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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114425356 | 11442535 | 6 | F | 20020429 | 20160803 | 20150901 | 20160809 | EXP | US-009507513-1508USA013910 | MERCK | 0.00 | F | Y | 57.70000 | KG | 20160809 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114425356 | 11442535 | 1 | PS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 70 MG, QW | 25620 | MG | 20560 | 70 | MG | TABLET | /wk | ||||
| 114425356 | 11442535 | 2 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | 25620 | MG | 20560 | TABLET | |||||||||
| 114425356 | 11442535 | 3 | SS | FOSAMAX PLUS D | ALENDRONATE SODIUMCHOLECALCIFEROL | 1 | Oral | 70 MG/2800UQW | 280 | MG | 0 | 70 | MG | TABLET | /wk | ||||
| 114425356 | 11442535 | 4 | SS | ACTONEL | RISEDRONATE SODIUM | 1 | Unknown | UNK UNK, QM | 0 | /month |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114425356 | 11442535 | 1 | Osteopenia |
| 114425356 | 11442535 | 2 | Osteoporosis |
| 114425356 | 11442535 | 3 | Osteopenia |
| 114425356 | 11442535 | 4 | Osteopenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114425356 | 11442535 | OT |
| 114425356 | 11442535 | DS |
| 114425356 | 11442535 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114425356 | 11442535 | Acute kidney injury | |
| 114425356 | 11442535 | Anaemia postoperative | |
| 114425356 | 11442535 | Arthralgia | |
| 114425356 | 11442535 | Atypical femur fracture | |
| 114425356 | 11442535 | Balance disorder | |
| 114425356 | 11442535 | Bursitis | |
| 114425356 | 11442535 | Constipation | |
| 114425356 | 11442535 | Depression | |
| 114425356 | 11442535 | Drug ineffective | |
| 114425356 | 11442535 | Emotional distress | |
| 114425356 | 11442535 | Femur fracture | |
| 114425356 | 11442535 | Fracture delayed union | |
| 114425356 | 11442535 | Gait disturbance | |
| 114425356 | 11442535 | Haemorrhagic anaemia | |
| 114425356 | 11442535 | Haemorrhagic disorder | |
| 114425356 | 11442535 | Haemorrhoid operation | |
| 114425356 | 11442535 | Hypercalcaemia | |
| 114425356 | 11442535 | Hypercholesterolaemia | |
| 114425356 | 11442535 | Hyperglycaemia | |
| 114425356 | 11442535 | Hypertension | |
| 114425356 | 11442535 | Hypogonadism | |
| 114425356 | 11442535 | Hypokalaemia | |
| 114425356 | 11442535 | Hypothyroidism | |
| 114425356 | 11442535 | Intervertebral disc degeneration | |
| 114425356 | 11442535 | Intramedullary rod insertion | |
| 114425356 | 11442535 | Leukocytosis | |
| 114425356 | 11442535 | Liver function test abnormal | |
| 114425356 | 11442535 | Low turnover osteopathy | |
| 114425356 | 11442535 | Medical device removal | |
| 114425356 | 11442535 | Muscle contracture | |
| 114425356 | 11442535 | Muscle spasms | |
| 114425356 | 11442535 | Nausea | |
| 114425356 | 11442535 | Osteoarthritis | |
| 114425356 | 11442535 | Osteogenesis imperfecta | |
| 114425356 | 11442535 | Pain | |
| 114425356 | 11442535 | Pain in extremity | |
| 114425356 | 11442535 | Rhabdomyolysis | |
| 114425356 | 11442535 | Spinal osteoarthritis | |
| 114425356 | 11442535 | Surgery | |
| 114425356 | 11442535 | Tenosynovitis |
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 |
|---|---|---|---|---|---|---|
| 114425356 | 11442535 | 1 | 20001201 | 20070122 | 0 | |
| 114425356 | 11442535 | 3 | 20051108 | 20051130 | 0 | |
| 114425356 | 11442535 | 4 | 2009 | 201308 | 0 |