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) | 0.74 [0.62, 0.88] | | < 1 | | 43% | 5 studies (5/-) | 100.0 % | some concern | not evaluable | moderate | crucial | - |
deaths (OS) (extension) | 0.66 [0.58, 0.75] | | < 1 | | 0% | 3 studies (3/-) | 100.0 % | some concern | not evaluable | moderate | important | - |
MFS | 0.73 [0.56, 0.96] | | < 1 | | 0% | 1 study (1/-) | 98.8 % | NA | not evaluable | | important | - |
PFS (extension) | 0.58 [0.52, 0.65] | | < 1 | | 0% | 3 studies (3/-) | 100.0 % | some concern | not evaluable | moderate | important | - |
progression or deaths (PFS) | 0.68 [0.50, 0.94] | | < 1 | | 85% | 4 studies (4/-) | 99.1 % | some concern | not evaluable | moderate | important | - |
RFS (extension) | 0.71 [0.59, 0.85] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
RFS/DFS | 0.65 [0.51, 0.83] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
DCR | 0.91 [0.63, 1.32] | | > 1 | | 0% | 1 study (1/-) | 31.6 % | NA | not evaluable | | non important | - |
objective responses (ORR) | 2.43 [1.10, 5.41] | | > 1 | | 92% | 4 studies (4/-) | 98.6 % | some concern | not evaluable | moderate | non important | - |
objective responses (ORR) (extension) | 3.54 [2.46, 5.10] | | > 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
safety endpoints 00 |
AE (any grade) | 2.52 [0.09, 68.35] | | < 1 | | 93% | 2 studies (2/-) | 29.4 % | low | not evaluable | high | non important | - |
AE (grade 3-4) | 1.05 [0.08, 14.50] | | < 1 | | 99% | 2 studies (2/-) | 48.5 % | low | not evaluable | high | 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 | - |
AE leading to treatment discontinuation (any grade) | 0.15 [0.10, 0.21] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
AE leading to treatment discontinuation (grade 3-4) | 0.11 [0.07, 0.18] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
STRAE (any grade) | 0.65 [0.46, 0.92] | | < 1 | | 0% | 2 studies (2/-) | 99.3 % | some concern | not evaluable | moderate | non important | - |
STRAE (grade 3-4) | 0.92 [0.06, 14.79] | | < 1 | | 0% | 2 studies (2/-) | 52.3 % | some concern | not evaluable | moderate | non important | - |
TRAE (any grade) | 0.84 [0.41, 1.74] | | < 1 | | 91% | 4 studies (4/-) | 67.9 % | some concern | not evaluable | moderate | non important | - |
TRAE (grade 3-4) | 0.55 [0.26, 1.18] | | < 1 | | 93% | 4 studies (4/-) | 93.8 % | low | not evaluable | high | non important | - |
TRAE leading to death (grade 5) | 0.74 [0.13, 4.33] | | < 1 | | 0% | 4 studies (4/-) | 63.1 % | low | not evaluable | high | non important | - |
TRAE leading to discontinuation (any grade) | 0.52 [0.17, 1.63] | | < 1 | | 95% | 4 studies (4/-) | 86.9 % | low | not evaluable | high | non important | - |
TRAE leading to discontinuation (grade 3-4) | 0.29 [0.07, 1.28] | | < 1 | | 87% | 4 studies (4/-) | 94.8 % | low | not evaluable | high | non important | - |
TRAE (grade 3-4) endpoints 00 |
Abdominal pain TRAE (grade 3-4) | 0.51 [0.09, 2.99] | | < 1 | | 0% | 4 studies (4/-) | 77.1 % | low | not evaluable | high | non important | - |
Adrenal insufficiency TRAE (grade 3-4) | 0.79 [0.20, 3.18] | | < 1 | | 0% | 2 studies (2/-) | 62.9 % | low | not evaluable | high | non important | - |
