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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127236151 | 12723615 | 1 | I | 20160825 | 20160908 | 20160908 | EXP | GB-AUROBINDO-AUR-APL-2016-10992 | AUROBINDO | 17.00 | YR | M | Y | 0.00000 | 20160908 | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127236151 | 12723615 | 1 | PS | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | Y | U | 78619 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127236151 | 12723615 | 1 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127236151 | 12723615 | OT |
| 127236151 | 12723615 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127236151 | 12723615 | Abnormal weight gain | |
| 127236151 | 12723615 | Anxiety | |
| 127236151 | 12723615 | Deafness | |
| 127236151 | 12723615 | Photophobia | |
| 127236151 | 12723615 | Pruritus generalised | |
| 127236151 | 12723615 | Suicidal ideation |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |