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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127678441 | 12767844 | 1 | I | 20100726 | 20160908 | 20160921 | 20160921 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00551 | AMNEAL | 74.00 | YR | M | Y | 110.00000 | KG | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127678441 | 12767844 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | Oral | UNK, 3X/DAY | Y | U | 75927 | TID | |||||||
| 127678441 | 12767844 | 2 | SS | NAPROXEN. | NAPROXEN | 1 | Y | U | 75927 | ||||||||||
| 127678441 | 12767844 | 3 | SS | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | 40 MG, 1X/DAY | 37240 | MG | Y | U | 0 | 40 | MG | QD | |||
| 127678441 | 12767844 | 4 | C | aprovel fc | 2 | Oral | UNK | 0 | |||||||||||
| 127678441 | 12767844 | 5 | C | COLCHICINE. | COLCHICINE | 1 | UNK | 0 | |||||||||||
| 127678441 | 12767844 | 6 | C | AMARYL | GLIMEPIRIDE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127678441 | 12767844 | 1 | Osteoarthritis |
| 127678441 | 12767844 | 2 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127678441 | 12767844 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127678441 | 12767844 | Coronary artery disease |
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 |
|---|---|---|---|---|---|---|
| 127678441 | 12767844 | 1 | 20080108 | 20080816 | 0 | |
| 127678441 | 12767844 | 3 | 20080108 | 20100816 | 0 | |
| 127678441 | 12767844 | 4 | 20060207 | 0 | ||
| 127678441 | 12767844 | 5 | 20060207 | 0 | ||
| 127678441 | 12767844 | 6 | 20081209 | 0 |