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head and neck cancer squamous cell cancer (HNSCC), nivolumab based treatment , 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) 0.70 [0.51, 0.96]< 10%1 study (1/-)98.6 %NAnot evaluable crucial-
deaths (OS) (extension) 0.68 [0.54, 0.86]< 10%1 study (1/-)99.9 %NAnot evaluable important-
PFS (extension) 0.87 [0.68, 1.11]< 10%1 study (1/-)86.7 %NAnot evaluable important-
progression or deaths (PFS) 0.89 [0.70, 1.13]< 10%1 study (1/-)83.0 %NAnot evaluable important-
objective responses (ORR) 2.51 [1.07, 5.86]> 10%1 study (1/-)98.3 %NAnot evaluable non important-
objective responses (ORR) (extension) 2.51 [1.07, 5.86]> 10%1 study (1/-)98.3 %NAnot evaluable non important-

safety endpoints 00

TRAE (any grade) 0.31 [0.18, 0.52]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 0.94 [0.08, 10.48]< 10%1 study (1/-)52.0 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 0.45 [0.18, 1.11]< 10%1 study (1/-)95.9 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Acute kidney injury TRAE (grade 3-4) 0.23 [0.01, 7.01]< 10%1 study (1/-)79.5 %NAnot evaluable non important-
Adrenal insufficiency TRAE (grade 3-4) 0.94 [0.03, 28.25]< 10%1 study (1/-)51.4 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.23 [0.06, 0.92]< 10%1 study (1/-)98.1 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 0.23 [0.02, 2.59]< 10%1 study (1/-)88.1 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 0.47 [0.01, 23.80]< 10%1 study (1/-)64.4 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.12 [0.01, 2.59]< 10%1 study (1/-)91.0 %NAnot evaluable non important-
Eczema TRAE (grade 3-4) 0.47 [0.01, 23.80]< 10%1 study (1/-)64.4 %NAnot evaluable non important-
Endocrine disorders TRAE (grade 3-4) 0.94 [0.03, 28.25]< 10%1 study (1/-)51.4 %NAnot evaluable non important-
Erythema TRAE (grade 3-4) 0.23 [0.01, 7.01]< 10%1 study (1/-)79.5 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.78 [0.18, 3.32]< 10%1 study (1/-)63.2 %NAnot evaluable non important-
Gastrointestinal disorders TRAE (grade 3-4) 0.23 [0.02, 2.59]< 10%1 study (1/-)88.1 %NAnot evaluable non important-
Hepatobiliary disorders TRAE (grade 3-4) 0.94 [0.08, 10.48]< 10%1 study (1/-)52.0 %NAnot evaluable non important-
Hypersensitivity TRAE (grade 3-4) 0.23 [0.01, 7.01]< 10%1 study (1/-)79.5 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 0.47 [0.01, 23.80]< 10%1 study (1/-)64.4 %NAnot evaluable non important-
Hypophysitis TRAE (grade 3-4) 0.94 [0.03, 28.25]< 10%1 study (1/-)51.4 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 0.47 [0.01, 23.80]< 10%1 study (1/-)64.4 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 0.47 [0.01, 23.80]< 10%1 study (1/-)64.4 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 0.47 [0.03, 7.55]< 10%1 study (1/-)70.2 %NAnot evaluable non important-
Increased lipase level TRAE (grade 3-4) 3.81 [0.20, 72.71]< 10%1 study (1/-)19.0 %NAnot evaluable non important-
Infusion-related reactions TRAE (grade 3-4) 0.23 [0.01, 7.01]< 10%1 study (1/-)79.5 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 0.08 [0.00, 1.54]< 10%1 study (1/-)95.1 %NAnot evaluable non important-
Maculopapular rash TRAE (grade 3-4) 0.47 [0.01, 23.80]< 10%1 study (1/-)64.4 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.23 [0.01, 7.01]< 10%1 study (1/-)79.5 %NAnot evaluable non important-
Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) 0.23 [0.01, 7.01]< 10%1 study (1/-)79.5 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 1.89 [0.08, 42.24]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.47 [0.01, 23.80]< 10%1 study (1/-)64.4 %NAnot evaluable non important-
Pyrexia TRAE (grade 3-4) 0.12 [0.01, 2.59]< 10%1 study (1/-)91.0 %NAnot evaluable non important-
Renal and urinary disorders TRAE (grade 3-4) 0.47 [0.01, 23.80]< 10%1 study (1/-)64.4 %NAnot evaluable non important-
Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) 1.89 [0.08, 42.24]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
Skin and subcutaneous tissue disorders TRAE (grade 3-4) 0.12 [0.01, 2.59]< 10%1 study (1/-)91.0 %NAnot evaluable non important-
Skin exfoliation TRAE (grade 3-4) 0.47 [0.01, 23.80]< 10%1 study (1/-)64.4 %NAnot evaluable non important-
Thrombocytopenia TRAE (grade 3-4) 0.12 [0.01, 2.59]< 10%1 study (1/-)91.0 %NAnot evaluable non important-
Thyroiditis TRAE (grade 3-4) 0.47 [0.01, 23.80]< 10%1 study (1/-)64.4 %NAnot evaluable non important-
Urticaria TRAE (grade 3-4) 0.47 [0.01, 23.80]< 10%1 study (1/-)64.4 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Rash AE (grade 3-4) 0.23 [0.01, 7.01]< 10%1 study (1/-)79.5 %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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