Choice of estimand and analysis methods in diabetes trials with rescue medication

Pharmaceutical Statistics

Volumn 14, Issue 6, 2015, Pages 433-447

  Holzhauer, Björn ^a   Akacha, Mouna ^a   Bermann, Georgina ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

analyzing HbA1c; deterministic missing at random; estimand; multiple imputation; rescue medication

Indexed keywords

ANTIDIABETIC AGENT; DAPAGLIFLOZIN; GLUCOSE; HEMOGLOBIN A1C; PLACEBO; GLUCOSE BLOOD LEVEL;

ARTICLE; CLINICAL TRIAL (TOPIC); COMPUTER SIMULATION; CONFIDENCE INTERVAL; DATA ANALYSIS; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG MEGADOSE; DRUG WITHDRAWAL; ESTIMAND; FEASIBILITY STUDY; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEMOGLOBIN BLOOD LEVEL; HUMAN; LAST-OBSERVATION-CARRIED-FORWARD; LOW DRUG DOSE; MEDICAL PROCEDURES; MIXED-EFFECTS MODEL FOR REPEATED MEASURES; NON INSULIN DEPENDENT DIABETES MELLITUS; PROPHYLAXIS; RANDOMIZATION; RANK-BASED METHOD; RESCUE MEDICATION; RESPONDER-BASED METHOD; SENSITIVITY ANALYSIS; STATISTICAL ANALYSIS; STATISTICAL BIAS; STATISTICAL CONCEPTS; STATISTICAL MODEL; DIABETES MELLITUS, TYPE 2; DRUG EFFECTS; ETHICS; OUTCOME ASSESSMENT; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC);

BLOOD GLUCOSE; DATA INTERPRETATION, STATISTICAL; DIABETES MELLITUS, TYPE 2; HUMANS; HYPOGLYCEMIC AGENTS; MODELS, STATISTICAL; OUTCOME ASSESSMENT (HEALTH CARE); RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84946575357     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.1705     Document Type: Article

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