| 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) | 0.66 [0.51, 0.86] | | < 1 | | 0% | 2 studies (2/-) | 99.9 % | some concern | not evaluable | moderate | crucial | - |
| deaths (OS) (extension) | 0.24 [0.03, 2.28] | | < 1 | | 0% | 1 study (1/-) | 89.2 % | NA | not evaluable | | important | - |
| RFS/DFS | 0.74 [0.32, 1.71] | | < 1 | | 0% | 1 study (1/-) | 76.0 % | NA | not evaluable | | important | - |
| events or deaths (EFS) | 0.65 [0.51, 0.83] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
| events or deaths (EFS) (extended) | 0.63 [0.49, 0.81] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
| pCR | 1.61 [1.30, 2.00] | | > 1 | | 0% | 4 studies (4/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
safety endpoints 00 |
| AE (any grade) | 0.33 [0.04, 3.09] | | < 1 | | 0% | 2 studies (2/-) | 83.2 % | some concern | not evaluable | moderate | non important | - |
| AE (grade 3-4) | 1.27 [0.99, 1.62] | | < 1 | | 0% | 2 studies (2/-) | 2.8 % | some concern | not evaluable | moderate | non important | - |
| AE leading to death (grade 5) | 0.97 [0.10, 9.43] | | < 1 | | 0% | 2 studies (2/-) | 50.9 % | low | not evaluable | high | non important | - |
| AE leading to treatment discontinuation (any grade) | 1.10 [0.75, 1.61] | | < 1 | | 0% | 2 studies (2/-) | 31.0 % | low | not evaluable | high | non important | - |
| SAE (any grade) | 1.36 [0.61, 3.02] | | < 1 | | 74% | 2 studies (2/-) | 22.7 % | low | not evaluable | high | non important | - |
| STRAE (any grade) | 1.58 [0.91, 2.75] | | < 1 | | 0% | 1 study (1/-) | 5.3 % | NA | not evaluable | | non important | - |
| TRAE (any grade) | 0.51 [0.12, 2.15] | | < 1 | | 0% | 2 studies (2/-) | 81.9 % | low | not evaluable | high | non important | - |
| TRAE (grade 3-4) | 1.23 [0.97, 1.55] | | < 1 | | 0% | 2 studies (2/-) | 4.2 % | some concern | not evaluable | moderate | non important | - |
| TRAE leading to death (grade 5) | 1.50 [0.16, 14.43] | | < 1 | | 0% | 1 study (1/-) | 36.5 % | NA | not evaluable | | non important | - |
| TRAE leading to discontinuation (any grade) | 2.16 [1.53, 3.05] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
TRAE (grade 3-4) endpoints 00 |
| Adrenal insufficiency TRAE (grade 3-4) | 4.58 [0.46, 45.81] | | < 1 | | 0% | 2 studies (2/-) | 9.9 % | some concern | not evaluable | moderate | non important | - |
| Alopecia TRAE (grade 3-4) | 0.87 [0.36, 2.09] | | < 1 | | 0% | 1 study (1/-) | 62.3 % | NA | not evaluable | | non important | - |
| Anaemia TRAE (grade 3-4) | 1.27 [0.91, 1.77] | | < 1 | | 0% | 1 study (1/-) | 8.1 % | NA | not evaluable | | non important | - |
| Asthenia TRAE (grade 3-4) | 1.40 [0.65, 3.02] | | < 1 | | 0% | 1 study (1/-) | 19.9 % | NA | not evaluable | | non important | - |
| Colitis TRAE (grade 3-4) | 3.02 [0.51, 18.04] | | < 1 | | 0% | 2 studies (2/-) | 11.3 % | some concern | not evaluable | moderate | non important | - |
| Constipation TRAE (grade 3-4) | 0.50 [0.01, 25.13] | | < 1 | | 0% | 1 study (1/-) | 63.4 % | NA | not evaluable | | non important | - |
| Decreased appetite TRAE (grade 3-4) | 3.51 [0.43, 28.62] | | < 1 | | 0% | 1 study (1/-) | 12.2 % | NA | not evaluable | | non important | - |
| Diabetes TRAE (grade 3-4) | 1.54 [0.14, 17.56] | | < 1 | | 0% | 2 studies (2/-) | 36.5 % | some concern | not evaluable | moderate | non important | - |
| Diarrhoea TRAE (grade 3-4) | 1.71 [0.63, 4.67] | | < 1 | | 0% | 1 study (1/-) | 14.8 % | NA | not evaluable | | non important | - |
| Dysgeusia TRAE (grade 3-4) | 0.50 [0.01, 25.13] | | < 1 | | 0% | 1 study (1/-) | 63.4 % | NA | not evaluable | | non important | - |
| Fatigue TRAE (grade 3-4) | 2.29 [0.94, 5.58] | | < 1 | | 0% | 1 study (1/-) | 3.5 % | NA | not evaluable | | non important | - |
| Febrile neutropenia TRAE (grade 3-4) | 1.13 [0.82, 1.57] | | < 1 | | 0% | 1 study (1/-) | 22.9 % | NA | not evaluable | | non important | - |
| Guillain-Barré syndrome TRAE (grade 3-4) | 0.51 [0.02, 15.24] | | < 1 | | 0% | 1 study (1/-) | 65.0 % | NA | not evaluable | | non important | - |
| Hepatitis TRAE (grade 3-4) | 4.26 [0.42, 42.77] | | < 1 | | 0% | 2 studies (2/-) | 11.1 % | some concern | not evaluable | moderate | non important | - |
| Hyperthyroidism TRAE (grade 3-4) | 1.54 [0.14, 17.56] | | < 1 | | 0% | 2 studies (2/-) | 36.5 % | some concern | not evaluable | moderate | non important | - |
| Hypophysitis TRAE (grade 3-4) | 8.04 [0.46, 140.38] | | < 1 | | 0% | 1 study (1/-) | 7.9 % | NA | not evaluable | | non important | - |
| Hypothyroidism TRAE (grade 3-4) | 2.01 [0.19, 21.80] | | < 1 | | 0% | 2 studies (2/-) | 28.4 % | some concern | not evaluable | moderate | non important | - |
| Increase AST TRAE (grade 3-4) | 9.67 [1.29, 72.54] | | < 1 | | 0% | 1 study (1/-) | 1.4 % | NA | not evaluable | | non important | - |
| Increased ALT TRAE (grade 3-4) | 2.34 [1.13, 4.86] | | < 1 | | 0% | 1 study (1/-) | 1.1 % | NA | not evaluable | | non important | - |
| Infusion-related reactions TRAE (grade 3-4) | 2.24 [0.82, 6.15] | | < 1 | | 0% | 2 studies (2/-) | 5.8 % | some concern | not evaluable | moderate | non important | - |
| Leucopenia TRAE (grade 3-4) | 0.76 [0.57, 1.03] | | < 1 | | 0% | 1 study (1/-) | 96.3 % | NA | not evaluable | | non important | - |
| Myocarditis TRAE (grade 3-4) | 1.99 [0.09, 44.34] | | < 1 | | 0% | 1 study (1/-) | 33.3 % | NA | not evaluable | | non important | - |
| Myositis TRAE (grade 3-4) | 1.11 [0.09, 14.55] | | < 1 | | 0% | 2 studies (2/-) | 46.7 % | low | not evaluable | high | non important | - |
| Nausea TRAE (grade 3-4) | 2.64 [1.01, 6.94] | | < 1 | | 0% | 1 study (1/-) | 2.4 % | NA | not evaluable | | non important | - |
| Nephritis TRAE (grade 3-4) | 7.03 [0.40, 124.15] | | < 1 | | 0% | 1 study (1/-) | 9.4 % | NA | not evaluable | | non important | - |
| Neutropenia TRAE (grade 3-4) | 1.06 [0.82, 1.38] | | < 1 | | 0% | 1 study (1/-) | 31.6 % | NA | not evaluable | | non important | - |
| Pancreatitis TRAE (grade 3-4) | 4.00 [0.21, 75.85] | | < 1 | | 0% | 1 study (1/-) | 18.1 % | NA | not evaluable | | non important | - |
| Peripheral neuropathy TRAE (grade 3-4) | 1.88 [0.62, 5.72] | | < 1 | | 0% | 1 study (1/-) | 13.2 % | NA | not evaluable | | non important | - |
| Peripheral sensory neuropathy TRAE (grade 3-4) | 1.20 [0.42, 3.43] | | < 1 | | 0% | 1 study (1/-) | 36.8 % | NA | not evaluable | | non important | - |
| Pneumonitis TRAE (grade 3-4) | 1.65 [0.25, 10.86] | | < 1 | | 0% | 2 studies (2/-) | 30.3 % | some concern | not evaluable | moderate | non important | - |
| Pyrexia TRAE (grade 3-4) | 4.02 [0.50, 32.22] | | < 1 | | 0% | 1 study (1/-) | 9.7 % | NA | not evaluable | | non important | - |
| Rash TRAE (grade 3-4) | 1.37 [0.49, 3.84] | | < 1 | | 2% | 2 studies (2/-) | 27.6 % | low | not evaluable | high | non important | - |
| Sarcoidosis TRAE (grade 3-4) | 0.50 [0.01, 25.13] | | < 1 | | 0% | 1 study (1/-) | 63.4 % | NA | not evaluable | | non important | - |
| Severe skin reaction TRAE (grade 3-4) | 6.86 [0.60, 79.02] | | < 1 | | 32% | 2 studies (2/-) | 6.3 % | some concern | not evaluable | moderate | non important | - |
| Stomatitis TRAE (grade 3-4) | 11.10 [0.65, 189.37] | | < 1 | | 0% | 1 study (1/-) | 5.0 % | NA | not evaluable | | non important | - |
| Thyroiditis TRAE (grade 3-4) | 1.99 [0.09, 44.34] | | < 1 | | 0% | 1 study (1/-) | 33.3 % | NA | not evaluable | | non important | - |
| Uveitis TRAE (grade 3-4) | 0.50 [0.01, 25.13] | | < 1 | | 0% | 1 study (1/-) | 63.4 % | NA | not evaluable | | non important | - |
| Vomiting TRAE (grade 3-4) | 1.51 [0.59, 3.82] | | < 1 | | 0% | 1 study (1/-) | 19.5 % | NA | not evaluable | | non important | - |
AE (grade 3-4) endpoints 00 |
| hepatitis (Autoimmune) AE (grade 3-4) | 1.79 [0.06, 54.10] | | < 1 | | 0% | 1 study (1/-) | 37.1 % | NA | not evaluable | | non important | - |
| Abdominal pain AE (grade 3-4) | 0.65 [0.05, 8.46] | | < 1 | | 0% | 2 studies (2/-) | 62.9 % | low | not evaluable | high | non important | - |
| Alopecia AE (grade 3-4) | 0.95 [0.06, 15.32] | | < 1 | | 0% | 2 studies (2/-) | 51.4 % | low | not evaluable | high | non important | - |
| Anaemia AE (grade 3-4) | 1.15 [0.55, 2.43] | | < 1 | | 0% | 2 studies (2/-) | 35.2 % | low | not evaluable | high | non important | - |
| Arthralgia AE (grade 3-4) | 1.54 [0.20, 12.07] | | < 1 | | 0% | 2 studies (2/-) | 34.2 % | some concern | not evaluable | moderate | non important | - |
| Asthenia AE (grade 3-4) | 1.54 [0.25, 9.32] | | < 1 | | 0% | 1 study (1/-) | 32.1 % | NA | not evaluable | | non important | - |
| Back pain AE (grade 3-4) | 0.63 [0.05, 8.30] | | < 1 | | 0% | 2 studies (2/-) | 63.5 % | some concern | not evaluable | moderate | non important | - |
| Blood creatinine increased AE (grade 3-4) | 0.05 [0.00, 0.89] | | < 1 | | 0% | 1 study (1/-) | 97.8 % | NA | not evaluable | | non important | - |
| Constipation AE (grade 3-4) | 0.71 [0.08, 6.14] | | < 1 | | 0% | 2 studies (2/-) | 62.1 % | some concern | not evaluable | moderate | non important | - |
| Cough AE (grade 3-4) | 0.95 [0.06, 15.32] | | < 1 | | 0% | 2 studies (2/-) | 51.4 % | low | not evaluable | high | non important | - |
| Decreased appetite AE (grade 3-4) | 1.02 [0.02, 51.63] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Diarrhoea AE (grade 3-4) | 4.58 [0.77, 27.06] | | < 1 | | 0% | 2 studies (2/-) | 4.7 % | low | not evaluable | high | non important | - |
| Dry skin AE (grade 3-4) | 1.43 [0.11, 18.75] | | < 1 | | 0% | 2 studies (2/-) | 39.3 % | low | not evaluable | high | non important | - |
| Dysgeusia AE (grade 3-4) | 1.02 [0.02, 51.63] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Dyspepsia AE (grade 3-4) | 1.02 [0.02, 51.63] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Dyspnoea AE (grade 3-4) | 0.99 [0.17, 5.78] | | < 1 | | 0% | 2 studies (2/-) | 50.4 % | low | not evaluable | high | non important | - |
| Epistaxis AE (grade 3-4) | 0.95 [0.06, 15.32] | | < 1 | | 0% | 2 studies (2/-) | 51.4 % | low | not evaluable | high | non important | - |
| Fatigue AE (grade 3-4) | 0.74 [0.29, 1.92] | | < 1 | | 24% | 2 studies (2/-) | 73.2 % | some concern | not evaluable | moderate | non important | - |
| Febrile neutropenia AE (grade 3-4) | 1.32 [0.68, 2.57] | | < 1 | | 0% | 2 studies (2/-) | 20.6 % | low | not evaluable | high | non important | - |
