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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122049925 | 12204992 | 5 | F | 20160801 | 20160323 | 20160804 | EXP | ES-OTSUKA-2016_006499 | OTSUKA | 51.00 | YR | F | Y | 0.00000 | 20160804 | MD | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122049925 | 12204992 | 1 | PS | ABILIFY MAINTENA | ARIPIPRAZOLE | 1 | Intramuscular | 400 MG, EVERY 28 DAYS | 202971 | 400 | MG | SUSPENSION FOR INJECTION | |||||||
| 122049925 | 12204992 | 2 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | 2 MG, QD | U | 0 | 2 | MG | QD | ||||||
| 122049925 | 12204992 | 3 | SS | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | 200 MG, QD | U | 0 | 200 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122049925 | 12204992 | 1 | Schizophrenia |
| 122049925 | 12204992 | 2 | Schizophrenia |
| 122049925 | 12204992 | 3 | Schizophrenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122049925 | 12204992 | OT |
| 122049925 | 12204992 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122049925 | 12204992 | Bradycardia | |
| 122049925 | 12204992 | Decreased appetite | |
| 122049925 | 12204992 | Hypotension | |
| 122049925 | 12204992 | Hypothermia | |
| 122049925 | 12204992 | Mutism | |
| 122049925 | 12204992 | Psychomotor hyperactivity |
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 |
|---|---|---|---|---|---|---|
| 122049925 | 12204992 | 1 | 201505 | 0 |