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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127552251 | 12755225 | 1 | I | 2016 | 20160830 | 20160916 | 20160916 | PER | US-TEVA-689717USA | TEVA | 25.66 | YR | M | Y | 72.64000 | KG | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127552251 | 12755225 | 1 | PS | NUVIGIL | ARMODAFINIL | 1 | Unknown | U | 21875 | QD | |||||||||
| 127552251 | 12755225 | 2 | SS | NUVIGIL | ARMODAFINIL | 1 | Unknown | U | 21875 | TABLET | |||||||||
| 127552251 | 12755225 | 3 | C | XYREM | SODIUM OXYBATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127552251 | 12755225 | 1 | Narcolepsy |
| 127552251 | 12755225 | 3 | Narcolepsy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127552251 | 12755225 | Headache | |
| 127552251 | 12755225 | Inappropriate schedule of drug administration | |
| 127552251 | 12755225 | Migraine | |
| 127552251 | 12755225 | Rash erythematous | |
| 127552251 | 12755225 | Rash generalised | |
| 127552251 | 12755225 | Rash macular | |
| 127552251 | 12755225 | Rash papular |
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 |
|---|---|---|---|---|---|---|
| 127552251 | 12755225 | 1 | 201604 | 0 | ||
| 127552251 | 12755225 | 2 | 20160623 | 0 |