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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
124720754 | 12472075 | 4 | F | 2009 | 20160805 | 20160616 | 20160810 | EXP | US-JNJFOC-20160612138 | JANSSEN | 0.00 | A | M | Y | 97.07000 | KG | 20160810 | MD | US | US |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
124720754 | 12472075 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | U | 85045;FBDJCRC;UNKNOWN | 0 | 5 | MG | TABLETS | BID | ||||
124720754 | 12472075 | 2 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | U | 85045;FBDJCRC;UNKNOWN | 0 | TABLETS | |||||||
124720754 | 12472075 | 3 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | STRENGTH OF EACH TABLET: 3 MG | Y | U | 85045;FBDJCRC;UNKNOWN | 20272 | 3 | MG | TABLETS | BID |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
124720754 | 12472075 | 1 | Psychotic disorder |
124720754 | 12472075 | 2 | Psychotic disorder |
124720754 | 12472075 | 3 | Psychotic disorder |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
124720754 | 12472075 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
124720754 | 12472075 | Abnormal loss of weight | |
124720754 | 12472075 | Adverse event | |
124720754 | 12472075 | Breast discharge | |
124720754 | 12472075 | Coma | |
124720754 | 12472075 | Drug ineffective for unapproved indication | |
124720754 | 12472075 | Feeling abnormal | |
124720754 | 12472075 | Hallucination, auditory | |
124720754 | 12472075 | Hypertension | |
124720754 | 12472075 | Incorrect dose administered | |
124720754 | 12472075 | Off label use | |
124720754 | 12472075 | Paranoia | |
124720754 | 12472075 | Renal failure | |
124720754 | 12472075 | Sluggishness | |
124720754 | 12472075 | Treatment noncompliance | |
124720754 | 12472075 | Unevaluable event |
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 |
---|---|---|---|---|---|---|
124720754 | 12472075 | 1 | 2005 | 2009 | 0 | |
124720754 | 12472075 | 2 | 2014 | 0 | ||
124720754 | 12472075 | 3 | 2009 | 2013 | 0 |