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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124499392 | 12449939 | 2 | F | 2002 | 20160630 | 20160609 | 20160711 | PER | US-JNJFOC-20160600961 | JANSSEN | 0.00 | A | M | Y | 0.00000 | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124499392 | 12449939 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | VARYING DOSES OF 1 MG TO 2 MG | U | U | 0 | UNSPECIFIED | |||||||
| 124499392 | 12449939 | 2 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | VARYING DOSES OF 1 MG TO 2 MG | U | U | 0 | UNSPECIFIED | |||||||
| 124499392 | 12449939 | 3 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | VARYING DOSES OF 1 MG TO 2 MG | U | U | 0 | UNSPECIFIED | |||||||
| 124499392 | 12449939 | 4 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | VARYING DOSES OF 1 MG TO 2 MG | U | U | 0 | UNSPECIFIED | |||||||
| 124499392 | 12449939 | 5 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | VARYING DOSES OF 1 MG TO 2 MG | U | U | 0 | UNSPECIFIED | |||||||
| 124499392 | 12449939 | 6 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | VARYING DOSES OF 1 MG TO 2 MG | U | U | 20272 | UNSPECIFIED | |||||||
| 124499392 | 12449939 | 7 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 0 | 3 | MG | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||
| 124499392 | 12449939 | 8 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 0 | 3 | MG | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||
| 124499392 | 12449939 | 9 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 0 | 3 | MG | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||
| 124499392 | 12449939 | 10 | SS | INVEGA | PALIPERIDONE | 1 | Oral | U | U | 21999 | 3 | MG | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | ||||||
| 124499392 | 12449939 | 11 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | U | U | 0 | 156 | MG | INJECTION | ||||||
| 124499392 | 12449939 | 12 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | U | U | 0 | 156 | MG | INJECTION | ||||||
| 124499392 | 12449939 | 13 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | U | U | 0 | 156 | MG | INJECTION | ||||||
| 124499392 | 12449939 | 14 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | U | U | 22264 | 156 | MG | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124499392 | 12449939 | 1 | Craniocerebral injury |
| 124499392 | 12449939 | 2 | Craniocerebral injury |
| 124499392 | 12449939 | 3 | Bipolar disorder |
| 124499392 | 12449939 | 4 | Bipolar disorder |
| 124499392 | 12449939 | 5 | Schizophrenia |
| 124499392 | 12449939 | 6 | Schizophrenia |
| 124499392 | 12449939 | 7 | Bipolar disorder |
| 124499392 | 12449939 | 8 | Bipolar disorder |
| 124499392 | 12449939 | 9 | Schizophrenia |
| 124499392 | 12449939 | 10 | Schizophrenia |
| 124499392 | 12449939 | 11 | Bipolar disorder |
| 124499392 | 12449939 | 12 | Bipolar disorder |
| 124499392 | 12449939 | 13 | Schizophrenia |
| 124499392 | 12449939 | 14 | Schizophrenia |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124499392 | 12449939 | Emotional distress | |
| 124499392 | 12449939 | Extrapyramidal disorder | |
| 124499392 | 12449939 | Gynaecomastia | |
| 124499392 | 12449939 | 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 |
|---|---|---|---|---|---|---|
| 124499392 | 12449939 | 1 | 200111 | 200210 | 0 | |
| 124499392 | 12449939 | 2 | 2010 | 2011 | 0 | |
| 124499392 | 12449939 | 3 | 2010 | 2011 | 0 | |
| 124499392 | 12449939 | 4 | 200111 | 200210 | 0 | |
| 124499392 | 12449939 | 5 | 200111 | 200210 | 0 | |
| 124499392 | 12449939 | 6 | 2010 | 2011 | 0 | |
| 124499392 | 12449939 | 7 | 201306 | 201410 | 0 | |
| 124499392 | 12449939 | 8 | 2010 | 2012 | 0 | |
| 124499392 | 12449939 | 9 | 2010 | 2012 | 0 | |
| 124499392 | 12449939 | 10 | 201306 | 201410 | 0 | |
| 124499392 | 12449939 | 11 | 201306 | 201410 | 0 | |
| 124499392 | 12449939 | 12 | 2010 | 2012 | 0 | |
| 124499392 | 12449939 | 13 | 2010 | 2012 | 0 | |
| 124499392 | 12449939 | 14 | 201306 | 201410 | 0 |