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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125620281 | 12562028 | 1 | I | 20160513 | 20160713 | 20160715 | 20160715 | EXP | CO-JNJFOC-20160712182 | JANSSEN | 20.95 | YR | A | F | Y | 70.00000 | KG | 20160715 | OT | CO | CO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125620281 | 12562028 | 1 | PS | RISPERDAL CONSTA | RISPERIDONE | 1 | Intramuscular | N | 21346 | 25 | MG | MICROSPHERES | |||||||
| 125620281 | 12562028 | 2 | C | VALPROIC ACID. | VALPROIC ACID | 1 | Oral | 0 | 500 | MG | UNSPECIFIED | Q12H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125620281 | 12562028 | 1 | Bipolar disorder |
| 125620281 | 12562028 | 2 | Bipolar disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125620281 | 12562028 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125620281 | 12562028 | Acne | |
| 125620281 | 12562028 | Constipation | |
| 125620281 | 12562028 | Diarrhoea | |
| 125620281 | 12562028 | Somnolence | |
| 125620281 | 12562028 | Thyroid mass | |
| 125620281 | 12562028 | Urinary incontinence | |
| 125620281 | 12562028 | 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 |
|---|---|---|---|---|---|---|
| 125620281 | 12562028 | 1 | 20150717 | 0 | ||
| 125620281 | 12562028 | 2 | 201007 | 0 |