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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114763682 | 11476368 | 2 | F | 2015 | 20160909 | 20150909 | 20160920 | PER | US-JAZZ-2015-US-007388 | JAZZ | 0.00 | F | Y | 0.00000 | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114763682 | 11476368 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | D | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 114763682 | 11476368 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, FIRST DOSE | D | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 114763682 | 11476368 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, SECOND DOSE | D | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 114763682 | 11476368 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2 G, THIRD DOSE | D | 21196 | 2 | G | ORAL SOLUTION | ||||||
| 114763682 | 11476368 | 5 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | UNK | U | 0 | INHALER | |||||||||
| 114763682 | 11476368 | 6 | C | TOPROL XL | METOPROLOL SUCCINATE | 1 | UNK | U | 0 | TABLET | |||||||||
| 114763682 | 11476368 | 7 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 114763682 | 11476368 | 8 | C | Doxepin | DOXEPIN | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 114763682 | 11476368 | 9 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114763682 | 11476368 | 1 | Narcolepsy |
| 114763682 | 11476368 | 2 | Cataplexy |
| 114763682 | 11476368 | 5 | Product used for unknown indication |
| 114763682 | 11476368 | 6 | Product used for unknown indication |
| 114763682 | 11476368 | 7 | Product used for unknown indication |
| 114763682 | 11476368 | 8 | Product used for unknown indication |
| 114763682 | 11476368 | 9 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114763682 | 11476368 | Exposure during pregnancy | |
| 114763682 | 11476368 | Feeling abnormal |
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 |
|---|---|---|---|---|---|---|
| 114763682 | 11476368 | 1 | 201412 | 201503 | 0 | |
| 114763682 | 11476368 | 2 | 201503 | 20150514 | 0 | |
| 114763682 | 11476368 | 3 | 201503 | 20150514 | 0 | |
| 114763682 | 11476368 | 4 | 201503 | 20150514 | 0 | |
| 114763682 | 11476368 | 5 | 20141224 | 0 | ||
| 114763682 | 11476368 | 6 | 20141212 | 0 | ||
| 114763682 | 11476368 | 7 | 20141224 | 0 | ||
| 114763682 | 11476368 | 8 | 20010101 | 0 | ||
| 114763682 | 11476368 | 9 | 20010101 | 0 |