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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97366814 | 9736681 | 4 | F | 19971118 | 20160728 | 20131206 | 20160805 | EXP | US-009507513-1312USA001906 | MERCK | 0.00 | F | Y | 92.63000 | KG | 20160805 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97366814 | 9736681 | 1 | PS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 10 MG, QD | 20560 | 10 | MG | TABLET | QD | ||||||
| 97366814 | 9736681 | 2 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | 5 MG, QD | 20560 | 5 | MG | TABLET | QD | ||||||
| 97366814 | 9736681 | 3 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | 70 MG, QW | 20560 | 70 | MG | TABLET | /wk | |||||||
| 97366814 | 9736681 | 4 | SS | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | Oral | 70 MG, QD | U | U | 0 | 70 | MG | QD | |||||
| 97366814 | 9736681 | 5 | SS | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | U | U | 0 | ||||||||||
| 97366814 | 9736681 | 6 | SS | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | U | U | 0 | ||||||||||
| 97366814 | 9736681 | 7 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 2.5-15 MG QD | U | U | 0 | ||||||||
| 97366814 | 9736681 | 8 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Oral | 200 MG, BID | U | 0 | 200 | MG | BID | ||||||
| 97366814 | 9736681 | 9 | C | VITAMINS (UNSPECIFIED) | VITAMINS | 1 | UNK | U | 0 | ||||||||||
| 97366814 | 9736681 | 10 | C | calcium (unspecified) (+) vitamin D (unspecified) | CALCIUM CARBONATEVITAMIN D | 1 | UNK | U | U | 0 | |||||||||
| 97366814 | 9736681 | 11 | C | VITAMIN B (UNSPECIFIED) | 2 | Unknown | 1 MG, UNKNOWN | U | 0 | 1 | MG | ||||||||
| 97366814 | 9736681 | 12 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | Unknown | 1 DF, UNK | U | 0 | 1 | DF | |||||||
| 97366814 | 9736681 | 13 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | Unknown | 400 IU, UNK | U | 0 | 400 | IU | |||||||
| 97366814 | 9736681 | 14 | C | ascorbic acid (+) rose hips | 2 | Unknown | 1000 MG, UNK | U | 0 | 1000 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 97366814 | 9736681 | 1 | Systemic lupus erythematosus |
| 97366814 | 9736681 | 2 | Osteoporosis |
| 97366814 | 9736681 | 3 | Osteopenia |
| 97366814 | 9736681 | 4 | Systemic lupus erythematosus |
| 97366814 | 9736681 | 5 | Osteoporosis |
| 97366814 | 9736681 | 6 | Osteopenia |
| 97366814 | 9736681 | 7 | Systemic lupus erythematosus |
| 97366814 | 9736681 | 8 | Systemic lupus erythematosus |
| 97366814 | 9736681 | 9 | Product used for unknown indication |
| 97366814 | 9736681 | 10 | Product used for unknown indication |
| 97366814 | 9736681 | 11 | Product used for unknown indication |
| 97366814 | 9736681 | 12 | Product used for unknown indication |
| 97366814 | 9736681 | 13 | Product used for unknown indication |
| 97366814 | 9736681 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 97366814 | 9736681 | HO |
| 97366814 | 9736681 | DS |
| 97366814 | 9736681 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 97366814 | 9736681 | Anaemia | |
| 97366814 | 9736681 | Anaemia postoperative | |
| 97366814 | 9736681 | Anxiety | |
| 97366814 | 9736681 | Arthropathy | |
| 97366814 | 9736681 | Asthenia | |
| 97366814 | 9736681 | Back pain | |
| 97366814 | 9736681 | Blood disorder | |
| 97366814 | 9736681 | Cardiomyopathy | |
| 97366814 | 9736681 | Chills | |
| 97366814 | 9736681 | Contusion | |
| 97366814 | 9736681 | Diarrhoea | |
| 97366814 | 9736681 | Dyspnoea | |
| 97366814 | 9736681 | Face injury | |
| 97366814 | 9736681 | Fatigue | |
| 97366814 | 9736681 | Femur fracture | |
| 97366814 | 9736681 | Flatulence | |
| 97366814 | 9736681 | Gastric disorder | |
| 97366814 | 9736681 | Gastrooesophageal reflux disease | |
| 97366814 | 9736681 | Headache | |
| 97366814 | 9736681 | Hip fracture | |
| 97366814 | 9736681 | Hypophosphataemia | |
| 97366814 | 9736681 | Increased tendency to bruise | |
| 97366814 | 9736681 | Injury | |
| 97366814 | 9736681 | Joint swelling | |
| 97366814 | 9736681 | Limb immobilisation | |
| 97366814 | 9736681 | Low turnover osteopathy | |
| 97366814 | 9736681 | Nausea | |
| 97366814 | 9736681 | Oedema peripheral | |
| 97366814 | 9736681 | Off label use | |
| 97366814 | 9736681 | Oophorectomy | |
| 97366814 | 9736681 | Osteoarthritis | |
| 97366814 | 9736681 | Osteoporosis | |
| 97366814 | 9736681 | Pain in extremity | |
| 97366814 | 9736681 | Phlebitis | |
| 97366814 | 9736681 | Polyarthritis | |
| 97366814 | 9736681 | Procedural haemorrhage | |
| 97366814 | 9736681 | Pyrexia | |
| 97366814 | 9736681 | Rash | |
| 97366814 | 9736681 | Surgery | |
| 97366814 | 9736681 | Tenosynovitis | |
| 97366814 | 9736681 | Tooth disorder | |
| 97366814 | 9736681 | Urinary tract infection | |
| 97366814 | 9736681 | Viral infection | |
| 97366814 | 9736681 | Vitamin D deficiency | |
| 97366814 | 9736681 | Vomiting | |
| 97366814 | 9736681 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 97366814 | 9736681 | 1 | 19971118 | 200102 | 0 | |
| 97366814 | 9736681 | 2 | 199803 | 200102 | 0 | |
| 97366814 | 9736681 | 3 | 20010902 | 201010 | 0 | |
| 97366814 | 9736681 | 4 | 20080217 | 20120117 | 0 | |
| 97366814 | 9736681 | 7 | 19971118 | 200504 | 0 | |
| 97366814 | 9736681 | 8 | 19971118 | 0 | ||
| 97366814 | 9736681 | 9 | 1996 | 2006 | 0 | |
| 97366814 | 9736681 | 10 | 1996 | 2006 | 0 | |
| 97366814 | 9736681 | 11 | 1996 | 2006 | 0 | |
| 97366814 | 9736681 | 12 | 1996 | 2006 | 0 | |
| 97366814 | 9736681 | 13 | 1996 | 2006 | 0 |