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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127496892 | 12749689 | 2 | F | 20160816 | 20160909 | 20160916 | 20160923 | EXP | IT-AUROBINDO-AUR-APL-2016-11469 | AUROBINDO | 52.76 | YR | F | Y | 0.00000 | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127496892 | 12749689 | 1 | PS | Mirtazapine tablet 30mg | MIRTAZAPINE | 1 | Oral | 30 MG, DAILY | D | U | 76921 | 30 | MG | TABLET | |||||
| 127496892 | 12749689 | 2 | SS | EN | DELORAZEPAM | 1 | Oral | 2 MG, UNK | D | U | 0 | 2 | MG | TABLET | |||||
| 127496892 | 12749689 | 3 | SS | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 75 MG, DAILY | D | U | 0 | 75 | MG | PROLONGED-RELEASE CAPSULE, HARD | |||||
| 127496892 | 12749689 | 4 | SS | RIVOTRIL | CLONAZEPAM | 1 | Oral | 0.5 MG, DAILY | D | U | 0 | .5 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127496892 | 12749689 | 1 | Major depression |
| 127496892 | 12749689 | 2 | Major depression |
| 127496892 | 12749689 | 3 | Major depression |
| 127496892 | 12749689 | 4 | Major depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127496892 | 12749689 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127496892 | 12749689 | Drug abuse | |
| 127496892 | 12749689 | Intentional self-injury | |
| 127496892 | 12749689 | Road traffic accident |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |