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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125426341 | 12542634 | 1 | I | 20150518 | 20160616 | 20160709 | 20160709 | PER | US-JNJFOC-20160616078 | JANSSEN | 34.22 | YR | A | M | Y | 98.88000 | KG | 20160709 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125426341 | 12542634 | 1 | SS | INVEGA TRINZA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | N | 0 | 410 | MG | SUSPENSION FOR INJECTION | ||||||
| 125426341 | 12542634 | 2 | PS | INVEGA TRINZA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | N | 207946 | 410 | MG | SUSPENSION FOR INJECTION | ||||||
| 125426341 | 12542634 | 3 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | N | 0 | 117 | MG | INJECTION | ||||||
| 125426341 | 12542634 | 4 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | N | 0 | 117 | MG | INJECTION | ||||||
| 125426341 | 12542634 | 5 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | N | 22264 | 117 | MG | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125426341 | 12542634 | 1 | Bipolar I disorder |
| 125426341 | 12542634 | 2 | Bipolar I disorder |
| 125426341 | 12542634 | 3 | Bipolar I disorder |
| 125426341 | 12542634 | 4 | Bipolar I disorder |
| 125426341 | 12542634 | 5 | Bipolar I disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125426341 | 12542634 | Hypersomnia | |
| 125426341 | 12542634 | Off label use | |
| 125426341 | 12542634 | Product use issue | |
| 125426341 | 12542634 | Refusal of treatment by patient |
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 |
|---|---|---|---|---|---|---|
| 125426341 | 12542634 | 1 | 20151113 | 0 | ||
| 125426341 | 12542634 | 2 | 20160129 | 0 | ||
| 125426341 | 12542634 | 3 | 20150518 | 0 | ||
| 125426341 | 12542634 | 4 | 20150716 | 0 | ||
| 125426341 | 12542634 | 5 | 20150618 | 0 |