| 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) | 0.58 [0.46, 0.74] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | low | not evaluable | high | crucial | - |
| deaths (OS) (extension) | 0.52 [0.42, 0.64] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | important | - |
| PFS (extension) | 0.41 [0.35, 0.49] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | low | not evaluable | high | important | - |
| progression or deaths (PFS) | 0.41 [0.32, 0.53] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | low | not evaluable | high | important | - |
| objective responses (ORR) | 9.45 [3.90, 22.89] | | > 1 | | 79% | 2 studies (2/-) | 100.0 % | low | not evaluable | high | non important | - |
| objective responses (ORR) (extension) | 7.36 [4.31, 12.57] | | > 1 | | 28% | 2 studies (2/-) | 100.0 % | low | not evaluable | high | non important | - |
safety endpoints 00 |
| TRAE (any grade) | 1.88 [0.40, 8.83] | | < 1 | | 76% | 2 studies (2/-) | 21.2 % | low | not evaluable | high | non important | - |
| TRAE (grade 3-4) | 3.82 [2.81, 5.21] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| TRAE leading to death (grade 5) | 0.99 [0.02, 50.24] | | < 1 | | 0% | 1 study (1/-) | 50.1 % | NA | not evaluable | | non important | - |
| TRAE leading to discontinuation (any grade) | 4.02 [2.83, 5.71] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| TRAE leading to discontinuation (grade 3-4) | 2.89 [2.00, 4.19] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
TRAE (grade 3-4) endpoints 00 |
| Abdominal pain TRAE (grade 3-4) | 0.39 [0.05, 2.78] | | < 1 | | 0% | 2 studies (2/-) | 82.5 % | low | not evaluable | high | non important | - |
| Adrenal insufficiency TRAE (grade 3-4) | 1.27 [0.05, 30.32] | | < 1 | | 74% | 2 studies (2/-) | 44.3 % | low | not evaluable | high | non important | - |
| Arthralgia TRAE (grade 3-4) | 1.78 [0.16, 20.38] | | < 1 | | 0% | 2 studies (2/-) | 32.2 % | low | not evaluable | high | non important | - |
| Asthenia TRAE (grade 3-4) | 0.49 [0.06, 3.84] | | < 1 | | 0% | 2 studies (2/-) | 74.9 % | low | not evaluable | high | non important | - |
| Chills TRAE (grade 3-4) | 0.49 [0.01, 24.92] | | < 1 | | 0% | 1 study (1/-) | 63.7 % | NA | not evaluable | | non important | - |
| Colitis TRAE (grade 3-4) | 1.50 [0.60, 3.76] | | < 1 | | 48% | 2 studies (2/-) | 19.3 % | low | not evaluable | high | non important | - |
| Constipation TRAE (grade 3-4) | 0.98 [0.03, 29.71] | | < 1 | | 0% | 1 study (1/-) | 50.5 % | NA | not evaluable | | non important | - |
| Cough TRAE (grade 3-4) | 0.99 [0.02, 50.24] | | < 1 | | 0% | 1 study (1/-) | 50.1 % | NA | not evaluable | | non important | - |
| Decreased appetite TRAE (grade 3-4) | 2.43 [0.36, 16.56] | | < 1 | | 0% | 2 studies (2/-) | 18.3 % | low | not evaluable | high | non important | - |
| Diarrhoea TRAE (grade 3-4) | 1.48 [0.86, 2.53] | | < 1 | | 0% | 2 studies (2/-) | 7.8 % | low | not evaluable | high | non important | - |
| Dry skin TRAE (grade 3-4) | 0.99 [0.02, 50.24] | | < 1 | | 0% | 1 study (1/-) | 50.1 % | NA | not evaluable | | non important | - |
| Dyspnoea TRAE (grade 3-4) | 4.25 [0.51, 35.65] | | < 1 | | 0% | 2 studies (2/-) | 9.2 % | low | not evaluable | high | non important | - |
| Endocrine disorders TRAE (grade 3-4) | 1.24 [0.23, 6.63] | | < 1 | | 0% | 1 study (1/-) | 40.3 % | NA | not evaluable | | non important | - |
| Fatigue TRAE (grade 3-4) | 4.55 [1.42, 14.53] | | < 1 | | 0% | 2 studies (2/-) | 0.5 % | low | not evaluable | high | non important | - |
