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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126719112 | 12671911 | 2 | F | 2016 | 20160817 | 20160822 | 20160830 | PER | US-JNJFOC-20160721433 | JANSSEN | 32.00 | YR | A | M | Y | 0.00000 | 20160830 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126719112 | 12671911 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | UNKNOWN | 0 | 4 | MG | UNSPECIFIED | BID | ||||
| 126719112 | 12671911 | 2 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | UNKNOWN | 20272 | UNSPECIFIED | |||||||
| 126719112 | 12671911 | 3 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | U | UNKNOWN | 22264 | INJECTION | ||||||||
| 126719112 | 12671911 | 4 | SS | RISPERDAL CONSTA | RISPERIDONE | 1 | Intramuscular | U | U | UNKNOWN | 21346 | 50 | MG | MICROSPHERES | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126719112 | 12671911 | 1 | Mania |
| 126719112 | 12671911 | 2 | Mania |
| 126719112 | 12671911 | 3 | Product used for unknown indication |
| 126719112 | 12671911 | 4 | Mania |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126719112 | 12671911 | Inappropriate schedule of drug administration | |
| 126719112 | 12671911 | Incorrect dose administered | |
| 126719112 | 12671911 | Mania | |
| 126719112 | 12671911 | Nonspecific reaction | |
| 126719112 | 12671911 | Off label use | |
| 126719112 | 12671911 | Product use issue | |
| 126719112 | 12671911 | Treatment noncompliance |
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 |
|---|---|---|---|---|---|---|
| 126719112 | 12671911 | 1 | 201607 | 0 | ||
| 126719112 | 12671911 | 2 | 2016 | 201606 | 0 | |
| 126719112 | 12671911 | 3 | 201606 | 2016 | 0 | |
| 126719112 | 12671911 | 4 | 20160702 | 0 |