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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114772002 | 11477200 | 2 | F | 20160805 | 20150909 | 20160816 | PER | US-JAZZ-2015-US-008221 | JAZZ | 0.00 | F | Y | 0.00000 | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114772002 | 11477200 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 114772002 | 11477200 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, QD | 21196 | 3.5 | G | ORAL SOLUTION | |||||||
| 114772002 | 11477200 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.375 G, QD | 21196 | 3.375 | G | ORAL SOLUTION | |||||||
| 114772002 | 11477200 | 4 | C | Fish oil concentrate | 2 | UNK | U | 0 | |||||||||||
| 114772002 | 11477200 | 5 | C | Multivitamin | VITAMINS | 1 | Oral | UNK | U | 0 | CAPSULE | ||||||||
| 114772002 | 11477200 | 6 | C | ABILIFY | ARIPIPRAZOLE | 1 | Oral | UNK | U | 0 | TABLET | ||||||||
| 114772002 | 11477200 | 7 | C | Amphetamine salts | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Oral | UNK | U | 0 | TABLET | ||||||||
| 114772002 | 11477200 | 8 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Oral | UNK | U | 0 | TABLET | ||||||||
| 114772002 | 11477200 | 9 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | UNK | U | 0 | CAPSULE | ||||||||
| 114772002 | 11477200 | 10 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Oral | UNK | U | 0 | TABLET | ||||||||
| 114772002 | 11477200 | 11 | C | SERTRALINE HCL | SERTRALINE HYDROCHLORIDE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114772002 | 11477200 | 1 | Narcolepsy |
| 114772002 | 11477200 | 4 | Product used for unknown indication |
| 114772002 | 11477200 | 5 | Product used for unknown indication |
| 114772002 | 11477200 | 6 | Affective disorder |
| 114772002 | 11477200 | 7 | Product used for unknown indication |
| 114772002 | 11477200 | 8 | Product used for unknown indication |
| 114772002 | 11477200 | 9 | Affective disorder |
| 114772002 | 11477200 | 10 | Product used for unknown indication |
| 114772002 | 11477200 | 11 | Affective disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114772002 | 11477200 | Hypersomnia | |
| 114772002 | 11477200 | Intentional product use issue | |
| 114772002 | 11477200 | Nocturia | |
| 114772002 | 11477200 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 114772002 | 11477200 | 1 | 201408 | 201410 | 0 | |
| 114772002 | 11477200 | 2 | 201410 | 0 | ||
| 114772002 | 11477200 | 4 | 20140812 | 0 | ||
| 114772002 | 11477200 | 5 | 20140812 | 0 | ||
| 114772002 | 11477200 | 6 | 20140811 | 0 | ||
| 114772002 | 11477200 | 7 | 20140811 | 0 | ||
| 114772002 | 11477200 | 8 | 20140811 | 0 | ||
| 114772002 | 11477200 | 9 | 20140811 | 0 | ||
| 114772002 | 11477200 | 10 | 20140811 | 0 |