| Gastrointestinal disorders TRAE (grade 3-4) | 2.22 [0.77, 6.34] | | < 1 | | 0% | 1 study (1/-) | 6.9 % | NA | not evaluable | | non important | - |
| Headache TRAE (grade 3-4) | 1.99 [0.30, 13.36] | | < 1 | | 0% | 2 studies (2/-) | 24.1 % | low | not evaluable | high | non important | - |
| Hepatitis TRAE (grade 3-4) | 5.62 [0.69, 45.61] | | < 1 | | 0% | 2 studies (2/-) | 5.4 % | low | not evaluable | high | non important | - |
| Hepatobiliary disorders TRAE (grade 3-4) | 15.93 [0.93, 273.74] | | < 1 | | 0% | 1 study (1/-) | 3.0 % | NA | not evaluable | | non important | - |
| Hyperthyroidism TRAE (grade 3-4) | 2.39 [0.22, 25.93] | | < 1 | | 0% | 2 studies (2/-) | 23.9 % | low | not evaluable | high | non important | - |
| Hypophysitis TRAE (grade 3-4) | 0.81 [0.28, 2.33] | | < 1 | | 0% | 2 studies (2/-) | 65.3 % | low | not evaluable | high | non important | - |
| Hypothyroidism TRAE (grade 3-4) | 1.09 [0.08, 14.28] | | < 1 | | 0% | 2 studies (2/-) | 47.4 % | low | not evaluable | high | non important | - |
| Increase AST TRAE (grade 3-4) | 9.37 [2.54, 34.64] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| Increased ALT TRAE (grade 3-4) | 6.16 [2.46, 15.41] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| Increased lipase level TRAE (grade 3-4) | 3.13 [1.64, 5.97] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | low | not evaluable | high | non important | - |
| Maculopapular rash TRAE (grade 3-4) | 4.80 [0.85, 27.23] | | < 1 | | 0% | 2 studies (2/-) | 3.9 % | low | not evaluable | high | non important | - |
| Myalgia TRAE (grade 3-4) | 1.09 [0.08, 14.28] | | < 1 | | 0% | 2 studies (2/-) | 47.4 % | low | not evaluable | high | non important | - |
| Nausea TRAE (grade 3-4) | 1.85 [0.30, 11.49] | | < 1 | | 32% | 2 studies (2/-) | 25.5 % | low | not evaluable | high | non important | - |
| Pneumonitis TRAE (grade 3-4) | 1.78 [0.34, 9.33] | | < 1 | | 0% | 2 studies (2/-) | 24.9 % | low | not evaluable | high | non important | - |
| Pruritic rash TRAE (grade 3-4) | 0.70 [0.04, 11.21] | | < 1 | | 0% | 2 studies (2/-) | 60.0 % | low | not evaluable | high | non important | - |
| Pruritus TRAE (grade 3-4) | 3.64 [0.60, 22.10] | | < 1 | | 0% | 2 studies (2/-) | 8.1 % | low | not evaluable | high | non important | - |
| Pyrexia TRAE (grade 3-4) | 2.34 [0.36, 15.32] | | < 1 | | 0% | 2 studies (2/-) | 18.9 % | low | not evaluable | high | non important | - |
| Rash TRAE (grade 3-4) | 2.26 [0.82, 6.25] | | < 1 | | 0% | 2 studies (2/-) | 5.8 % | low | not evaluable | high | non important | - |
| Renal and urinary disorders TRAE (grade 3-4) | 0.98 [0.03, 29.71] | | < 1 | | 0% | 1 study (1/-) | 50.5 % | NA | not evaluable | | non important | - |
| Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) | 1.48 [0.15, 14.67] | | < 1 | | 0% | 1 study (1/-) | 36.9 % | NA | not evaluable | | non important | - |
| Skin and subcutaneous tissue disorders TRAE (grade 3-4) | 9.64 [0.55, 170.02] | | < 1 | | 0% | 1 study (1/-) | 6.3 % | NA | not evaluable | | non important | - |
| Thyroiditis TRAE (grade 3-4) | 1.99 [0.07, 59.55] | | < 1 | | 0% | 1 study (1/-) | 34.8 % | NA | not evaluable | | non important | - |
| Vitiligo TRAE (grade 3-4) | 0.70 [0.04, 11.21] | | < 1 | | 0% | 2 studies (2/-) | 60.0 % | low | not evaluable | high | non important | - |
| Vomiting TRAE (grade 3-4) | 4.11 [0.69, 24.63] | | < 1 | | 0% | 2 studies (2/-) | 6.1 % | low | not evaluable | high | non important | - |
| Weight decreased TRAE (grade 3-4) | 0.50 [0.02, 14.84] | | < 1 | | 0% | 1 study (1/-) | 65.5 % | NA | not evaluable | | non important | - |
