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) | 0.76 [0.62, 0.93] | | < 1 | | 35% | 2 studies (2/-) | 99.6 % | some concern | not evaluable | moderate | crucial | - |
deaths (OS) (extension) | 0.76 [0.63, 0.92] | | < 1 | | 0% | 1 study (1/-) | 99.8 % | NA | not evaluable | | important | - |
PFS (extension) | 0.54 [0.45, 0.64] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
progression or deaths (PFS) | 0.62 [0.52, 0.74] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
RFS/DFS | 0.72 [0.59, 0.88] | | < 1 | | 0% | 1 study (1/-) | 99.9 % | NA | not evaluable | | important | - |
DCR | 1.85 [1.35, 2.54] | | > 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
DMFS | 0.75 [0.59, 0.95] | | < 1 | | 0% | 1 study (1/-) | 99.2 % | NA | not evaluable | | non important | - |
events or deaths (EFS) | 0.80 [0.63, 1.01] | | < 1 | | 57% | 2 studies (2/-) | 96.9 % | some concern | not evaluable | moderate | non important | - |
objective responses (ORR) | 7.46 [2.53, 21.97] | | > 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
safety endpoints 00 |
AE (any grade) | 13.83 [6.28, 30.48] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
AE (grade 3-4) | 3.85 [2.72, 5.44] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
AE leading to death (grade 5) | 4.03 [0.18, 89.68] | | < 1 | | 0% | 1 study (1/-) | 19.2 % | NA | not evaluable | | non important | - |
AE leading to treatment discontinuation (any grade) | 93.23 [5.71, 1522.42] | | < 1 | | 0% | 1 study (1/-) | 0.1 % | NA | not evaluable | | non important | - |
SAE (any grade) | 1.55 [1.09, 2.21] | | < 1 | | 0% | 1 study (1/-) | 0.8 % | NA | not evaluable | | non important | - |
STRAE (any grade) | 68.24 [4.16, 1120.28] | | < 1 | | 0% | 1 study (1/-) | 0.2 % | NA | not evaluable | | non important | - |
TRAE (any grade) | 27.97 [0.30, 2613.16] | | < 1 | | 99% | 2 studies (2/-) | 8.0 % | low | not evaluable | high | non important | - |
TRAE (grade 3-4) | 10.57 [0.11, 986.65] | | < 1 | | 91% | 2 studies (2/-) | 16.0 % | low | not evaluable | high | non important | - |
TRAE leading to death (grade 5) | 2.01 [0.07, 60.08] | | < 1 | | 0% | 1 study (1/-) | 34.6 % | NA | not evaluable | | non important | - |
TRAE leading to discontinuation (any grade) | 73.11 [4.46, 1198.64] | | < 1 | | 0% | 1 study (1/-) | 0.1 % | NA | not evaluable | | non important | - |
TRAE (grade 3-4) endpoints 00 |
Acute kidney injury TRAE (grade 3-4) | 3.98 [0.18, 88.64] | | < 1 | | 0% | 1 study (1/-) | 19.4 % | NA | not evaluable | | non important | - |
Adrenal insufficiency TRAE (grade 3-4) | 1.00 [0.06, 15.97] | | < 1 | | 0% | 2 studies (2/-) | 50.1 % | low | not evaluable | high | non important | - |
Arthralgia TRAE (grade 3-4) | 2.01 [0.07, 60.08] | | < 1 | | 0% | 1 study (1/-) | 34.6 % | NA | not evaluable | | non important | - |
Arthritis TRAE (grade 3-4) | 1.00 [0.02, 50.69] | | < 1 | | 0% | 1 study (1/-) | 49.9 % | NA | not evaluable | | non important | - |
Asthenia TRAE (grade 3-4) | 2.34 [0.21, 26.70] | | < 1 | | 0% | 2 studies (2/-) | 24.8 % | low | not evaluable | high | non important | - |
Blood creatinine increased TRAE (grade 3-4) | 1.99 [0.07, 59.38] | | < 1 | | 0% | 1 study (1/-) | 34.8 % | NA | not evaluable | | non important | - |
Chills TRAE (grade 3-4) | 1.00 [0.02, 50.69] | | < 1 | | 0% | 1 study (1/-) | 49.9 % | NA | not evaluable | | non important | - |
Colitis TRAE (grade 3-4) | 1.91 [0.40, 9.05] | | < 1 | | 0% | 2 studies (2/-) | 20.7 % | low | not evaluable | high | non important | - |
Decreased appetite TRAE (grade 3-4) | 3.98 [0.18, 88.64] | | < 1 | | 0% | 1 study (1/-) | 19.4 % | NA | not evaluable | | non important | - |
Dermatitis acneiform TRAE (grade 3-4) | 0.99 [0.02, 50.11] | | < 1 | | 0% | 1 study (1/-) | 50.2 % | NA | not evaluable | | non important | - |
Diabetes TRAE (grade 3-4) | 1.00 [0.06, 15.97] | | < 1 | | 0% | 2 studies (2/-) | 50.1 % | low | not evaluable | high | non important | - |
Diarrhoea TRAE (grade 3-4) | 2.27 [0.32, 16.21] | | < 1 | | 0% | 2 studies (2/-) | 20.7 % | low | not evaluable | high | non important | - |
Dry skin TRAE (grade 3-4) | 1.00 [0.02, 50.69] | | < 1 | | 0% | 1 study (1/-) | 49.9 % | NA | not evaluable | | non important | - |
Eczema TRAE (grade 3-4) | 0.99 [0.02, 50.11] | | < 1 | | 0% | 1 study (1/-) | 50.2 % | NA | not evaluable | | non important | - |
Endocrine disorders TRAE (grade 3-4) | 1.99 [0.07, 59.38] | | < 1 | | 0% | 1 study (1/-) | 34.8 % | NA | not evaluable | | non important | - |
Erythema TRAE (grade 3-4) | 0.99 [0.02, 50.11] | | < 1 | | 0% | 1 study (1/-) | 50.2 % | NA | not evaluable | | non important | - |
Fatigue TRAE (grade 3-4) | 2.00 [0.18, 22.08] | | < 1 | | 0% | 2 studies (2/-) | 28.8 % | low | not evaluable | high | non important | - |
Gastrointestinal disorders TRAE (grade 3-4) | 2.00 [0.50, 8.06] | | < 1 | | 0% | 1 study (1/-) | 16.5 % | NA | not evaluable | | non important | - |
Guillain-Barré syndrome TRAE (grade 3-4) | 2.01 [0.07, 60.08] | | < 1 | | 0% | 1 study (1/-) | 34.6 % | NA | not evaluable | | non important | - |
Hyperthyroidism TRAE (grade 3-4) | 1.00 [0.02, 50.69] | | < 1 | | 0% | 1 study (1/-) | 49.9 % | NA | not evaluable | | non important | - |
Hypothyroidism TRAE (grade 3-4) | 2.01 [0.07, 60.08] | | < 1 | | 0% | 1 study (1/-) | 34.6 % | NA | not evaluable | | non important | - |
Increase AST TRAE (grade 3-4) | 1.99 [0.07, 59.38] | | < 1 | | 0% | 1 study (1/-) | 34.8 % | NA | not evaluable | | non important | - |
Increased ALT TRAE (grade 3-4) | 3.98 [0.18, 88.64] | | < 1 | | 0% | 1 study (1/-) | 19.4 % | NA | not evaluable | | non important | - |
Increased lipase level TRAE (grade 3-4) | 20.63 [1.20, 354.60] | | < 1 | | 0% | 1 study (1/-) | 2.0 % | NA | not evaluable | | non important | - |
Infusion-related reactions TRAE (grade 3-4) | 6.06 [0.30, 121.47] | | < 1 | | 0% | 1 study (1/-) | 12.2 % | NA | not evaluable | | non important | - |
Maculopapular rash TRAE (grade 3-4) | 3.98 [0.18, 88.64] | | < 1 | | 0% | 1 study (1/-) | 19.4 % | NA | not evaluable | | non important | - |
Myositis TRAE (grade 3-4) | 4.03 [0.18, 89.68] | | < 1 | | 0% | 1 study (1/-) | 19.2 % | NA | not evaluable | | non important | - |
Nausea TRAE (grade 3-4) | 1.48 [0.11, 19.36] | | < 1 | | 0% | 2 studies (2/-) | 38.3 % | some concern | not evaluable | moderate | non important | - |
Nephritis TRAE (grade 3-4) | 1.48 [0.11, 19.33] | | < 1 | | 0% | 2 studies (2/-) | 38.3 % | low | not evaluable | high | non important | - |
Pancreatitis TRAE (grade 3-4) | 2.01 [0.07, 60.08] | | < 1 | | 0% | 1 study (1/-) | 34.6 % | NA | not evaluable | | non important | - |
Pneumonitis TRAE (grade 3-4) | 2.00 [0.18, 22.08] | | < 1 | | 0% | 2 studies (2/-) | 28.8 % | low | not evaluable | high | non important | - |
Pruritic rash TRAE (grade 3-4) | 0.99 [0.02, 50.11] | | < 1 | | 0% | 1 study (1/-) | 50.2 % | NA | not evaluable | | non important | - |
Pruritus TRAE (grade 3-4) | 1.48 [0.11, 19.36] | | < 1 | | 0% | 2 studies (2/-) | 38.3 % | some concern | not evaluable | moderate | non important | - |
