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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125784801 | 12578480 | 1 | I | 2014 | 20160711 | 20160721 | 20160721 | EXP | JP-PAR PHARMACEUTICAL COMPANIES-2016SCPR015645 | PAR | KATAOKA H., KAJIWARA H., YANO E.. PSYCHOTROPIC DRUG-ASSOCIATED ELECTROCARDIOGRAPHIC PRESENTATION OF DIFFUSE J-WAVES IN HYPOTHERMIA: CASE REPORT AND LITERATURE REVIEW. HEART AND VESSELS. 2016;31(6):996-1002 | 0.00 | Y | 0.00000 | 20160721 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125784801 | 12578480 | 1 | PS | OLANZAPINE. | OLANZAPINE | 1 | Unknown | 5 MG, DAILY | Y | 78109 | 5 | MG | |||||||
125784801 | 12578480 | 2 | SS | SODIUM VALPROATE | VALPROATE SODIUM | 1 | Unknown | 400 MG, DAILY | Y | 0 | 400 | MG | |||||||
125784801 | 12578480 | 3 | SS | FLUNITRAZEPAM | FLUNITRAZEPAM | 1 | Unknown | 2 MG, DAILY | Y | 0 | 2 | MG |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125784801 | 12578480 | 1 | Schizophrenia |
125784801 | 12578480 | 2 | Schizophrenia |
125784801 | 12578480 | 3 | Schizophrenia |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125784801 | 12578480 | OT |
125784801 | 12578480 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125784801 | 12578480 | Hypothermia | |
125784801 | 12578480 | Neuroleptic malignant syndrome | |
125784801 | 12578480 | Pneumonia aspiration | |
125784801 | 12578480 | Rhabdomyolysis |
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 |
---|---|---|---|---|---|---|
125784801 | 12578480 | 1 | 201305 | 201402 | 0 | |
125784801 | 12578480 | 2 | 201305 | 201402 | 0 | |
125784801 | 12578480 | 3 | 201305 | 201402 | 0 |