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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125980521 | 12598052 | 1 | I | 20160218 | 20160613 | 20160726 | 20160726 | EXP | CA-HLSUS-2016-CA-000245 | HLS THERAPEUTICS | 78.00 | YR | E | F | Y | 0.00000 | 20160726 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125980521 | 12598052 | 1 | PS | CLOZARIL | CLOZAPINE | 1 | Oral | 400 MG, QD | 204000 | MG | U | 0 | 400 | MG | TABLET | QD | |||
| 125980521 | 12598052 | 2 | C | LAX-A-DAY | 2 | 17 G | U | 0 | 17 | G | |||||||||
| 125980521 | 12598052 | 3 | C | SENOKOT | SENNOSIDES | 1 | 8.6 MG | U | 0 | 8.6 | MG | TABLET | |||||||
| 125980521 | 12598052 | 4 | C | PANTOLOC//PANTOPRAZOLE SODIUM SESQUIHYDRATE | PANTOPRAZOLE SODIUM | 1 | 40 MG | U | 0 | 40 | MG | ||||||||
| 125980521 | 12598052 | 5 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 10000 OT | U | 0 | ||||||||||
| 125980521 | 12598052 | 6 | C | HALDOL | HALOPERIDOL | 1 | 5 MG | U | 0 | 5 | MG | TABLET | |||||||
| 125980521 | 12598052 | 7 | C | HALDOL | HALOPERIDOL | 1 | 5 MG | 0 | 5 | MG | INJECTION | ||||||||
| 125980521 | 12598052 | 8 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | 0 | TABLET | |||||||||||
| 125980521 | 12598052 | 9 | C | AVAPRO | IRBESARTAN | 1 | 0 | TABLET | |||||||||||
| 125980521 | 12598052 | 10 | C | TYLENOL | ACETAMINOPHEN | 1 | U | 0 | 500 | MG | CAPSULE | ||||||||
| 125980521 | 12598052 | 11 | C | ABILIFY | ARIPIPRAZOLE | 1 | 10 MG | U | 0 | 10 | MG | TABLET | |||||||
| 125980521 | 12598052 | 12 | C | MAGLUCATE | 2 | 500 MG | U | 0 | 500 | MG | TABLET | ||||||||
| 125980521 | 12598052 | 13 | C | COLACE | DOCUSATE SODIUM | 1 | 100 MG | U | 0 | 100 | MG | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125980521 | 12598052 | 1 | Schizophrenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125980521 | 12598052 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125980521 | 12598052 | Aggression | |
| 125980521 | 12598052 | Antipsychotic drug level increased | |
| 125980521 | 12598052 | Cardio-respiratory arrest | |
| 125980521 | 12598052 | Delirium | |
| 125980521 | 12598052 | Disorientation | |
| 125980521 | 12598052 | Electrocardiogram QT prolonged | |
| 125980521 | 12598052 | Haematocrit decreased | |
| 125980521 | 12598052 | Haemoglobin decreased | |
| 125980521 | 12598052 | Lymphocyte count decreased | |
| 125980521 | 12598052 | Psychiatric decompensation | |
| 125980521 | 12598052 | Red blood cell count decreased | |
| 125980521 | 12598052 | Sudden death | |
| 125980521 | 12598052 | Torsade de pointes | |
| 125980521 | 12598052 | Urinary tract infection | |
| 125980521 | 12598052 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 125980521 | 12598052 | 1 | 20130805 | 20150111 | 0 |