Pyrexia TRAE (grade 3-4) | 1.00 [0.02, 50.69] | | < 1 | | 0% | 1 study (1/-) | 49.9 % | NA | not evaluable | | non important | - |
Rash TRAE (grade 3-4) | 2.92 [0.30, 28.85] | | < 1 | | 0% | 2 studies (2/-) | 18.1 % | low | not evaluable | high | non important | - |
Renal and urinary disorders TRAE (grade 3-4) | 8.01 [0.42, 152.12] | | < 1 | | 0% | 1 study (1/-) | 8.5 % | NA | not evaluable | | non important | - |
Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) | 5.99 [0.30, 120.06] | | < 1 | | 0% | 1 study (1/-) | 12.4 % | NA | not evaluable | | non important | - |
Thyroiditis TRAE (grade 3-4) | 1.00 [0.06, 15.97] | | < 1 | | 0% | 2 studies (2/-) | 50.1 % | low | not evaluable | high | non important | - |
Urticaria TRAE (grade 3-4) | 0.99 [0.02, 50.11] | | < 1 | | 0% | 1 study (1/-) | 50.2 % | NA | not evaluable | | non important | - |
Uveitis TRAE (grade 3-4) | 1.00 [0.02, 50.69] | | < 1 | | 0% | 1 study (1/-) | 49.9 % | NA | not evaluable | | non important | - |
Vitiligo TRAE (grade 3-4) | 1.00 [0.02, 50.69] | | < 1 | | 0% | 1 study (1/-) | 49.9 % | NA | not evaluable | | non important | - |
AE (grade 3-4) endpoints 00 |
hepatitis (Autoimmune) AE (grade 3-4) | 2.01 [0.07, 60.08] | | < 1 | | 0% | 1 study (1/-) | 34.6 % | NA | not evaluable | | non important | - |
Anaemia AE (grade 3-4) | 1.32 [0.57, 3.04] | | < 1 | | 0% | 1 study (1/-) | 26.1 % | NA | not evaluable | | non important | - |
Arthralgia AE (grade 3-4) | 4.03 [0.18, 89.68] | | < 1 | | 0% | 1 study (1/-) | 19.2 % | NA | not evaluable | | non important | - |
Asthenia AE (grade 3-4) | 0.12 [0.01, 2.36] | | < 1 | | 0% | 1 study (1/-) | 91.5 % | NA | not evaluable | | non important | - |
Back pain AE (grade 3-4) | 0.50 [0.15, 1.66] | | < 1 | | 0% | 1 study (1/-) | 87.2 % | NA | not evaluable | | non important | - |
Constipation AE (grade 3-4) | 4.03 [0.18, 89.68] | | < 1 | | 0% | 1 study (1/-) | 19.2 % | NA | not evaluable | | non important | - |
Cough AE (grade 3-4) | 2.01 [0.07, 60.08] | | < 1 | | 0% | 1 study (1/-) | 34.6 % | NA | not evaluable | | non important | - |
Decreased appetite AE (grade 3-4) | 0.50 [0.05, 5.54] | | < 1 | | 0% | 1 study (1/-) | 71.2 % | NA | not evaluable | | non important | - |
Diarrhoea AE (grade 3-4) | 2.01 [0.18, 22.29] | | < 1 | | 0% | 1 study (1/-) | 28.6 % | NA | not evaluable | | non important | - |
Fatigue AE (grade 3-4) | 3.04 [0.61, 15.19] | | < 1 | | 0% | 1 study (1/-) | 8.8 % | NA | not evaluable | | non important | - |
Hypothyroidism AE (grade 3-4) | 2.01 [0.07, 60.08] | | < 1 | | 0% | 1 study (1/-) | 34.6 % | NA | not evaluable | | non important | - |
Infusion-related reaction AE (grade 3-4) | 6.06 [0.30, 121.47] | | < 1 | | 0% | 1 study (1/-) | 12.2 % | NA | not evaluable | | non important | - |
Nausea AE (grade 3-4) | 0.50 [0.05, 5.54] | | < 1 | | 0% | 1 study (1/-) | 71.2 % | NA | not evaluable | | non important | - |
Pruritus AE (grade 3-4) | 2.01 [0.07, 60.08] | | < 1 | | 0% | 1 study (1/-) | 34.6 % | NA | not evaluable | | non important | - |
Pyrexia AE (grade 3-4) | 2.01 [0.07, 60.08] | | < 1 | | 0% | 1 study (1/-) | 34.6 % | NA | not evaluable | | non important | - |
Rash AE (grade 3-4) | 2.01 [0.07, 60.08] | | < 1 | | 0% | 1 study (1/-) | 34.6 % | NA | not evaluable | | non important | - |
Skin and subcutaneous tissue disorders AE (grade 3-4) | 12.09 [0.67, 217.24] | | < 1 | | 0% | 1 study (1/-) | 4.7 % | NA | not evaluable | | non important | - |
Vomiting AE (grade 3-4) | 2.02 [0.37, 11.09] | | < 1 | | 0% | 1 study (1/-) | 21.1 % | NA | not evaluable | | non important | - |