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) | 0.54 [0.41, 0.69] | | < 1 | | 61% | 4 studies (4/-) | 100.0 % | low | not evaluable | high | crucial | - |
deaths (OS) (extension) | 0.63 [0.46, 0.85] | | < 1 | | 84% | 3 studies (3/-) | 99.8 % | low | not evaluable | high | important | - |
PFS (extension) | 0.56 [0.40, 0.80] | | < 1 | | 88% | 3 studies (3/-) | 99.9 % | low | not evaluable | high | important | - |
progression or deaths (PFS) | 0.53 [0.40, 0.70] | | < 1 | | 80% | 4 studies (4/-) | 100.0 % | low | not evaluable | high | important | - |
DOR (extension) | 3.45 [1.46, 8.18] | | > 1 | | 0% | 1 study (1/-) | 99.8 % | NA | not evaluable | | non important | - |
objective responses (ORR) | 3.07 [1.93, 4.90] | | > 1 | | 78% | 4 studies (4/-) | 100.0 % | low | not evaluable | high | non important | - |
objective responses (ORR) (extension) | 4.57 [3.31, 6.32] | | > 1 | | 50% | 3 studies (3/-) | 100.0 % | low | not evaluable | high | non important | - |
safety endpoints 00 |
AE (any grade) | 0.78 [0.34, 1.76] | | < 1 | | 0% | 1 study (1/-) | 72.7 % | NA | not evaluable | | non important | - |
AE (grade 3-4) | 0.84 [0.56, 1.25] | | < 1 | | 0% | 1 study (1/-) | 80.5 % | NA | not evaluable | | non important | - |
AE leading to death (grade 5) | 1.00 [0.02, 50.40] | | < 1 | | 0% | 1 study (1/-) | 50.1 % | NA | not evaluable | | non important | - |
AE leading to treatment discontinuation (any grade) | 0.55 [0.28, 1.10] | | < 1 | | 0% | 1 study (1/-) | 95.5 % | NA | not evaluable | | non important | - |
AE leading to treatment discontinuation (grade 3-4) | 0.61 [0.29, 1.28] | | < 1 | | 0% | 1 study (1/-) | 90.5 % | NA | not evaluable | | non important | - |
SAE (any grade) | 0.73 [0.49, 1.10] | | < 1 | | 0% | 1 study (1/-) | 93.1 % | NA | not evaluable | | non important | - |
SAE (grade 3-4) | 0.74 [0.47, 1.17] | | < 1 | | 0% | 1 study (1/-) | 90.4 % | NA | not evaluable | | non important | - |
STRAE (any grade) | 1.06 [0.54, 2.07] | | < 1 | | 0% | 1 study (1/-) | 43.8 % | NA | not evaluable | | non important | - |
STRAE (grade 3-4) | 0.99 [0.44, 2.27] | | < 1 | | 0% | 1 study (1/-) | 50.5 % | NA | not evaluable | | non important | - |
TRAE (any grade) | 1.44 [0.69, 3.03] | | < 1 | | 84% | 3 studies (3/-) | 16.5 % | low | not evaluable | high | non important | - |
TRAE (grade 3-4) | 1.30 [0.32, 5.21] | | < 1 | | 97% | 3 studies (3/-) | 35.8 % | 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) | 1.87 [0.29, 12.18] | | < 1 | | 97% | 2 studies (2/-) | 25.7 % | low | not evaluable | high | non important | - |
TRAE leading to discontinuation (grade 3-4) | 1.63 [0.17, 15.32] | | < 1 | | 98% | 2 studies (2/-) | 33.6 % | low | not evaluable | high | non important | - |
TRAE (grade 3-4) endpoints 00 |
