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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111236123 | 11123612 | 3 | F | 20050413 | 20160823 | 20150519 | 20160929 | PER | US-JNJFOC-20150505867 | JANSSEN | 10.12 | YR | C | M | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111236123 | 11123612 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | 1MG TO 3 MG | U | U | 0 | UNSPECIFIED | |||||||
| 111236123 | 11123612 | 2 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | 1MG TO 3 MG | U | U | 0 | UNSPECIFIED | |||||||
| 111236123 | 11123612 | 3 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | 1MG TO 3 MG | U | U | 20272 | UNSPECIFIED | |||||||
| 111236123 | 11123612 | 4 | SS | INVEGA | PALIPERIDONE | 1 | Oral | D | N | 21999 | 3 | MG | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111236123 | 11123612 | 1 | Affective disorder |
| 111236123 | 11123612 | 2 | Oppositional defiant disorder |
| 111236123 | 11123612 | 3 | Attention deficit/hyperactivity disorder |
| 111236123 | 11123612 | 4 | Attention deficit/hyperactivity disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111236123 | 11123612 | Gynaecomastia | |
| 111236123 | 11123612 | Hyperprolactinaemia | |
| 111236123 | 11123612 | 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 |
|---|---|---|---|---|---|---|
| 111236123 | 11123612 | 1 | 20050413 | 20100323 | 0 | |
| 111236123 | 11123612 | 2 | 20050413 | 20100323 | 0 | |
| 111236123 | 11123612 | 3 | 20050413 | 20100323 | 0 | |
| 111236123 | 11123612 | 4 | 20100825 | 20101008 | 0 |