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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125425931 | 12542593 | 1 | I | 201511 | 20160519 | 20160709 | 20160709 | PER | US-JNJFOC-20160518874 | JANSSEN | 35.37 | YR | A | F | Y | 48.99000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125425931 | 12542593 | 1 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | Y | N | 0 | 234 | MG | INJECTION | /month | |||||
| 125425931 | 12542593 | 2 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | Y | N | 0 | 234 | MG | INJECTION | /month | |||||
| 125425931 | 12542593 | 3 | PS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | Y | N | 22264 | 234 | MG | INJECTION | /month | |||||
| 125425931 | 12542593 | 4 | C | ZYPREXA | OLANZAPINE | 1 | Unknown | 0 | 2.5 | MG | UNSPECIFIED | QD | |||||||
| 125425931 | 12542593 | 5 | C | XANAX | ALPRAZOLAM | 1 | Unknown | 0 | .5 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125425931 | 12542593 | 1 | Autism spectrum disorder |
| 125425931 | 12542593 | 2 | Anxiety disorder |
| 125425931 | 12542593 | 3 | Obsessive-compulsive disorder |
| 125425931 | 12542593 | 4 | Anxiety |
| 125425931 | 12542593 | 5 | Anxiety |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125425931 | 12542593 | Dyskinesia | |
| 125425931 | 12542593 | Muscular weakness | |
| 125425931 | 12542593 | Musculoskeletal stiffness | |
| 125425931 | 12542593 | Myalgia | |
| 125425931 | 12542593 | Off label use | |
| 125425931 | 12542593 | Product use issue | |
| 125425931 | 12542593 | Refusal of treatment by patient | |
| 125425931 | 12542593 | Restlessness | |
| 125425931 | 12542593 | Sensory loss |
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 |
|---|---|---|---|---|---|---|
| 125425931 | 12542593 | 1 | 20151103 | 20151103 | 0 | |
| 125425931 | 12542593 | 2 | 20151103 | 20151103 | 0 | |
| 125425931 | 12542593 | 3 | 20151103 | 20151103 | 0 | |
| 125425931 | 12542593 | 4 | 20151006 | 201511 | 0 | |
| 125425931 | 12542593 | 5 | 20150114 | 201512 | 0 |