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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127777541 | 12777754 | 1 | I | 2016 | 20160606 | 20160924 | 20160924 | PER | US-JAZZ-2016-US-010552 | JAZZ | 0.00 | M | Y | 0.00000 | 20160924 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127777541 | 12777754 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127777541 | 12777754 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127777541 | 12777754 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127777541 | 12777754 | 4 | SS | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127777541 | 12777754 | 5 | C | ABILIFY | ARIPIPRAZOLE | 1 | 5 MG, UNK | U | 0 | 5 | MG | TABLET | |||||||
| 127777541 | 12777754 | 6 | C | DEXEDRINE | DEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 127777541 | 12777754 | 7 | C | DULOXETINE HYDROCHLORIDE. | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127777541 | 12777754 | 8 | C | Gabapentin 800 | 2 | UNK | U | 0 | TABLET | ||||||||||
| 127777541 | 12777754 | 9 | C | WELLBUTRIN XL | BUPROPION HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127777541 | 12777754 | 10 | C | Ondansetron hcl | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127777541 | 12777754 | 11 | C | L-METHYL MC | CYANOCOBALAMINLEVOMEFOLATE CALCIUMPYRIDOXINERIBOFLAVIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 127777541 | 12777754 | 12 | C | BACLOFEN. | BACLOFEN | 1 | U | 0 | TABLET | ||||||||||
| 127777541 | 12777754 | 13 | C | MIRTAZAPINE. | MIRTAZAPINE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127777541 | 12777754 | 1 | Narcolepsy |
| 127777541 | 12777754 | 4 | Product used for unknown indication |
| 127777541 | 12777754 | 5 | Product used for unknown indication |
| 127777541 | 12777754 | 6 | Product used for unknown indication |
| 127777541 | 12777754 | 7 | Product used for unknown indication |
| 127777541 | 12777754 | 8 | Product used for unknown indication |
| 127777541 | 12777754 | 9 | Product used for unknown indication |
| 127777541 | 12777754 | 10 | Product used for unknown indication |
| 127777541 | 12777754 | 11 | Product used for unknown indication |
| 127777541 | 12777754 | 12 | Product used for unknown indication |
| 127777541 | 12777754 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127777541 | 12777754 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127777541 | 12777754 | Anxiety | |
| 127777541 | 12777754 | Paranoia | |
| 127777541 | 12777754 | Psychotic disorder |
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 |
|---|---|---|---|---|---|---|
| 127777541 | 12777754 | 1 | 201509 | 201509 | 0 | |
| 127777541 | 12777754 | 2 | 201509 | 2015 | 0 | |
| 127777541 | 12777754 | 3 | 2015 | 0 | ||
| 127777541 | 12777754 | 4 | 20160113 | 0 | ||
| 127777541 | 12777754 | 5 | 201606 | 0 | ||
| 127777541 | 12777754 | 6 | 201604 | 0 | ||
| 127777541 | 12777754 | 7 | 201603 | 0 | ||
| 127777541 | 12777754 | 8 | 20160209 | 0 | ||
| 127777541 | 12777754 | 9 | 20160208 | 201605 | 0 | |
| 127777541 | 12777754 | 10 | 20160113 | 0 | ||
| 127777541 | 12777754 | 11 | 20151109 | 0 | ||
| 127777541 | 12777754 | 13 | 201604 | 0 |