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) | 0.59 [0.45, 0.77] | | < 1 | | 72% | 5 studies (5/-) | 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 | - |
MFS | 0.73 [0.56, 0.96] | | < 1 | | 0% | 1 study (1/-) | 98.8 % | NA | not evaluable | | 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 | - |
RFS (extension) | 0.71 [0.59, 0.85] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
RFS/DFS | 0.61 [0.49, 0.75] | | < 1 | | 0% | 3 studies (3/-) | 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) | 0.63 [0.35, 1.17] | | < 1 | | 0% | 2 studies (2/-) | 92.8 % | low | not evaluable | high | non important | - |
AE (grade 3-4) | 0.48 [0.16, 1.41] | | < 1 | | 95% | 2 studies (2/-) | 90.9 % | low | not evaluable | high | non important | - |
AE leading to death (grade 5) | 0.98 [0.10, 9.49] | | < 1 | | 0% | 3 studies (3/-) | 50.7 % | low | not evaluable | high | non important | - |
AE leading to treatment discontinuation (any grade) | 1.26 [0.18, 8.98] | | < 1 | | 96% | 4 studies (4/-) | 40.9 % | low | not evaluable | high | non important | - |
AE leading to treatment discontinuation (grade 3-4) | 1.26 [0.15, 10.80] | | < 1 | | 96% | 4 studies (4/-) | 41.7 % | low | not evaluable | high | non important | - |
SAE (any grade) | 1.45 [0.55, 3.84] | | < 1 | | 85% | 3 studies (3/-) | 22.7 % | low | not evaluable | high | non important | - |
SAE (grade 3-4) | 1.77 [0.60, 5.28] | | < 1 | | 85% | 3 studies (3/-) | 15.2 % | low | not evaluable | high | non important | - |
STRAE (any grade) | 3.06 [0.84, 11.20] | | < 1 | | 82% | 3 studies (3/-) | 4.6 % | low | not evaluable | high | non important | - |
STRAE (grade 3-4) | 3.08 [0.73, 13.04] | | < 1 | | 77% | 3 studies (3/-) | 6.3 % | low | not evaluable | high | non important | - |
TRAE (any grade) | 1.47 [0.63, 3.44] | | < 1 | | 91% | 6 studies (6/-) | 18.9 % | low | not evaluable | high | non important | - |
TRAE (grade 3-4) | 1.52 [0.44, 5.28] | | < 1 | | 98% | 6 studies (6/-) | 25.4 % | low | not evaluable | high | non important | - |
TRAE leading to death (grade 5) | 0.66 [0.13, 3.49] | | < 1 | | 0% | 5 studies (5/-) | 68.5 % | low | serious | high | non important | - |
TRAE leading to discontinuation (any grade) | 1.87 [0.31, 11.26] | | < 1 | | 98% | 5 studies (5/-) | 24.8 % | low | not evaluable | high | non important | - |
TRAE leading to discontinuation (grade 3-4) | 1.67 [0.24, 11.45] | | < 1 | | 97% | 5 studies (5/-) | 30.1 % | low | not evaluable | high | non important | - |
TRAE (grade 3-4) endpoints 00 |
Abdominal pain TRAE (grade 3-4) | 0.73 [0.17, 3.12] | | < 1 | | 0% | 6 studies (6/-) | 66.6 % | low | not evaluable | high | non important | - |
Acute kidney injury TRAE (grade 3-4) | 1.45 [0.11, 19.13] | | < 1 | | 0% | 2 studies (2/-) | 39.0 % | low | not evaluable | high | non important | - |
Adrenal insufficiency TRAE (grade 3-4) | 1.41 [0.53, 3.74] | | < 1 | | 0% | 5 studies (5/-) | 24.3 % | low | not evaluable | high | non important | - |
