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) | 0.80 [0.50, 1.29] | | < 1 | | 76% | 2 studies (2/-) | 82.1 % | low | not evaluable | high | 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) | 0.92 [0.59, 1.41] | | < 1 | | 84% | 2 studies (2/-) | 65.5 % | low | not evaluable | high | important | - |
DCR | 0.91 [0.63, 1.32] | | > 1 | | 0% | 1 study (1/-) | 31.6 % | NA | not evaluable | | non important | - |
objective responses (ORR) | 1.17 [0.52, 2.64] | | > 1 | | 89% | 2 studies (2/-) | 65.1 % | low | not evaluable | high | 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 |
AE (any grade) | 14.27 [3.34, 61.03] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
AE (grade 3-4) | 4.03 [2.70, 6.00] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
AE leading to death (grade 5) | 1.39 [0.43, 4.44] | | < 1 | | 0% | 1 study (1/-) | 29.1 % | NA | not evaluable | | non important | - |
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 | - |
AE (grade 3-4) endpoints 00 |
Abdominal pain AE (grade 3-4) | 0.98 [0.14, 7.03] | | < 1 | | 0% | 1 study (1/-) | 50.7 % | NA | not evaluable | | non important | - |
Anaemia AE (grade 3-4) | 1.74 [0.50, 6.04] | | < 1 | | 0% | 1 study (1/-) | 19.1 % | NA | not evaluable | | non important | - |
Arthralgia AE (grade 3-4) | 0.98 [0.02, 49.71] | | < 1 | | 0% | 1 study (1/-) | 50.4 % | NA | not evaluable | | non important | - |
Asthenia AE (grade 3-4) | 1.74 [0.50, 6.04] | | < 1 | | 0% | 1 study (1/-) | 19.1 % | NA | not evaluable | | non important | - |
Constipation AE (grade 3-4) | 0.98 [0.02, 49.71] | | < 1 | | 0% | 1 study (1/-) | 50.4 % | NA | not evaluable | | non important | - |
Decreased appetite AE (grade 3-4) | 1.97 [0.07, 58.97] | | < 1 | | 0% | 1 study (1/-) | 35.0 % | NA | not evaluable | | non important | - |
Dermatitis acneiform AE (grade 3-4) | 22.68 [1.32, 388.47] | | < 1 | | 0% | 1 study (1/-) | 1.7 % | NA | not evaluable | | non important | - |
Diarrhoea AE (grade 3-4) | 4.44 [1.47, 13.42] | | < 1 | | 0% | 1 study (1/-) | 0.4 % | NA | not evaluable | | non important | - |
Fatigue AE (grade 3-4) | 1.65 [0.39, 7.00] | | < 1 | | 0% | 1 study (1/-) | 24.9 % | NA | not evaluable | | non important | - |
Headache AE (grade 3-4) | 1.97 [0.07, 58.97] | | < 1 | | 0% | 1 study (1/-) | 35.0 % | NA | not evaluable | | non important | - |
Hypertension AE (grade 3-4) | 1.77 [0.73, 4.30] | | < 1 | | 0% | 1 study (1/-) | 10.5 % | NA | not evaluable | | non important | - |
Increase AST AE (grade 3-4) | 3.00 [0.60, 15.03] | | < 1 | | 0% | 1 study (1/-) | 9.1 % | NA | not evaluable | | non important | - |
Increased ALT AE (grade 3-4) | 1.99 [0.49, 8.06] | | < 1 | | 0% | 1 study (1/-) | 16.8 % | NA | not evaluable | | non important | - |
Increased Lipase Level AE (grade 3-4) | 2.00 [0.59, 6.74] | | < 1 | | 0% | 1 study (1/-) | 13.2 % | NA | not evaluable | | non important | - |
Nausea AE (grade 3-4) | 10.02 [0.54, 184.60] | | < 1 | | 0% | 1 study (1/-) | 6.3 % | NA | not evaluable | | non important | - |
Peripheral oedema AE (grade 3-4) | 0.98 [0.06, 15.80] | | < 1 | | 0% | 1 study (1/-) | 50.5 % | NA | not evaluable | | non important | - |
Pruritus AE (grade 3-4) | 0.98 [0.02, 49.71] | | < 1 | | 0% | 1 study (1/-) | 50.4 % | NA | not evaluable | | non important | - |
Pyrexia AE (grade 3-4) | 6.03 [0.72, 50.50] | | < 1 | | 0% | 1 study (1/-) | 5.0 % | NA | not evaluable | | non important | - |
Rash AE (grade 3-4) | 7.83 [1.77, 34.66] | | < 1 | | 0% | 1 study (1/-) | 0.3 % | NA | not evaluable | | non important | - |
Rash maculopapular AE (grade 3-4) | 7.98 [0.42, 151.89] | | < 1 | | 0% | 1 study (1/-) | 8.6 % | NA | not evaluable | | non important | - |
Sepsis AE (grade 3-4) | 12.08 [0.67, 217.70] | | < 1 | | 0% | 1 study (1/-) | 4.7 % | NA | not evaluable | | non important | - |
Vomiting AE (grade 3-4) | 2.49 [0.48, 12.97] | | < 1 | | 0% | 1 study (1/-) | 14.0 % | NA | not evaluable | | non important | - |