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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116385904 | 11638590 | 4 | F | 2015 | 20160907 | 20151016 | 20160914 | EXP | US-JAZZ-2015-US-016018 | JAZZ | 55.21 | YR | M | Y | 87.98000 | KG | 20160914 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116385904 | 11638590 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.5 G, BID | Y | 21196 | 2.5 | G | ORAL SOLUTION | ||||||
| 116385904 | 11638590 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | Y | 21196 | 3.5 | G | ORAL SOLUTION | ||||||
| 116385904 | 11638590 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 116385904 | 11638590 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 116385904 | 11638590 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | Y | 21196 | 3.5 | G | ORAL SOLUTION | ||||||
| 116385904 | 11638590 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | Y | 21196 | 3.5 | G | ORAL SOLUTION | ||||||
| 116385904 | 11638590 | 7 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 116385904 | 11638590 | 8 | C | Hydrocodone/ibuprofen | HYDROCODONEIBUPROFEN | 1 | UNK, PRN | U | 0 | ||||||||||
| 116385904 | 11638590 | 9 | C | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 116385904 | 11638590 | 10 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 116385904 | 11638590 | 11 | C | ALLEGRA-D | FEXOFENADINEPSEUDOEPHEDRINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 116385904 | 11638590 | 12 | C | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 116385904 | 11638590 | 13 | C | TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116385904 | 11638590 | 1 | Narcolepsy |
| 116385904 | 11638590 | 2 | Cataplexy |
| 116385904 | 11638590 | 7 | Narcolepsy |
| 116385904 | 11638590 | 8 | Headache |
| 116385904 | 11638590 | 9 | Product used for unknown indication |
| 116385904 | 11638590 | 10 | Product used for unknown indication |
| 116385904 | 11638590 | 11 | Product used for unknown indication |
| 116385904 | 11638590 | 12 | Product used for unknown indication |
| 116385904 | 11638590 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116385904 | 11638590 | OT |
| 116385904 | 11638590 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116385904 | 11638590 | Brain oedema | |
| 116385904 | 11638590 | Concussion | |
| 116385904 | 11638590 | Dizziness | |
| 116385904 | 11638590 | Haemorrhage | |
| 116385904 | 11638590 | Headache | |
| 116385904 | 11638590 | Memory impairment | |
| 116385904 | 11638590 | Road traffic accident | |
| 116385904 | 11638590 | Sensory loss | |
| 116385904 | 11638590 | Thrombosis |
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 |
|---|---|---|---|---|---|---|
| 116385904 | 11638590 | 1 | 200608 | 200611 | 0 | |
| 116385904 | 11638590 | 2 | 200611 | 2008 | 0 | |
| 116385904 | 11638590 | 3 | 201412 | 201412 | 0 | |
| 116385904 | 11638590 | 4 | 201412 | 2015 | 0 | |
| 116385904 | 11638590 | 5 | 2015 | 20150726 | 0 | |
| 116385904 | 11638590 | 6 | 201510 | 201510 | 0 | |
| 116385904 | 11638590 | 8 | 20100101 | 0 | ||
| 116385904 | 11638590 | 9 | 20150126 | 0 | ||
| 116385904 | 11638590 | 10 | 20150126 | 0 | ||
| 116385904 | 11638590 | 11 | 20100101 | 0 | ||
| 116385904 | 11638590 | 12 | 20090101 | 0 | ||
| 116385904 | 11638590 | 13 | 20060101 | 0 |