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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125351392 | 12535139 | 2 | F | 20160614 | 20160805 | 20160707 | 20160810 | EXP | DE-AUROBINDO-AUR-APL-2016-08503 | AUROBINDO | 30.00 | YR | F | Y | 0.00000 | 20160810 | CN | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125351392 | 12535139 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | 50 MG, ONCE A DAY | 2300 | MG | Y | U | 77206 | 50 | MG | FILM-COATED TABLET | QD | ||
| 125351392 | 12535139 | 2 | C | OPIPRAMOL | OPIPRAMOL | 1 | Unknown | 50 MG, UNK | U | 0 | 50 | MG | |||||||
| 125351392 | 12535139 | 3 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 300 MG, UNK | U | 0 | 300 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125351392 | 12535139 | 1 | Migraine |
| 125351392 | 12535139 | 2 | Product used for unknown indication |
| 125351392 | 12535139 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125351392 | 12535139 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125351392 | 12535139 | Abdominal pain | |
| 125351392 | 12535139 | Diarrhoea | |
| 125351392 | 12535139 | Gastric haemorrhage | |
| 125351392 | 12535139 | Gastrointestinal disorder | |
| 125351392 | 12535139 | Haematoma | |
| 125351392 | 12535139 | Nausea |
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 |
|---|---|---|---|---|---|---|
| 125351392 | 12535139 | 1 | 20160429 | 20160614 | 0 |