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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127103672 | 12710367 | 2 | F | 201608 | 20160825 | 20160902 | 20160920 | PER | US-TEVA-688347USA | TEVA | 18.81 | YR | F | Y | 59.02000 | KG | 20160920 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127103672 | 12710367 | 1 | PS | PROVIGIL | MODAFINIL | 1 | U | 20717 | 200 | MG | |||||||||
| 127103672 | 12710367 | 2 | SS | PROVIGIL | MODAFINIL | 1 | U | 20717 | |||||||||||
| 127103672 | 12710367 | 3 | C | LUNESTA | ESZOPICLONE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127103672 | 12710367 | 1 | Fatigue |
| 127103672 | 12710367 | 2 | Hypersomnia |
| 127103672 | 12710367 | 3 | Sleep disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127103672 | 12710367 | Drug ineffective | |
| 127103672 | 12710367 | Intentional product use issue | |
| 127103672 | 12710367 | Poor quality sleep | |
| 127103672 | 12710367 | Product use issue | |
| 127103672 | 12710367 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 127103672 | 12710367 | 1 | 20160816 | 20160818 | 0 |