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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117484863 | 11748486 | 3 | F | 20151105 | 20160725 | 20151117 | 20160801 | EXP | US-JAZZ-2015-US-019024 | JAZZ | 27.62 | YR | F | Y | 76.64000 | KG | 20160801 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117484863 | 11748486 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2 G, BID | N | 21196 | 2 | G | ORAL SOLUTION | ||||||
| 117484863 | 11748486 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.5 G, BID | N | 21196 | 2.5 | G | ORAL SOLUTION | ||||||
| 117484863 | 11748486 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2 G, BID | N | 21196 | 2 | G | ORAL SOLUTION | ||||||
| 117484863 | 11748486 | 4 | C | PROVIGIL | MODAFINIL | 1 | UNK | 0 | TABLET | ||||||||||
| 117484863 | 11748486 | 5 | C | ACETAZOLAMIDE. | ACETAZOLAMIDE | 1 | UNK | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117484863 | 11748486 | 1 | Narcolepsy |
| 117484863 | 11748486 | 2 | Cataplexy |
| 117484863 | 11748486 | 4 | Narcolepsy |
| 117484863 | 11748486 | 5 | Intracranial pressure increased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117484863 | 11748486 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117484863 | 11748486 | Intracranial pressure increased | |
| 117484863 | 11748486 | Nausea | |
| 117484863 | 11748486 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 117484863 | 11748486 | 1 | 20151104 | 201511 | 0 | |
| 117484863 | 11748486 | 2 | 20151111 | 20151114 | 0 | |
| 117484863 | 11748486 | 3 | 20151115 | 0 | ||
| 117484863 | 11748486 | 4 | 20151029 | 0 | ||
| 117484863 | 11748486 | 5 | 20150921 | 0 |