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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114735713 | 11473571 | 3 | F | 20100901 | 20160919 | 20150908 | 20160929 | PER | BE-JAZZ-JPI-P-022772 | JAZZ | 36.81 | YR | F | Y | 60.00000 | KG | 20160929 | MD | BE | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114735713 | 11473571 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.65 G, BID | Y | U | 21196 | 2.65 | G | ORAL SOLUTION | |||||
| 114735713 | 11473571 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.5 G, BID | Y | U | 21196 | 2.5 | G | ORAL SOLUTION | |||||
| 114735713 | 11473571 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 10 OR 12 G | Y | U | 21196 | ORAL SOLUTION | |||||||
| 114735713 | 11473571 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 12 G, QD | Y | U | 21196 | 12 | G | ORAL SOLUTION | |||||
| 114735713 | 11473571 | 5 | SS | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, QD | 0 | 20 | MG | ||||||||
| 114735713 | 11473571 | 6 | C | MODAFINIL. | MODAFINIL | 1 | Oral | 600 MG, QD | U | 0 | 600 | MG | |||||||
| 114735713 | 11473571 | 7 | C | Mercilon | DESOGESTRELETHINYL ESTRADIOL | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114735713 | 11473571 | 1 | Narcolepsy |
| 114735713 | 11473571 | 2 | Cataplexy |
| 114735713 | 11473571 | 5 | Cataplexy |
| 114735713 | 11473571 | 6 | Narcolepsy |
| 114735713 | 11473571 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114735713 | 11473571 | DS |
| 114735713 | 11473571 | OT |
| 114735713 | 11473571 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114735713 | 11473571 | Confusional state | |
| 114735713 | 11473571 | Hallucination | |
| 114735713 | 11473571 | Intentional overdose | |
| 114735713 | 11473571 | Nightmare | |
| 114735713 | 11473571 | Somnambulism | |
| 114735713 | 11473571 | Suicide attempt |
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 |
|---|---|---|---|---|---|---|
| 114735713 | 11473571 | 1 | 20100303 | 0 | ||
| 114735713 | 11473571 | 2 | 20101115 | 0 | ||
| 114735713 | 11473571 | 4 | 201101 | 0 | ||
| 114735713 | 11473571 | 5 | 2002 | 0 | ||
| 114735713 | 11473571 | 6 | 20101129 | 0 | ||
| 114735713 | 11473571 | 7 | 2000 | 0 |