pdf   xlsx method abbreviations

mBC - TNBC - L1 - all population, anti-PD-(L)1 , 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) 0.88 [0.78, 0.99]< 10%2 studies (2/-)98.6 %lownot evaluable highcrucial-
PFS (extension) 0.80 [0.69, 0.92]< 10%1 study (1/-)99.9 %NAnot evaluable important-
progression or deaths (PFS) 0.81 [0.72, 0.90]< 10%2 studies (2/-)100.0 %lownot evaluable highimportant-
DOR 0.78 [0.63, 0.97]< 10%1 study (1/-)98.6 %NAnot evaluable non important-
objective responses (ORR) 0.60 [0.10, 3.71]> 199%2 studies (2/-)29.3 %lownot evaluable highnon important-

safety endpoints 00

AE (any grade) 1.87 [0.76, 4.56]< 18%2 studies (2/-)8.6 %lownot evaluable highnon important-
AE (grade 3-4) 1.29 [1.05, 1.59]< 10%2 studies (2/-)0.8 %lownot evaluable highnon important-
AE leading to death (grade 5) 1.94 [0.48, 7.81]< 10%1 study (1/-)17.6 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 2.24 [1.46, 3.43]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
SAE (any grade) 1.33 [0.96, 1.84]< 10%1 study (1/-)4.5 %NAnot evaluable non important-
STRAE (any grade) 1.82 [1.16, 2.87]< 10%1 study (1/-)0.5 %NAnot evaluable non important-
TRAE (any grade) 1.58 [0.99, 2.52]< 10%2 studies (2/-)2.8 %lownot evaluable highnon important-
TRAE (grade 3-4) 1.28 [0.89, 1.82]< 166%2 studies (2/-)8.9 %lownot evaluable highnon important-
TRAE leading to death (grade 5) 2.55 [0.41, 15.93]< 10%2 studies (2/-)15.9 %lownot evaluable highnon important-

TRAE (grade 3-4) endpoints 00

Alopecia TRAE (grade 3-4) 0.83 [0.20, 3.51]< 10%1 study (1/-)59.9 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 1.15 [0.77, 1.71]< 10%1 study (1/-)25.2 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 2.00 [0.09, 44.58]< 10%1 study (1/-)33.2 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 1.15 [0.47, 2.82]< 10%1 study (1/-)38.3 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 1.00 [0.03, 29.90]< 10%1 study (1/-)50.0 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 2.00 [0.09, 44.58]< 10%1 study (1/-)33.2 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 1.29 [0.67, 2.48]< 10%1 study (1/-)22.7 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 0.83 [0.58, 1.19]< 10%1 study (1/-)84.3 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 1.13 [0.34, 3.69]< 10%1 study (1/-)42.2 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.99 [0.73, 1.36]< 10%1 study (1/-)52.1 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 6.05 [0.34, 108.78]< 10%1 study (1/-)11.3 %NAnot evaluable non important-
Severe skin reaction TRAE (grade 3-4) 10.16 [0.59, 174.64]< 10%1 study (1/-)5.7 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

hepatitis (Autoimmune) AE (grade 3-4) 0.96 [0.06, 15.47]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Abdominal pain AE (grade 3-4) 1.93 [0.17, 21.40]< 10%1 study (1/-)29.7 %NAnot evaluable non important-
Acute kidney injury AE (grade 3-4) 1.93 [0.06, 57.72]< 10%1 study (1/-)35.4 %NAnot evaluable non important-
Adrenal insufficiency AE (grade 3-4) 1.93 [0.06, 57.72]< 10%1 study (1/-)35.4 %NAnot evaluable non important-
Alopecia AE (grade 3-4) 1.93 [0.17, 21.40]< 10%1 study (1/-)29.7 %NAnot evaluable non important-
Anaemia AE (grade 3-4) 1.04 [0.48, 2.24]< 10%1 study (1/-)46.0 %NAnot evaluable non important-
Arthralgia AE (grade 3-4) 0.96 [0.06, 15.47]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Asthenia AE (grade 3-4) 0.72 [0.16, 3.24]< 10%1 study (1/-)66.4 %NAnot evaluable non important-
Back pain AE (grade 3-4) 2.92 [0.59, 14.54]< 10%1 study (1/-)9.6 %NAnot evaluable non important-
Cardiomyopathy AE (grade 3-4) 1.93 [0.06, 57.72]< 10%1 study (1/-)35.4 %NAnot evaluable non important-
Chills AE (grade 3-4) 1.93 [0.06, 57.72]< 10%1 study (1/-)35.4 %NAnot evaluable non important-
Colitis AE (grade 3-4) 0.96 [0.06, 15.47]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Constipation AE (grade 3-4) 2.91 [0.30, 28.05]< 10%1 study (1/-)18.0 %NAnot evaluable non important-
Cough AE (grade 3-4) 0.96 [0.02, 48.73]< 10%1 study (1/-)50.7 %NAnot evaluable non important-
Decreased appetite AE (grade 3-4) 0.96 [0.19, 4.80]< 10%1 study (1/-)51.8 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 0.85 [0.33, 2.24]< 10%1 study (1/-)62.5 %NAnot evaluable non important-
Dizziness AE (grade 3-4) 0.96 [0.02, 48.73]< 10%1 study (1/-)50.7 %NAnot evaluable non important-
Dysgeusia AE (grade 3-4) 0.96 [0.02, 48.73]< 10%1 study (1/-)50.7 %NAnot evaluable non important-
Dysphonia AE (grade 3-4) 1.93 [0.06, 57.72]< 10%1 study (1/-)35.4 %NAnot evaluable non important-
Dyspnoea AE (grade 3-4) 0.96 [0.19, 4.80]< 10%1 study (1/-)51.8 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 1.10 [0.54, 2.22]< 10%1 study (1/-)39.9 %NAnot evaluable non important-
Headache AE (grade 3-4) 0.48 [0.09, 2.63]< 10%1 study (1/-)80.0 %NAnot evaluable non important-
Hypertension AE (grade 3-4) 0.35 [0.11, 1.09]< 10%1 study (1/-)96.5 %NAnot evaluable non important-
Hyperthyroidism AE (grade 3-4) 1.93 [0.06, 57.72]< 10%1 study (1/-)35.4 %NAnot evaluable non important-
Hypothyroidism AE (grade 3-4) 0.96 [0.02, 48.73]< 10%1 study (1/-)50.7 %NAnot evaluable non important-
Increase AST AE (grade 3-4) 0.96 [0.38, 2.45]< 10%1 study (1/-)53.1 %NAnot evaluable non important-
Increased ALT AE (grade 3-4) 1.55 [0.50, 4.79]< 10%1 study (1/-)22.2 %NAnot evaluable non important-
Leucopenia AE (grade 3-4) 1.55 [0.50, 4.79]< 10%1 study (1/-)22.2 %NAnot evaluable non important-
Mucosal inflammation AE (grade 3-4) 1.94 [0.35, 10.63]< 10%1 study (1/-)22.4 %NAnot evaluable non important-
Myalgia AE (grade 3-4) 0.64 [0.11, 3.86]< 10%1 study (1/-)68.5 %NAnot evaluable non important-
Myopathy AE (grade 3-4) 1.93 [0.06, 57.72]< 10%1 study (1/-)35.4 %NAnot evaluable non important-
Nausea AE (grade 3-4) 0.60 [0.19, 1.84]< 10%1 study (1/-)81.4 %NAnot evaluable non important-
Neutropenia AE (grade 3-4) 1.02 [0.63, 1.64]< 10%1 study (1/-)46.8 %NAnot evaluable non important-
Paraesthesia AE (grade 3-4) 1.93 [0.17, 21.40]< 10%1 study (1/-)29.7 %NAnot evaluable non important-
Pericarditis AE (grade 3-4) 1.93 [0.06, 57.72]< 10%1 study (1/-)35.4 %NAnot evaluable non important-
Peripheral neuropathy AE (grade 3-4) 2.07 [1.03, 4.17]< 10%1 study (1/-)2.1 %NAnot evaluable non important-
Peripheral oedema AE (grade 3-4) 0.16 [0.02, 1.33]< 10%1 study (1/-)95.4 %NAnot evaluable non important-
Pneumonia AE (grade 3-4) 3.27 [0.89, 11.95]< 10%1 study (1/-)3.7 %NAnot evaluable non important-
Pneumonitis AE (grade 3-4) 3.87 [0.17, 86.09]< 10%1 study (1/-)19.9 %NAnot evaluable non important-
Pruritus AE (grade 3-4) 0.96 [0.02, 48.73]< 10%1 study (1/-)50.7 %NAnot evaluable non important-
Pyrexia AE (grade 3-4) 5.82 [0.29, 116.53]< 10%1 study (1/-)12.7 %NAnot evaluable non important-
Rash AE (grade 3-4) 0.96 [0.14, 6.88]< 10%1 study (1/-)51.4 %NAnot evaluable non important-
Sepsis AE (grade 3-4) 0.16 [0.01, 3.20]< 10%1 study (1/-)88.2 %NAnot evaluable non important-
Stomatitis AE (grade 3-4) 0.96 [0.06, 15.47]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Thrombocytopenia AE (grade 3-4) 1.93 [0.17, 21.40]< 10%1 study (1/-)29.7 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 0.77 [0.21, 2.89]< 10%1 study (1/-)65.1 %NAnot evaluable non important-
Weight decreased AE (grade 3-4) 5.82 [0.29, 116.53]< 10%1 study (1/-)12.7 %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.



 

- About us - Contact us - Method - RSS Made with in Lyon - Credits - Privacy policy - Licence Creative Commons