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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126098341 | 12609834 | 1 | I | 201402 | 20160727 | 20160801 | 20160801 | EXP | JP-FRESENIUS KABI-FK201604860 | FRESENIUS KABI | 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;NO. 6:996-1002. | 63.00 | YR | F | Y | 0.00000 | 20160801 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126098341 | 12609834 | 1 | PS | VALPROATE | VALPROIC ACID | 1 | Unknown | U | UNKNOWN | 76539 | 400 | MG | UNKNOWN | QD | |||||
| 126098341 | 12609834 | 2 | SS | OLANZAPINE. | OLANZAPINE | 1 | Unknown | 0 | 5 | MG | QD | ||||||||
| 126098341 | 12609834 | 3 | SS | FLUNITRAZEPAM | FLUNITRAZEPAM | 1 | Unknown | 0 | 2 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126098341 | 12609834 | 1 | Schizophrenia |
| 126098341 | 12609834 | 2 | Schizophrenia |
| 126098341 | 12609834 | 3 | Schizophrenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126098341 | 12609834 | HO |
| 126098341 | 12609834 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126098341 | 12609834 | Electrocardiogram J wave abnormal | |
| 126098341 | 12609834 | Electrocardiogram QT prolonged | |
| 126098341 | 12609834 | Hypothermia | |
| 126098341 | 12609834 | Neuroleptic malignant syndrome | |
| 126098341 | 12609834 | Product use issue | |
| 126098341 | 12609834 | Sinus bradycardia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |