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mHNSCC - 2nd line (L2), 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) 0.80 [0.65, 0.98]< 10%1 study (1/-)98.3 %NAnot evaluable crucial-
progression or deaths (PFS) 0.96 [0.79, 1.16]< 10%1 study (1/-)66.1 %NAnot evaluable important-
objective responses (ORR) 1.52 [0.88, 2.62]> 10%1 study (1/-)93.5 %NAnot evaluable non important-

safety endpoints 00

TRAE (any grade) 0.33 [0.21, 0.51]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (grade 3-4) 0.24 [0.15, 0.39]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 1.92 [0.35, 10.57]< 10%1 study (1/-)22.8 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 1.20 [0.55, 2.62]< 10%1 study (1/-)32.3 %NAnot evaluable non important-
TRAE leading to discontinuation (grade 3-4) 1.28 [0.53, 3.10]< 10%1 study (1/-)29.1 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Acute kidney injury TRAE (grade 3-4) 1.91 [0.06, 57.09]< 10%1 study (1/-)35.7 %NAnot evaluable non important-
Adrenal insufficiency TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Alopecia TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.10 [0.01, 0.81]< 10%1 study (1/-)98.4 %NAnot evaluable non important-
Arthralgia TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 0.23 [0.03, 2.12]< 10%1 study (1/-)90.0 %NAnot evaluable non important-
Blood and lymphatic system disorders TRAE (grade 3-4) 0.04 [0.01, 0.31]< 10%1 study (1/-)99.9 %NAnot evaluable non important-
Blood creatinine increased TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Cardiac disorders TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Chills TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Constipation TRAE (grade 3-4) 0.47 [0.02, 14.21]< 10%1 study (1/-)66.4 %NAnot evaluable non important-
Cough TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 1.91 [0.06, 57.09]< 10%1 study (1/-)35.7 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 3.85 [0.43, 34.71]< 10%1 study (1/-)11.6 %NAnot evaluable non important-
Dyspepsia TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Dyspnoea TRAE (grade 3-4) 3.83 [0.17, 85.33]< 10%1 study (1/-)20.1 %NAnot evaluable non important-
Endocrine disorders TRAE (grade 3-4) 1.91 [0.06, 57.09]< 10%1 study (1/-)35.7 %NAnot evaluable non important-
Epistaxis TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Eye disorders TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 1.92 [0.35, 10.57]< 10%1 study (1/-)22.8 %NAnot evaluable non important-
Febrile neutropenia TRAE (grade 3-4) 0.05 [0.00, 0.79]< 10%1 study (1/-)98.2 %NAnot evaluable non important-
Gastritis TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Gastrointestinal disorders TRAE (grade 3-4) 0.35 [0.14, 0.86]< 10%1 study (1/-)98.9 %NAnot evaluable non important-
General disorders and administration site conditions TRAE (grade 3-4) 0.57 [0.23, 1.40]< 10%1 study (1/-)88.8 %NAnot evaluable non important-
Guillain-Barré syndrome TRAE (grade 3-4) 1.91 [0.06, 57.09]< 10%1 study (1/-)35.7 %NAnot evaluable non important-
Headache TRAE (grade 3-4) 0.47 [0.02, 14.21]< 10%1 study (1/-)66.4 %NAnot evaluable non important-
Hepatitis TRAE (grade 3-4) 2.01 [0.07, 60.26]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Hepatobiliary disorders TRAE (grade 3-4) 0.95 [0.06, 15.29]< 10%1 study (1/-)51.4 %NAnot evaluable non important-
Hypersensitivity TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Hypertension TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 1.91 [0.06, 57.09]< 10%1 study (1/-)35.7 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 0.31 [0.03, 3.04]< 10%1 study (1/-)84.0 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 0.16 [0.01, 3.15]< 10%1 study (1/-)88.4 %NAnot evaluable non important-
Infusion-related reactions TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 0.07 [0.00, 1.17]< 10%1 study (1/-)96.7 %NAnot evaluable non important-
Maculopapular rash TRAE (grade 3-4) 0.47 [0.02, 14.21]< 10%1 study (1/-)66.4 %NAnot evaluable non important-
Metabolism and nutrition disorders TRAE (grade 3-4) 0.40 [0.10, 1.57]< 10%1 study (1/-)90.5 %NAnot evaluable non important-
Mucosal inflammation TRAE (grade 3-4) 0.19 [0.02, 1.61]< 10%1 study (1/-)93.5 %NAnot evaluable non important-
Musculoskeletal and connective tissue disorders TRAE (grade 3-4) 1.91 [0.06, 57.09]< 10%1 study (1/-)35.7 %NAnot evaluable non important-
Myalgia TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.47 [0.02, 14.21]< 10%1 study (1/-)66.4 %NAnot evaluable non important-
Nervous system disorders TRAE (grade 3-4) 0.47 [0.04, 5.26]< 10%1 study (1/-)72.7 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.04 [0.01, 0.33]< 10%1 study (1/-)99.9 %NAnot evaluable non important-
Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Pancytopenia TRAE (grade 3-4) 0.16 [0.01, 3.15]< 10%1 study (1/-)88.4 %NAnot evaluable non important-
Paraesthesia TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Peripheral oedema TRAE (grade 3-4) 1.91 [0.06, 57.09]< 10%1 study (1/-)35.7 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 0.95 [0.06, 15.29]< 10%1 study (1/-)51.4 %NAnot evaluable non important-
Pruritic rash TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Pruritus generalised TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.24 [0.01, 5.27]< 10%1 study (1/-)81.6 %NAnot evaluable non important-
Pyrexia TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 0.95 [0.06, 15.29]< 10%1 study (1/-)51.4 %NAnot evaluable non important-
Renal and urinary disorders TRAE (grade 3-4) 1.91 [0.06, 57.09]< 10%1 study (1/-)35.7 %NAnot evaluable non important-
Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) 1.44 [0.40, 5.16]< 10%1 study (1/-)28.9 %NAnot evaluable non important-
Sepsis TRAE (grade 3-4) 0.24 [0.01, 5.27]< 10%1 study (1/-)81.6 %NAnot evaluable non important-
Severe skin reaction TRAE (grade 3-4) 0.54 [0.15, 1.86]< 10%1 study (1/-)83.7 %NAnot evaluable non important-
Skin and subcutaneous tissue disorders TRAE (grade 3-4) 0.31 [0.08, 1.15]< 10%1 study (1/-)95.9 %NAnot evaluable non important-
Skin exfoliation TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Stevens-Johnson syndrome TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Stomatitis TRAE (grade 3-4) 0.08 [0.01, 0.65]< 10%1 study (1/-)99.1 %NAnot evaluable non important-
Thrombocytopenia TRAE (grade 3-4) 0.09 [0.01, 1.72]< 10%1 study (1/-)94.3 %NAnot evaluable non important-
Vascular disorders TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Weight decreased TRAE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Back pain AE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Dizziness AE (grade 3-4) 0.95 [0.02, 48.13]< 10%1 study (1/-)51.0 %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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