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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117353993 | 11735399 | 3 | F | 2006 | 20160610 | 20151113 | 20160830 | PER | US-JNJFOC-20151008359 | JANSSEN | 13.56 | YR | C | M | Y | 0.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117353993 | 11735399 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | IN VARYING DOSES OF 1 MG + 1.5 MG | U | U | 0 | UNSPECIFIED | |||||||
| 117353993 | 11735399 | 2 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | UNSPECIFIED | ||||||
| 117353993 | 11735399 | 3 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 20272 | UNSPECIFIED | ||||||||
| 117353993 | 11735399 | 4 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | U | 20272 | 1 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117353993 | 11735399 | 1 | Agitation |
| 117353993 | 11735399 | 2 | Agitation |
| 117353993 | 11735399 | 3 | Agitation |
| 117353993 | 11735399 | 4 | Agitation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117353993 | 11735399 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117353993 | 11735399 | Abnormal weight gain | |
| 117353993 | 11735399 | Gynaecomastia | |
| 117353993 | 11735399 | Off label use | |
| 117353993 | 11735399 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 117353993 | 11735399 | 1 | 20060615 | 20060904 | 0 | |
| 117353993 | 11735399 | 2 | 20060217 | 200606 | 0 | |
| 117353993 | 11735399 | 3 | 200609 | 20061007 | 0 | |
| 117353993 | 11735399 | 4 | 20061007 | 20110907 | 0 |