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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
112200432 | 11220043 | 2 | F | 201504 | 20160815 | 20150625 | 20160823 | EXP | US-JAZZ-2015-US-007579 | JAZZ | 46.92 | YR | F | Y | 0.00000 | 20160823 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
112200432 | 11220043 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
112200432 | 11220043 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 4.5 G, BID | 21196 | 4.5 | G | ORAL SOLUTION | |||||||
112200432 | 11220043 | 3 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | UNK | U | 0 | TABLET |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
112200432 | 11220043 | 1 | Narcolepsy |
112200432 | 11220043 | 2 | Cataplexy |
112200432 | 11220043 | 3 | Product used for unknown indication |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
112200432 | 11220043 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
112200432 | 11220043 | Allergy to chemicals | |
112200432 | 11220043 | Chest pain | |
112200432 | 11220043 | Dizziness | |
112200432 | 11220043 | Dyspnoea | |
112200432 | 11220043 | Feeling abnormal | |
112200432 | 11220043 | Nausea | |
112200432 | 11220043 | Palpitations | |
112200432 | 11220043 | Perfume sensitivity | |
112200432 | 11220043 | Peripheral swelling | |
112200432 | 11220043 | Throat tightness |
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 |
---|---|---|---|---|---|---|
112200432 | 11220043 | 1 | 201410 | 201504 | 0 | |
112200432 | 11220043 | 2 | 2015 | 0 | ||
112200432 | 11220043 | 3 | 20141028 | 0 |