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) | 0.68 [0.40, 1.15] | | < 1 | | 93% | 5 studies (5/-) | 92.5 % | low | serious | high | crucial | - |
deaths (OS) (extension) | 0.71 [0.41, 1.20] | | < 1 | | 95% | 3 studies (3/-) | 90.0 % | 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) | 0.66 [0.34, 1.26] | | < 1 | | 97% | 3 studies (3/-) | 89.7 % | low | not evaluable | high | important | - |
progression or deaths (PFS) | 0.62 [0.34, 1.10] | | < 1 | | 96% | 4 studies (4/-) | 94.8 % | 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 | 0.92 [0.45, 1.89] | | < 1 | | 86% | 3 studies (3/-) | 59.3 % | 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) | 2.35 [0.77, 7.20] | | > 1 | | 96% | 4 studies (4/-) | 93.3 % | low | not evaluable | high | non important | - |
objective responses (ORR) (extension) | 1.38 [0.16, 11.98] | | > 1 | | 99% | 3 studies (3/-) | 61.5 % | 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) | 0.97 [0.10, 9.38] | | < 1 | | 0% | 3 studies (3/-) | 51.1 % | low | not evaluable | high | non important | - |
AE leading to treatment discontinuation (any grade) | 0.34 [0.11, 1.04] | | < 1 | | 89% | 4 studies (4/-) | 97.1 % | low | not evaluable | high | non important | - |
AE leading to treatment discontinuation (grade 3-4) | 0.31 [0.09, 1.14] | | < 1 | | 88% | 4 studies (4/-) | 96.1 % | low | not evaluable | high | non important | - |
SAE (any grade) | 0.64 [0.30, 1.34] | | < 1 | | 74% | 3 studies (3/-) | 88.2 % | low | not evaluable | high | non important | - |
SAE (grade 3-4) | 0.78 [0.29, 2.12] | | < 1 | | 82% | 3 studies (3/-) | 68.9 % | low | not evaluable | high | non important | - |
STRAE (any grade) | 0.94 [0.17, 5.12] | | < 1 | | 89% | 3 studies (3/-) | 52.9 % | low | not evaluable | high | non important | - |
STRAE (grade 3-4) | 0.97 [0.17, 5.43] | | < 1 | | 84% | 3 studies (3/-) | 51.3 % | low | not evaluable | high | non important | - |
TRAE (any grade) | 0.65 [0.30, 1.39] | | < 1 | | 89% | 6 studies (6/-) | 86.9 % | low | not evaluable | high | non important | - |
TRAE (grade 3-4) | 0.44 [0.22, 0.86] | | < 1 | | 92% | 6 studies (6/-) | 99.1 % | low | not evaluable | high | non important | - |
TRAE leading to death (grade 5) | 0.66 [0.13, 3.47] | | < 1 | | 0% | 5 studies (5/-) | 68.7 % | low | serious | high | non important | - |
TRAE leading to discontinuation (any grade) | 0.30 [0.12, 0.74] | | < 1 | | 92% | 5 studies (5/-) | 99.5 % | low | not evaluable | high | non important | - |
TRAE leading to discontinuation (grade 3-4) | 0.23 [0.09, 0.56] | | < 1 | | 87% | 5 studies (5/-) | 99.9 % | low | not evaluable | high | non important | - |
TRAE (grade 3-4) endpoints 00 |
Abdominal pain TRAE (grade 3-4) | 0.56 [0.13, 2.41] | | < 1 | | 0% | 6 studies (6/-) | 78.1 % | low | serious | high | non important | - |
Acute kidney injury TRAE (grade 3-4) | 0.64 [0.05, 8.40] | | < 1 | | 0% | 2 studies (2/-) | 63.3 % | low | not evaluable | high | non important | - |
Adrenal insufficiency TRAE (grade 3-4) | 0.56 [0.21, 1.47] | | < 1 | | 0% | 5 studies (5/-) | 88.1 % | low | not evaluable | high | non important | - |
Alopecia TRAE (grade 3-4) | 0.96 [0.10, 9.32] | | < 1 | | 0% | 3 studies (3/-) | 51.3 % | low | not evaluable | high | non important | - |
Anaemia TRAE (grade 3-4) | 0.73 [0.08, 6.29] | | < 1 | | 0% | 3 studies (3/-) | 61.3 % | low | not evaluable | high | non important | - |
Arthralgia TRAE (grade 3-4) | 1.15 [0.35, 3.79] | | < 1 | | 0% | 6 studies (6/-) | 41.0 % | 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) | 2.98 [0.27, 32.69] | | < 1 | | 0% | 2 studies (2/-) | 18.8 % | 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) | 0.95 [0.06, 15.31] | | < 1 | | 0% | 2 studies (2/-) | 51.6 % | low | not evaluable | high | non important | - |
