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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125693511 | 12569351 | 1 | I | 201101 | 20150702 | 20160719 | 20160719 | EXP | US-JNJFOC-20150713878 | JANSSEN | 15.49 | YR | T | M | Y | 0.00000 | 20160719 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125693511 | 12569351 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | TABLETS | ||||||||
| 125693511 | 12569351 | 2 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | TABLETS | ||||||||
| 125693511 | 12569351 | 3 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 2 | MG | TABLETS | ||||||
| 125693511 | 12569351 | 4 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | TABLETS | ||||||||
| 125693511 | 12569351 | 5 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | TABLETS | ||||||||
| 125693511 | 12569351 | 6 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | TABLETS | ||||||||
| 125693511 | 12569351 | 7 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | TABLETS | ||||||||
| 125693511 | 12569351 | 8 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 2 | MG | TABLETS | ||||||
| 125693511 | 12569351 | 9 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | TABLETS | ||||||||
| 125693511 | 12569351 | 10 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 2 | MG | TABLETS | ||||||
| 125693511 | 12569351 | 11 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | TABLETS | ||||||||
| 125693511 | 12569351 | 12 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 20272 | TABLETS | ||||||||
| 125693511 | 12569351 | 13 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | U | 20272 | TABLETS | ||||||||
| 125693511 | 12569351 | 14 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | 0 | UNSPECIFIED | |||||||||
| 125693511 | 12569351 | 15 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | 0 | UNSPECIFIED | |||||||||
| 125693511 | 12569351 | 16 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125693511 | 12569351 | 1 | Psychotic disorder |
| 125693511 | 12569351 | 2 | Psychotic disorder |
| 125693511 | 12569351 | 3 | Psychotic disorder |
| 125693511 | 12569351 | 4 | Psychotic disorder |
| 125693511 | 12569351 | 5 | Aggression |
| 125693511 | 12569351 | 6 | Aggression |
| 125693511 | 12569351 | 7 | Aggression |
| 125693511 | 12569351 | 8 | Aggression |
| 125693511 | 12569351 | 9 | Bipolar disorder |
| 125693511 | 12569351 | 10 | Bipolar disorder |
| 125693511 | 12569351 | 11 | Bipolar disorder |
| 125693511 | 12569351 | 12 | Bipolar disorder |
| 125693511 | 12569351 | 13 | Product used for unknown indication |
| 125693511 | 12569351 | 14 | Product used for unknown indication |
| 125693511 | 12569351 | 15 | Product used for unknown indication |
| 125693511 | 12569351 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125693511 | 12569351 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125693511 | 12569351 | Abnormal weight gain | |
| 125693511 | 12569351 | Galactorrhoea | |
| 125693511 | 12569351 | Gynaecomastia | |
| 125693511 | 12569351 | Hyperprolactinaemia | |
| 125693511 | 12569351 | Suicidal ideation |
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 |
|---|---|---|---|---|---|---|
| 125693511 | 12569351 | 1 | 2013 | 0 | ||
| 125693511 | 12569351 | 2 | 2012 | 0 | ||
| 125693511 | 12569351 | 3 | 2011 | 0 | ||
| 125693511 | 12569351 | 4 | 2014 | 0 | ||
| 125693511 | 12569351 | 5 | 2014 | 0 | ||
| 125693511 | 12569351 | 6 | 2013 | 0 | ||
| 125693511 | 12569351 | 7 | 2012 | 0 | ||
| 125693511 | 12569351 | 8 | 2011 | 0 | ||
| 125693511 | 12569351 | 9 | 2014 | 0 | ||
| 125693511 | 12569351 | 10 | 2011 | 0 | ||
| 125693511 | 12569351 | 11 | 2013 | 0 | ||
| 125693511 | 12569351 | 12 | 2012 | 0 | ||
| 125693511 | 12569351 | 14 | 20131021 | 20131121 | 0 | |
| 125693511 | 12569351 | 15 | 20120523 | 20120910 | 0 | |
| 125693511 | 12569351 | 16 | 20100316 | 20100416 | 0 |