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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127790011 | 12779001 | 1 | I | 200905 | 20090608 | 20160926 | 20160926 | PER | US-JAZZ-JPI-P-007528 | JAZZ | 40.49 | YR | F | Y | 71.36000 | KG | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127790011 | 12779001 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.5 G, BID | 21196 | 2.5 | G | ORAL SOLUTION | |||||||
| 127790011 | 12779001 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 21196 | 2.75 | G | ORAL SOLUTION | ||||||||
| 127790011 | 12779001 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 21196 | 3 | G | ORAL SOLUTION | ||||||||
| 127790011 | 12779001 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 21196 | 4.5 | G | ORAL SOLUTION | ||||||||
| 127790011 | 12779001 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, FIRST DOSE | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 127790011 | 12779001 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.25 G, FIRST DOSE | 21196 | 4.25 | G | ORAL SOLUTION | |||||||
| 127790011 | 12779001 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 127790011 | 12779001 | 8 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | 0 | 12.5 | MG | ||||||||||
| 127790011 | 12779001 | 9 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | 0 | 25 | MG | ||||||||||
| 127790011 | 12779001 | 10 | SS | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | 0 | ||||||||||||
| 127790011 | 12779001 | 11 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 127790011 | 12779001 | 12 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127790011 | 12779001 | 1 | Narcolepsy |
| 127790011 | 12779001 | 8 | Bipolar disorder |
| 127790011 | 12779001 | 10 | Bipolar disorder |
| 127790011 | 12779001 | 11 | Blood glucose increased |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127790011 | 12779001 | Anxiety | |
| 127790011 | 12779001 | Condition aggravated | |
| 127790011 | 12779001 | Headache | |
| 127790011 | 12779001 | Nervousness |
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 |
|---|---|---|---|---|---|---|
| 127790011 | 12779001 | 1 | 20090529 | 20090531 | 0 | |
| 127790011 | 12779001 | 2 | 20090601 | 20090603 | 0 | |
| 127790011 | 12779001 | 3 | 20090604 | 0 | ||
| 127790011 | 12779001 | 4 | 2011 | 0 | ||
| 127790011 | 12779001 | 7 | 201103 | 0 | ||
| 127790011 | 12779001 | 8 | 200905 | 200906 | 0 | |
| 127790011 | 12779001 | 9 | 200906 | 0 | ||
| 127790011 | 12779001 | 10 | 200905 | 2009 | 0 |