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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124268042 | 12426804 | 2 | F | 2014 | 20160713 | 20160601 | 20160721 | EXP | US-JAZZ-2014-US-001252 | JAZZ | 0.00 | F | Y | 0.00000 | 20160721 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124268042 | 12426804 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 124268042 | 12426804 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 124268042 | 12426804 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 6 G, BID | U | 3117614 | 21196 | 6 | G | ORAL SOLUTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124268042 | 12426804 | 1 | Narcolepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124268042 | 12426804 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124268042 | 12426804 | Activities of daily living impaired | |
| 124268042 | 12426804 | Communication disorder | |
| 124268042 | 12426804 | Condition aggravated | |
| 124268042 | 12426804 | Disorientation | |
| 124268042 | 12426804 | Feeling abnormal | |
| 124268042 | 12426804 | Headache | |
| 124268042 | 12426804 | Hypophagia | |
| 124268042 | 12426804 | Incontinence | |
| 124268042 | 12426804 | Intentional self-injury | |
| 124268042 | 12426804 | Nausea | |
| 124268042 | 12426804 | Pituitary tumour | |
| 124268042 | 12426804 | Sluggishness | |
| 124268042 | 12426804 | Stress |
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 |
|---|---|---|---|---|---|---|
| 124268042 | 12426804 | 1 | 200604 | 2006 | 0 | |
| 124268042 | 12426804 | 2 | 2006 | 200907 | 0 | |
| 124268042 | 12426804 | 3 | 200907 | 2014 | 0 |