Alopecia TRAE (grade 3-4) | 0.97 [0.10, 9.43] | | < 1 | | 0% | 3 studies (3/-) | 50.9 % | low | not evaluable | high | non important | - |
Anaemia TRAE (grade 3-4) | 1.29 [0.15, 11.17] | | < 1 | | 0% | 3 studies (3/-) | 40.8 % | low | not evaluable | high | non important | - |
Arthralgia TRAE (grade 3-4) | 1.08 [0.33, 3.55] | | < 1 | | 0% | 6 studies (6/-) | 45.2 % | low | not evaluable | high | non important | - |
Asthenia TRAE (grade 3-4) | 0.45 [0.12, 1.66] | | < 1 | | 0% | 4 studies (4/-) | 88.3 % | low | not evaluable | high | non important | - |
Blood and lymphatic system disorders TRAE (grade 3-4) | 3.02 [0.28, 33.13] | | < 1 | | 0% | 2 studies (2/-) | 18.5 % | low | not evaluable | high | non important | - |
Blood creatinine increased TRAE (grade 3-4) | 0.91 [0.02, 46.72] | | < 1 | | 0% | 1 study (1/-) | 51.8 % | NA | not evaluable | | non important | - |
Chills TRAE (grade 3-4) | 0.96 [0.06, 15.59] | | < 1 | | 0% | 2 studies (2/-) | 51.1 % | low | not evaluable | high | non important | - |
Colitis TRAE (grade 3-4) | 1.53 [0.09, 25.31] | | < 1 | | 89% | 4 studies (4/-) | 38.4 % | 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) | 0.99 [0.20, 4.77] | | < 1 | | 0% | 5 studies (5/-) | 50.7 % | low | not evaluable | high | non important | - |
Decreased appetite TRAE (grade 3-4) | 1.56 [0.32, 7.63] | | < 1 | | 0% | 5 studies (5/-) | 29.3 % | low | not evaluable | high | non important | - |
Diabetes TRAE (grade 3-4) | 1.23 [0.17, 8.82] | | < 1 | | 0% | 3 studies (3/-) | 41.8 % | low | not evaluable | high | non important | - |
Diarrhoea TRAE (grade 3-4) | 0.86 [0.23, 3.28] | | < 1 | | 85% | 6 studies (6/-) | 58.6 % | low | not evaluable | high | non important | - |
Dizziness TRAE (grade 3-4) | 0.96 [0.06, 15.59] | | < 1 | | 0% | 2 studies (2/-) | 51.1 % | low | not evaluable | high | non important | - |
Dry skin TRAE (grade 3-4) | 0.98 [0.17, 5.70] | | < 1 | | 0% | 5 studies (5/-) | 50.8 % | low | not evaluable | high | non important | - |
Dysgeusia TRAE (grade 3-4) | 0.96 [0.06, 15.59] | | < 1 | | 0% | 2 studies (2/-) | 51.1 % | low | not evaluable | high | non important | - |
Dyspepsia TRAE (grade 3-4) | 0.96 [0.06, 15.59] | | < 1 | | 0% | 2 studies (2/-) | 51.1 % | low | not evaluable | high | non important | - |
Dyspnoea TRAE (grade 3-4) | 1.93 [0.40, 9.20] | | < 1 | | 0% | 4 studies (4/-) | 20.5 % | low | not evaluable | high | non important | - |
Endocrine disorders TRAE (grade 3-4) | 4.00 [0.64, 25.16] | | < 1 | | 0% | 2 studies (2/-) | 7.0 % | low | not evaluable | high | non important | - |
Eye disorders TRAE (grade 3-4) | 1.45 [0.11, 19.13] | | < 1 | | 0% | 2 studies (2/-) | 39.0 % | low | not evaluable | high | non important | - |
Fatigue TRAE (grade 3-4) | 1.26 [0.50, 3.21] | | < 1 | | 18% | 6 studies (6/-) | 31.2 % | low | not evaluable | high | non important | - |
Gastritis TRAE (grade 3-4) | 2.32 [0.20, 26.84] | | < 1 | | 0% | 2 studies (2/-) | 25.1 % | low | not evaluable | high | non important | - |
