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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127599301 | 12759930 | 1 | I | 20111228 | 20160908 | 20160919 | 20160919 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00544 | AMNEAL | 65.00 | YR | F | Y | 98.40000 | KG | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127599301 | 12759930 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | Oral | UNK | Y | 75927 | |||||||||
| 127599301 | 12759930 | 2 | SS | NAPROXEN. | NAPROXEN | 1 | Y | 75927 | |||||||||||
| 127599301 | 12759930 | 3 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | UNK | Y | U | 0 | |||||||||
| 127599301 | 12759930 | 4 | C | ACTOS | PIOGLITAZONE HYDROCHLORIDE | 1 | UNK | U | U | 0 | TABLET | ||||||||
| 127599301 | 12759930 | 5 | C | amitriptyline | AMITRIPTYLINE | 1 | UNK | U | U | 0 | |||||||||
| 127599301 | 12759930 | 6 | C | ZOCOR | SIMVASTATIN | 1 | UNK | U | U | 0 | |||||||||
| 127599301 | 12759930 | 7 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | 0 | |||||||||||
| 127599301 | 12759930 | 8 | C | LOVAZA | OMEGA-3-ACID ETHYL ESTERS | 1 | UNK | 0 | |||||||||||
| 127599301 | 12759930 | 9 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127599301 | 12759930 | 1 | Osteoarthritis |
| 127599301 | 12759930 | 2 | Rheumatoid arthritis |
| 127599301 | 12759930 | 3 | Prophylaxis |
| 127599301 | 12759930 | 4 | Diabetes mellitus |
| 127599301 | 12759930 | 5 | Insomnia |
| 127599301 | 12759930 | 6 | Dyslipidaemia |
| 127599301 | 12759930 | 7 | Diabetic neuropathy |
| 127599301 | 12759930 | 8 | Dyslipidaemia |
| 127599301 | 12759930 | 9 | Supplementation therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127599301 | 12759930 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127599301 | 12759930 | Chest pain |
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 |
|---|---|---|---|---|---|---|
| 127599301 | 12759930 | 1 | 20080515 | 20111214 | 0 | |
| 127599301 | 12759930 | 3 | 20080514 | 20111214 | 0 | |
| 127599301 | 12759930 | 4 | 200803 | 0 | ||
| 127599301 | 12759930 | 5 | 200803 | 0 | ||
| 127599301 | 12759930 | 6 | 2007 | 0 | ||
| 127599301 | 12759930 | 7 | 2004 | 0 | ||
| 127599301 | 12759930 | 8 | 2007 | 0 | ||
| 127599301 | 12759930 | 9 | 2002 | 0 |