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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126511511 | 12651151 | 1 | I | 201602 | 20160318 | 20160815 | 20160815 | PER | US-JAZZ-2016-US-005360 | JAZZ | 40.81 | YR | F | Y | 0.00000 | 20160815 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126511511 | 12651151 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126511511 | 12651151 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 126511511 | 12651151 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 126511511 | 12651151 | 4 | SS | LEXAPRO | ESCITALOPRAM OXALATE | 1 | 0 | ||||||||||||
| 126511511 | 12651151 | 5 | SS | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126511511 | 12651151 | 6 | C | NEURONTIN | GABAPENTIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126511511 | 12651151 | 7 | C | NORDETTE | ETHINYL ESTRADIOLLEVONORGESTREL | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126511511 | 12651151 | 1 | Narcolepsy |
| 126511511 | 12651151 | 4 | Product used for unknown indication |
| 126511511 | 12651151 | 5 | Depressive symptom |
| 126511511 | 12651151 | 6 | Product used for unknown indication |
| 126511511 | 12651151 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126511511 | 12651151 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126511511 | 12651151 | Depression | |
| 126511511 | 12651151 | Paraesthesia | |
| 126511511 | 12651151 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 126511511 | 12651151 | 1 | 200411 | 200501 | 0 | |
| 126511511 | 12651151 | 3 | 201201 | 0 | ||
| 126511511 | 12651151 | 6 | 20151116 | 20160301 | 0 | |
| 126511511 | 12651151 | 7 | 20151116 | 0 |