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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125452105 | 12545210 | 5 | F | 201606 | 20160831 | 20160711 | 20160906 | EXP | US-JNJFOC-20160706818 | JANSSEN | 32.82 | YR | A | M | Y | 104.33000 | KG | 20160906 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125452105 | 12545210 | 1 | PS | RISPERDAL CONSTA | RISPERIDONE | 1 | Intramuscular | N | 474188;UNKNOWN | 21346 | 25 | MG | MICROSPHERES | ||||||
| 125452105 | 12545210 | 2 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | Y | U | UNKNOWN;UNKNOWN | 0 | 3 | MG | TABLETS | BID | ||||
| 125452105 | 12545210 | 3 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | DOSE: 3 MG AT NIGHT, 1 MG IN MORNING | Y | U | UNKNOWN;UNKNOWN | 0 | TABLETS | ||||||
| 125452105 | 12545210 | 4 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | DOSE: 2 MG AT NIGHT, 1 MG IN MORNING | Y | U | UNKNOWN;UNKNOWN | 20272 | TABLETS |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125452105 | 12545210 | 1 | Psychotic disorder |
| 125452105 | 12545210 | 2 | Psychotic disorder |
| 125452105 | 12545210 | 3 | Psychotic disorder |
| 125452105 | 12545210 | 4 | Psychotic disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125452105 | 12545210 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125452105 | 12545210 | Akathisia | |
| 125452105 | 12545210 | Hospitalisation | |
| 125452105 | 12545210 | Inappropriate schedule of drug administration | |
| 125452105 | 12545210 | Increased appetite | |
| 125452105 | 12545210 | Nonspecific reaction | |
| 125452105 | 12545210 | Psychotic disorder | |
| 125452105 | 12545210 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 125452105 | 12545210 | 1 | 20160607 | 0 |