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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116167015 | 11616701 | 5 | F | 2015 | 20160624 | 20151009 | 20160701 | EXP | IT-OTSUKA-2015_011499 | OTSUKA | 53.00 | YR | M | Y | 0.00000 | 20160701 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116167015 | 11616701 | 1 | PS | ABILIFY MAINTENA | ARIPIPRAZOLE | 1 | Intramuscular | UNK, QM | Y | 202971 | 400 | MG | SUSPENSION FOR INJECTION | /month | |||||
| 116167015 | 11616701 | 2 | SS | HALDOL DECANOATE | HALOPERIDOL DECANOATE | 1 | Intramuscular | 100 MG, EVERY 28 DAYS | Y | 0 | 100 | MG | |||||||
| 116167015 | 11616701 | 3 | SS | HALDOL DECANOATE | HALOPERIDOL DECANOATE | 1 | Intramuscular | 75 MG, UNK | Y | 0 | 75 | MG | |||||||
| 116167015 | 11616701 | 4 | SS | HALOPERIDOL. | HALOPERIDOL | 1 | Oral | 4.5 MG, UNK | U | 0 | 4.5 | MG | ORAL SOLUTION | ||||||
| 116167015 | 11616701 | 5 | SS | HALOPERIDOL. | HALOPERIDOL | 1 | Oral | 3 MG, UNK | U | 0 | 3 | MG | ORAL SOLUTION | ||||||
| 116167015 | 11616701 | 6 | SS | HALOPERIDOL. | HALOPERIDOL | 1 | Oral | 12 MG, UNK | U | 0 | 12 | MG | ORAL SOLUTION | ||||||
| 116167015 | 11616701 | 7 | SS | HALOPERIDOL. | HALOPERIDOL | 1 | Oral | 15 MG, UNK | U | 0 | 15 | MG | ORAL SOLUTION | ||||||
| 116167015 | 11616701 | 8 | SS | HALOPERIDOL. | HALOPERIDOL | 1 | Oral | 10 MG, QD | U | 0 | 10 | MG | ORAL SOLUTION | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116167015 | 11616701 | 1 | Schizophrenia |
| 116167015 | 11616701 | 2 | Schizophrenia |
| 116167015 | 11616701 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116167015 | 11616701 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116167015 | 11616701 | Asthenia | |
| 116167015 | 11616701 | Blood creatine phosphokinase increased | |
| 116167015 | 11616701 | Drug ineffective | |
| 116167015 | 11616701 | Drug monitoring procedure incorrectly performed | |
| 116167015 | 11616701 | Pneumonia | |
| 116167015 | 11616701 | Psychiatric decompensation | |
| 116167015 | 11616701 | Treatment noncompliance |
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 |
|---|---|---|---|---|---|---|
| 116167015 | 11616701 | 1 | 20150504 | 20150702 | 0 | |
| 116167015 | 11616701 | 2 | 20150307 | 0 | ||
| 116167015 | 11616701 | 3 | 20150407 | 0 | ||
| 116167015 | 11616701 | 4 | 2015 | 0 | ||
| 116167015 | 11616701 | 5 | 201505 | 0 |