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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125580321 | 12558032 | 1 | I | 2010 | 20160115 | 20160714 | 20160714 | PER | US-JAZZ-2016-US-000835 | JAZZ | 0.00 | F | Y | 0.00000 | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125580321 | 12558032 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125580321 | 12558032 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125580321 | 12558032 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125580321 | 12558032 | 4 | SS | PROVIGIL | MODAFINIL | 1 | Y | 0 | |||||||||||
| 125580321 | 12558032 | 5 | C | ATIVAN | LORAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580321 | 12558032 | 6 | C | CELEBREX | CELECOXIB | 1 | 100 MG, UNK | U | 0 | 100 | MG | CAPSULE | |||||||
| 125580321 | 12558032 | 7 | C | CELEBREX | CELECOXIB | 1 | 200 MG, UNK | U | 0 | 200 | MG | CAPSULE | |||||||
| 125580321 | 12558032 | 8 | C | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580321 | 12558032 | 9 | C | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580321 | 12558032 | 10 | C | PREDNISONE. | PREDNISONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580321 | 12558032 | 11 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580321 | 12558032 | 12 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580321 | 12558032 | 13 | C | Aspir | ASPIRIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580321 | 12558032 | 14 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125580321 | 12558032 | 15 | C | MOBIC | MELOXICAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580321 | 12558032 | 16 | C | XANAX | ALPRAZOLAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580321 | 12558032 | 17 | C | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125580321 | 12558032 | 18 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | UNK | U | 0 | ||||||||||
| 125580321 | 12558032 | 19 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125580321 | 12558032 | 1 | Narcolepsy |
| 125580321 | 12558032 | 2 | Cataplexy |
| 125580321 | 12558032 | 4 | Product used for unknown indication |
| 125580321 | 12558032 | 5 | Product used for unknown indication |
| 125580321 | 12558032 | 6 | Product used for unknown indication |
| 125580321 | 12558032 | 8 | Product used for unknown indication |
| 125580321 | 12558032 | 10 | Product used for unknown indication |
| 125580321 | 12558032 | 11 | Product used for unknown indication |
| 125580321 | 12558032 | 12 | Product used for unknown indication |
| 125580321 | 12558032 | 13 | Product used for unknown indication |
| 125580321 | 12558032 | 14 | Product used for unknown indication |
| 125580321 | 12558032 | 15 | Product used for unknown indication |
| 125580321 | 12558032 | 16 | Product used for unknown indication |
| 125580321 | 12558032 | 17 | Product used for unknown indication |
| 125580321 | 12558032 | 18 | Product used for unknown indication |
| 125580321 | 12558032 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125580321 | 12558032 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125580321 | 12558032 | Abdominal pain upper | |
| 125580321 | 12558032 | Condition aggravated | |
| 125580321 | 12558032 | Depression | |
| 125580321 | 12558032 | Fibromyalgia | |
| 125580321 | 12558032 | Influenza like illness | |
| 125580321 | 12558032 | Myalgia | |
| 125580321 | 12558032 | Nausea | |
| 125580321 | 12558032 | Neuralgia | |
| 125580321 | 12558032 | Palpitations | |
| 125580321 | 12558032 | Sleep apnoea syndrome | |
| 125580321 | 12558032 | Tachycardia |
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 |
|---|---|---|---|---|---|---|
| 125580321 | 12558032 | 1 | 200807 | 2008 | 0 | |
| 125580321 | 12558032 | 3 | 201507 | 0 | ||
| 125580321 | 12558032 | 5 | 20151014 | 0 | ||
| 125580321 | 12558032 | 6 | 20140210 | 20150504 | 0 | |
| 125580321 | 12558032 | 7 | 20151013 | 0 | ||
| 125580321 | 12558032 | 8 | 20130729 | 20130730 | 0 | |
| 125580321 | 12558032 | 9 | 20150504 | 20160115 | 0 | |
| 125580321 | 12558032 | 10 | 20150330 | 20151014 | 0 | |
| 125580321 | 12558032 | 11 | 20150326 | 20150330 | 0 | |
| 125580321 | 12558032 | 12 | 20150101 | 0 | ||
| 125580321 | 12558032 | 13 | 20141013 | 0 | ||
| 125580321 | 12558032 | 14 | 20130729 | 0 | ||
| 125580321 | 12558032 | 15 | 20130729 | 20140210 | 0 | |
| 125580321 | 12558032 | 16 | 20130729 | 20150504 | 0 | |
| 125580321 | 12558032 | 17 | 20111001 | 20160115 | 0 | |
| 125580321 | 12558032 | 18 | 20130728 | 0 | ||
| 125580321 | 12558032 | 19 | 20121014 | 0 |