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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124336862 | 12433686 | 2 | F | 2016 | 20160621 | 20160603 | 20160705 | PER | US-JNJFOC-20160508553 | JANSSEN | 0.00 | A | M | Y | 0.00000 | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124336862 | 12433686 | 1 | PS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | FEB5S00 | 22264 | 156 | MG | INJECTION | /month | |||||
| 124336862 | 12433686 | 2 | SS | INVEGA | PALIPERIDONE | 1 | Oral | N | UNKNOWN | 21999 | 3 | MG | OROS (ORAL OSMOTIC) THERAPEUTIC SYSTEM TABLET | QD | |||||
| 124336862 | 12433686 | 3 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | Oral | AT BEDTIME | 0 | 500 | MG | UNSPECIFIED | QID | ||||||
| 124336862 | 12433686 | 4 | C | BENZTROPINE | BENZTROPINE | 1 | Oral | 0 | 2 | MG | UNSPECIFIED | ||||||||
| 124336862 | 12433686 | 5 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Oral | 0 | 50 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124336862 | 12433686 | 1 | Schizoaffective disorder bipolar type |
| 124336862 | 12433686 | 2 | Schizoaffective disorder bipolar type |
| 124336862 | 12433686 | 3 | Product used for unknown indication |
| 124336862 | 12433686 | 4 | Product used for unknown indication |
| 124336862 | 12433686 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124336862 | 12433686 | Flight of ideas | |
| 124336862 | 12433686 | Hallucination | |
| 124336862 | 12433686 | Loose associations | |
| 124336862 | 12433686 | Pressure of speech | |
| 124336862 | 12433686 | Treatment noncompliance | |
| 124336862 | 12433686 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 124336862 | 12433686 | 2 | 201604 | 0 |