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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125891191 | 12589119 | 1 | I | 201402 | 20160714 | 20160725 | 20160725 | EXP | PHHY2016JP098689 | SANDOZ | KATAOKA H, KAJIWARA H, YANO E. PSYCHOTROPIC DRUG-ASSOCIATED ELECTROCARDIOGRAPHIC PRESENTATION OF DIFFUSE J-WAVES IN HYPOTHERMIA: CASE REPORT AND LITERATURE REVIEW.. HEART + VESSELS. 2016;31(6):996-1002 | 63.00 | YR | F | Y | 0.00000 | 20160725 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125891191 | 12589119 | 1 | PS | OLANZAPINE. | OLANZAPINE | 1 | Unknown | 5 MG, QD | Y | U | 201588 | 5 | MG | QD | |||||
| 125891191 | 12589119 | 2 | SS | SODIUM VALPROATE | VALPROATE SODIUM | 1 | Unknown | 400 MG, QD | Y | U | 0 | 400 | MG | QD | |||||
| 125891191 | 12589119 | 3 | SS | FLUNITRAZEPAM | FLUNITRAZEPAM | 1 | Unknown | 2 MG, QD | Y | U | 0 | 2 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125891191 | 12589119 | 1 | Schizophrenia |
| 125891191 | 12589119 | 2 | Schizophrenia |
| 125891191 | 12589119 | 3 | Schizophrenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125891191 | 12589119 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125891191 | 12589119 | Electrocardiogram J wave | |
| 125891191 | 12589119 | Electrocardiogram QT prolonged | |
| 125891191 | 12589119 | Hypothermia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |