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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 99599513 | 9959951 | 3 | F | 201403 | 20140922 | 20140228 | 20141001 | EXP | 2014-US-001922 | JAZZ | 36.00 | YR | F | N | 0.00000 | 20140930 | N | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 99599513 | 9959951 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | ORAL | D | D | A00970 | 21196 | 2.25 | GM | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 99599513 | 9959951 | 1 | Cataplexy |
| 99599513 | 9959951 | 1 | Narcolepsy |
| 99599513 | 9959951 | 1 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 99599513 | 9959951 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 99599513 | 9959951 | Arthritis | |
| 99599513 | 9959951 | Condition aggravated | |
| 99599513 | 9959951 | Rheumatoid arthritis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 99599513 | 9959951 | CSM |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 99599513 | 9959951 | 1 | 200411 | 0 | ||
| 99599513 | 9959951 | 1 | 201310 | 0 | ||
| 99599513 | 9959951 | 1 | 201409 | 0 |