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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106144053 | 10614405 | 3 | F | 20160803 | 20141129 | 20160930 | EXP | US-AUROBINDO-AUR-APL-2014-12600 | AUROBINDO | 0.00 | F | Y | 107.00000 | KG | 20160928 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106144053 | 10614405 | 1 | PS | Alendronate Sodium Tablets USP 70mg | ALENDRONATE SODIUM | 1 | Oral | 70 MG, EVERY WEEK | Y | U | UA7014006-A | 90124 | 70 | MG | TABLET | /wk | |||
| 106144053 | 10614405 | 2 | C | LISINOPRIL. | LISINOPRIL | 1 | Unknown | U | 0 | ||||||||||
| 106144053 | 10614405 | 3 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 106144053 | 10614405 | 4 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 106144053 | 10614405 | 1 | Osteoporosis |
| 106144053 | 10614405 | 2 | Product used for unknown indication |
| 106144053 | 10614405 | 3 | Product used for unknown indication |
| 106144053 | 10614405 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 106144053 | 10614405 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 106144053 | 10614405 | Generalised oedema | |
| 106144053 | 10614405 | Pain | |
| 106144053 | 10614405 | Peripheral swelling |
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 |
|---|---|---|---|---|---|---|
| 106144053 | 10614405 | 1 | 201409 | 201412 | 0 |