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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
124497252 | 12449725 | 2 | F | 2015 | 20160720 | 20160609 | 20160830 | PER | US-JNJFOC-20160601434 | JANSSEN | 0.00 | A | M | Y | 64.86000 | KG | 20160830 | CN | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
124497252 | 12449725 | 1 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | AT A ^SMALLER DOSE^; FREQUENCY-4 OR 5 TIMES | N | UNKNOWN | 0 | TABLETS | |||||||
124497252 | 12449725 | 2 | PS | RISPERIDONE. | RISPERIDONE | 1 | Oral | DOSE INCREASED TO 2 OR 3 TIMES, FREQUENCY-4 OR 5 TIMES | N | UNKNOWN | 20272 | TABLETS | |||||||
124497252 | 12449725 | 3 | C | LITHIUM. | LITHIUM | 1 | Unknown | 0 | 100 | MG | UNSPECIFIED |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
124497252 | 12449725 | 1 | Bipolar disorder |
124497252 | 12449725 | 2 | Bipolar disorder |
124497252 | 12449725 | 3 | Bipolar disorder |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
124497252 | 12449725 | Breast enlargement | |
124497252 | 12449725 | Drug ineffective | |
124497252 | 12449725 | Inappropriate schedule of drug administration | |
124497252 | 12449725 | Off label use | |
124497252 | 12449725 | Weight increased |
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 |
---|---|---|---|---|---|---|
124497252 | 12449725 | 1 | 2015 | 2015 | 0 | |
124497252 | 12449725 | 2 | 2015 | 0 |