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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113372013 | 11337201 | 3 | F | 20160916 | 20150804 | 20160923 | EXP | US-JAZZ-2015-US-011391 | JAZZ | 0.00 | M | Y | 0.00000 | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113372013 | 11337201 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 113372013 | 11337201 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
| 113372013 | 11337201 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 113372013 | 11337201 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | U | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 113372013 | 11337201 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | U | 21196 | ORAL SOLUTION | ||||||||
| 113372013 | 11337201 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 113372013 | 11337201 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | U | 21196 | 4.5 | G | ORAL SOLUTION | ||||||
| 113372013 | 11337201 | 8 | C | NUVIGIL | ARMODAFINIL | 1 | UNK | U | 0 | ||||||||||
| 113372013 | 11337201 | 9 | C | PREVACID | LANSOPRAZOLE | 1 | UNK | U | 0 | ||||||||||
| 113372013 | 11337201 | 10 | C | SYMBYAX | FLUOXETINE HYDROCHLORIDEOLANZAPINE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113372013 | 11337201 | 1 | Narcolepsy |
| 113372013 | 11337201 | 8 | Product used for unknown indication |
| 113372013 | 11337201 | 9 | Product used for unknown indication |
| 113372013 | 11337201 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113372013 | 11337201 | OT |
| 113372013 | 11337201 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113372013 | 11337201 | Anxiety | |
| 113372013 | 11337201 | Bipolar I disorder | |
| 113372013 | 11337201 | Depression |
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 |
|---|---|---|---|---|---|---|
| 113372013 | 11337201 | 1 | 201003 | 2010 | 0 | |
| 113372013 | 11337201 | 2 | 2010 | 2010 | 0 | |
| 113372013 | 11337201 | 3 | 2010 | 0 | ||
| 113372013 | 11337201 | 4 | 201405 | 2014 | 0 | |
| 113372013 | 11337201 | 5 | 2014 | 2014 | 0 | |
| 113372013 | 11337201 | 6 | 2014 | 20140930 | 0 | |
| 113372013 | 11337201 | 7 | 201508 | 0 |