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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126735512 | 12673551 | 2 | F | 201608 | 20160829 | 20160822 | 20160831 | EXP | US-JNJFOC-20160813256 | JANSSEN | 53.98 | YR | A | M | Y | 90.72000 | KG | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126735512 | 12673551 | 1 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | UNKNOWN | 0 | INJECTION | ||||||||
| 126735512 | 12673551 | 2 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | UNKNOWN | 0 | 234 | MG | INJECTION | ||||||
| 126735512 | 12673551 | 3 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | UNKNOWN | 0 | 234 | MG | INJECTION | ||||||
| 126735512 | 12673551 | 4 | PS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | UNKNOWN | 22264 | INJECTION | ||||||||
| 126735512 | 12673551 | 5 | C | TEGRETOL | CARBAMAZEPINE | 1 | Unknown | 200 MG IN THE AM, 400 MG IN THE PM | 0 | UNSPECIFIED | |||||||||
| 126735512 | 12673551 | 6 | C | CARBAMAZEPINE. | CARBAMAZEPINE | 1 | Unknown | 0 | 200 | MG | UNSPECIFIED | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126735512 | 12673551 | 1 | Psychotic disorder |
| 126735512 | 12673551 | 2 | Psychotic disorder |
| 126735512 | 12673551 | 3 | Bipolar disorder |
| 126735512 | 12673551 | 4 | Bipolar disorder |
| 126735512 | 12673551 | 5 | Product used for unknown indication |
| 126735512 | 12673551 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126735512 | 12673551 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126735512 | 12673551 | Aggression | |
| 126735512 | 12673551 | Drug dose omission | |
| 126735512 | 12673551 | Judgement impaired |
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 |
|---|---|---|---|---|---|---|
| 126735512 | 12673551 | 1 | 20160714 | 0 | ||
| 126735512 | 12673551 | 2 | 2015 | 0 | ||
| 126735512 | 12673551 | 3 | 2015 | 0 | ||
| 126735512 | 12673551 | 4 | 20160714 | 0 |