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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116210503 | 11621050 | 3 | F | 2014 | 20160819 | 20151012 | 20160826 | EXP | US-JAZZ-2015-US-015733 | JAZZ | 0.00 | F | Y | 0.00000 | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116210503 | 11621050 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 116210503 | 11621050 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 116210503 | 11621050 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | U | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 116210503 | 11621050 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | U | 21196 | 3.75 | G | ORAL SOLUTION | ||||||
| 116210503 | 11621050 | 5 | C | ASPIRIN. | ASPIRIN | 1 | UNK | U | 0 | CHEWABLE TABLET | |||||||||
| 116210503 | 11621050 | 6 | C | CARVEDILOL. | CARVEDILOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 116210503 | 11621050 | 7 | C | DIAZEPAM. | DIAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 116210503 | 11621050 | 8 | C | LISINOPRIL. | LISINOPRIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 116210503 | 11621050 | 9 | C | Oxycodone | OXYCODONE | 1 | UNK | U | 0 | TABLET | |||||||||
| 116210503 | 11621050 | 10 | C | TEMAZEPAM. | TEMAZEPAM | 1 | 15 MG, UNK | U | 0 | 15 | MG | CAPSULE | |||||||
| 116210503 | 11621050 | 11 | C | TEMAZEPAM. | TEMAZEPAM | 1 | 30 MG, UNK | U | 0 | 30 | MG | CAPSULE | |||||||
| 116210503 | 11621050 | 12 | C | HCTZ | HYDROCHLOROTHIAZIDE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116210503 | 11621050 | 1 | Sleep apnoea syndrome |
| 116210503 | 11621050 | 2 | Insomnia |
| 116210503 | 11621050 | 3 | Narcolepsy |
| 116210503 | 11621050 | 5 | Product used for unknown indication |
| 116210503 | 11621050 | 6 | Product used for unknown indication |
| 116210503 | 11621050 | 7 | Product used for unknown indication |
| 116210503 | 11621050 | 8 | Product used for unknown indication |
| 116210503 | 11621050 | 9 | Product used for unknown indication |
| 116210503 | 11621050 | 10 | Product used for unknown indication |
| 116210503 | 11621050 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116210503 | 11621050 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116210503 | 11621050 | Hypertension | |
| 116210503 | 11621050 | Mitral valve repair | |
| 116210503 | 11621050 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 116210503 | 11621050 | 1 | 200303 | 0 | ||
| 116210503 | 11621050 | 3 | 200608 | 0 | ||
| 116210503 | 11621050 | 4 | 201403 | 0 | ||
| 116210503 | 11621050 | 5 | 20151001 | 0 | ||
| 116210503 | 11621050 | 6 | 20151001 | 0 | ||
| 116210503 | 11621050 | 7 | 20151001 | 0 | ||
| 116210503 | 11621050 | 8 | 20151001 | 0 | ||
| 116210503 | 11621050 | 9 | 20151001 | 0 | ||
| 116210503 | 11621050 | 10 | 20140321 | 20140321 | 0 | |
| 116210503 | 11621050 | 11 | 20151001 | 20151005 | 0 | |
| 116210503 | 11621050 | 12 | 20010101 | 20151005 | 0 |