Alopecia TRAE (grade 3-4) | 0.92 [0.06, 14.79] | | < 1 | | 0% | 2 studies (2/-) | 52.3 % | some concern | not evaluable | moderate | non important | - |
Anaemia TRAE (grade 3-4) | 1.16 [0.16, 8.29] | | < 1 | | 0% | 2 studies (2/-) | 44.1 % | some concern | not evaluable | moderate | non important | - |
Arthralgia TRAE (grade 3-4) | 0.83 [0.17, 4.14] | | < 1 | | 0% | 4 studies (4/-) | 58.8 % | low | not evaluable | high | non important | - |
Asthenia TRAE (grade 3-4) | 0.35 [0.10, 1.19] | | < 1 | | 0% | 4 studies (4/-) | 95.4 % | low | not evaluable | high | non important | - |
Chills TRAE (grade 3-4) | 0.92 [0.06, 14.79] | | < 1 | | 0% | 2 studies (2/-) | 52.3 % | some concern | not evaluable | moderate | non important | - |
Colitis TRAE (grade 3-4) | 0.22 [0.12, 0.41] | | < 1 | | 4% | 3 studies (3/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
Constipation TRAE (grade 3-4) | 0.92 [0.06, 14.79] | | < 1 | | 0% | 2 studies (2/-) | 52.3 % | some concern | not evaluable | moderate | non important | - |
Cough TRAE (grade 3-4) | 1.77 [0.22, 13.99] | | < 1 | | 0% | 3 studies (3/-) | 29.5 % | some concern | not evaluable | moderate | non important | - |
Decreased appetite TRAE (grade 3-4) | 0.72 [0.08, 6.17] | | < 1 | | 0% | 3 studies (3/-) | 61.7 % | some concern | not evaluable | moderate | non important | - |
Diabetes TRAE (grade 3-4) | 1.93 [0.17, 21.31] | | < 1 | | 0% | 2 studies (2/-) | 29.8 % | low | not evaluable | high | non important | - |
Diarrhoea TRAE (grade 3-4) | 0.39 [0.17, 0.86] | | < 1 | | 62% | 4 studies (4/-) | 99.0 % | low | not evaluable | high | non important | - |
Dry skin TRAE (grade 3-4) | 0.95 [0.10, 9.11] | | < 1 | | 0% | 3 studies (3/-) | 51.9 % | some concern | not evaluable | moderate | non important | - |
Dyspnoea TRAE (grade 3-4) | 0.94 [0.15, 5.80] | | < 1 | | 0% | 3 studies (3/-) | 52.5 % | some concern | not evaluable | moderate | non important | - |
Fatigue TRAE (grade 3-4) | 0.68 [0.28, 1.63] | | < 1 | | 0% | 4 studies (4/-) | 80.6 % | low | not evaluable | high | non important | - |
Gastrointestinal disorders TRAE (grade 3-4) | 0.10 [0.05, 0.20] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
Headache TRAE (grade 3-4) | 0.31 [0.07, 1.40] | | < 1 | | 0% | 4 studies (4/-) | 93.5 % | low | not evaluable | high | non important | - |
Hepatitis TRAE (grade 3-4) | 3.06 [0.72, 13.07] | | < 1 | | 0% | 3 studies (3/-) | 6.6 % | some concern | not evaluable | moderate | non important | - |
Hepatobiliary disorders TRAE (grade 3-4) | 0.15 [0.07, 0.32] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
Hypersensitivity TRAE (grade 3-4) | 2.01 [0.07, 59.97] | | < 1 | | 0% | 1 study (1/-) | 34.6 % | NA | not evaluable | | non important | - |
Hyperthyroidism TRAE (grade 3-4) | 0.69 [0.13, 3.61] | | < 1 | | 0% | 4 studies (4/-) | 66.7 % | low | not evaluable | high | non important | - |
Hypophysitis TRAE (grade 3-4) | 0.22 [0.08, 0.63] | | < 1 | | 0% | 4 studies (4/-) | 99.8 % | low | not evaluable | high | non important | - |
Hypothyroidism TRAE (grade 3-4) | 0.83 [0.17, 4.12] | | < 1 | | 0% | 4 studies (4/-) | 59.0 % | low | not evaluable | high | non important | - |
Increase AST TRAE (grade 3-4) | 0.34 [0.09, 1.36] | | < 1 | | 44% | 4 studies (4/-) | 93.5 % | low | not evaluable | high | non important | - |
