| 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) | 0.56 [0.43, 0.73] | | < 1 | | 49% | 2 studies (2/-) | 100.0 % | low | not evaluable | high | crucial | - |
| deaths (OS) (extension) | 0.56 [0.45, 0.70] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
| PFS (extension) | 0.48 [0.40, 0.58] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
| progression or deaths (PFS) | 0.54 [0.46, 0.62] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | low | not evaluable | high | important | - |
| objective responses (ORR) | 2.90 [1.66, 5.04] | | > 1 | | 78% | 2 studies (2/-) | 100.0 % | low | not evaluable | high | non important | - |
| objective responses (ORR) (extension) | 3.84 [2.58, 5.70] | | > 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
safety endpoints 00 |
| AE (any grade) | 1.52 [0.52, 4.45] | | < 1 | | 0% | 2 studies (2/-) | 22.1 % | low | not evaluable | high | non important | - |
| AE (grade 3-4) | 1.01 [0.79, 1.28] | | < 1 | | 0% | 2 studies (2/-) | 47.9 % | low | not evaluable | high | non important | - |
| AE leading to death (grade 5) | 1.23 [0.76, 1.97] | | < 1 | | 0% | 2 studies (2/-) | 19.9 % | low | not evaluable | high | non important | - |
| AE leading to treatment discontinuation (any grade) | 2.24 [1.59, 3.15] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| AE leading to treatment discontinuation (grade 3-4) | 2.07 [1.43, 2.99] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| TRAE leading to death (grade 5) | 1.70 [0.61, 4.75] | | < 1 | | 0% | 1 study (1/-) | 15.5 % | NA | not evaluable | | non important | - |
TRAE (grade 3-4) endpoints 00 |
| Adrenal insufficiency TRAE (grade 3-4) | 0.50 [0.03, 8.00] | | < 1 | | 0% | 1 study (1/-) | 68.7 % | NA | not evaluable | | non important | - |
| Colitis TRAE (grade 3-4) | 3.01 [0.15, 60.33] | | < 1 | | 0% | 1 study (1/-) | 23.8 % | NA | not evaluable | | non important | - |
| Diabetes TRAE (grade 3-4) | 1.00 [0.03, 29.86] | | < 1 | | 0% | 1 study (1/-) | 50.1 % | NA | not evaluable | | non important | - |
| Hepatitis TRAE (grade 3-4) | 4.02 [0.21, 76.41] | | < 1 | | 0% | 1 study (1/-) | 18.0 % | NA | not evaluable | | non important | - |
| Hyperthyroidism TRAE (grade 3-4) | 0.50 [0.01, 25.20] | | < 1 | | 0% | 1 study (1/-) | 63.4 % | NA | not evaluable | | non important | - |
| Hypophysitis TRAE (grade 3-4) | 0.50 [0.01, 25.20] | | < 1 | | 0% | 1 study (1/-) | 63.4 % | NA | not evaluable | | non important | - |
| Hypothyroidism TRAE (grade 3-4) | 2.00 [0.09, 44.56] | | < 1 | | 0% | 1 study (1/-) | 33.3 % | NA | not evaluable | | non important | - |
| Infusion-related reactions TRAE (grade 3-4) | 1.00 [0.03, 29.86] | | < 1 | | 0% | 1 study (1/-) | 50.1 % | NA | not evaluable | | non important | - |
| Myositis TRAE (grade 3-4) | 0.50 [0.01, 25.20] | | < 1 | | 0% | 1 study (1/-) | 63.4 % | NA | not evaluable | | non important | - |
| Nephritis TRAE (grade 3-4) | 6.06 [0.34, 109.04] | | < 1 | | 0% | 1 study (1/-) | 11.3 % | NA | not evaluable | | non important | - |
| Pancreatitis TRAE (grade 3-4) | 2.00 [0.09, 44.56] | | < 1 | | 0% | 1 study (1/-) | 33.3 % | NA | not evaluable | | non important | - |
| Pneumonitis TRAE (grade 3-4) | 1.00 [0.30, 3.35] | | < 1 | | 0% | 1 study (1/-) | 50.2 % | NA | not evaluable | | non important | - |
| Severe skin reaction TRAE (grade 3-4) | 1.00 [0.30, 3.35] | | < 1 | | 0% | 1 study (1/-) | 50.2 % | NA | not evaluable | | non important | - |
| Thyroiditis TRAE (grade 3-4) | 0.50 [0.01, 25.20] | | < 1 | | 0% | 1 study (1/-) | 63.4 % | NA | not evaluable | | non important | - |
AE (grade 3-4) endpoints 00 |
| hepatitis (Autoimmune) AE (grade 3-4) | 10.24 [0.56, 188.30] | | < 1 | | 0% | 1 study (1/-) | 6.1 % | NA | not evaluable | | non important | - |
| Alopecia AE (grade 3-4) | 0.33 [0.03, 3.22] | | < 1 | | 0% | 1 study (1/-) | 82.7 % | NA | not evaluable | | non important | - |
