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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126455581 | 12645558 | 1 | I | 20160802 | 20160808 | 20160811 | 20160811 | EXP | DE-MYLANLABS-2016M1033680 | MYLAN | 0.00 | Y | 0.00000 | 20160811 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126455581 | 12645558 | 1 | PS | CLOZAPINE. | CLOZAPINE | 1 | Oral | 175 MG, QD | Y | U | 75417 | 175 | MG | QD | |||||
| 126455581 | 12645558 | 2 | SS | CLOZAPINE. | CLOZAPINE | 1 | Oral | 75 MG, QD | Y | U | 75417 | 75 | MG | QD | |||||
| 126455581 | 12645558 | 3 | SS | CLOZAPINE. | CLOZAPINE | 1 | Oral | 125 MG, QD | Y | U | 75417 | 50 | MG | QD | |||||
| 126455581 | 12645558 | 4 | C | LYRICA | PREGABALIN | 1 | Oral | 250 MG, QD | 0 | 250 | MG | QD | |||||||
| 126455581 | 12645558 | 5 | C | GASTROZEPIN | PIRENZEPINE HYDROCHLORIDE | 1 | Oral | 50 MG, QD | 600 | MG | 0 | 50 | MG | QD | |||||
| 126455581 | 12645558 | 6 | C | AKINETON | BIPERIDEN HYDROCHLORIDE | 1 | Oral | 8 MG, QD | 0 | 8 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126455581 | 12645558 | 1 | Schizoaffective disorder |
| 126455581 | 12645558 | 4 | Anxiety |
| 126455581 | 12645558 | 5 | Salivary hypersecretion |
| 126455581 | 12645558 | 6 | Extrapyramidal disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126455581 | 12645558 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126455581 | 12645558 | Thrombocytosis | |
| 126455581 | 12645558 | White blood cell count increased |
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 |
|---|---|---|---|---|---|---|
| 126455581 | 12645558 | 1 | 20160713 | 0 | ||
| 126455581 | 12645558 | 2 | 20160805 | 0 | ||
| 126455581 | 12645558 | 3 | 20160808 | 0 | ||
| 126455581 | 12645558 | 4 | 20160705 | 20160804 | 0 | |
| 126455581 | 12645558 | 5 | 20160722 | 20160806 | 0 | |
| 126455581 | 12645558 | 6 | 20160613 | 20160722 | 0 |