Colitis TRAE (grade 3-4) | 0.12 [0.06, 0.28] | | < 1 | | 0% | 4 studies (4/-) | 100.0 % | 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) | 2.01 [0.42, 9.75] | | < 1 | | 0% | 5 studies (5/-) | 19.3 % | low | serious | high | non important | - |
Decreased appetite TRAE (grade 3-4) | 0.46 [0.09, 2.24] | | < 1 | | 0% | 5 studies (5/-) | 83.2 % | low | serious | high | non important | - |
Diabetes TRAE (grade 3-4) | 1.94 [0.27, 13.89] | | < 1 | | 0% | 3 studies (3/-) | 25.6 % | low | not evaluable | high | non important | - |
Diarrhoea TRAE (grade 3-4) | 0.36 [0.18, 0.69] | | < 1 | | 39% | 6 studies (6/-) | 99.9 % | low | not evaluable | high | non important | - |
Dizziness TRAE (grade 3-4) | 0.95 [0.06, 15.31] | | < 1 | | 0% | 2 studies (2/-) | 51.6 % | low | not evaluable | high | non important | - |
Dry skin TRAE (grade 3-4) | 0.98 [0.17, 5.66] | | < 1 | | 0% | 5 studies (5/-) | 51.1 % | low | not evaluable | high | non important | - |
Dysgeusia TRAE (grade 3-4) | 0.95 [0.06, 15.31] | | < 1 | | 0% | 2 studies (2/-) | 51.6 % | low | not evaluable | high | non important | - |
Dyspepsia TRAE (grade 3-4) | 0.95 [0.06, 15.31] | | < 1 | | 0% | 2 studies (2/-) | 51.6 % | low | not evaluable | high | non important | - |
Dyspnoea TRAE (grade 3-4) | 0.67 [0.14, 3.21] | | < 1 | | 0% | 4 studies (4/-) | 69.0 % | low | not evaluable | high | non important | - |
Endocrine disorders TRAE (grade 3-4) | 0.39 [0.05, 3.31] | | < 1 | | 20% | 2 studies (2/-) | 80.4 % | low | not evaluable | high | non important | - |
Eye disorders TRAE (grade 3-4) | 0.64 [0.05, 8.40] | | < 1 | | 0% | 2 studies (2/-) | 63.3 % | low | not evaluable | high | non important | - |
Fatigue TRAE (grade 3-4) | 0.43 [0.20, 0.96] | | < 1 | | 0% | 6 studies (6/-) | 98.1 % | low | not evaluable | high | non important | - |
Gastritis TRAE (grade 3-4) | 0.40 [0.03, 4.62] | | < 1 | | 0% | 2 studies (2/-) | 76.7 % | low | not evaluable | high | non important | - |
Gastrointestinal disorders TRAE (grade 3-4) | 0.13 [0.04, 0.40] | | < 1 | | 25% | 3 studies (3/-) | 100.0 % | low | not evaluable | high | non important | - |
General disorders and administration site conditions TRAE (grade 3-4) | 0.40 [0.03, 4.62] | | < 1 | | 0% | 2 studies (2/-) | 76.7 % | low | not evaluable | high | non important | - |
Headache TRAE (grade 3-4) | 0.34 [0.10, 1.23] | | < 1 | | 0% | 6 studies (6/-) | 95.0 % | low | serious | high | non important | - |
Hepatitis TRAE (grade 3-4) | 0.42 [0.11, 1.55] | | < 1 | | 5% | 4 studies (4/-) | 90.3 % | low | not evaluable | high | non important | - |
Hepatobiliary disorders TRAE (grade 3-4) | 0.22 [0.06, 0.77] | | < 1 | | 50% | 3 studies (3/-) | 99.1 % | 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) | 0.95 [0.06, 15.31] | | < 1 | | 0% | 2 studies (2/-) | 51.6 % | low | not evaluable | high | non important | - |
Hyperthyroidism TRAE (grade 3-4) | 0.54 [0.14, 2.03] | | < 1 | | 0% | 6 studies (6/-) | 81.9 % | low | not evaluable | high | non important | - |
Hypophysitis TRAE (grade 3-4) | 0.27 [0.10, 0.73] | | < 1 | | 0% | 5 studies (5/-) | 99.5 % | low | serious | high | non important | - |
Hypothyroidism TRAE (grade 3-4) | 0.70 [0.17, 2.79] | | < 1 | | 0% | 6 studies (6/-) | 69.5 % | low | serious | high | non important | - |
Increase AST TRAE (grade 3-4) | 0.40 [0.14, 1.16] | | < 1 | | 54% | 6 studies (6/-) | 95.3 % | low | serious | high | non important | - |
Increased ALT TRAE (grade 3-4) | 0.36 [0.15, 0.89] | | < 1 | | 57% | 6 studies (6/-) | 98.6 % | low | serious | high | non important | - |
Increased lipase level TRAE (grade 3-4) | 0.60 [0.30, 1.18] | | < 1 | | 45% | 4 studies (4/-) | 93.0 % | low | not evaluable | high | non important | - |
Infusion-related reactions TRAE (grade 3-4) | 0.96 [0.10, 9.32] | | < 1 | | 0% | 3 studies (3/-) | 51.3 % | low | not evaluable | high | non important | - |
