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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109468635 | 10946863 | 5 | F | 20150225 | 20160808 | 20150323 | 20160819 | EXP | FR-OTSUKA-US-2015-11274 | OTSUKA | 23.00 | YR | M | Y | 0.00000 | 20160819 | CN | FR | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109468635 | 10946863 | 1 | PS | ABILIFY MAINTENA | ARIPIPRAZOLE | 1 | Intramuscular | 400 MG, UNK | Y | 202971 | 400 | MG | SUSPENSION FOR INJECTION | ||||||
| 109468635 | 10946863 | 2 | SS | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Oral | 40 MG, QD | Y | 0 | 40 | MG | TABLET | QD | |||||
| 109468635 | 10946863 | 3 | SS | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Oral | 20 MG, QD | Y | 0 | 20 | MG | TABLET | QD | |||||
| 109468635 | 10946863 | 4 | SS | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Oral | 40 MG, UNK | Y | 0 | 40 | MG | TABLET | ||||||
| 109468635 | 10946863 | 5 | C | DEPAKINE | VALPROATE SODIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 109468635 | 10946863 | 6 | C | LITHIUM. | LITHIUM | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109468635 | 10946863 | 1 | Bipolar disorder |
| 109468635 | 10946863 | 2 | Bipolar disorder |
| 109468635 | 10946863 | 5 | Product used for unknown indication |
| 109468635 | 10946863 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109468635 | 10946863 | HO |
| 109468635 | 10946863 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109468635 | 10946863 | Aggression | |
| 109468635 | 10946863 | Dermatitis bullous | |
| 109468635 | 10946863 | Disorientation | |
| 109468635 | 10946863 | Dysarthria | |
| 109468635 | 10946863 | Euphoric mood | |
| 109468635 | 10946863 | Mania | |
| 109468635 | 10946863 | Oedema peripheral | |
| 109468635 | 10946863 | Off label use | |
| 109468635 | 10946863 | Pruritus | |
| 109468635 | 10946863 | Psychiatric decompensation | |
| 109468635 | 10946863 | Psychomotor hyperactivity | |
| 109468635 | 10946863 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 109468635 | 10946863 | 1 | 20150225 | 20150225 | 0 | |
| 109468635 | 10946863 | 2 | 20150213 | 0 | ||
| 109468635 | 10946863 | 3 | 20150225 | 0 | ||
| 109468635 | 10946863 | 4 | 20150227 | 20150309 | 0 |