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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127445011 | 12744501 | 1 | I | 20160518 | 20160914 | 20160914 | PER | US-JAZZ-2016-US-009475 | JAZZ | 0.00 | F | Y | 0.00000 | 20160914 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127445011 | 12744501 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 127445011 | 12744501 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 127445011 | 12744501 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127445011 | 12744501 | 4 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | UNK | Y | 0 | TABLET | |||||||||
| 127445011 | 12744501 | 5 | C | DULOXETINE HYDROCHLORIDE. | DULOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 127445011 | 12744501 | 6 | C | BUSPIRONE HCL | BUSPIRONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127445011 | 12744501 | 7 | C | Diphenoxylate/atropine | ATROPINEDIPHENOXYLATE | 1 | UNK | U | 0 | ||||||||||
| 127445011 | 12744501 | 8 | C | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 127445011 | 12744501 | 9 | C | CLONAZEPAM. | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 127445011 | 12744501 | 10 | C | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127445011 | 12744501 | 11 | C | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
| 127445011 | 12744501 | 12 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | U | 0 | TABLET | ||||||||||
| 127445011 | 12744501 | 13 | C | METOPROLOL SUCCINATE. | METOPROLOL SUCCINATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127445011 | 12744501 | 14 | C | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 127445011 | 12744501 | 15 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 127445011 | 12744501 | 16 | C | VICODIN ES | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127445011 | 12744501 | 1 | Narcolepsy |
| 127445011 | 12744501 | 2 | Cataplexy |
| 127445011 | 12744501 | 4 | Product used for unknown indication |
| 127445011 | 12744501 | 5 | Product used for unknown indication |
| 127445011 | 12744501 | 6 | Product used for unknown indication |
| 127445011 | 12744501 | 7 | Product used for unknown indication |
| 127445011 | 12744501 | 8 | Product used for unknown indication |
| 127445011 | 12744501 | 9 | Product used for unknown indication |
| 127445011 | 12744501 | 10 | Product used for unknown indication |
| 127445011 | 12744501 | 11 | Product used for unknown indication |
| 127445011 | 12744501 | 12 | Product used for unknown indication |
| 127445011 | 12744501 | 13 | Product used for unknown indication |
| 127445011 | 12744501 | 14 | Product used for unknown indication |
| 127445011 | 12744501 | 15 | Product used for unknown indication |
| 127445011 | 12744501 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127445011 | 12744501 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127445011 | 12744501 | Anxiety | |
| 127445011 | 12744501 | Herpes zoster | |
| 127445011 | 12744501 | Hypertension | |
| 127445011 | 12744501 | Sleep apnoea syndrome | |
| 127445011 | 12744501 | 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 |
|---|---|---|---|---|---|---|
| 127445011 | 12744501 | 1 | 201101 | 201103 | 0 | |
| 127445011 | 12744501 | 2 | 201103 | 201411 | 0 | |
| 127445011 | 12744501 | 3 | 201411 | 0 | ||
| 127445011 | 12744501 | 4 | 20140905 | 201409 | 0 | |
| 127445011 | 12744501 | 5 | 201604 | 0 | ||
| 127445011 | 12744501 | 6 | 20150201 | 0 | ||
| 127445011 | 12744501 | 7 | 20140805 | 20140815 | 0 | |
| 127445011 | 12744501 | 8 | 20140619 | 0 | ||
| 127445011 | 12744501 | 9 | 20120719 | 0 | ||
| 127445011 | 12744501 | 10 | 20120719 | 0 | ||
| 127445011 | 12744501 | 14 | 201404 | 0 | ||
| 127445011 | 12744501 | 15 | 201505 | 0 | ||
| 127445011 | 12744501 | 16 | 201207 | 0 |