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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117756284 | 11775628 | 4 | F | 2001 | 20160804 | 20151125 | 20160816 | EXP | US-JNJFOC-20151102246 | JANSSEN | 31.61 | YR | A | M | Y | 0.00000 | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117756284 | 11775628 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | U | 0 | UNSPECIFIED | ||||||||
| 117756284 | 11775628 | 2 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | U | 0 | 2 | MG | UNSPECIFIED | ||||||
| 117756284 | 11775628 | 3 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | U | 0 | UNSPECIFIED | ||||||||
| 117756284 | 11775628 | 4 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | Y | U | 20272 | UNSPECIFIED | ||||||||
| 117756284 | 11775628 | 5 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 21999 | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||||
| 117756284 | 11775628 | 6 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 117756284 | 11775628 | 7 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | U | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117756284 | 11775628 | 1 | Bipolar disorder |
| 117756284 | 11775628 | 2 | Bipolar disorder |
| 117756284 | 11775628 | 3 | Bipolar disorder |
| 117756284 | 11775628 | 4 | Bipolar disorder |
| 117756284 | 11775628 | 5 | Product used for unknown indication |
| 117756284 | 11775628 | 6 | Product used for unknown indication |
| 117756284 | 11775628 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117756284 | 11775628 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117756284 | 11775628 | Benign breast neoplasm | |
| 117756284 | 11775628 | Gynaecomastia | |
| 117756284 | 11775628 | 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 |
|---|---|---|---|---|---|---|
| 117756284 | 11775628 | 1 | 20140331 | 0 | ||
| 117756284 | 11775628 | 2 | 1998 | 2001 | 0 | |
| 117756284 | 11775628 | 3 | 20060503 | 20080725 | 0 | |
| 117756284 | 11775628 | 4 | 20140409 | 0 | ||
| 117756284 | 11775628 | 6 | 20080729 | 20121229 | 0 | |
| 117756284 | 11775628 | 7 | 20121231 | 20140406 | 0 |