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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127208542 | 12720854 | 2 | F | 20160919 | 20160907 | 20160926 | EXP | US-JAZZ-2016-US-016836 | JAZZ | 0.00 | F | Y | 0.00000 | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127208542 | 12720854 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 127208542 | 12720854 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 127208542 | 12720854 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | |||||||||
| 127208542 | 12720854 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 127208542 | 12720854 | 5 | SS | NUVIGIL | ARMODAFINIL | 1 | U | 0 | |||||||||||
| 127208542 | 12720854 | 6 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 127208542 | 12720854 | 7 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127208542 | 12720854 | 1 | Narcolepsy |
| 127208542 | 12720854 | 2 | Cataplexy |
| 127208542 | 12720854 | 5 | Product used for unknown indication |
| 127208542 | 12720854 | 6 | Product used for unknown indication |
| 127208542 | 12720854 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127208542 | 12720854 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127208542 | 12720854 | Blindness | |
| 127208542 | 12720854 | Drug dose omission | |
| 127208542 | 12720854 | Migraine | |
| 127208542 | 12720854 | Pain in jaw |
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 |
|---|---|---|---|---|---|---|
| 127208542 | 12720854 | 1 | 201412 | 2015 | 0 | |
| 127208542 | 12720854 | 2 | 201602 | 201602 | 0 | |
| 127208542 | 12720854 | 3 | 201602 | 201604 | 0 | |
| 127208542 | 12720854 | 4 | 201607 | 0 | ||
| 127208542 | 12720854 | 6 | 20141101 | 0 | ||
| 127208542 | 12720854 | 7 | 20121101 | 0 |