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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 78922316 | 7892231 | 6 | F | 2004 | 20160721 | 20110408 | 20160725 | EXP | US-009507513-1103USA03954 | MERCK | 0.00 | F | Y | 58.51000 | KG | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 78922316 | 7892231 | 1 | PS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 70 MG, QW | 20560 | 70 | MG | TABLET | /wk | ||||||
| 78922316 | 7892231 | 2 | SS | FOSAMAX PLUS D | ALENDRONATE SODIUMCHOLECALCIFEROL | 1 | Oral | 70 MG, QW | 0 | 70 | MG | TABLET | /wk | ||||||
| 78922316 | 7892231 | 3 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 70 MG, UNK | 20560 | 70 | MG | TABLET | |||||||
| 78922316 | 7892231 | 4 | C | CALCIUM (UNSPECIFIED) | CALCIUM | 1 | 600 MG, BID | U | 0 | 600 | MG | TABLET | BID | ||||||
| 78922316 | 7892231 | 5 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 400 IU, QD | U | 0 | 400 | IU | CAPSULE | QD | ||||||
| 78922316 | 7892231 | 6 | C | BONIVA | IBANDRONATE SODIUM | 1 | 150 MG, QM | 0 | 150 | MG | TABLET | /month |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 78922316 | 7892231 | 1 | Osteoporosis |
| 78922316 | 7892231 | 2 | Osteoporosis |
| 78922316 | 7892231 | 3 | Osteoporosis |
| 78922316 | 7892231 | 4 | Osteoporosis |
| 78922316 | 7892231 | 5 | Osteoporosis |
| 78922316 | 7892231 | 6 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 78922316 | 7892231 | DS |
| 78922316 | 7892231 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 78922316 | 7892231 | Adverse drug reaction | |
| 78922316 | 7892231 | Arthralgia | |
| 78922316 | 7892231 | Arthropathy | |
| 78922316 | 7892231 | Back pain | |
| 78922316 | 7892231 | Cystitis | |
| 78922316 | 7892231 | Drug hypersensitivity | |
| 78922316 | 7892231 | Dysaesthesia | |
| 78922316 | 7892231 | Essential hypertension | |
| 78922316 | 7892231 | Fall | |
| 78922316 | 7892231 | Femur fracture | |
| 78922316 | 7892231 | Foot deformity | |
| 78922316 | 7892231 | Haematuria | |
| 78922316 | 7892231 | Hyperkeratosis | |
| 78922316 | 7892231 | Hypertrophy | |
| 78922316 | 7892231 | Intervertebral disc degeneration | |
| 78922316 | 7892231 | Intervertebral disc protrusion | |
| 78922316 | 7892231 | Intervertebral disc space narrowing | |
| 78922316 | 7892231 | Lumbar radiculopathy | |
| 78922316 | 7892231 | Lumbar spinal stenosis | |
| 78922316 | 7892231 | Muscular weakness | |
| 78922316 | 7892231 | Musculoskeletal disorder | |
| 78922316 | 7892231 | Nausea | |
| 78922316 | 7892231 | Neoplasm | |
| 78922316 | 7892231 | Nephrolithiasis | |
| 78922316 | 7892231 | Oedema peripheral | |
| 78922316 | 7892231 | Onychomycosis | |
| 78922316 | 7892231 | Pain in extremity | |
| 78922316 | 7892231 | Paraesthesia | |
| 78922316 | 7892231 | Peroneal nerve palsy | |
| 78922316 | 7892231 | Radius fracture | |
| 78922316 | 7892231 | Scar | |
| 78922316 | 7892231 | Spinal compression fracture | |
| 78922316 | 7892231 | Spinal osteoarthritis | |
| 78922316 | 7892231 | Tendon disorder | |
| 78922316 | 7892231 | Urinary tract infection | |
| 78922316 | 7892231 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 78922316 | 7892231 | 1 | 200109 | 20100901 | 0 | |
| 78922316 | 7892231 | 2 | 200109 | 201009 | 0 | |
| 78922316 | 7892231 | 3 | 20080721 | 20100818 | 0 | |
| 78922316 | 7892231 | 6 | 20080925 | 0 |