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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125426152 | 12542615 | 2 | F | 20160517 | 20160809 | 20160709 | 20160822 | PER | US-JNJFOC-20160610585 | JANSSEN | 45.92 | YR | A | F | Y | 46.27000 | KG | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125426152 | 12542615 | 1 | PS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | U | UNKNOWN | 22264 | 234 | MG | INJECTION | ||||||
| 125426152 | 12542615 | 2 | SS | INVEGA TRINZA | PALIPERIDONE PALMITATE | 1 | Intramuscular | U | U | UNKNOWN | 207946 | 819 | MG | SUSPENSION FOR INJECTION | |||||
| 125426152 | 12542615 | 3 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | N | 20272 | 3 | MG | TABLETS | |||||||
| 125426152 | 12542615 | 4 | SS | RISPERDAL CONSTA | RISPERIDONE | 1 | Intramuscular | N | 21346 | 50 | MG | MICROSPHERES | |||||||
| 125426152 | 12542615 | 5 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 0 | 150 | MG | UNSPECIFIED | ||||||||
| 125426152 | 12542615 | 6 | C | ATIVAN | LORAZEPAM | 1 | Unknown | 0 | 2 | MG | UNSPECIFIED | ||||||||
| 125426152 | 12542615 | 7 | C | ATIVAN | LORAZEPAM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125426152 | 12542615 | 8 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125426152 | 12542615 | 1 | Schizophrenia |
| 125426152 | 12542615 | 2 | Schizophrenia |
| 125426152 | 12542615 | 3 | Schizophrenia |
| 125426152 | 12542615 | 4 | Schizophrenia |
| 125426152 | 12542615 | 5 | Product used for unknown indication |
| 125426152 | 12542615 | 6 | Product used for unknown indication |
| 125426152 | 12542615 | 7 | Product used for unknown indication |
| 125426152 | 12542615 | 8 | Weight increased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125426152 | 12542615 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125426152 | 12542615 | Blood prolactin increased | |
| 125426152 | 12542615 | Inappropriate schedule of drug administration | |
| 125426152 | 12542615 | Off label use | |
| 125426152 | 12542615 | Psychotic disorder |
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 |
|---|---|---|---|---|---|---|
| 125426152 | 12542615 | 2 | 20160517 | 0 | ||
| 125426152 | 12542615 | 6 | 2016 | 0 |