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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124885144 | 12488514 | 4 | F | 2016 | 20160712 | 20160622 | 20160720 | EXP | US-JAZZ-2016-US-011220 | JAZZ | 0.00 | F | Y | 0.00000 | 20160720 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124885144 | 12488514 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | N | 21196 | 2.25 | G | ORAL SOLUTION | ||||||
| 124885144 | 12488514 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | N | 21196 | ORAL SOLUTION | ||||||||
| 124885144 | 12488514 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4 G, BID | N | 21196 | 4 | G | ORAL SOLUTION | ||||||
| 124885144 | 12488514 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.25 G, BID | N | 21196 | 3.25 | G | ORAL SOLUTION | ||||||
| 124885144 | 12488514 | 5 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | 75 MG | U | 0 | CAPSULE | |||||||||
| 124885144 | 12488514 | 6 | C | VENLAFAXINE HCL | VENLAFAXINE HYDROCHLORIDE | 1 | 37.5 MG | U | 0 | CAPSULE | |||||||||
| 124885144 | 12488514 | 7 | C | ACETAZOLAMIDE. | ACETAZOLAMIDE | 1 | U | 0 | TABLET | ||||||||||
| 124885144 | 12488514 | 8 | C | MODAFINIL. | MODAFINIL | 1 | U | 0 | TABLET | ||||||||||
| 124885144 | 12488514 | 9 | C | TRINESSA | ETHINYL ESTRADIOLNORGESTIMATE | 1 | U | 0 | TABLET | ||||||||||
| 124885144 | 12488514 | 10 | C | DIAMOX SEQUELS | ACETAZOLAMIDE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124885144 | 12488514 | 1 | Narcolepsy |
| 124885144 | 12488514 | 2 | Cataplexy |
| 124885144 | 12488514 | 5 | Depression |
| 124885144 | 12488514 | 7 | Product used for unknown indication |
| 124885144 | 12488514 | 8 | Product used for unknown indication |
| 124885144 | 12488514 | 9 | Product used for unknown indication |
| 124885144 | 12488514 | 10 | Intracranial pressure increased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124885144 | 12488514 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124885144 | 12488514 | Blood pressure increased | |
| 124885144 | 12488514 | Fatigue | |
| 124885144 | 12488514 | Snoring | |
| 124885144 | 12488514 | Visual impairment | |
| 124885144 | 12488514 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 124885144 | 12488514 | 1 | 201604 | 2016 | 0 | |
| 124885144 | 12488514 | 2 | 201604 | 201605 | 0 | |
| 124885144 | 12488514 | 3 | 201605 | 2016 | 0 | |
| 124885144 | 12488514 | 4 | 2016 | 0 | ||
| 124885144 | 12488514 | 6 | 201604 | 0 |