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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106500013 | 10650001 | 3 | F | 20141120 | 20160809 | 20141212 | 20160818 | EXP | CH-OTSUKA-US-2014-14527 | OTSUKA | 29.00 | YR | F | Y | 0.00000 | 20160818 | MD | DK | CH |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106500013 | 10650001 | 1 | PS | ABILIFY MAINTENA | ARIPIPRAZOLE | 1 | Intramuscular | 400 MG, QM | Y | 202971 | 400 | MG | SUSPENSION FOR INJECTION | /month | |||||
| 106500013 | 10650001 | 2 | SS | ABILIFY MAINTENA | ARIPIPRAZOLE | 1 | Intramuscular | 300 MG, QM | Y | 202971 | 300 | MG | SUSPENSION FOR INJECTION | /month | |||||
| 106500013 | 10650001 | 3 | SS | ABILIFY MAINTENA | ARIPIPRAZOLE | 1 | Intramuscular | 400 MG, QM | Y | 202971 | 400 | MG | SUSPENSION FOR INJECTION | /month | |||||
| 106500013 | 10650001 | 4 | SS | ARIPIPRAZOLE. | ARIPIPRAZOLE | 1 | Oral | UNK | 0 | TABLET | |||||||||
| 106500013 | 10650001 | 5 | SS | Quilonorm retard (Lithium) | LITHIUM CARBONATE | 1 | Unknown | 2.5 TABLETS/DAY (1 TABLET IN MORNING, AND 1.5 TABLETS IN EVENING) | Y | 0 | |||||||||
| 106500013 | 10650001 | 6 | C | SEROQUEL XR | QUETIAPINE FUMARATE | 1 | Unknown | 300 MG, QM | 0 | 300 | MG | /month |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 106500013 | 10650001 | 1 | Bipolar disorder |
| 106500013 | 10650001 | 2 | Bipolar disorder relapse prophylaxis |
| 106500013 | 10650001 | 4 | Bipolar disorder relapse prophylaxis |
| 106500013 | 10650001 | 5 | Bipolar disorder relapse prophylaxis |
| 106500013 | 10650001 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 106500013 | 10650001 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 106500013 | 10650001 | Circulatory collapse | |
| 106500013 | 10650001 | Extrapyramidal disorder | |
| 106500013 | 10650001 | Hypoaesthesia | |
| 106500013 | 10650001 | Loss of consciousness | |
| 106500013 | 10650001 | Mania | |
| 106500013 | 10650001 | Product use issue | |
| 106500013 | 10650001 | Tension |
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 |
|---|---|---|---|---|---|---|
| 106500013 | 10650001 | 1 | 20140922 | 20141029 | 0 | |
| 106500013 | 10650001 | 2 | 201411 | 2014 | 0 | |
| 106500013 | 10650001 | 3 | 201502 | 0 | ||
| 106500013 | 10650001 | 4 | 2014 | 201402 | 0 |