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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 83515337 | 8351533 | 7 | F | 2000 | 20160913 | 20120124 | 20160920 | EXP | PR-MERCK-1112USA02420 | MERCK | 0.00 | F | Y | 68.39000 | KG | 20160920 | CN | PR | PR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 83515337 | 8351533 | 1 | PS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 70 MG, QD | D | 20560 | 70 | MG | TABLET | QD | |||||
| 83515337 | 8351533 | 2 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 70 MG, QW | D | 20560 | 70 | MG | TABLET | /wk | |||||
| 83515337 | 8351533 | 3 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 70 MG, QW | D | 20560 | 70 | MG | TABLET | /wk | |||||
| 83515337 | 8351533 | 4 | SS | FOSAMAX PLUS D | ALENDRONATE SODIUMCHOLECALCIFEROL | 1 | Oral | 70 MG, QW | D | 0 | 70 | MG | TABLET | /wk | |||||
| 83515337 | 8351533 | 5 | SS | FOSAMAX PLUS D | ALENDRONATE SODIUMCHOLECALCIFEROL | 1 | Oral | 70 MG, QW | D | 0 | 70 | MG | TABLET | /wk | |||||
| 83515337 | 8351533 | 6 | SS | FOSAMAX PLUS D | ALENDRONATE SODIUMCHOLECALCIFEROL | 1 | Oral | 70 MG, QW | D | 0 | 70 | MG | TABLET | /wk | |||||
| 83515337 | 8351533 | 7 | SS | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | Oral | 70 MG, QW | 1820 | MG | D | 20560 | 70 | MG | TABLET | /wk | |||
| 83515337 | 8351533 | 8 | SS | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | 70 MG, QW | 1820 | MG | D | 20560 | 70 | MG | TABLET | /wk | ||||
| 83515337 | 8351533 | 9 | SS | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | Oral | 70 MG, QW | 1820 | MG | D | 20560 | 70 | MG | TABLET | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 83515337 | 8351533 | 1 | Osteoporosis |
| 83515337 | 8351533 | 2 | Osteopenia |
| 83515337 | 8351533 | 4 | Osteoporosis |
| 83515337 | 8351533 | 5 | Osteopenia |
| 83515337 | 8351533 | 7 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 83515337 | 8351533 | DS |
| 83515337 | 8351533 | HO |
| 83515337 | 8351533 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 83515337 | 8351533 | Adverse drug reaction | |
| 83515337 | 8351533 | Adverse event | |
| 83515337 | 8351533 | Alopecia | |
| 83515337 | 8351533 | Anxiety | |
| 83515337 | 8351533 | Appendix disorder | |
| 83515337 | 8351533 | Arthralgia | |
| 83515337 | 8351533 | Back pain | |
| 83515337 | 8351533 | Balance disorder | |
| 83515337 | 8351533 | Bone disorder | |
| 83515337 | 8351533 | Cardiac valve disease | |
| 83515337 | 8351533 | Cerebral ischaemia | |
| 83515337 | 8351533 | Constipation | |
| 83515337 | 8351533 | Cough | |
| 83515337 | 8351533 | Demyelinating polyneuropathy | |
| 83515337 | 8351533 | Dental caries | |
| 83515337 | 8351533 | Diverticulum | |
| 83515337 | 8351533 | Dizziness | |
| 83515337 | 8351533 | Drug hypersensitivity | |
| 83515337 | 8351533 | Dyspnoea | |
| 83515337 | 8351533 | Exostosis | |
| 83515337 | 8351533 | Facet joint syndrome | |
| 83515337 | 8351533 | Fall | |
| 83515337 | 8351533 | Femur fracture | |
| 83515337 | 8351533 | Foot fracture | |
| 83515337 | 8351533 | Gait disturbance | |
| 83515337 | 8351533 | Haemorrhoidal haemorrhage | |
| 83515337 | 8351533 | Hepatic enzyme increased | |
| 83515337 | 8351533 | Hip fracture | |
| 83515337 | 8351533 | Hypertension | |
| 83515337 | 8351533 | Hysterectomy | |
| 83515337 | 8351533 | Inappropriate schedule of drug administration | |
| 83515337 | 8351533 | Injury | |
| 83515337 | 8351533 | Intervertebral disc protrusion | |
| 83515337 | 8351533 | Joint effusion | |
| 83515337 | 8351533 | Lacunar infarction | |
| 83515337 | 8351533 | Lumbar vertebral fracture | |
| 83515337 | 8351533 | Muscle spasms | |
| 83515337 | 8351533 | Muscular weakness | |
| 83515337 | 8351533 | Musculoskeletal disorder | |
| 83515337 | 8351533 | Nausea | |
| 83515337 | 8351533 | Neuropathy peripheral | |
| 83515337 | 8351533 | Oedema peripheral | |
| 83515337 | 8351533 | Osteoarthritis | |
| 83515337 | 8351533 | Pain in extremity | |
| 83515337 | 8351533 | Patellofemoral pain syndrome | |
| 83515337 | 8351533 | Pelvic fracture | |
| 83515337 | 8351533 | Poor quality sleep | |
| 83515337 | 8351533 | Post procedural haemorrhage | |
| 83515337 | 8351533 | Psoriatic arthropathy | |
| 83515337 | 8351533 | Rheumatoid arthritis | |
| 83515337 | 8351533 | Skin disorder | |
| 83515337 | 8351533 | Spinal osteoarthritis | |
| 83515337 | 8351533 | Spondylolisthesis | |
| 83515337 | 8351533 | Spondylolysis | |
| 83515337 | 8351533 | Synovial cyst | |
| 83515337 | 8351533 | Tremor | |
| 83515337 | 8351533 | Wrist 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 |
|---|---|---|---|---|---|---|
| 83515337 | 8351533 | 1 | 2000 | 0 | ||
| 83515337 | 8351533 | 2 | 20030912 | 20040918 | 0 | |
| 83515337 | 8351533 | 3 | 20070621 | 20080205 | 0 | |
| 83515337 | 8351533 | 4 | 20070522 | 0 | ||
| 83515337 | 8351533 | 5 | 20080606 | 20090114 | 0 | |
| 83515337 | 8351533 | 6 | 20100521 | 20100820 | 0 | |
| 83515337 | 8351533 | 7 | 20080410 | 20080506 | 0 | |
| 83515337 | 8351533 | 8 | 20100129 | 20100422 | 0 | |
| 83515337 | 8351533 | 9 | 20101002 | 20101129 | 0 |