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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110634974 | 11063497 | 4 | F | 2015 | 20160704 | 20150424 | 20160712 | EXP | CA-JAZZ-2015-CA-004275 | JAZZ | 0.00 | M | Y | 0.00000 | 20160712 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110634974 | 11063497 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 110634974 | 11063497 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, BID | 21196 | 3 | G | ORAL SOLUTION | |||||||
| 110634974 | 11063497 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 110634974 | 11063497 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 110634974 | 11063497 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 110634974 | 11063497 | 6 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.5 G, BID | 21196 | 3.5 | G | ORAL SOLUTION | |||||||
| 110634974 | 11063497 | 7 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | 21196 | 3.75 | G | ORAL SOLUTION | |||||||
| 110634974 | 11063497 | 8 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
| 110634974 | 11063497 | 9 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 37.5 MG, QD | 0 | 37.5 | MG | TABLET | |||||||
| 110634974 | 11063497 | 10 | C | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 72 MG, QD | 0 | 72 | MG | TABLET | |||||||
| 110634974 | 11063497 | 11 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | 1 DF, IN THE MORNING | 0 | 1 | DF | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 110634974 | 11063497 | 1 | Cataplexy |
| 110634974 | 11063497 | 9 | Product used for unknown indication |
| 110634974 | 11063497 | 10 | Product used for unknown indication |
| 110634974 | 11063497 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 110634974 | 11063497 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 110634974 | 11063497 | Drug ineffective | |
| 110634974 | 11063497 | Epididymitis | |
| 110634974 | 11063497 | Insomnia | |
| 110634974 | 11063497 | Medication error |
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 |
|---|---|---|---|---|---|---|
| 110634974 | 11063497 | 1 | 20150210 | 0 | ||
| 110634974 | 11063497 | 2 | 201502 | 0 | ||
| 110634974 | 11063497 | 3 | 20150325 | 0 | ||
| 110634974 | 11063497 | 4 | 20150331 | 0 | ||
| 110634974 | 11063497 | 5 | 20150210 | 0 | ||
| 110634974 | 11063497 | 7 | 20150630 | 0 | ||
| 110634974 | 11063497 | 8 | 20160701 | 0 |