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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125230302 | 12523030 | 2 | F | 2015 | 20160720 | 20160701 | 20160728 | EXP | US-JAZZ-2016-US-011560 | JAZZ | 41.98 | YR | M | Y | 85.26000 | KG | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125230302 | 12523030 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 125230302 | 12523030 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 125230302 | 12523030 | 3 | SS | NUVIGIL | ARMODAFINIL | 1 | U | 0 | TABLET | ||||||||||
| 125230302 | 12523030 | 4 | SS | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | 0 | TABLET | ||||||||||
| 125230302 | 12523030 | 5 | SS | Amphetamines | AMPHETAMINE | 1 | U | 0 | |||||||||||
| 125230302 | 12523030 | 6 | C | BACTRIM DS | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125230302 | 12523030 | 7 | C | ADDERALL XR | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | U | 0 | CAPSULE | ||||||||||
| 125230302 | 12523030 | 8 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | U | 0 | TABLET | ||||||||||
| 125230302 | 12523030 | 9 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | U | 0 | TABLET | ||||||||||
| 125230302 | 12523030 | 10 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | 150 MG, UNK | U | 0 | 150 | MG | CAPSULE | |||||||
| 125230302 | 12523030 | 11 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125230302 | 12523030 | 1 | Narcolepsy |
| 125230302 | 12523030 | 2 | Cataplexy |
| 125230302 | 12523030 | 3 | Narcolepsy |
| 125230302 | 12523030 | 4 | Product used for unknown indication |
| 125230302 | 12523030 | 5 | Narcolepsy |
| 125230302 | 12523030 | 6 | Product used for unknown indication |
| 125230302 | 12523030 | 7 | Narcolepsy |
| 125230302 | 12523030 | 8 | Product used for unknown indication |
| 125230302 | 12523030 | 9 | Product used for unknown indication |
| 125230302 | 12523030 | 10 | Cataplexy |
| 125230302 | 12523030 | 11 | Narcolepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125230302 | 12523030 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125230302 | 12523030 | Abdominal discomfort | |
| 125230302 | 12523030 | Abdominal pain upper | |
| 125230302 | 12523030 | Ageusia | |
| 125230302 | 12523030 | Anosmia | |
| 125230302 | 12523030 | Croup infectious | |
| 125230302 | 12523030 | Diverticulitis | |
| 125230302 | 12523030 | Drug ineffective | |
| 125230302 | 12523030 | Feeling abnormal | |
| 125230302 | 12523030 | Frequent bowel movements | |
| 125230302 | 12523030 | Hypertension | |
| 125230302 | 12523030 | Pain | |
| 125230302 | 12523030 | Sinusitis |
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 |
|---|---|---|---|---|---|---|
| 125230302 | 12523030 | 1 | 201402 | 2016 | 0 | |
| 125230302 | 12523030 | 2 | 201602 | 0 |