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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125449721 | 12544972 | 1 | I | 20160606 | 20160627 | 20160711 | 20160711 | PER | US-TEVA-672691USA | TEVA | 46.28 | YR | F | Y | 62.20000 | KG | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125449721 | 12544972 | 1 | PS | NUVIGIL | ARMODAFINIL | 1 | 150 MILLIGRAM DAILY; | Y | 42601609A | 21875 | 150 | MG | QD | ||||||
| 125449721 | 12544972 | 2 | SS | NUVIGIL | ARMODAFINIL | 1 | 125 MILLIGRAM DAILY; | Y | 42601609A | 21875 | 125 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125449721 | 12544972 | 1 | Hypersomnia |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125449721 | 12544972 | Dyspepsia | |
| 125449721 | 12544972 | Feeling jittery | |
| 125449721 | 12544972 | Product use issue | |
| 125449721 | 12544972 | 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 |
|---|---|---|---|---|---|---|
| 125449721 | 12544972 | 1 | 20160606 | 20160613 | 0 | |
| 125449721 | 12544972 | 2 | 20160613 | 20160620 | 0 |