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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126094001 | 12609400 | 1 | I | 201402 | 20160721 | 20160801 | 20160801 | EXP | JP-ORCHID HEALTHCARE-1055728 | ORCHID | KATAOKA H, KAJIWARA H, YANO E. PSYCHOTROPIC DRUG-ASSOCIATED ELECTROCARDIOGRAPHIC PRESENTATION OF DIFFUSE J-WAVES IN HYPOTHERMIA: CASE REPORT AND LITERATURE REVIEW. 2016 JUN; 31 (6):996-1002. | 63.00 | YR | F | Y | 0.00000 | 20160801 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126094001 | 12609400 | 1 | PS | OLANZAPINE. | OLANZAPINE | 1 | Unknown | Y | U | 202287 | 5 | MG | |||||||
| 126094001 | 12609400 | 2 | SS | VALPROATE SODIUM. | VALPROATE SODIUM | 1 | Unknown | Y | U | 0 | 400 | MG | |||||||
| 126094001 | 12609400 | 3 | SS | Flunitrazepam | FLUNITRAZEPAM | 1 | Unknown | Y | U | 0 | 2 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126094001 | 12609400 | 1 | Schizophrenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126094001 | 12609400 | OT |
| 126094001 | 12609400 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126094001 | 12609400 | Blood potassium decreased | |
| 126094001 | 12609400 | Electrocardiogram J wave abnormal | |
| 126094001 | 12609400 | Electrocardiogram QT prolonged | |
| 126094001 | 12609400 | Hepatic enzyme increased | |
| 126094001 | 12609400 | Hypothermia | |
| 126094001 | 12609400 | Neuroleptic malignant syndrome | |
| 126094001 | 12609400 | 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 |
|---|---|---|---|---|---|---|
| 126094001 | 12609400 | 1 | 201305 | 201402 | 0 | |
| 126094001 | 12609400 | 2 | 201305 | 201402 | 0 | |
| 126094001 | 12609400 | 3 | 201305 | 201402 | 0 |