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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127944441 | 12794444 | 1 | I | 20160816 | 20160929 | 20160929 | PER | US-JNJFOC-20160816605 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127944441 | 12794444 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | UNSPECIFIED | ||||||||
| 127944441 | 12794444 | 2 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 20272 | .5 | MG | UNSPECIFIED | ||||||
| 127944441 | 12794444 | 3 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 0 | 3 | MG | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||
| 127944441 | 12794444 | 4 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 21999 | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||||
| 127944441 | 12794444 | 5 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | 0 | .25 | MG | TABLET | |||||||
| 127944441 | 12794444 | 6 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | 0.25-0.5 MG | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127944441 | 12794444 | 1 | Attention deficit/hyperactivity disorder |
| 127944441 | 12794444 | 2 | Attention deficit/hyperactivity disorder |
| 127944441 | 12794444 | 3 | Attention deficit/hyperactivity disorder |
| 127944441 | 12794444 | 4 | Attention deficit/hyperactivity disorder |
| 127944441 | 12794444 | 5 | Attention deficit/hyperactivity disorder |
| 127944441 | 12794444 | 6 | Attention deficit/hyperactivity disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127944441 | 12794444 | Emotional disorder | |
| 127944441 | 12794444 | Galactorrhoea | |
| 127944441 | 12794444 | Gynaecomastia | |
| 127944441 | 12794444 | Off label use | |
| 127944441 | 12794444 | Product use issue | |
| 127944441 | 12794444 | 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 |
|---|---|---|---|---|---|---|
| 127944441 | 12794444 | 1 | 20090328 | 20131109 | 0 | |
| 127944441 | 12794444 | 2 | 20110518 | 20120316 | 0 | |
| 127944441 | 12794444 | 3 | 20090602 | 20090702 | 0 | |
| 127944441 | 12794444 | 4 | 20090602 | 20090802 | 0 | |
| 127944441 | 12794444 | 5 | 20121214 | 20131109 | 0 | |
| 127944441 | 12794444 | 6 | 20090328 | 20090909 | 0 |