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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
118167682 | 11816768 | 2 | F | 2009 | 20160804 | 20151210 | 20160929 | PER | US-JNJFOC-20150812402 | JANSSEN | 0.00 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
118167682 | 11816768 | 1 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | VARYING DOSES OF 0.25 MG, 0.5 MG, 1 MG AND 3 MG. | U | U | 20272 | UNSPECIFIED | |||||||
118167682 | 11816768 | 2 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 21999 | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
118167682 | 11816768 | 1 | Autism |
118167682 | 11816768 | 2 | Product used for unknown indication |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
118167682 | 11816768 | Abnormal weight gain | |
118167682 | 11816768 | Gynaecomastia | |
118167682 | 11816768 | Off label use | |
118167682 | 11816768 | 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 |
---|---|---|---|---|---|---|
118167682 | 11816768 | 1 | 2009 | 2015 | 0 |