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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126040661 | 12604066 | 1 | I | 20160208 | 20160728 | 20160728 | PER | US-JAZZ-2016-US-002355 | JAZZ | 0.00 | F | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126040661 | 12604066 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 126040661 | 12604066 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 126040661 | 12604066 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 5 G, FIRST DOSE | 21196 | 5 | G | ORAL SOLUTION | |||||||
| 126040661 | 12604066 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, SECOND DOSE | 21196 | 4 | G | ORAL SOLUTION | |||||||
| 126040661 | 12604066 | 5 | SS | NUVIGIL | ARMODAFINIL | 1 | UNK | Y | 0 | TABLET | |||||||||
| 126040661 | 12604066 | 6 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040661 | 12604066 | 7 | C | ADVIL | IBUPROFEN | 1 | U | 0 | |||||||||||
| 126040661 | 12604066 | 8 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 126040661 | 12604066 | 9 | C | BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040661 | 12604066 | 10 | C | CABERGOLINE. | CABERGOLINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040661 | 12604066 | 11 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040661 | 12604066 | 12 | C | TRAMADOL. | TRAMADOL | 1 | UNK | U | 0 | TABLET | |||||||||
| 126040661 | 12604066 | 13 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126040661 | 12604066 | 1 | Narcolepsy |
| 126040661 | 12604066 | 5 | Product used for unknown indication |
| 126040661 | 12604066 | 6 | Hypertension |
| 126040661 | 12604066 | 7 | Product used for unknown indication |
| 126040661 | 12604066 | 8 | Product used for unknown indication |
| 126040661 | 12604066 | 9 | Product used for unknown indication |
| 126040661 | 12604066 | 10 | Product used for unknown indication |
| 126040661 | 12604066 | 11 | Product used for unknown indication |
| 126040661 | 12604066 | 12 | Product used for unknown indication |
| 126040661 | 12604066 | 13 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126040661 | 12604066 | Drug hypersensitivity |
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 |
|---|---|---|---|---|---|---|
| 126040661 | 12604066 | 1 | 201102 | 201105 | 0 | |
| 126040661 | 12604066 | 3 | 201501 | 0 | ||
| 126040661 | 12604066 | 4 | 201501 | 0 | ||
| 126040661 | 12604066 | 5 | 20140101 | 0 | ||
| 126040661 | 12604066 | 8 | 20150729 | 0 | ||
| 126040661 | 12604066 | 9 | 20150429 | 20150701 | 0 | |
| 126040661 | 12604066 | 10 | 20140318 | 20150301 | 0 | |
| 126040661 | 12604066 | 11 | 20120723 | 20150701 | 0 | |
| 126040661 | 12604066 | 12 | 20150701 | 0 |