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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125214341 | 12521434 | 1 | I | 201606 | 20160628 | 20160701 | 20160701 | EXP | CH-JNJFOC-20160625004 | JANSSEN | 83.00 | YR | E | M | Y | 0.00000 | 20160701 | MD | CH | CH |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125214341 | 12521434 | 1 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | U | UNKNOWN | 20272 | 1 | MG | UNSPECIFIED | BID | ||||
125214341 | 12521434 | 2 | SS | HALDOL | HALOPERIDOL | 1 | Unknown | Y | U | 15923 | 1 | MG | UNSPECIFIED | TID | |||||
125214341 | 12521434 | 3 | SS | ORFIRIL | VALPROIC ACID | 1 | Oral | Y | 0 | 377.5 | MG | UNSPECIFIED | BID | ||||||
125214341 | 12521434 | 4 | SS | ORFIRIL | VALPROIC ACID | 1 | Oral | INCREASED 3 DAYS AFTER | Y | 0 | 755 | MG | UNSPECIFIED | BID |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125214341 | 12521434 | 1 | Product used for unknown indication |
125214341 | 12521434 | 2 | Product used for unknown indication |
125214341 | 12521434 | 3 | Product used for unknown indication |
125214341 | 12521434 | 4 | Product used for unknown indication |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125214341 | 12521434 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125214341 | 12521434 | Coma | |
125214341 | 12521434 | Disturbance in attention | |
125214341 | 12521434 | Extrapyramidal disorder | |
125214341 | 12521434 | Hypophagia | |
125214341 | 12521434 | Hypotension | |
125214341 | 12521434 | Mutism | |
125214341 | 12521434 | Restlessness | |
125214341 | 12521434 | Toxicity to various agents |
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 |
---|---|---|---|---|---|---|
125214341 | 12521434 | 1 | 20160606 | 20160610 | 0 | |
125214341 | 12521434 | 2 | 20160525 | 20160606 | 0 | |
125214341 | 12521434 | 3 | 20160525 | 20160528 | 0 | |
125214341 | 12521434 | 4 | 20160610 | 20160614 | 0 |