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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127937431 | 12793743 | 1 | I | 2016 | 20160907 | 20160929 | 20160929 | PER | US-JNJFOC-20160907552 | JANSSEN | 47.01 | YR | A | F | Y | 0.00000 | 20160929 | MD | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127937431 | 12793743 | 1 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | N | 0 | INJECTION | ||||||||
127937431 | 12793743 | 2 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | N | 0 | 117 | MG | INJECTION | ||||||
127937431 | 12793743 | 3 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | N | 0 | INJECTION | ||||||||
127937431 | 12793743 | 4 | PS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | N | 22264 | 117 | MG | INJECTION | ||||||
127937431 | 12793743 | 5 | C | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Oral | AS NECESSARY | D | 0 | 50 | MG | UNSPECIFIED | ||||||
127937431 | 12793743 | 6 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | 2 QAM | D | 0 | 100 | MG | UNSPECIFIED | QD | |||||
127937431 | 12793743 | 7 | C | ATORVASTATIN | ATORVASTATIN | 1 | Oral | D | 0 | 10 | MG | UNSPECIFIED | QD |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
127937431 | 12793743 | 1 | Schizoaffective disorder |
127937431 | 12793743 | 2 | Schizoaffective disorder |
127937431 | 12793743 | 3 | Schizophrenia |
127937431 | 12793743 | 4 | Schizophrenia |
127937431 | 12793743 | 5 | Insomnia |
127937431 | 12793743 | 6 | Product used for unknown indication |
127937431 | 12793743 | 7 | Product used for unknown indication |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
127937431 | 12793743 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
127937431 | 12793743 | Fatigue | |
127937431 | 12793743 | Hyperprolactinaemia | |
127937431 | 12793743 | 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 |
---|---|---|---|---|---|---|
127937431 | 12793743 | 2 | 20160519 | 0 | ||
127937431 | 12793743 | 4 | 20160519 | 0 |