| Anaemia AE (grade 3-4) | 0.87 [0.58, 1.29] | | < 1 | | 36% | 2 studies (2/-) | 75.5 % | low | not evaluable | high | non important | - |
| Arthralgia AE (grade 3-4) | 2.03 [0.37, 11.17] | | < 1 | | 0% | 1 study (1/-) | 20.9 % | NA | not evaluable | | non important | - |
| Asthenia AE (grade 3-4) | 1.08 [0.36, 3.25] | | < 1 | | 63% | 2 studies (2/-) | 44.3 % | low | not evaluable | high | non important | - |
| Colitis AE (grade 3-4) | 2.04 [0.50, 8.23] | | < 1 | | 0% | 1 study (1/-) | 16.0 % | NA | not evaluable | | non important | - |
| Constipation AE (grade 3-4) | 1.04 [0.26, 4.17] | | < 1 | | 0% | 2 studies (2/-) | 47.9 % | low | not evaluable | high | non important | - |
| Cough AE (grade 3-4) | 0.64 [0.12, 3.26] | | < 1 | | 0% | 2 studies (2/-) | 70.6 % | low | not evaluable | high | non important | - |
| Decreased appetite AE (grade 3-4) | 1.51 [0.53, 4.30] | | < 1 | | 0% | 2 studies (2/-) | 21.9 % | low | not evaluable | high | non important | - |
| Diarrhoea AE (grade 3-4) | 1.83 [0.93, 3.61] | | < 1 | | 0% | 2 studies (2/-) | 4.1 % | low | not evaluable | high | non important | - |
| Dyspnoea AE (grade 3-4) | 0.97 [0.27, 3.47] | | < 1 | | 35% | 2 studies (2/-) | 52.0 % | low | not evaluable | high | non important | - |
| Epistaxis AE (grade 3-4) | 1.01 [0.02, 50.94] | | < 1 | | 0% | 1 study (1/-) | 49.9 % | NA | not evaluable | | non important | - |
| Fatigue AE (grade 3-4) | 1.37 [0.48, 3.87] | | < 1 | | 59% | 2 studies (2/-) | 27.9 % | low | not evaluable | high | non important | - |
| Hyperthyroidism AE (grade 3-4) | 2.02 [0.07, 60.40] | | < 1 | | 0% | 1 study (1/-) | 34.5 % | NA | not evaluable | | non important | - |
| Hypophysitis AE (grade 3-4) | 4.05 [0.18, 90.23] | | < 1 | | 0% | 1 study (1/-) | 19.1 % | NA | not evaluable | | non important | - |
| Hypothyroidism AE (grade 3-4) | 2.02 [0.07, 60.40] | | < 1 | | 0% | 1 study (1/-) | 34.5 % | NA | not evaluable | | non important | - |
| Infusion-related reaction AE (grade 3-4) | 4.07 [0.45, 36.67] | | < 1 | | 0% | 1 study (1/-) | 10.7 % | NA | not evaluable | | non important | - |
| Lacrimation increased AE (grade 3-4) | 0.50 [0.01, 25.20] | | < 1 | | 0% | 1 study (1/-) | 63.4 % | NA | not evaluable | | non important | - |
| Myalgia AE (grade 3-4) | 2.02 [0.18, 22.43] | | < 1 | | 0% | 1 study (1/-) | 28.5 % | NA | not evaluable | | non important | - |
| Nausea AE (grade 3-4) | 0.92 [0.42, 2.03] | | < 1 | | 0% | 2 studies (2/-) | 57.8 % | low | not evaluable | high | non important | - |
| Neutropenia AE (grade 3-4) | 1.08 [0.71, 1.66] | | < 1 | | 46% | 2 studies (2/-) | 35.6 % | low | not evaluable | high | non important | - |
| Peripheral neuropathy AE (grade 3-4) | 1.52 [0.25, 9.15] | | < 1 | | 0% | 1 study (1/-) | 32.6 % | NA | not evaluable | | non important | - |
| Peripheral oedema AE (grade 3-4) | 1.00 [0.03, 29.86] | | < 1 | | 0% | 1 study (1/-) | 50.1 % | NA | not evaluable | | non important | - |
| Pneumonitis AE (grade 3-4) | 3.07 [0.61, 15.32] | | < 1 | | 0% | 1 study (1/-) | 8.7 % | NA | not evaluable | | non important | - |
| Pyrexia AE (grade 3-4) | 1.00 [0.18, 5.51] | | < 1 | | 0% | 2 studies (2/-) | 49.8 % | low | not evaluable | high | non important | - |
| Rash AE (grade 3-4) | 1.17 [0.30, 4.56] | | < 1 | | 0% | 1 study (1/-) | 41.3 % | NA | not evaluable | | non important | - |
| Severe skin reactions AE (grade 3-4) | 3.04 [0.31, 29.44] | | < 1 | | 0% | 1 study (1/-) | 17.0 % | NA | not evaluable | | non important | - |
| Thrombocytopenia AE (grade 3-4) | 1.11 [0.70, 1.77] | | < 1 | | 0% | 2 studies (2/-) | 33.0 % | low | not evaluable | high | non important | - |
| Thyroiditis AE (grade 3-4) | 2.02 [0.07, 60.40] | | < 1 | | 0% | 1 study (1/-) | 34.5 % | NA | not evaluable | | non important | - |
| Vomiting AE (grade 3-4) | 0.57 [0.08, 3.98] | | < 1 | | 66% | 2 studies (2/-) | 71.3 % | low | not evaluable | high | non important | - |
