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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126284861 | 12628486 | 1 | I | 20160302 | 20160808 | 20160808 | PER | US-JAZZ-2016-US-004218 | JAZZ | 0.00 | F | Y | 0.00000 | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126284861 | 12628486 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 126284861 | 12628486 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENT | 21196 | ORAL SOLUTION | |||||||||
| 126284861 | 12628486 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 126284861 | 12628486 | 4 | SS | Oxycodone | OXYCODONE | 1 | U | 0 | |||||||||||
| 126284861 | 12628486 | 5 | SS | Hydrocodone | HYDROCODONE | 1 | U | 0 | |||||||||||
| 126284861 | 12628486 | 6 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | U | 0 | |||||||||||
| 126284861 | 12628486 | 7 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | U | 0 | |||||||||||
| 126284861 | 12628486 | 8 | C | CALTRATE WITH VITAMIN D | CALCIUM CARBONATECHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 126284861 | 12628486 | 9 | C | COENZYME Q10 | UBIDECARENONE | 1 | U | 0 | |||||||||||
| 126284861 | 12628486 | 10 | C | DEXEDRINE | DEXTROAMPHETAMINE SULFATE | 1 | U | 0 | |||||||||||
| 126284861 | 12628486 | 11 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 126284861 | 12628486 | 12 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | U | 0 | |||||||||||
| 126284861 | 12628486 | 13 | C | METHIMAZOLE. | METHIMAZOLE | 1 | U | 0 | |||||||||||
| 126284861 | 12628486 | 14 | C | NEURONTIN | GABAPENTIN | 1 | U | 0 | |||||||||||
| 126284861 | 12628486 | 15 | C | NICORETTE | NICOTINE | 1 | U | 0 | |||||||||||
| 126284861 | 12628486 | 16 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | U | 0 | |||||||||||
| 126284861 | 12628486 | 17 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126284861 | 12628486 | 1 | Narcolepsy |
| 126284861 | 12628486 | 2 | Cataplexy |
| 126284861 | 12628486 | 4 | Pain |
| 126284861 | 12628486 | 5 | Pain |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126284861 | 12628486 | Nausea | |
| 126284861 | 12628486 | Pain |
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 |
|---|---|---|---|---|---|---|
| 126284861 | 12628486 | 1 | 200901 | 200902 | 0 | |
| 126284861 | 12628486 | 3 | 201102 | 0 |