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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126255112 | 12625511 | 2 | F | 201402 | 20160820 | 20160805 | 20160902 | EXP | JP-TEVA-681458ISR | TEVA | 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 | 47.90000 | KG | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126255112 | 12625511 | 1 | PS | ZYPREXA | OLANZAPINE | 1 | Oral | 5 MILLIGRAM DAILY; | Y | 76000 | 5 | MG | TABLET | QD | |||||
| 126255112 | 12625511 | 2 | SS | DEPAKENE | VALPROIC ACID | 1 | Oral | 400 MILLIGRAM DAILY; | Y | 0 | 400 | MG | QD | ||||||
| 126255112 | 12625511 | 3 | SS | POHYPNOL | FLUNITRAZEPAM | 1 | Oral | 2 MILLIGRAM DAILY; | Y | 0 | 2 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126255112 | 12625511 | 1 | Schizophrenia |
| 126255112 | 12625511 | 2 | Schizophrenia |
| 126255112 | 12625511 | 3 | Schizophrenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126255112 | 12625511 | HO |
| 126255112 | 12625511 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126255112 | 12625511 | Electrocardiogram J wave abnormal | |
| 126255112 | 12625511 | Electrocardiogram QT prolonged | |
| 126255112 | 12625511 | Hypothermia | |
| 126255112 | 12625511 | Neuroleptic malignant syndrome | |
| 126255112 | 12625511 | Pancreatitis acute | |
| 126255112 | 12625511 | Pneumonia aspiration | |
| 126255112 | 12625511 | Sinus bradycardia |
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 |
|---|---|---|---|---|---|---|
| 126255112 | 12625511 | 1 | 20130709 | 20140221 | 0 | |
| 126255112 | 12625511 | 2 | 20130611 | 20140222 | 0 | |
| 126255112 | 12625511 | 3 | 20130625 | 20140220 | 0 |