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breast cancer - triple negative, pembrolizumab alone , 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) 0.97 [0.82, 1.15]< 10%1 study (1/-)63.8 %NAnot evaluable crucial-
progression or deaths (PFS) 1.60 [1.33, 1.92]< 10%1 study (1/-)0.0 %NAnot evaluable important-
DCR 0.60 [0.39, 0.94]> 10%1 study (1/-)1.3 %NAnot evaluable non important-
events or deaths (EFS) 0.63 [0.43, 0.93]< 10%1 study (1/-)99.1 %NAnot evaluable non important-
objective responses (ORR) 0.89 [0.53, 1.50]> 10%1 study (1/-)33.5 %NAnot evaluable non important-
pCR 13.60 [6.77, 27.33]> 10%1 study (1/-)100.0 %NAnot evaluable non 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-
SAE (any grade) 0.99 [0.66, 1.48]< 10%1 study (1/-)51.5 %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) 0.61 [0.14, 2.59]< 197%2 studies (2/-)74.9 %lownot evaluable highnon important-
TRAE leading to death (grade 5) 1.01 [0.42, 2.40]< 10%2 studies (2/-)49.2 %some concernnot evaluable moderatenon important-
TRAE leading to discontinuation (any grade) 1.72 [0.89, 3.31]< 152%2 studies (2/-)5.4 %lownot evaluable highnon important-

TRAE (grade 3-4) endpoints 00

Abdominal pain TRAE (grade 3-4) 0.94 [0.06, 15.18]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Acute kidney injury TRAE (grade 3-4) 0.47 [0.02, 14.11]< 10%1 study (1/-)66.5 %NAnot evaluable non important-
Adrenal insufficiency TRAE (grade 3-4) 5.06 [0.57, 44.81]< 10%2 studies (2/-)7.4 %lownot evaluable highnon important-
Alopecia TRAE (grade 3-4) 0.87 [0.37, 2.05]< 10%2 studies (2/-)62.2 %lownot evaluable highnon important-
Anaemia TRAE (grade 3-4) 0.68 [0.16, 2.95]< 180%2 studies (2/-)69.8 %lownot evaluable highnon important-
Asthenia TRAE (grade 3-4) 1.37 [0.69, 2.72]< 10%2 studies (2/-)18.6 %lownot evaluable highnon important-
Colitis TRAE (grade 3-4) 2.02 [0.34, 12.03]< 10%2 studies (2/-)22.2 %lownot evaluable highnon important-
Constipation TRAE (grade 3-4) 0.48 [0.04, 6.30]< 10%2 studies (2/-)70.9 %some concernnot evaluable moderatenon important-
Cough TRAE (grade 3-4) 1.89 [0.06, 56.64]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 2.02 [0.34, 12.03]< 10%2 studies (2/-)22.2 %lownot evaluable highnon important-
Diabetes TRAE (grade 3-4) 1.32 [0.17, 10.43]< 10%2 studies (2/-)39.8 %some concernnot evaluable moderatenon important-
Diarrhoea TRAE (grade 3-4) 0.69 [0.10, 4.85]< 178%2 studies (2/-)64.5 %lownot evaluable highnon important-
Dysgeusia TRAE (grade 3-4) 0.50 [0.01, 25.13]< 10%1 study (1/-)63.4 %NAnot evaluable non important-
Dyspnoea TRAE (grade 3-4) 1.89 [0.06, 56.64]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 1.86 [0.85, 4.05]< 10%2 studies (2/-)6.0 %lownot evaluable highnon important-
Febrile neutropenia TRAE (grade 3-4) 0.31 [0.01, 6.85]< 179%2 studies (2/-)76.6 %lownot evaluable highnon important-
Headache TRAE (grade 3-4) 1.89 [0.06, 56.64]< 10%1 study (1/-)35.8 %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) 1.50 [0.13, 17.05]< 10%2 studies (2/-)37.4 %lownot evaluable highnon 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) 2.45 [0.26, 23.20]< 10%2 studies (2/-)21.9 %lownot evaluable highnon important-
Increase AST TRAE (grade 3-4) 3.49 [0.75, 16.21]< 145%2 studies (2/-)5.6 %some concernnot evaluable moderatenon important-
Increased ALT TRAE (grade 3-4) 2.30 [1.14, 4.63]< 10%2 studies (2/-)1.0 %lownot evaluable highnon 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) 0.45 [0.07, 2.70]< 150%2 studies (2/-)80.9 %lownot evaluable highnon important-
Maculopapular rash TRAE (grade 3-4) 1.89 [0.06, 56.64]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Myalgia TRAE (grade 3-4) 0.47 [0.02, 14.11]< 10%1 study (1/-)66.5 %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) 2.32 [0.21, 25.15]< 10%2 studies (2/-)24.6 %some concernnot evaluable moderatenon important-
Nausea TRAE (grade 3-4) 2.33 [0.92, 5.88]< 10%2 studies (2/-)3.8 %lownot evaluable highnon important-
Nephritis TRAE (grade 3-4) 3.49 [0.34, 35.41]< 10%2 studies (2/-)14.7 %lownot evaluable highnon important-
Neutropenia TRAE (grade 3-4) 0.11 [0.00, 13.86]< 192%2 studies (2/-)80.8 %lownot evaluable highnon important-
Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) 0.13 [0.02, 1.08]< 10%1 study (1/-)97.0 %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-
Pancytopenia TRAE (grade 3-4) 0.24 [0.01, 5.23]< 10%1 study (1/-)81.7 %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) 0.72 [0.13, 4.06]< 137%2 studies (2/-)64.7 %lownot evaluable highnon important-
Pneumonia TRAE (grade 3-4) 0.24 [0.01, 5.23]< 10%1 study (1/-)81.7 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 2.44 [0.40, 14.85]< 10%2 studies (2/-)16.8 %lownot evaluable highnon important-
Pruritus TRAE (grade 3-4) 1.89 [0.06, 56.64]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Pyrexia TRAE (grade 3-4) 2.39 [0.45, 12.62]< 10%2 studies (2/-)15.4 %lownot evaluable highnon 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-
Sepsis TRAE (grade 3-4) 0.94 [0.02, 47.78]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Severe skin reaction TRAE (grade 3-4) 6.06 [0.78, 46.96]< 142%2 studies (2/-)4.3 %lownot evaluable highnon important-
Stomatitis TRAE (grade 3-4) 2.64 [0.12, 57.65]< 149%2 studies (2/-)27.1 %lownot evaluable highnon important-
Thrombocytopenia TRAE (grade 3-4) 0.94 [0.06, 15.18]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Thyroiditis TRAE (grade 3-4) 1.50 [0.13, 17.05]< 10%2 studies (2/-)37.4 %lownot evaluable highnon important-
Urticaria TRAE (grade 3-4) 1.89 [0.06, 56.64]< 10%1 study (1/-)35.8 %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-
Weight decreased TRAE (grade 3-4) 0.47 [0.04, 5.22]< 10%1 study (1/-)72.9 %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.



 

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