | 0.79 [0.65, 0.97] | | < 1 | | 0% | 1 study (1/-) | 98.9 % | NA | not evaluable | | important | - |
progression or deaths (PFS) | 0.74 [0.60, 0.92] | | < 1 | | 0% | 1 study (1/-) | 99.7 % | NA | not evaluable | | important | - |
objective responses (ORR) | 1.76 [1.28, 2.41] | | > 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
objective responses (ORR) (extension) | 5.96 [4.16, 8.54] | | > 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
safety endpoints 00 |
TRAE (any grade) | 3.58 [1.88, 6.81] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
TRAE (grade 3-4) | 4.82 [3.41, 6.80] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
TRAE leading to death (grade 5) | 1.00 [0.02, 50.56] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
TRAE leading to discontinuation (any grade) | 4.85 [3.25, 7.24] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
TRAE leading to discontinuation (grade 3-4) | 5.10 [3.17, 8.19] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
TRAE (grade 3-4) endpoints 00 |
Abdominal pain TRAE (grade 3-4) | 2.00 [0.07, 59.93] | | < 1 | | 0% | 1 study (1/-) | 34.6 % | NA | not evaluable | | non important | - |
Adrenal insufficiency TRAE (grade 3-4) | 3.04 [0.61, 15.17] | | < 1 | | 0% | 1 study (1/-) | 8.8 % | NA | not evaluable | | non important | - |
Arthralgia TRAE (grade 3-4) | 2.01 [0.18, 22.24] | | < 1 | | 0% | 1 study (1/-) | 28.7 % | NA | not evaluable | | non important | - |
Asthenia TRAE (grade 3-4) | 1.00 [0.06, 16.06] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
Colitis TRAE (grade 3-4) | 9.36 [2.80, 31.26] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
Cough TRAE (grade 3-4) | 0.25 [0.01, 5.54] | | < 1 | | 0% | 1 study (1/-) | 80.7 % | NA | not evaluable | | non important | - |
Decreased appetite TRAE (grade 3-4) | 8.09 [0.43, 153.69] | | < 1 | | 0% | 1 study (1/-) | 8.4 % | NA | not evaluable | | non important | - |
Diarrhoea TRAE (grade 3-4) | 3.45 [1.60, 7.41] | | < 1 | | 0% | 1 study (1/-) | 0.1 % | NA | not evaluable | | non important | - |
Dry skin TRAE (grade 3-4) | 1.00 [0.02, 50.56] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
Dyspnoea TRAE (grade 3-4) | 3.02 [0.31, 29.19] | | < 1 | | 0% | 1 study (1/-) | 17.1 % | NA | not evaluable | | non important | - |
Fatigue TRAE (grade 3-4) | 4.48 [1.26, 15.87] | | < 1 | | 0% | 1 study (1/-) | 1.0 % | NA | not evaluable | | non important | - |
Headache TRAE (grade 3-4) | 4.02 [0.18, 89.49] | | < 1 | | 0% | 1 study (1/-) | 19.3 % | NA | not evaluable | | non important | - |
Hepatitis TRAE (grade 3-4) | 10.15 [0.55, 186.51] | | < 1 | | 0% | 1 study (1/-) | 6.1 % | NA | not evaluable | | non important | - |
Hyperthyroidism TRAE (grade 3-4) | 6.05 [0.30, 121.25] | | < 1 | | 0% | 1 study (1/-) | 12.2 % | NA | not evaluable | | non important | - |
Hypophysitis TRAE (grade 3-4) | 5.06 [0.59, 43.61] | | < 1 | | 0% | 1 study (1/-) | 7.1 % | NA | not evaluable | | non important | - |
Hypothyroidism TRAE (grade 3-4) | 2.00 [0.07, 59.93] | | < 1 | | 0% | 1 study (1/-) | 34.6 % | NA | not evaluable | | non important | - |
Increase AST TRAE (grade 3-4) | 6.68 [1.96, 22.80] | | < 1 | | 0% | 1 study (1/-) | 0.1 % | NA | not evaluable | | non important | - |
Increased ALT TRAE (grade 3-4) | 7.29 [2.52, 21.10] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
Increased lipase level TRAE (grade 3-4) | 2.60 [1.37, 4.95] | | < 1 | | 0% | 1 study (1/-) | 0.2 % | NA | not evaluable | | non important | - |
Maculopapular rash TRAE (grade 3-4) | 3.04 [0.61, 15.17] | | < 1 | | 0% | 1 study (1/-) | 8.8 % | NA | not evaluable | | non important | - |
Myalgia TRAE (grade 3-4) | 1.00 [0.06, 16.06] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
Nausea TRAE (grade 3-4) | 14.30 [0.81, 253.04] | | < 1 | | 0% | 1 study (1/-) | 3.6 % | NA | not evaluable | | non important | - |
Pneumonitis TRAE (grade 3-4) | 3.02 [0.31, 29.19] | | < 1 | | 0% | 1 study (1/-) | 17.1 % | NA | not evaluable | | non important | - |
Pruritic rash TRAE (grade 3-4) | 1.00 [0.02, 50.56] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
Pruritus TRAE (grade 3-4) | 6.10 [0.73, 50.95] | | < 1 | | 0% | 1 study (1/-) | 4.9 % | NA | not evaluable | | non important | - |
Pyrexia TRAE (grade 3-4) | 4.02 [0.18, 89.49] | | < 1 | | 0% | 1 study (1/-) | 19.3 % | NA | not evaluable | | non important | - |
Rash TRAE (grade 3-4) | 10.30 [1.31, 80.93] | | < 1 | | 0% | 1 study (1/-) | 1.4 % | NA | not evaluable | | non important | - |
Thyroiditis TRAE (grade 3-4) | 2.00 [0.07, 59.93] | | < 1 | | 0% | 1 study (1/-) | 34.6 % | NA | not evaluable | | non important | - |
Vitiligo TRAE (grade 3-4) | 0.50 [0.02, 14.93] | | < 1 | | 0% | 1 study (1/-) | 65.4 % | NA | not evaluable | | non important | - |
Vomiting TRAE (grade 3-4) | 7.14 [0.87, 58.36] | | < 1 | | 0% | 1 study (1/-) | 3.4 % | NA | not evaluable | | non important | - |
Weight decreased TRAE (grade 3-4) | 1.00 [0.02, 50.56] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |