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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125425992 | 12542599 | 2 | F | 20160526 | 20160706 | 20160709 | 20160711 | PER | US-JNJFOC-20160526670 | JANSSEN | 16.31 | YR | T | M | Y | 124.74000 | KG | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125425992 | 12542599 | 1 | PS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | N | 232451;FKB2D00 | 22264 | 234 | MG | INJECTION | /month | |||||
| 125425992 | 12542599 | 2 | C | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 0 | 72 | MG | SUSTAINED RELEASE TABLETS | QD | |||||||
| 125425992 | 12542599 | 3 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Oral | 0 | 70 | MG | TABLET | QD | |||||||
| 125425992 | 12542599 | 4 | C | RISPERDAL | RISPERIDONE | 1 | Oral | 0 | 2 | MG | TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125425992 | 12542599 | 1 | Schizophrenia |
| 125425992 | 12542599 | 2 | Attention deficit/hyperactivity disorder |
| 125425992 | 12542599 | 3 | Attention deficit/hyperactivity disorder |
| 125425992 | 12542599 | 4 | Agitation |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125425992 | 12542599 | Accidental exposure to product | |
| 125425992 | 12542599 | Drug dose omission | |
| 125425992 | 12542599 | Product leakage | |
| 125425992 | 12542599 | Product quality issue |
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 |
|---|---|---|---|---|---|---|
| 125425992 | 12542599 | 1 | 201509 | 0 | ||
| 125425992 | 12542599 | 2 | 201602 | 0 | ||
| 125425992 | 12542599 | 3 | 201601 | 201602 | 0 | |
| 125425992 | 12542599 | 4 | 2010 | 0 |