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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123648833 | 12364883 | 3 | F | 20160406 | 20160922 | 20160512 | 20160930 | EXP | US-JAZZ-2016-US-008448 | JAZZ | 47.00 | YR | F | Y | 0.00000 | 20160930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123648833 | 12364883 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | U | 21196 | ORAL SOLUTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123648833 | 12364883 | 1 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123648833 | 12364883 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123648833 | 12364883 | Abnormal behaviour | |
| 123648833 | 12364883 | Adverse drug reaction | |
| 123648833 | 12364883 | Agitation | |
| 123648833 | 12364883 | Confusional state | |
| 123648833 | 12364883 | Delusion | |
| 123648833 | 12364883 | Hallucination | |
| 123648833 | 12364883 | Hypertension | |
| 123648833 | 12364883 | Insomnia | |
| 123648833 | 12364883 | Irritability | |
| 123648833 | 12364883 | Tachycardia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |