pdf   xlsx method abbreviations

es-BC - TNBC - NA - all population, anti-PD-(L)1 versus non active control, meta-analysis of study results

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) (extension) 0.24 [0.03, 2.28]< 10%1 study (1/-)89.2 %NAnot evaluable important-
events or deaths (EFS) 0.63 [0.43, 0.93]< 10%1 study (1/-)99.1 %NAnot evaluable non important-
pCR 4.41 [0.49, 39.52]> 196%2 studies (2/-)90.6 %some concernnot evaluable moderatenon important-

safety endpoints 00

AE (any grade) 0.25 [0.01, 4.74]< 10%1 study (1/-)81.9 %NAnot evaluable non important-
AE (grade 3-4) 1.35 [1.01, 1.80]< 10%1 study (1/-)2.2 %NAnot evaluable non important-
AE leading to death (grade 5) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
SAE (any grade) 0.88 [0.47, 1.66]< 10%1 study (1/-)64.9 %NAnot evaluable non important-
TRAE (any grade) 0.25 [0.03, 2.00]< 10%1 study (1/-)90.3 %NAnot evaluable non important-
TRAE (grade 3-4) 1.26 [0.96, 1.66]< 10%1 study (1/-)4.9 %NAnot evaluable non important-
TRAE leading to death (grade 5) 1.50 [0.16, 14.43]< 10%1 study (1/-)36.5 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 2.16 [1.53, 3.05]< 10%1 study (1/-)0.0 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Adrenal insufficiency TRAE (grade 3-4) 10.08 [0.59, 173.00]< 10%1 study (1/-)5.7 %NAnot evaluable non important-
Alopecia TRAE (grade 3-4) 0.87 [0.36, 2.09]< 10%1 study (1/-)62.3 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 1.27 [0.91, 1.77]< 10%1 study (1/-)8.1 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 1.40 [0.65, 3.02]< 10%1 study (1/-)19.9 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 3.51 [0.43, 28.62]< 10%1 study (1/-)12.2 %NAnot evaluable non important-
Constipation TRAE (grade 3-4) 0.50 [0.01, 25.13]< 10%1 study (1/-)63.4 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 3.51 [0.43, 28.62]< 10%1 study (1/-)12.2 %NAnot evaluable non important-
Diabetes TRAE (grade 3-4) 1.99 [0.09, 44.34]< 10%1 study (1/-)33.3 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 1.71 [0.63, 4.67]< 10%1 study (1/-)14.8 %NAnot evaluable non important-
Dysgeusia TRAE (grade 3-4) 0.50 [0.01, 25.13]< 10%1 study (1/-)63.4 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 2.29 [0.94, 5.58]< 10%1 study (1/-)3.5 %NAnot evaluable non important-
Febrile neutropenia TRAE (grade 3-4) 1.13 [0.82, 1.57]< 10%1 study (1/-)22.9 %NAnot evaluable non important-
Hepatitis TRAE (grade 3-4) 9.06 [0.52, 156.66]< 10%1 study (1/-)6.7 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 1.99 [0.09, 44.34]< 10%1 study (1/-)33.3 %NAnot evaluable non important-
Hypophysitis TRAE (grade 3-4) 8.04 [0.46, 140.38]< 10%1 study (1/-)7.9 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 3.00 [0.15, 59.96]< 10%1 study (1/-)23.9 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 9.67 [1.29, 72.54]< 10%1 study (1/-)1.4 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 2.34 [1.13, 4.86]< 10%1 study (1/-)1.1 %NAnot evaluable non important-
Infusion-related reactions TRAE (grade 3-4) 2.53 [0.86, 7.45]< 10%1 study (1/-)4.6 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 0.76 [0.57, 1.03]< 10%1 study (1/-)96.3 %NAnot evaluable non important-
Myocarditis TRAE (grade 3-4) 1.99 [0.09, 44.34]< 10%1 study (1/-)33.3 %NAnot evaluable non important-
Myositis TRAE (grade 3-4) 0.50 [0.01, 25.13]< 10%1 study (1/-)63.4 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 2.64 [1.01, 6.94]< 10%1 study (1/-)2.4 %NAnot evaluable non important-
Nephritis TRAE (grade 3-4) 7.03 [0.40, 124.15]< 10%1 study (1/-)9.4 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 1.06 [0.82, 1.38]< 10%1 study (1/-)31.6 %NAnot evaluable non important-
Pancreatitis TRAE (grade 3-4) 4.00 [0.21, 75.85]< 10%1 study (1/-)18.1 %NAnot evaluable non important-
Peripheral neuropathy TRAE (grade 3-4) 1.88 [0.62, 5.72]< 10%1 study (1/-)13.2 %NAnot evaluable non important-
Peripheral sensory neuropathy TRAE (grade 3-4) 1.20 [0.42, 3.43]< 10%1 study (1/-)36.8 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 1.50 [0.16, 14.43]< 10%1 study (1/-)36.5 %NAnot evaluable non important-
Pyrexia TRAE (grade 3-4) 4.02 [0.50, 32.22]< 10%1 study (1/-)9.7 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 3.51 [0.43, 28.62]< 10%1 study (1/-)12.2 %NAnot evaluable non important-
Sarcoidosis TRAE (grade 3-4) 0.50 [0.01, 25.13]< 10%1 study (1/-)63.4 %NAnot evaluable non important-
Severe skin reaction TRAE (grade 3-4) 15.50 [2.11, 114.09]< 10%1 study (1/-)0.4 %NAnot evaluable non important-
Stomatitis TRAE (grade 3-4) 11.10 [0.65, 189.37]< 10%1 study (1/-)5.0 %NAnot evaluable non important-
Thyroiditis TRAE (grade 3-4) 1.99 [0.09, 44.34]< 10%1 study (1/-)33.3 %NAnot evaluable non important-
Uveitis TRAE (grade 3-4) 0.50 [0.01, 25.13]< 10%1 study (1/-)63.4 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 1.51 [0.59, 3.82]< 10%1 study (1/-)19.5 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

hepatitis (Autoimmune) AE (grade 3-4) 1.79 [0.06, 54.10]< 10%1 study (1/-)37.1 %NAnot evaluable non important-
Abdominal pain AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Alopecia AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Anaemia AE (grade 3-4) 0.89 [0.12, 6.46]< 10%1 study (1/-)54.6 %NAnot evaluable non important-
Arthralgia AE (grade 3-4) 1.80 [0.16, 20.23]< 10%1 study (1/-)31.8 %NAnot evaluable non important-
Back pain AE (grade 3-4) 0.44 [0.01, 13.37]< 10%1 study (1/-)67.8 %NAnot evaluable non important-
Blood creatinine increased AE (grade 3-4) 0.05 [0.00, 0.89]< 10%1 study (1/-)97.8 %NAnot evaluable non important-
Constipation AE (grade 3-4) 0.89 [0.05, 14.46]< 10%1 study (1/-)53.2 %NAnot evaluable non important-
Cough AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 5.49 [0.27, 111.35]< 10%1 study (1/-)13.6 %NAnot evaluable non important-
Dry skin AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Dyspnoea AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Epistaxis AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 0.47 [0.15, 1.45]< 10%1 study (1/-)90.6 %NAnot evaluable non important-
Febrile neutropenia AE (grade 3-4) 1.82 [0.32, 10.20]< 10%1 study (1/-)24.9 %NAnot evaluable non important-
Headache AE (grade 3-4) 1.79 [0.06, 54.10]< 10%1 study (1/-)37.1 %NAnot evaluable non important-
Hyperthyroidism AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Hypophysitis AE (grade 3-4) 1.79 [0.06, 54.10]< 10%1 study (1/-)37.1 %NAnot evaluable non important-
Hypothyroidism AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Increase AST AE (grade 3-4) 5.49 [0.27, 111.35]< 10%1 study (1/-)13.6 %NAnot evaluable non important-
Increased ALT AE (grade 3-4) 1.20 [0.26, 5.51]< 10%1 study (1/-)40.9 %NAnot evaluable non important-
Infusion-related reaction AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Injury, poisoning and procedure AE (grade 3-4) 0.89 [0.05, 14.46]< 10%1 study (1/-)53.2 %NAnot evaluable non important-
Leucopenia AE (grade 3-4) 0.84 [0.45, 1.57]< 10%1 study (1/-)70.9 %NAnot evaluable non important-
Myalgia AE (grade 3-4) 1.82 [0.32, 10.20]< 10%1 study (1/-)24.9 %NAnot evaluable non important-
Nausea AE (grade 3-4) 0.06 [0.00, 1.05]< 10%1 study (1/-)97.2 %NAnot evaluable non important-
Neutropenia AE (grade 3-4) 0.83 [0.45, 1.52]< 10%1 study (1/-)72.8 %NAnot evaluable non important-
Peripheral neuropathy AE (grade 3-4) 0.88 [0.33, 2.33]< 10%1 study (1/-)60.2 %NAnot evaluable non important-
Pneumonitis AE (grade 3-4) 0.89 [0.02, 45.40]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Rash AE (grade 3-4) 0.89 [0.05, 14.46]< 10%1 study (1/-)53.2 %NAnot evaluable non important-
Stomatitis AE (grade 3-4) 3.62 [0.16, 81.50]< 10%1 study (1/-)21.2 %NAnot evaluable non important-
Thrombocytopenia AE (grade 3-4) 0.44 [0.04, 4.94]< 10%1 study (1/-)74.6 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 0.89 [0.05, 14.46]< 10%1 study (1/-)53.2 %NAnot evaluable non important-

LoD: level of statistical demonstration: Statistically conclusive: statistically significant with a strict control of overall risk of type 1 error (statistically demonstrated), does not take into account the risk of bias; suggested: nominally statistically significant but without a strict control of overall risk of type 1 error; inconclusive: not nominally statistically significant; safety concerns;
Bayesian probability: Bayesian posterior probability of treatment effect (computed with a noninformative prior); ROB: risk of bias; k: number of studies; published MA: number of published meta-analysis on the same topic; degree of certainty adapted from GRADE. Trt. better when: indicates when the relative treatment effect shows that the studied treatment is better than control.