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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127938021 | 12793802 | 1 | I | 2016 | 20160623 | 20160929 | 20160929 | PER | US-JAZZ-2016-US-011866 | JAZZ | 0.00 | F | Y | 0.00000 | 20160929 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127938021 | 12793802 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
127938021 | 12793802 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
127938021 | 12793802 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
127938021 | 12793802 | 4 | SS | SINGULAIR | MONTELUKAST SODIUM | 1 | 0 | ||||||||||||
127938021 | 12793802 | 5 | C | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
127938021 | 12793802 | 6 | C | HIBICLENS | CHLORHEXIDINE GLUCONATE | 1 | U | 0 | |||||||||||
127938021 | 12793802 | 7 | C | Prenatal | VITAMINS | 1 | U | 0 | |||||||||||
127938021 | 12793802 | 8 | C | PROVENTIL HFA | ALBUTEROL SULFATE | 1 | U | 0 | |||||||||||
127938021 | 12793802 | 9 | C | PROVIGIL | MODAFINIL | 1 | U | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
127938021 | 12793802 | 1 | Narcolepsy |
127938021 | 12793802 | 4 | Hypersensitivity |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
127938021 | 12793802 | Drug ineffective | |
127938021 | 12793802 | Hypersensitivity |
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 |
---|---|---|---|---|---|---|
127938021 | 12793802 | 1 | 201602 | 201602 | 0 | |
127938021 | 12793802 | 2 | 201602 | 201603 | 0 | |
127938021 | 12793802 | 3 | 201603 | 0 |