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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126439251 | 12643925 | 1 | I | 20160708 | 20160728 | 20160811 | 20160811 | EXP | IT-AUROBINDO-AUR-APL-2016-09996 | AUROBINDO | 33.25 | YR | F | Y | 0.00000 | 20160811 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126439251 | 12643925 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | U | 77206 | ||||||||||
| 126439251 | 12643925 | 2 | SS | ALPRAZOLAM. | ALPRAZOLAM | 1 | Unknown | U | 0 | ||||||||||
| 126439251 | 12643925 | 3 | SS | BROTIZOLAM | BROTIZOLAM | 1 | Unknown | U | 0 | ||||||||||
| 126439251 | 12643925 | 4 | SS | SODIUM VALPROATE | VALPROATE SODIUM | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126439251 | 12643925 | 1 | Bipolar disorder |
| 126439251 | 12643925 | 2 | Bipolar disorder |
| 126439251 | 12643925 | 3 | Bipolar disorder |
| 126439251 | 12643925 | 4 | Bipolar disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126439251 | 12643925 | LT |
| 126439251 | 12643925 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126439251 | 12643925 | Drug abuse | |
| 126439251 | 12643925 | Poisoning | |
| 126439251 | 12643925 | Suicide attempt | |
| 126439251 | 12643925 | Toxicity to various agents |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |