Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126731331 | 12673133 | 1 | I | 201010 | 20160802 | 20160822 | 20160822 | PER | US-WARNER CHILCOTT, LLC-1056591 | WARNER CHILCOTT | 77.00 | YR | F | Y | 0.00000 | 20160822 | OT | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126731331 | 12673133 | 1 | PS | ACTONEL | RISEDRONATE SODIUM | 1 | Oral | U | 20835 | 35 | MG | TABLET | |||||||
| 126731331 | 12673133 | 2 | C | EVISTA | RALOXIFENE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126731331 | 12673133 | 3 | C | ASPIRIN. | ASPIRIN | 1 | 0 | ||||||||||||
| 126731331 | 12673133 | 4 | C | FISH OIL | FISH OIL | 1 | 0 | ||||||||||||
| 126731331 | 12673133 | 5 | C | BUSPAR | BUSPIRONE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126731331 | 12673133 | 6 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | 0 | ||||||||||||
| 126731331 | 12673133 | 7 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 0 | ||||||||||||
| 126731331 | 12673133 | 8 | C | MOBIC | MELOXICAM | 1 | 0 | ||||||||||||
| 126731331 | 12673133 | 9 | C | VIOXX | ROFECOXIB | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126731331 | 12673133 | 1 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126731331 | 12673133 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126731331 | 12673133 | Atypical femur fracture | |
| 126731331 | 12673133 | Femur fracture | |
| 126731331 | 12673133 | Gait disturbance | |
| 126731331 | 12673133 | Groin pain | |
| 126731331 | 12673133 | Limb asymmetry | |
| 126731331 | 12673133 | Low turnover osteopathy | |
| 126731331 | 12673133 | Pain in extremity | |
| 126731331 | 12673133 | Stress fracture |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 126731331 | 12673133 | 1 | 20041021 | 201012 | 0 |