| Headache AE (grade 3-4) | 0.95 [0.09, 10.58] | | < 1 | | 0% | 2 studies (2/-) | 51.6 % | low | not evaluable | high | non important | - |
| Hypertension AE (grade 3-4) | 0.84 [0.35, 2.00] | | < 1 | | 0% | 1 study (1/-) | 65.4 % | NA | not evaluable | | non important | - |
| Hyperthyroidism AE (grade 3-4) | 0.89 [0.02, 45.40] | | < 1 | | 0% | 1 study (1/-) | 52.3 % | NA | not evaluable | | non important | - |
| Hypophysitis AE (grade 3-4) | 1.79 [0.06, 54.10] | | < 1 | | 0% | 1 study (1/-) | 37.1 % | NA | not evaluable | | non important | - |
| Hypothyroidism AE (grade 3-4) | 0.89 [0.02, 45.40] | | < 1 | | 0% | 1 study (1/-) | 52.3 % | NA | not evaluable | | non important | - |
| Increase AST AE (grade 3-4) | 2.80 [0.81, 9.75] | | < 1 | | 0% | 2 studies (2/-) | 5.3 % | low | not evaluable | high | non important | - |
| Increased ALT AE (grade 3-4) | 0.98 [0.44, 2.17] | | < 1 | | 0% | 2 studies (2/-) | 51.9 % | low | not evaluable | high | non important | - |
| Infusion-related reaction AE (grade 3-4) | 0.97 [0.10, 9.43] | | < 1 | | 0% | 2 studies (2/-) | 50.9 % | low | not evaluable | high | non important | - |
| Injury, poisoning and procedure AE (grade 3-4) | 0.89 [0.05, 14.46] | | < 1 | | 0% | 1 study (1/-) | 53.2 % | NA | not evaluable | | non important | - |
| Lacrimation increased AE (grade 3-4) | 1.02 [0.02, 51.63] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Leucopenia AE (grade 3-4) | 1.17 [0.54, 2.51] | | < 1 | | 51% | 2 studies (2/-) | 34.8 % | some concern | not evaluable | moderate | non important | - |
| Mucosal inflammation AE (grade 3-4) | 2.04 [0.07, 61.32] | | < 1 | | 0% | 1 study (1/-) | 34.3 % | NA | not evaluable | | non important | - |
| Myalgia AE (grade 3-4) | 1.86 [0.40, 8.67] | | < 1 | | 0% | 2 studies (2/-) | 21.5 % | some concern | not evaluable | moderate | non important | - |
| Nausea AE (grade 3-4) | 0.20 [0.05, 0.79] | | < 1 | | 0% | 2 studies (2/-) | 98.9 % | low | not evaluable | high | non important | - |
| Neutropenia AE (grade 3-4) | 0.98 [0.66, 1.45] | | < 1 | | 0% | 2 studies (2/-) | 55.0 % | low | not evaluable | high | non important | - |
| Oropharyngeal pain AE (grade 3-4) | 2.04 [0.07, 61.32] | | < 1 | | 0% | 1 study (1/-) | 34.3 % | NA | not evaluable | | non important | - |
| Paraesthesia AE (grade 3-4) | 1.02 [0.02, 51.63] | | < 1 | | 0% | 1 study (1/-) | 49.6 % | NA | not evaluable | | non important | - |
| Peripheral neuropathy AE (grade 3-4) | 0.72 [0.31, 1.66] | | < 1 | | 0% | 2 studies (2/-) | 78.0 % | some concern | not evaluable | moderate | non important | - |
| Peripheral oedema AE (grade 3-4) | 0.51 [0.02, 15.24] | | < 1 | | 0% | 1 study (1/-) | 65.0 % | NA | not evaluable | | non important | - |
| Peripheral sensory neuropathy AE (grade 3-4) | 1.28 [0.34, 4.86] | | < 1 | | 0% | 1 study (1/-) | 35.8 % | NA | not evaluable | | non important | - |
| Pneumonitis AE (grade 3-4) | 0.89 [0.02, 45.40] | | < 1 | | 0% | 1 study (1/-) | 52.3 % | NA | not evaluable | | non important | - |
| Pruritus AE (grade 3-4) | 0.25 [0.03, 2.26] | | < 1 | | 0% | 1 study (1/-) | 89.0 % | NA | not evaluable | | non important | - |
| Pyrexia AE (grade 3-4) | 4.11 [0.18, 91.86] | | < 1 | | 0% | 1 study (1/-) | 18.9 % | NA | not evaluable | | non important | - |
| Rash AE (grade 3-4) | 2.30 [0.41, 12.93] | | < 1 | | 0% | 2 studies (2/-) | 17.4 % | low | not evaluable | high | non important | - |
