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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109232204 | 10923220 | 4 | F | 20150217 | 20160825 | 20150317 | 20160915 | EXP | FR-OTSUKA-US-2015-11172 | OTSUKA | 51.10 | YR | F | Y | 0.00000 | 20160915 | OT | US | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109232204 | 10923220 | 1 | PS | ABILIFY MAINTENA | ARIPIPRAZOLE | 1 | Intramuscular | 400 MG, UNK | UNKNOWN | 202971 | 400 | MG | SUSPENSION FOR INJECTION | ||||||
| 109232204 | 10923220 | 2 | SS | ABILIFY MAINTENA | ARIPIPRAZOLE | 1 | Intramuscular | 300 MG, UNK | 202971 | 300 | MG | SUSPENSION FOR INJECTION | |||||||
| 109232204 | 10923220 | 3 | SS | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Unknown | 15 MG, QD | 0 | 15 | MG | TABLET | QD | ||||||
| 109232204 | 10923220 | 4 | SS | TERCIAN | CYAMEMAZINE | 1 | Unknown | 25 MG, UNK | 0 | 25 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109232204 | 10923220 | 1 | Schizophrenia |
| 109232204 | 10923220 | 3 | Schizophrenia |
| 109232204 | 10923220 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109232204 | 10923220 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109232204 | 10923220 | Abnormal behaviour | |
| 109232204 | 10923220 | Delirium | |
| 109232204 | 10923220 | Feeling abnormal | |
| 109232204 | 10923220 | Incorrect dose administered | |
| 109232204 | 10923220 | Off label use | |
| 109232204 | 10923220 | Psychotic disorder | |
| 109232204 | 10923220 | Rhinitis |
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 |
|---|---|---|---|---|---|---|
| 109232204 | 10923220 | 1 | 20150127 | 0 | ||
| 109232204 | 10923220 | 2 | 20150224 | 0 | ||
| 109232204 | 10923220 | 3 | 201501 | 20150211 | 0 | |
| 109232204 | 10923220 | 4 | 20150127 | 0 |