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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108922752 | 10892275 | 2 | F | 2014 | 20160826 | 20150306 | 20160902 | EXP | US-JAZZ-2014-US-004346 | JAZZ | 0.00 | M | Y | 0.00000 | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108922752 | 10892275 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 1.5 G, BID | U | 21196 | 1.5 | G | ORAL SOLUTION | ||||||
| 108922752 | 10892275 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 108922752 | 10892275 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 3112102 | 21196 | 4.5 | G | ORAL SOLUTION | |||||
| 108922752 | 10892275 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 3112102 | 21196 | 4.5 | G | ORAL SOLUTION | |||||
| 108922752 | 10892275 | 5 | C | PROVIGIL | MODAFINIL | 1 | Oral | UNK | U | 0 | |||||||||
| 108922752 | 10892275 | 6 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | Oral | UNK | U | 0 | |||||||||
| 108922752 | 10892275 | 7 | C | Daily vitamins | 2 | Oral | UNK | U | 0 | ||||||||||
| 108922752 | 10892275 | 8 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | UNK, PRN | U | 0 | ||||||||||
| 108922752 | 10892275 | 9 | C | FENTANYL TRANSDERMAL SYSTEM | FENTANYL | 1 | Transdermal | 100 ?G, UNK | U | 0 | 100 | UG | |||||||
| 108922752 | 10892275 | 10 | C | MIRTAZAPINE. | MIRTAZAPINE | 1 | Oral | UNK | U | 0 | |||||||||
| 108922752 | 10892275 | 11 | C | TIZANIDINE. | TIZANIDINE | 1 | Oral | .8 MG, TID | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 108922752 | 10892275 | 1 | Cataplexy |
| 108922752 | 10892275 | 2 | Narcolepsy |
| 108922752 | 10892275 | 5 | Somnolence |
| 108922752 | 10892275 | 6 | Convulsion prophylaxis |
| 108922752 | 10892275 | 7 | Vitamin supplementation |
| 108922752 | 10892275 | 8 | Breakthrough pain |
| 108922752 | 10892275 | 9 | Pain |
| 108922752 | 10892275 | 10 | Sleep disorder |
| 108922752 | 10892275 | 11 | Muscle spasms |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 108922752 | 10892275 | OT |
| 108922752 | 10892275 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 108922752 | 10892275 | Brain injury | |
| 108922752 | 10892275 | Cataplexy | |
| 108922752 | 10892275 | Condition aggravated | |
| 108922752 | 10892275 | Dementia | |
| 108922752 | 10892275 | Emotional distress | |
| 108922752 | 10892275 | Narcolepsy | |
| 108922752 | 10892275 | Parkinson's disease |
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 |
|---|---|---|---|---|---|---|
| 108922752 | 10892275 | 1 | 200906 | 2009 | 0 | |
| 108922752 | 10892275 | 3 | 200911 | 2014 | 0 | |
| 108922752 | 10892275 | 4 | 2014 | 0 |