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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117244344 | 11724434 | 4 | F | 2014 | 20160922 | 20151111 | 20160930 | EXP | US-JAZZ-2015-US-018579 | JAZZ | 0.00 | F | Y | 0.00000 | 20160930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117244344 | 11724434 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 117244344 | 11724434 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 117244344 | 11724434 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, TID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 117244344 | 11724434 | 4 | SS | LUVOX CR | FLUVOXAMINE MALEATE | 1 | UNK | D | 0 | CAPSULE | |||||||||
| 117244344 | 11724434 | 5 | C | NUVARING | ETHINYL ESTRADIOLETONOGESTREL | 1 | UNK | U | 0 | ||||||||||
| 117244344 | 11724434 | 6 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 117244344 | 11724434 | 7 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 117244344 | 11724434 | 8 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117244344 | 11724434 | 1 | Narcolepsy |
| 117244344 | 11724434 | 2 | Cataplexy |
| 117244344 | 11724434 | 4 | Obsessive-compulsive disorder |
| 117244344 | 11724434 | 5 | Contraception |
| 117244344 | 11724434 | 6 | Narcolepsy |
| 117244344 | 11724434 | 7 | Gastrooesophageal reflux disease |
| 117244344 | 11724434 | 8 | Unevaluable event |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117244344 | 11724434 | HO |
| 117244344 | 11724434 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117244344 | 11724434 | Ataxia | |
| 117244344 | 11724434 | Cholelithiasis | |
| 117244344 | 11724434 | Diplopia | |
| 117244344 | 11724434 | Hepatic steatosis | |
| 117244344 | 11724434 | Hypertension | |
| 117244344 | 11724434 | Neuropathy peripheral | |
| 117244344 | 11724434 | Ophthalmoplegia | |
| 117244344 | 11724434 | Parasomnia | |
| 117244344 | 11724434 | Urinary incontinence | |
| 117244344 | 11724434 | Vomiting | |
| 117244344 | 11724434 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 117244344 | 11724434 | 1 | 200601 | 200602 | 0 | |
| 117244344 | 11724434 | 3 | 201410 | 0 | ||
| 117244344 | 11724434 | 4 | 20150930 | 0 | ||
| 117244344 | 11724434 | 5 | 20150930 | 0 | ||
| 117244344 | 11724434 | 6 | 20150930 | 0 | ||
| 117244344 | 11724434 | 7 | 20150930 | 0 | ||
| 117244344 | 11724434 | 8 | 20010101 | 0 |