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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127444011 | 12744401 | 1 | I | 20160516 | 20160914 | 20160914 | PER | US-JAZZ-2016-US-009227 | JAZZ | 0.00 | M | Y | 0.00000 | 20160914 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127444011 | 12744401 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 127444011 | 12744401 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | Y | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 127444011 | 12744401 | 3 | SS | NUVIGIL | ARMODAFINIL | 1 | Y | 0 | |||||||||||
| 127444011 | 12744401 | 4 | C | CIALIS | TADALAFIL | 1 | U | 0 | |||||||||||
| 127444011 | 12744401 | 5 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | U | 0 | |||||||||||
| 127444011 | 12744401 | 6 | C | BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127444011 | 12744401 | 7 | C | CELEBREX | CELECOXIB | 1 | U | 0 | |||||||||||
| 127444011 | 12744401 | 8 | C | COLACE | DOCUSATE SODIUM | 1 | U | 0 | |||||||||||
| 127444011 | 12744401 | 9 | C | COMBIVENT | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | U | 0 | |||||||||||
| 127444011 | 12744401 | 10 | C | MODAFINIL. | MODAFINIL | 1 | 100 MG, UNK | U | 0 | 100 | MG | ||||||||
| 127444011 | 12744401 | 11 | C | MODAFINIL. | MODAFINIL | 1 | 200 MG, UNK | U | 0 | 200 | MG | ||||||||
| 127444011 | 12744401 | 12 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | U | 0 | |||||||||||
| 127444011 | 12744401 | 13 | C | SIMVASTATIN. | SIMVASTATIN | 1 | U | 0 | |||||||||||
| 127444011 | 12744401 | 14 | C | ASPIRIN. | ASPIRIN | 1 | U | 0 | |||||||||||
| 127444011 | 12744401 | 15 | C | LASIX | FUROSEMIDE | 1 | U | 0 | |||||||||||
| 127444011 | 12744401 | 16 | C | Multivitamins | VITAMINS | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127444011 | 12744401 | 1 | Narcolepsy |
| 127444011 | 12744401 | 2 | Cataplexy |
| 127444011 | 12744401 | 3 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127444011 | 12744401 | Feeling abnormal | |
| 127444011 | 12744401 | Headache |
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 |
|---|---|---|---|---|---|---|
| 127444011 | 12744401 | 1 | 201511 | 201512 | 0 | |
| 127444011 | 12744401 | 2 | 201512 | 0 |