Leucopenia TRAE (grade 3-4) | 0.36 [0.05, 2.73] | | < 1 | | 0% | 3 studies (3/-) | 83.7 % | low | not evaluable | high | non important | - |
Maculopapular rash TRAE (grade 3-4) | 0.48 [0.17, 1.36] | | < 1 | | 0% | 6 studies (6/-) | 91.6 % | low | not evaluable | high | non important | - |
Metabolism and nutrition disorders TRAE (grade 3-4) | 1.26 [0.14, 10.99] | | < 1 | | 0% | 2 studies (2/-) | 41.7 % | low | not evaluable | high | non important | - |
Musculoskeletal and connective tissue disorders TRAE (grade 3-4) | 5.94 [0.70, 50.19] | | < 1 | | 0% | 2 studies (2/-) | 5.2 % | low | not evaluable | high | non important | - |
Myalgia TRAE (grade 3-4) | 1.46 [0.33, 6.44] | | < 1 | | 0% | 5 studies (5/-) | 31.1 % | low | not evaluable | high | non important | - |
Myositis TRAE (grade 3-4) | 0.95 [0.06, 15.31] | | < 1 | | 0% | 2 studies (2/-) | 51.6 % | low | not evaluable | high | non important | - |
Nausea TRAE (grade 3-4) | 0.44 [0.11, 1.80] | | < 1 | | 0% | 6 studies (6/-) | 87.3 % | low | serious | high | non important | - |
Nervous system disorders TRAE (grade 3-4) | 2.53 [0.37, 17.24] | | < 1 | | 0% | 2 studies (2/-) | 17.2 % | low | not evaluable | high | non important | - |
Neutropenia TRAE (grade 3-4) | 0.23 [0.03, 1.71] | | < 1 | | 0% | 3 studies (3/-) | 92.3 % | low | not evaluable | high | non important | - |
Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) | 0.95 [0.06, 15.31] | | < 1 | | 0% | 2 studies (2/-) | 51.6 % | low | not evaluable | high | non important | - |
Pancreatitis TRAE (grade 3-4) | 0.95 [0.06, 15.31] | | < 1 | | 0% | 2 studies (2/-) | 51.6 % | 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) | 0.96 [0.10, 9.32] | | < 1 | | 0% | 3 studies (3/-) | 51.3 % | low | not evaluable | high | non important | - |
Peripheral neuropathy TRAE (grade 3-4) | 0.64 [0.05, 8.40] | | < 1 | | 0% | 2 studies (2/-) | 63.3 % | low | not evaluable | high | non important | - |
Pneumonitis TRAE (grade 3-4) | 0.61 [0.14, 2.70] | | < 1 | | 0% | 4 studies (4/-) | 74.1 % | 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) | 0.40 [0.12, 1.35] | | < 1 | | 0% | 6 studies (6/-) | 92.9 % | low | not evaluable | high | non important | - |
Pyrexia TRAE (grade 3-4) | 0.36 [0.09, 1.38] | | < 1 | | 0% | 6 studies (6/-) | 93.2 % | low | serious | high | non important | - |
Rash TRAE (grade 3-4) | 0.29 [0.13, 0.66] | | < 1 | | 0% | 4 studies (4/-) | 99.8 % | 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) | 0.36 [0.05, 2.74] | | < 1 | | 0% | 3 studies (3/-) | 83.6 % | low | not evaluable | high | non important | - |
Sarcoidosis TRAE (grade 3-4) | 0.95 [0.06, 15.31] | | < 1 | | 0% | 2 studies (2/-) | 51.6 % | low | not evaluable | high | non important | - |
Skin and subcutaneous tissue disorders TRAE (grade 3-4) | 0.22 [0.09, 0.52] | | < 1 | | 0% | 3 studies (3/-) | 100.0 % | low | not evaluable | high | non important | - |
Stomatitis TRAE (grade 3-4) | 0.95 [0.06, 15.31] | | < 1 | | 0% | 2 studies (2/-) | 51.6 % | low | not evaluable | high | non important | - |
Thrombocytopenia TRAE (grade 3-4) | 0.20 [0.03, 1.34] | | < 1 | | 0% | 3 studies (3/-) | 95.1 % | low | not evaluable | high | non important | - |
Thyroiditis TRAE (grade 3-4) | 0.79 [0.12, 5.19] | | < 1 | | 0% | 4 studies (4/-) | 59.9 % | low | not evaluable | high | non important | - |
Uveitis TRAE (grade 3-4) | 0.95 [0.06, 15.31] | | < 1 | | 0% | 2 studies (2/-) | 51.6 % | low | not evaluable | high | non important | - |
Vitiligo TRAE (grade 3-4) | 1.36 [0.26, 7.07] | | < 1 | | 0% | 5 studies (5/-) | 35.9 % | low | serious | high | non important | - |
Vomiting TRAE (grade 3-4) | 0.48 [0.13, 1.71] | | < 1 | | 0% | 5 studies (5/-) | 87.1 % | low | not evaluable | high | non important | - |
Weight decreased TRAE (grade 3-4) | 0.78 [0.12, 5.19] | | < 1 | | 0% | 4 studies (4/-) | 59.9 % | low | not evaluable | high | non important | - |