Abdominal pain TRAE (grade 3-4) | 0.72 [0.10, 5.18] | | < 1 | | 0% | 3 studies (3/-) | 62.9 % | low | not evaluable | high | non important | - |
Adrenal insufficiency TRAE (grade 3-4) | 2.67 [0.70, 10.16] | | < 1 | | 0% | 2 studies (2/-) | 7.6 % | low | not evaluable | high | non important | - |
Alopecia TRAE (grade 3-4) | 1.00 [0.02, 50.40] | | < 1 | | 0% | 1 study (1/-) | 50.1 % | NA | not evaluable | | non important | - |
Anaemia TRAE (grade 3-4) | 1.00 [0.02, 50.40] | | < 1 | | 0% | 1 study (1/-) | 50.1 % | NA | not evaluable | | non important | - |
Arthralgia TRAE (grade 3-4) | 1.74 [0.30, 10.07] | | < 1 | | 0% | 3 studies (3/-) | 26.9 % | low | not evaluable | high | non important | - |
Asthenia TRAE (grade 3-4) | 0.63 [0.13, 3.11] | | < 1 | | 0% | 3 studies (3/-) | 71.6 % | low | not evaluable | high | non important | - |
Colitis TRAE (grade 3-4) | 1.04 [0.01, 77.14] | | < 1 | | 96% | 2 studies (2/-) | 49.3 % | low | not evaluable | high | non important | - |
Constipation TRAE (grade 3-4) | 1.00 [0.02, 50.40] | | < 1 | | 0% | 1 study (1/-) | 50.1 % | NA | not evaluable | | non important | - |
Cough TRAE (grade 3-4) | 1.00 [0.15, 6.76] | | < 1 | | 0% | 3 studies (3/-) | 50.1 % | low | not evaluable | high | non important | - |
Decreased appetite TRAE (grade 3-4) | 1.96 [0.28, 13.61] | | < 1 | | 0% | 3 studies (3/-) | 24.8 % | low | not evaluable | high | non important | - |
Diarrhoea TRAE (grade 3-4) | 1.42 [0.30, 6.65] | | < 1 | | 83% | 3 studies (3/-) | 32.8 % | low | not evaluable | high | non important | - |
Dry skin TRAE (grade 3-4) | 1.00 [0.10, 9.60] | | < 1 | | 0% | 3 studies (3/-) | 50.1 % | low | not evaluable | high | non important | - |
Dyspnoea TRAE (grade 3-4) | 2.66 [0.40, 17.52] | | < 1 | | 0% | 2 studies (2/-) | 15.6 % | low | not evaluable | high | non important | - |
Fatigue TRAE (grade 3-4) | 1.55 [0.35, 6.83] | | < 1 | | 50% | 3 studies (3/-) | 28.2 % | low | not evaluable | high | non important | - |
Headache TRAE (grade 3-4) | 1.39 [0.19, 10.03] | | < 1 | | 0% | 3 studies (3/-) | 37.4 % | low | not evaluable | high | non important | - |
Hepatitis TRAE (grade 3-4) | 4.45 [0.43, 46.06] | | < 1 | | 0% | 2 studies (2/-) | 10.7 % | low | not evaluable | high | non important | - |
Hypersensitivity TRAE (grade 3-4) | 1.00 [0.02, 50.40] | | < 1 | | 0% | 1 study (1/-) | 50.1 % | NA | not evaluable | | non important | - |
Hyperthyroidism TRAE (grade 3-4) | 2.69 [0.38, 18.90] | | < 1 | | 0% | 3 studies (3/-) | 16.2 % | low | not evaluable | high | non important | - |
Hypophysitis TRAE (grade 3-4) | 1.00 [0.04, 24.12] | | < 1 | | 77% | 2 studies (2/-) | 50.1 % | low | not evaluable | high | non important | - |
Hypothyroidism TRAE (grade 3-4) | 1.32 [0.15, 11.29] | | < 1 | | 0% | 3 studies (3/-) | 40.2 % | low | not evaluable | high | non important | - |
