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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127938951 | 12793895 | 1 | I | 201606 | 20160620 | 20160929 | 20160929 | PER | US-JAZZ-2016-US-011530 | JAZZ | 24.84 | YR | F | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127938951 | 12793895 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127938951 | 12793895 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 127938951 | 12793895 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 127938951 | 12793895 | 4 | SS | NUVIGIL | ARMODAFINIL | 1 | Y | 0 | |||||||||||
| 127938951 | 12793895 | 5 | SS | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Y | 0 | |||||||||||
| 127938951 | 12793895 | 6 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | U | 0 | |||||||||||
| 127938951 | 12793895 | 7 | C | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127938951 | 12793895 | 8 | C | FLOVENT HFA | FLUTICASONE PROPIONATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127938951 | 12793895 | 1 | Narcolepsy |
| 127938951 | 12793895 | 2 | Cataplexy |
| 127938951 | 12793895 | 4 | Narcolepsy |
| 127938951 | 12793895 | 5 | Narcolepsy |
| 127938951 | 12793895 | 6 | Hypersensitivity |
| 127938951 | 12793895 | 7 | Hypersensitivity |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127938951 | 12793895 | Activities of daily living impaired | |
| 127938951 | 12793895 | Anxiety | |
| 127938951 | 12793895 | Dizziness | |
| 127938951 | 12793895 | Feeling abnormal | |
| 127938951 | 12793895 | Headache | |
| 127938951 | 12793895 | Pain |
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 |
|---|---|---|---|---|---|---|
| 127938951 | 12793895 | 1 | 201606 | 201606 | 0 | |
| 127938951 | 12793895 | 2 | 201606 | 201606 | 0 | |
| 127938951 | 12793895 | 3 | 201606 | 0 |