Fluoroquinolone Associated Disability
| Status: | Completed |
|---|---|
| Conditions: | Bronchitis, Other Indications, Sinusitis, Urology, Urinary Tract Infections |
| Therapuetic Areas: | Nephrology / Urology, Otolaryngology, Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/31/2019 |
| Start Date: | May 17, 2018 |
| End Date: | December 31, 2018 |
The purpose of this study is to: 1) describe drug utilization for Fluoroquinolone(FQ),
Azithromycin (AZ) and Sulfamethoxazole/Trimethoprim(ST) in the entire Truven MarketScan
Commercial Claims and Encounters database (CCAE) database, and specifically among individuals
in the Health and Productivity Management (HPM) during the observation period; 2) describe
the rate of disability associated with 2 or more System Organ Class adverse events (SOC AEs)
and exposure to FQs for several acute, uncomplicated indications; and 3) compare the rates of
disability for 2 or more SOC AEs and exposure to FQs and AZ/ST for the same indications.
Azithromycin (AZ) and Sulfamethoxazole/Trimethoprim(ST) in the entire Truven MarketScan
Commercial Claims and Encounters database (CCAE) database, and specifically among individuals
in the Health and Productivity Management (HPM) during the observation period; 2) describe
the rate of disability associated with 2 or more System Organ Class adverse events (SOC AEs)
and exposure to FQs for several acute, uncomplicated indications; and 3) compare the rates of
disability for 2 or more SOC AEs and exposure to FQs and AZ/ST for the same indications.
Inclusion Criteria:
- Participants in the Truven CCAE database who were eligible for disability insurance
and can be linked to the Truven Health and Productivity Management (HPM) database
- Study participants will be included if they have 6 months of history before the first
day on FQ or AZ/ST and at least 120 days afterward
Exclusion Criteria:
- If any protocol specified medical conditions or exposure to the protocol specified
medications in the 6 months preceding the first qualifying dose of FQ or AZ/ST
- If participants have any disability claim in the 6 months preceding the qualifying FQ
or AZ/ST dose
- If participants have the protocol specified condition-specific diagnoses within the 3
months preceding the qualifying FQ or AZ/ST exposure
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