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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124537634 | 12453763 | 4 | F | 20141024 | 20160707 | 20160609 | 20160711 | EXP | US-SUNOVION-2016SUN001421 | SUNOVION | 31.90 | YR | M | Y | 86.17000 | KG | 20160711 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124537634 | 12453763 | 1 | PS | LUNESTA | ESZOPICLONE | 1 | Oral | 3 MG, HS | Y | N | 21476 | 3 | MG | QD | |||||
| 124537634 | 12453763 | 2 | SS | LUNESTA | ESZOPICLONE | 1 | Oral | UNK | Y | N | 21476 | ||||||||
| 124537634 | 12453763 | 3 | SS | LYRICA | PREGABALIN | 1 | 300 MG, BID | Y | 0 | 300 | MG | BID | |||||||
| 124537634 | 12453763 | 4 | SS | LYRICA | PREGABALIN | 1 | UNK | Y | 0 | ||||||||||
| 124537634 | 12453763 | 5 | SS | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK, AS NECESSARY | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124537634 | 12453763 | 1 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124537634 | 12453763 | HO |
| 124537634 | 12453763 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124537634 | 12453763 | Brain injury | |
| 124537634 | 12453763 | Cognitive disorder | |
| 124537634 | 12453763 | Sedation |
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 |
|---|---|---|---|---|---|---|
| 124537634 | 12453763 | 1 | 201410 | 0 |