Gastrointestinal disorders TRAE (grade 3-4) | 1.04 [0.04, 29.48] | | < 1 | | 89% | 3 studies (3/-) | 49.0 % | low | not evaluable | high | non important | - |
General disorders and administration site conditions TRAE (grade 3-4) | 2.32 [0.20, 26.84] | | < 1 | | 0% | 2 studies (2/-) | 25.1 % | low | not evaluable | high | non important | - |
Headache TRAE (grade 3-4) | 0.55 [0.15, 1.98] | | < 1 | | 0% | 6 studies (6/-) | 82.0 % | low | not evaluable | high | non important | - |
Hepatitis TRAE (grade 3-4) | 3.66 [1.06, 12.60] | | < 1 | | 0% | 4 studies (4/-) | 2.0 % | low | not evaluable | high | non important | - |
Hepatobiliary disorders TRAE (grade 3-4) | 1.42 [0.07, 29.90] | | < 1 | | 91% | 3 studies (3/-) | 41.2 % | low | not evaluable | high | non important | - |
Hypersensitivity TRAE (grade 3-4) | 1.49 [0.11, 19.39] | | < 1 | | 0% | 2 studies (2/-) | 38.2 % | low | not evaluable | high | non important | - |
Hypertension TRAE (grade 3-4) | 0.96 [0.06, 15.59] | | < 1 | | 0% | 2 studies (2/-) | 51.1 % | low | not evaluable | high | non important | - |
Hyperthyroidism TRAE (grade 3-4) | 2.24 [0.59, 8.46] | | < 1 | | 0% | 6 studies (6/-) | 11.7 % | low | not evaluable | high | non important | - |
Hypophysitis TRAE (grade 3-4) | 0.59 [0.14, 2.49] | | < 1 | | 47% | 5 studies (5/-) | 76.2 % | low | not evaluable | high | non important | - |
Hypothyroidism TRAE (grade 3-4) | 0.88 [0.22, 3.53] | | < 1 | | 0% | 6 studies (6/-) | 57.1 % | low | not evaluable | high | non important | - |
Increase AST TRAE (grade 3-4) | 1.54 [0.36, 6.58] | | < 1 | | 76% | 6 studies (6/-) | 28.0 % | low | not evaluable | high | non important | - |
Increased ALT TRAE (grade 3-4) | 1.84 [0.42, 8.10] | | < 1 | | 84% | 6 studies (6/-) | 21.1 % | low | not evaluable | high | non important | - |
Increased lipase level TRAE (grade 3-4) | 1.84 [1.10, 3.09] | | < 1 | | 16% | 4 studies (4/-) | 1.1 % | low | not evaluable | high | non important | - |
Infusion-related reactions TRAE (grade 3-4) | 0.97 [0.10, 9.43] | | < 1 | | 0% | 3 studies (3/-) | 50.9 % | low | not evaluable | high | non important | - |
Leucopenia TRAE (grade 3-4) | 0.36 [0.05, 2.75] | | < 1 | | 0% | 3 studies (3/-) | 83.5 % | low | not evaluable | high | non important | - |
Maculopapular rash TRAE (grade 3-4) | 1.27 [0.38, 4.22] | | < 1 | | 18% | 6 studies (6/-) | 35.1 % | low | not evaluable | high | non important | - |
Metabolism and nutrition disorders TRAE (grade 3-4) | 1.29 [0.15, 11.24] | | < 1 | | 0% | 2 studies (2/-) | 40.9 % | low | not evaluable | high | non important | - |
Musculoskeletal and connective tissue disorders TRAE (grade 3-4) | 0.96 [0.03, 31.61] | | < 1 | | 63% | 2 studies (2/-) | 50.8 % | low | not evaluable | high | non important | - |
Myalgia TRAE (grade 3-4) | 1.12 [0.25, 4.97] | | < 1 | | 0% | 5 studies (5/-) | 43.9 % | low | not evaluable | high | non important | - |
Myositis TRAE (grade 3-4) | 0.96 [0.06, 15.59] | | < 1 | | 0% | 2 studies (2/-) | 51.1 % | low | not evaluable | high | non important | - |
Nausea TRAE (grade 3-4) | 1.58 [0.39, 6.46] | | < 1 | | 0% | 6 studies (6/-) | 26.2 % | low | not evaluable | high | non important | - |
Nervous system disorders TRAE (grade 3-4) | 1.07 [0.16, 7.27] | | < 1 | | 0% | 2 studies (2/-) | 47.3 % | low | not evaluable | high | non important | - |
Neutropenia TRAE (grade 3-4) | 0.24 [0.03, 1.77] | | < 1 | | 2% | 3 studies (3/-) | 91.9 % | low | not evaluable | high | non important | - |
Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) | 0.96 [0.06, 15.59] | | < 1 | | 0% | 2 studies (2/-) | 51.1 % | low | not evaluable | high | non important | - |
Pancreatitis TRAE (grade 3-4) | 0.96 [0.06, 15.59] | | < 1 | | 0% | 2 studies (2/-) | 51.1 % | low | not evaluable | high | 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) | 0.97 [0.10, 9.43] | | < 1 | | 0% | 3 studies (3/-) | 50.9 % | low | not evaluable | high | non important | - |
Peripheral neuropathy TRAE (grade 3-4) | 1.45 [0.11, 19.13] | | < 1 | | 0% | 2 studies (2/-) | 39.0 % | low | not evaluable | high | non important | - |
Pneumonitis TRAE (grade 3-4) | 1.59 [0.36, 7.01] | | < 1 | | 0% | 4 studies (4/-) | 27.2 % | 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) | 1.28 [0.37, 4.42] | | < 1 | | 4% | 6 studies (6/-) | 34.6 % | low | not evaluable | high | non important | - |
Pyrexia TRAE (grade 3-4) | 1.04 [0.27, 4.00] | | < 1 | | 0% | 6 studies (6/-) | 47.9 % | low | not evaluable | high | non important | - |
Rash TRAE (grade 3-4) | 0.95 [0.16, 5.74] | | < 1 | | 70% | 4 studies (4/-) | 52.3 % | 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) | 0.37 [0.05, 2.77] | | < 1 | | 0% | 3 studies (3/-) | 83.4 % | low | not evaluable | high | non important | - |
Sarcoidosis TRAE (grade 3-4) | 0.96 [0.06, 15.59] | | < 1 | | 0% | 2 studies (2/-) | 51.1 % | low | not evaluable | high | non important | - |
Skin and subcutaneous tissue disorders TRAE (grade 3-4) | 0.75 [0.09, 6.51] | | < 1 | | 68% | 3 studies (3/-) | 60.2 % | low | not evaluable | high | non important | - |
Stomatitis TRAE (grade 3-4) | 0.96 [0.06, 15.59] | | < 1 | | 0% | 2 studies (2/-) | 51.1 % | low | not evaluable | high | non important | - |
Thrombocytopenia TRAE (grade 3-4) | 0.36 [0.03, 4.07] | | < 1 | | 36% | 3 studies (3/-) | 79.4 % | low | not evaluable | high | non important | - |
Thyroiditis TRAE (grade 3-4) | 1.22 [0.18, 8.03] | | < 1 | | 0% | 4 studies (4/-) | 42.0 % | low | not evaluable | high | non important | - |
Uveitis TRAE (grade 3-4) | 0.96 [0.06, 15.59] | | < 1 | | 0% | 2 studies (2/-) | 51.1 % | low | not evaluable | high | non important | - |
Vitiligo TRAE (grade 3-4) | 0.98 [0.19, 5.13] | | < 1 | | 0% | 5 studies (5/-) | 50.7 % | low | not evaluable | high | non important | - |
Vomiting TRAE (grade 3-4) | 2.04 [0.57, 7.31] | | < 1 | | 0% | 5 studies (5/-) | 13.7 % | low | not evaluable | high | non important | - |
Weight decreased TRAE (grade 3-4) | 0.79 [0.12, 5.23] | | < 1 | | 0% | 4 studies (4/-) | 59.6 % | low | not evaluable | high | non important | - |