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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108335742 | 10833574 | 2 | F | 20140904 | 20160919 | 20150219 | 20160928 | EXP | CA-OTSUKA-US-2014-14568 | OTSUKA | 57.71 | YR | F | Y | 78.00000 | KG | 20160928 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108335742 | 10833574 | 1 | PS | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Intramuscular | 400 MG, UNKNOWN, RECEIVED 3 SHOTS | Y | UNKNOWN | 202971 | 400 | MG | SUSPENSION FOR INJECTION | |||||
| 108335742 | 10833574 | 2 | SS | ABILIFY | ARIPIPRAZOLE | 1 | Intramuscular | UNK | Y | 0 | INJECTION | ||||||||
| 108335742 | 10833574 | 3 | C | CLOZARIL | CLOZAPINE | 1 | Unknown | 500 MG, SINGLE | 0 | 500 | MG | QD | |||||||
| 108335742 | 10833574 | 4 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 250 MG, TID | 0 | 250 | MG | TID | |||||||
| 108335742 | 10833574 | 5 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | 50 ?G, QD | 0 | 50 | UG | QD | |||||||
| 108335742 | 10833574 | 6 | C | ATROPINE DROPS | 2 | Sublingual | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 108335742 | 10833574 | 1 | Schizoaffective disorder |
| 108335742 | 10833574 | 2 | Schizoaffective disorder |
| 108335742 | 10833574 | 3 | Product used for unknown indication |
| 108335742 | 10833574 | 4 | Product used for unknown indication |
| 108335742 | 10833574 | 5 | Product used for unknown indication |
| 108335742 | 10833574 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 108335742 | 10833574 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 108335742 | 10833574 | Drug ineffective | |
| 108335742 | 10833574 | Off label use | |
| 108335742 | 10833574 | Psychiatric decompensation |
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 |
|---|---|---|---|---|---|---|
| 108335742 | 10833574 | 1 | 20140904 | 20141120 | 0 | |
| 108335742 | 10833574 | 2 | 20140904 | 20141120 | 0 |