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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125303722 | 12530372 | 2 | F | 20160708 | 20160706 | 20160722 | EXP | US-AUROBINDO-AUR-APL-2016-08645 | AUROBINDO | 70.00 | YR | M | Y | 0.00000 | 20160722 | OT | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125303722 | 12530372 | 1 | PS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | UNK | Y | U | 78269 | ||||||||
| 125303722 | 12530372 | 2 | SS | HALOPERIDOL. | HALOPERIDOL | 1 | Unknown | UNK | Y | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125303722 | 12530372 | 1 | Aggression |
| 125303722 | 12530372 | 2 | Aggression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125303722 | 12530372 | OT |
| 125303722 | 12530372 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125303722 | 12530372 | Blood creatine phosphokinase increased | |
| 125303722 | 12530372 | Catatonia | |
| 125303722 | 12530372 | Cogwheel rigidity | |
| 125303722 | 12530372 | Disturbance in attention | |
| 125303722 | 12530372 | Gait disturbance | |
| 125303722 | 12530372 | Hypertonia | |
| 125303722 | 12530372 | Hyporeflexia | |
| 125303722 | 12530372 | Medication error | |
| 125303722 | 12530372 | Muscle rigidity | |
| 125303722 | 12530372 | Resting tremor | |
| 125303722 | 12530372 | Unresponsive to stimuli | |
| 125303722 | 12530372 | Urinary incontinence |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |