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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125393732 | 12539373 | 2 | F | 20160630 | 20160708 | 20160714 | EXP | FR-AUROBINDO-AUR-APL-2016-08916 | AUROBINDO | 42.00 | YR | F | Y | 0.00000 | 20160713 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125393732 | 12539373 | 1 | SS | Bromazepam | BROMAZEPAM | 1 | Unknown | 180 MG, UNK | U | 0 | 180 | MG | |||||||
| 125393732 | 12539373 | 2 | PS | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | Unknown | 840 MG, UNK | U | 79062 | 840 | MG | |||||||
| 125393732 | 12539373 | 3 | SS | Lormetazepam | LORMETAZEPAM | 1 | Unknown | 14 MG, UNK | U | 0 | 14 | MG | |||||||
| 125393732 | 12539373 | 4 | SS | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 7875 MG, UNK | U | 0 | 7875 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125393732 | 12539373 | 1 | Product used for unknown indication |
| 125393732 | 12539373 | 2 | Product used for unknown indication |
| 125393732 | 12539373 | 3 | Product used for unknown indication |
| 125393732 | 12539373 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125393732 | 12539373 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125393732 | 12539373 | Confusional state | |
| 125393732 | 12539373 | Electrocardiogram QT prolonged | |
| 125393732 | 12539373 | Hypoglycaemia | |
| 125393732 | 12539373 | Intentional overdose | |
| 125393732 | 12539373 | Nystagmus | |
| 125393732 | 12539373 | 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 |