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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127224061 | 12722406 | 1 | I | 20140923 | 20140924 | 20160907 | 20160907 | EXP | US-BAUSCH-BL-2014-006482 | BAUSCH AND LOMB | 30.37 | YR | F | Y | 0.00000 | 20160907 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127224061 | 12722406 | 1 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | Y | 3082257,3118404 | 0 | 2.25 | G | ORAL SOLUTION | BID | |||||
| 127224061 | 12722406 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSAGE ADJUSTMENTS | Y | 3082257,3118404 | 0 | ORAL SOLUTION | |||||||
| 127224061 | 12722406 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | Y | 3082257,3118404 | 0 | 4.25 | G | ORAL SOLUTION | BID | |||||
| 127224061 | 12722406 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | Y | 3082257,3118404 | 0 | 4 | G | ORAL SOLUTION | BID | |||||
| 127224061 | 12722406 | 5 | PS | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | Unknown | U | 21515 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127224061 | 12722406 | 1 | Narcolepsy |
| 127224061 | 12722406 | 2 | Cataplexy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127224061 | 12722406 | HO |
| 127224061 | 12722406 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127224061 | 12722406 | Anxiety | |
| 127224061 | 12722406 | Depression | |
| 127224061 | 12722406 | Suicidal ideation | |
| 127224061 | 12722406 | Unevaluable event |
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 |
|---|---|---|---|---|---|---|
| 127224061 | 12722406 | 1 | 201101 | 2011 | 0 | |
| 127224061 | 12722406 | 3 | 201405 | 20140922 | 0 | |
| 127224061 | 12722406 | 4 | 2014 | 0 |