Increase AST TRAE (grade 3-4) | 3.07 [0.94, 10.04] | | < 1 | | 26% | 3 studies (3/-) | 3.2 % | low | not evaluable | high | non important | - |
Increased ALT TRAE (grade 3-4) | 2.40 [0.50, 11.63] | | < 1 | | 70% | 3 studies (3/-) | 13.9 % | low | not evaluable | high | non important | - |
Increased lipase level TRAE (grade 3-4) | 1.80 [0.82, 3.94] | | < 1 | | 58% | 2 studies (2/-) | 7.1 % | low | not evaluable | high | non important | - |
Infusion-related reactions TRAE (grade 3-4) | 1.00 [0.02, 50.40] | | < 1 | | 0% | 1 study (1/-) | 50.1 % | NA | not evaluable | | non important | - |
Leucopenia TRAE (grade 3-4) | 0.12 [0.01, 2.33] | | < 1 | | 0% | 1 study (1/-) | 91.7 % | NA | not evaluable | | non important | - |
Maculopapular rash TRAE (grade 3-4) | 2.57 [0.74, 8.91] | | < 1 | | 0% | 3 studies (3/-) | 6.9 % | low | not evaluable | high | non important | - |
Myalgia TRAE (grade 3-4) | 1.23 [0.19, 8.14] | | < 1 | | 0% | 3 studies (3/-) | 41.4 % | low | not evaluable | high | non important | - |
Nausea TRAE (grade 3-4) | 1.68 [0.13, 21.48] | | < 1 | | 45% | 3 studies (3/-) | 34.6 % | low | not evaluable | high | non important | - |
Neutropenia TRAE (grade 3-4) | 0.05 [0.00, 0.92] | | < 1 | | 0% | 1 study (1/-) | 97.7 % | NA | not evaluable | | non important | - |
Pancytopenia TRAE (grade 3-4) | 0.16 [0.01, 3.29] | | < 1 | | 0% | 1 study (1/-) | 87.9 % | NA | not evaluable | | non important | - |
Paraesthesia TRAE (grade 3-4) | 1.00 [0.02, 50.40] | | < 1 | | 0% | 1 study (1/-) | 50.1 % | NA | not evaluable | | non important | - |
Pneumonitis TRAE (grade 3-4) | 1.93 [0.33, 11.21] | | < 1 | | 0% | 2 studies (2/-) | 23.2 % | low | not evaluable | high | non important | - |
Pruritic rash TRAE (grade 3-4) | 1.00 [0.06, 15.97] | | < 1 | | 0% | 2 studies (2/-) | 50.1 % | low | not evaluable | high | non important | - |
Pruritus TRAE (grade 3-4) | 2.86 [0.63, 12.95] | | < 1 | | 0% | 3 studies (3/-) | 8.7 % | low | not evaluable | high | non important | - |
Pyrexia TRAE (grade 3-4) | 1.09 [0.16, 7.27] | | < 1 | | 0% | 3 studies (3/-) | 46.6 % | low | not evaluable | high | non important | - |
Rash TRAE (grade 3-4) | 1.58 [0.11, 21.84] | | < 1 | | 71% | 3 studies (3/-) | 36.8 % | low | not evaluable | high | non important | - |
Thrombocytopenia TRAE (grade 3-4) | 0.05 [0.00, 0.82] | | < 1 | | 0% | 1 study (1/-) | 98.1 % | NA | not evaluable | | non important | - |
Thyroiditis TRAE (grade 3-4) | 1.48 [0.11, 19.35] | | < 1 | | 0% | 2 studies (2/-) | 38.3 % | low | not evaluable | high | non important | - |
Vitiligo TRAE (grade 3-4) | 1.00 [0.13, 7.74] | | < 1 | | 0% | 3 studies (3/-) | 50.1 % | low | not evaluable | high | non important | - |
Vomiting TRAE (grade 3-4) | 2.49 [0.59, 10.47] | | < 1 | | 0% | 3 studies (3/-) | 10.7 % | 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 | - |