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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114792493 | 11479249 | 3 | F | 2015 | 20160923 | 20150909 | 20160929 | PER | US-JAZZ-2015-US-009538 | JAZZ | 0.00 | M | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114792493 | 11479249 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 114792493 | 11479249 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | 21196 | ORAL SOLUTION | ||||||||
| 114792493 | 11479249 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | Y | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 114792493 | 11479249 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | Y | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 114792493 | 11479249 | 5 | C | TOPIRAMATE. | TOPIRAMATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 114792493 | 11479249 | 6 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 114792493 | 11479249 | 7 | C | COMBIGAN | BRIMONIDINE TARTRATETIMOLOL MALEATE | 1 | UNK | U | 0 | EYE DROPS | |||||||||
| 114792493 | 11479249 | 8 | C | GLYBURIDE. | GLYBURIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 114792493 | 11479249 | 9 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 114792493 | 11479249 | 10 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 114792493 | 11479249 | 11 | C | LISINOPRIL. | LISINOPRIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 114792493 | 11479249 | 12 | C | METHYLIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 114792493 | 11479249 | 13 | C | SIMVASTATIN. | SIMVASTATIN | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114792493 | 11479249 | 1 | Hypersomnia |
| 114792493 | 11479249 | 5 | Product used for unknown indication |
| 114792493 | 11479249 | 6 | Product used for unknown indication |
| 114792493 | 11479249 | 7 | Product used for unknown indication |
| 114792493 | 11479249 | 8 | Product used for unknown indication |
| 114792493 | 11479249 | 9 | Product used for unknown indication |
| 114792493 | 11479249 | 10 | Product used for unknown indication |
| 114792493 | 11479249 | 11 | Product used for unknown indication |
| 114792493 | 11479249 | 12 | Product used for unknown indication |
| 114792493 | 11479249 | 13 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114792493 | 11479249 | Condition aggravated | |
| 114792493 | 11479249 | Drug ineffective | |
| 114792493 | 11479249 | Insomnia | |
| 114792493 | 11479249 | Nonspecific reaction | |
| 114792493 | 11479249 | Somnambulism |
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 |
|---|---|---|---|---|---|---|
| 114792493 | 11479249 | 1 | 201108 | 201108 | 0 | |
| 114792493 | 11479249 | 3 | 201211 | 0 | ||
| 114792493 | 11479249 | 4 | 201608 | 0 | ||
| 114792493 | 11479249 | 5 | 20131120 | 0 |