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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125371801 | 12537180 | 1 | I | 20151230 | 20160707 | 20160707 | PER | US-JAZZ-2015-US-022762 | JAZZ | 0.00 | F | Y | 0.00000 | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125371801 | 12537180 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125371801 | 12537180 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.5 G, BID | 21196 | 2.5 | G | ORAL SOLUTION | |||||||
| 125371801 | 12537180 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 125371801 | 12537180 | 4 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125371801 | 12537180 | 5 | C | Daily vitamins | 2 | UNK | U | 0 | TABLET | ||||||||||
| 125371801 | 12537180 | 6 | C | DOCUSATE SODIUM. | DOCUSATE SODIUM | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125371801 | 12537180 | 7 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125371801 | 12537180 | 8 | C | BUTRANS | BUPRENORPHINE | 1 | UNK | U | 0 | PATCH | |||||||||
| 125371801 | 12537180 | 9 | C | Amitriptyline hcl | AMITRIPTYLINE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125371801 | 12537180 | 10 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | UNK | U | 0 | ||||||||||
| 125371801 | 12537180 | 11 | C | OPANA | OXYMORPHONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125371801 | 12537180 | 12 | C | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | ||||||||||
| 125371801 | 12537180 | 13 | C | RESTORIL | TEMAZEPAM | 1 | UNK | U | 0 | ||||||||||
| 125371801 | 12537180 | 14 | C | TRIAZOLAM. | TRIAZOLAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125371801 | 12537180 | 15 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125371801 | 12537180 | 1 | Narcolepsy |
| 125371801 | 12537180 | 4 | Product used for unknown indication |
| 125371801 | 12537180 | 5 | Product used for unknown indication |
| 125371801 | 12537180 | 6 | Product used for unknown indication |
| 125371801 | 12537180 | 7 | Product used for unknown indication |
| 125371801 | 12537180 | 8 | Product used for unknown indication |
| 125371801 | 12537180 | 9 | Product used for unknown indication |
| 125371801 | 12537180 | 10 | Product used for unknown indication |
| 125371801 | 12537180 | 11 | Product used for unknown indication |
| 125371801 | 12537180 | 12 | Product used for unknown indication |
| 125371801 | 12537180 | 13 | Product used for unknown indication |
| 125371801 | 12537180 | 14 | Product used for unknown indication |
| 125371801 | 12537180 | 15 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125371801 | 12537180 | Malaise |
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 |
|---|---|---|---|---|---|---|
| 125371801 | 12537180 | 1 | 200705 | 200708 | 0 | |
| 125371801 | 12537180 | 2 | 200708 | 200708 | 0 | |
| 125371801 | 12537180 | 3 | 200708 | 0 | ||
| 125371801 | 12537180 | 4 | 20151005 | 0 | ||
| 125371801 | 12537180 | 5 | 20151005 | 0 | ||
| 125371801 | 12537180 | 6 | 20151005 | 0 | ||
| 125371801 | 12537180 | 7 | 20151005 | 0 | ||
| 125371801 | 12537180 | 8 | 20151002 | 0 | ||
| 125371801 | 12537180 | 9 | 20150101 | 0 | ||
| 125371801 | 12537180 | 10 | 20150101 | 0 | ||
| 125371801 | 12537180 | 11 | 20150101 | 20151005 | 0 | |
| 125371801 | 12537180 | 12 | 20150101 | 20151005 | 0 | |
| 125371801 | 12537180 | 13 | 20150101 | 20151005 | 0 | |
| 125371801 | 12537180 | 14 | 20130415 | 0 | ||
| 125371801 | 12537180 | 15 | 20130412 | 0 |