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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125484071 | 12548407 | 1 | I | 20160514 | 0 | 20160711 | 20160711 | DIR | 84.00 | YR | M | N | 76.80000 | KG | 20160519 | N | PH | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125484071 | 12548407 | 1 | PS | OLANZAPINE. | OLANZAPINE | 1 | Oral | Y | D | 0 | 5 | MG | 1X | ||||||
| 125484071 | 12548407 | 2 | SS | HALOPERIDOL. | HALOPERIDOL | 1 | Intravenous (not otherwise specified) | Y | D | 0 | 5 | MG | 1X |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125484071 | 12548407 | 1 | Agitation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125484071 | 12548407 | RI |
| 125484071 | 12548407 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125484071 | 12548407 | Aggression | |
| 125484071 | 12548407 | Agitation | |
| 125484071 | 12548407 | Autonomic nervous system imbalance | |
| 125484071 | 12548407 | Disorientation | |
| 125484071 | 12548407 | Neuroleptic malignant syndrome | |
| 125484071 | 12548407 | Pneumonia aspiration |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 125484071 | 12548407 | HP |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125484071 | 12548407 | 1 | 20160510 | 20160510 | 0 | |
| 125484071 | 12548407 | 2 | 20160509 | 20160509 | 0 |