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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127453462 | 12745346 | 2 | F | 20160908 | 20160915 | 20160922 | EXP | BR-CONCORDIA PHARMACEUTICALS INC.-GSH201609-004570 | CONCORDIA | 0.00 | F | Y | 0.00000 | 20160921 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127453462 | 12745346 | 1 | PS | PARNATE | TRANYLCYPROMINE SULFATE | 1 | Oral | 12342 | TABLET | ||||||||||
| 127453462 | 12745346 | 2 | SS | STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | 1 | Oral | 0 | |||||||||||
| 127453462 | 12745346 | 3 | SS | FRONTAL | ALPRAZOLAM | 1 | Oral | U | 0 | BID | |||||||||
| 127453462 | 12745346 | 4 | SS | RIVOTRIL | CLONAZEPAM | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127453462 | 12745346 | 1 | Cardiac failure |
| 127453462 | 12745346 | 2 | Ill-defined disorder |
| 127453462 | 12745346 | 3 | Anxiolytic therapy |
| 127453462 | 12745346 | 4 | Ill-defined disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127453462 | 12745346 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127453462 | 12745346 | Crying | |
| 127453462 | 12745346 | Depression | |
| 127453462 | 12745346 | Dizziness | |
| 127453462 | 12745346 | Dyspnoea | |
| 127453462 | 12745346 | Fatigue | |
| 127453462 | 12745346 | Fear | |
| 127453462 | 12745346 | Ill-defined disorder | |
| 127453462 | 12745346 | Insomnia | |
| 127453462 | 12745346 | Product supply issue | |
| 127453462 | 12745346 | Suicide attempt |
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 |
|---|---|---|---|---|---|---|
| 127453462 | 12745346 | 1 | 20160904 | 0 |