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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125231351 | 12523135 | 1 | I | 20160621 | 20160701 | 20160701 | EXP | DE-JAZZ-2016-DE-012369 | JAZZ | T. DROGIES, A WILLENBERG, A. RAMSHORN-ZIMMER, L. WEIDHASE, S. PETROS, C. HADRICH, ET. AL. DETECTION OF GAMMA HYDROXYBUTYRATE IN EMERGENCY DEPARTMENT: NICE TO HAVE OR A VALUABLE DIAGNOSTIC TOOL?. HUMAN AND EXPERIMENTAL TOXICOLOGY. 2016;35 (7):785-792 | 28.00 | YR | M | Y | 0.00000 | 20160701 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125231351 | 12523135 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | 21196 | ORAL SOLUTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125231351 | 12523135 | 1 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125231351 | 12523135 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125231351 | 12523135 | Aggression | |
| 125231351 | 12523135 | Coma | |
| 125231351 | 12523135 | Intentional self-injury | |
| 125231351 | 12523135 | Loss of consciousness | |
| 125231351 | 12523135 | Somnolence |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |