Defining treatment-emergent adverse events with the medical dictionary for regulatory activities (MedDRA)

Drug Information Journal

Volumn 35, Issue 4, 2001, Pages 1289-1299

  Nilsson, Mary E ^a   Koke, Stephanie C ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

Adverse events; Lowest level term; MedDRA; Preferred term; Treatment emergent

Indexed keywords

DRUG;

ARTICLE; DRUG INDUCED DISEASE; DRUG INDUSTRY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FATIGUE; HEADACHE; HUMAN; METHODOLOGY; NAUSEA; PRIORITY JOURNAL; RASH; SKIN ALLERGY; SUNBURN; SYMPTOM;

EID: 0035739154     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150103500425     Document Type: Article

References (9)

1. Safety analysis in controlled clinical trials
2. Safety analysis: Too much? Not enough? And how?
3. Evaluation of safety data from controlled clinical trials: The clinical principles explained
4. Describing risk in long-term clinical trials
5. Assessment of safety
6. Statistical evaluation of adverse events
7. The medical dictionary for regulatory activities (MedDRA)
8. Adverse event frequencies generate hypotheses of efficacy and safety
9. A preliminary assessment of the impact of MedDRA on adverse event reports and product labeling