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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
124782872 | 12478287 | 2 | F | 201606 | 20160610 | 20160617 | 20160816 | EXP | US-JAZZ-2016-US-010954 | JAZZ | 13.98 | YR | M | Y | 0.00000 | 20160816 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
124782872 | 12478287 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.5 G, FIRST DOSE | U | 21196 | 2.5 | G | ORAL SOLUTION | ||||||
124782872 | 12478287 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | APPROXIMATELY 1.275 G SECOND DOSE | U | 21196 | ORAL SOLUTION | ||||||||
124782872 | 12478287 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3 G, QD | U | 21196 | 3 | G | ORAL SOLUTION | ||||||
124782872 | 12478287 | 4 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.2 G, QD | U | 21196 | 3.2 | G | ORAL SOLUTION | ||||||
124782872 | 12478287 | 5 | SS | XYREM | SODIUM OXYBATE | 1 | 2.25 G, QD | U | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
124782872 | 12478287 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | 100 MG, TID | U | 0 | 100 | MG | CAPSULE | |||||||
124782872 | 12478287 | 7 | C | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 1 | U | 0 | TABLET | ||||||||||
124782872 | 12478287 | 8 | C | Mvi | VITAMINS | 1 | U | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
124782872 | 12478287 | 1 | Narcolepsy |
124782872 | 12478287 | 6 | Product used for unknown indication |
124782872 | 12478287 | 7 | Product used for unknown indication |
124782872 | 12478287 | 8 | Product used for unknown indication |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
124782872 | 12478287 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
124782872 | 12478287 | Abnormal behaviour | |
124782872 | 12478287 | Crying | |
124782872 | 12478287 | Delirium | |
124782872 | 12478287 | Dysarthria | |
124782872 | 12478287 | Fatigue | |
124782872 | 12478287 | Feeling abnormal | |
124782872 | 12478287 | Hangover | |
124782872 | 12478287 | Head banging | |
124782872 | 12478287 | Headache | |
124782872 | 12478287 | Hypoaesthesia | |
124782872 | 12478287 | Inappropriate affect | |
124782872 | 12478287 | Inappropriate schedule of drug administration | |
124782872 | 12478287 | Moaning | |
124782872 | 12478287 | Muscle twitching | |
124782872 | 12478287 | Somnolence | |
124782872 | 12478287 | 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 |
---|---|---|---|---|---|---|
124782872 | 12478287 | 1 | 20160607 | 20160607 | 0 | |
124782872 | 12478287 | 2 | 20160607 | 20160607 | 0 | |
124782872 | 12478287 | 3 | 20160608 | 20160608 | 0 | |
124782872 | 12478287 | 4 | 20160609 | 201606 | 0 | |
124782872 | 12478287 | 5 | 201606 | 0 |