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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125255972 | 12525597 | 2 | F | 2012 | 20160811 | 20160705 | 20160822 | PER | US-JNJFOC-20160505857 | JANSSEN | 24.54 | YR | A | M | Y | 108.86000 | KG | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125255972 | 12525597 | 1 | PS | INVEGA | PALIPERIDONE | 1 | Oral | Y | N | UNKNOWN | 21999 | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | |||||||
| 125255972 | 12525597 | 2 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | UNKNOWN;UNKNOWN;UNKNOWN | 0 | 156 | MG | INJECTION | /month | |||||
| 125255972 | 12525597 | 3 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | UNKNOWN;UNKNOWN;UNKNOWN | 22264 | 234 | MG | INJECTION | /month | |||||
| 125255972 | 12525597 | 4 | C | LITHIUM. | LITHIUM | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125255972 | 12525597 | 1 | Bipolar disorder |
| 125255972 | 12525597 | 2 | Bipolar disorder |
| 125255972 | 12525597 | 3 | Bipolar disorder |
| 125255972 | 12525597 | 4 | Bipolar disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125255972 | 12525597 | Aggression | |
| 125255972 | 12525597 | Agitation | |
| 125255972 | 12525597 | Anxiety | |
| 125255972 | 12525597 | Delusion | |
| 125255972 | 12525597 | Drug ineffective | |
| 125255972 | 12525597 | Hypersomnia | |
| 125255972 | 12525597 | Poor quality sleep | |
| 125255972 | 12525597 | Restlessness | |
| 125255972 | 12525597 | Stress | |
| 125255972 | 12525597 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 125255972 | 12525597 | 1 | 2012 | 2012 | 0 | |
| 125255972 | 12525597 | 2 | 2012 | 201602 | 0 | |
| 125255972 | 12525597 | 3 | 201602 | 0 |