se of Metamizole in a Brazilian populatio
- Conditions
- unspecified pain
- Registration Number
- RBR-5mfy5tx
- Lead Sponsor
- Sanofi-Aventis Farmacêutica Ltda.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Data analysis completed
- Sex
- All
- Target Recruitment
- Not specified
Cohort 1: metamizole-based cohort
Any patient active in the system with at least one record of metamizole prescription during the study period.
Cohort 2: symptoms-based cohort
-Any active patient in the system with at least one record of headache, migraine or fever between December 1, 2016 and March 31, 2017 or between May 1, 2017 and August 31, 2017.
Cancer (oncology patients under treatment during the period of the study);
Rheumatic and autoimmune disorders (Rheumatoid arthritis, Ankylosing spondylitis, Crohn’s disease, Ulcerative colitis, Psoriasis or psoriatic arthritis, Lupus, Fibromyalgia, Osteoarthritis);
Pregnancy (during the period of the study, not including c-section post-operative use, i.e., metamizole use post-delivery will be included);
History of metamizole allergy, including anaphylactic reactions;
Haematological history: bone marrow dysfunction;
Deficiency of glucose-6-phosphate dehydrogenase (G6PD);
Had an invalid Amil member identification;
Denied having used the drug.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method