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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127017931 | 12701793 | 1 | I | 20160410 | 20160420 | 20160831 | 20160831 | PER | US-JAZZ-2016-US-007491 | JAZZ | 31.94 | YR | M | Y | 0.00000 | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127017931 | 12701793 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | 21196 | 3.5 | G | ORAL SOLUTION | |||||||
| 127017931 | 12701793 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 127017931 | 12701793 | 3 | SS | TOPAMAX | TOPIRAMATE | 1 | UNK | U | 0 | ||||||||||
| 127017931 | 12701793 | 4 | SS | TOPAMAX | TOPIRAMATE | 1 | UNK | U | 0 | ||||||||||
| 127017931 | 12701793 | 5 | C | CLONAZEPAM. | CLONAZEPAM | 1 | U | 0 | |||||||||||
| 127017931 | 12701793 | 6 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | UNK | U | 0 | ||||||||||
| 127017931 | 12701793 | 7 | C | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | U | 0 | |||||||||||
| 127017931 | 12701793 | 8 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | U | 0 | |||||||||||
| 127017931 | 12701793 | 9 | C | SUMATRIPTAN. | SUMATRIPTAN | 1 | U | 0 | |||||||||||
| 127017931 | 12701793 | 10 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 127017931 | 12701793 | 11 | C | WELLBUTRIN XL | BUPROPION HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127017931 | 12701793 | 1 | Narcolepsy |
| 127017931 | 12701793 | 3 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127017931 | 12701793 | Dyspnoea | |
| 127017931 | 12701793 | Euphoric mood | |
| 127017931 | 12701793 | Heart rate increased | |
| 127017931 | 12701793 | Paraesthesia | |
| 127017931 | 12701793 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 127017931 | 12701793 | 1 | 20150903 | 201601 | 0 | |
| 127017931 | 12701793 | 2 | 201601 | 0 | ||
| 127017931 | 12701793 | 3 | 20160204 | 0 | ||
| 127017931 | 12701793 | 4 | 20160409 | 0 | ||
| 127017931 | 12701793 | 6 | 2016 | 0 |