Increased ALT TRAE (grade 3-4) | 0.32 [0.15, 0.69] | | < 1 | | 6% | 4 studies (4/-) | 99.8 % | low | not evaluable | high | non important | - |
Increased lipase level TRAE (grade 3-4) | 1.17 [0.53, 2.56] | | < 1 | | 0% | 1 study (1/-) | 35.1 % | NA | not evaluable | | non important | - |
Maculopapular rash TRAE (grade 3-4) | 0.52 [0.11, 2.51] | | < 1 | | 20% | 4 studies (4/-) | 79.1 % | low | not evaluable | high | non important | - |
Myalgia TRAE (grade 3-4) | 0.94 [0.15, 5.80] | | < 1 | | 0% | 3 studies (3/-) | 52.6 % | some concern | not evaluable | moderate | non important | - |
Myositis TRAE (grade 3-4) | 0.92 [0.06, 14.79] | | < 1 | | 0% | 2 studies (2/-) | 52.3 % | some concern | not evaluable | moderate | non important | - |
Nausea TRAE (grade 3-4) | 0.74 [0.13, 4.35] | | < 1 | | 0% | 4 studies (4/-) | 62.9 % | low | not evaluable | high | non important | - |
Nephritis TRAE (grade 3-4) | 0.46 [0.04, 5.09] | | < 1 | | 0% | 2 studies (2/-) | 73.5 % | some concern | not evaluable | moderate | non important | - |
Neutropenia TRAE (grade 3-4) | 0.92 [0.06, 14.79] | | < 1 | | 0% | 2 studies (2/-) | 52.3 % | some concern | not evaluable | moderate | non important | - |
Paraesthesia TRAE (grade 3-4) | 0.46 [0.04, 5.09] | | < 1 | | 0% | 2 studies (2/-) | 73.5 % | some concern | not evaluable | moderate | non important | - |
Pneumonitis TRAE (grade 3-4) | 0.80 [0.15, 4.36] | | < 1 | | 0% | 3 studies (3/-) | 60.3 % | some concern | not evaluable | moderate | non important | - |
Pruritic rash TRAE (grade 3-4) | 0.95 [0.10, 9.11] | | < 1 | | 0% | 3 studies (3/-) | 51.9 % | some concern | not evaluable | moderate | non important | - |
Pruritus TRAE (grade 3-4) | 0.47 [0.09, 2.40] | | < 1 | | 0% | 4 studies (4/-) | 81.7 % | low | not evaluable | high | non important | - |
Pyrexia TRAE (grade 3-4) | 0.51 [0.09, 2.99] | | < 1 | | 0% | 4 studies (4/-) | 77.1 % | low | not evaluable | high | non important | - |
Rash TRAE (grade 3-4) | 0.35 [0.15, 0.85] | | < 1 | | 0% | 4 studies (4/-) | 99.0 % | low | not evaluable | high | non important | - |
Renal and urinary disorders TRAE (grade 3-4) | 1.00 [0.02, 50.62] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) | 0.12 [0.01, 2.36] | | < 1 | | 0% | 1 study (1/-) | 91.5 % | NA | not evaluable | | non important | - |
Skin and subcutaneous tissue disorders TRAE (grade 3-4) | 0.18 [0.07, 0.46] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
Thyroiditis TRAE (grade 3-4) | 0.99 [0.02, 50.24] | | < 1 | | 0% | 1 study (1/-) | 50.1 % | NA | not evaluable | | non important | - |
Uveitis TRAE (grade 3-4) | 0.92 [0.06, 14.79] | | < 1 | | 0% | 2 studies (2/-) | 52.3 % | some concern | not evaluable | moderate | non important | - |
Vitiligo TRAE (grade 3-4) | 1.99 [0.07, 59.55] | | < 1 | | 0% | 1 study (1/-) | 34.8 % | NA | not evaluable | | non important | - |
Vomiting TRAE (grade 3-4) | 1.18 [0.18, 7.79] | | < 1 | | 0% | 3 studies (3/-) | 43.1 % | some concern | not evaluable | moderate | non important | - |
Weight decreased TRAE (grade 3-4) | 0.47 [0.07, 3.36] | | < 1 | | 0% | 3 studies (3/-) | 77.2 % | some concern | not evaluable | moderate | 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 | - |