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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126673484 | 12667348 | 4 | F | 20160805 | 20160909 | 20160819 | 20160915 | EXP | US-JAZZ-2016-US-015191 | JAZZ | 19.21 | YR | F | Y | 47.62000 | KG | 20160915 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126673484 | 12667348 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126673484 | 12667348 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, QD | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 126673484 | 12667348 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, FIRST DOSE | Y | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 126673484 | 12667348 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2 G, SECOND DOSE | Y | 21196 | 2 | G | ORAL SOLUTION | ||||||
| 126673484 | 12667348 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | UNKNOWN DOSE | Y | 21196 | ORAL SOLUTION | ||||||||
| 126673484 | 12667348 | 6 | SS | ATIVAN | LORAZEPAM | 1 | Y | 0 | |||||||||||
| 126673484 | 12667348 | 7 | C | BACLOFEN. | BACLOFEN | 1 | UNK | U | 0 | TABLET | |||||||||
| 126673484 | 12667348 | 8 | C | Doxepin | DOXEPIN | 1 | Oral | UNK | U | 0 | |||||||||
| 126673484 | 12667348 | 9 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126673484 | 12667348 | 1 | Narcolepsy |
| 126673484 | 12667348 | 2 | Cataplexy |
| 126673484 | 12667348 | 7 | Sleep disorder |
| 126673484 | 12667348 | 8 | Product used for unknown indication |
| 126673484 | 12667348 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126673484 | 12667348 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126673484 | 12667348 | Anxiety | |
| 126673484 | 12667348 | Apnoea | |
| 126673484 | 12667348 | Chest discomfort | |
| 126673484 | 12667348 | Chest pain | |
| 126673484 | 12667348 | Dizziness | |
| 126673484 | 12667348 | Dry skin | |
| 126673484 | 12667348 | Dyspnoea | |
| 126673484 | 12667348 | Fatigue | |
| 126673484 | 12667348 | Mood swings | |
| 126673484 | 12667348 | Panic attack | |
| 126673484 | 12667348 | Unevaluable event |
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 |
|---|---|---|---|---|---|---|
| 126673484 | 12667348 | 1 | 20160805 | 20160808 | 0 | |
| 126673484 | 12667348 | 2 | 20160809 | 20160809 | 0 | |
| 126673484 | 12667348 | 3 | 201608 | 0 | ||
| 126673484 | 12667348 | 4 | 201608 | 0 | ||
| 126673484 | 12667348 | 5 | 201608 | 0 | ||
| 126673484 | 12667348 | 7 | 20160629 | 0 | ||
| 126673484 | 12667348 | 8 | 20160629 | 0 | ||
| 126673484 | 12667348 | 9 | 20160211 | 0 |