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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106986032 | 10698603 | 2 | F | 20141118 | 20141125 | 20150108 | 20160729 | EXP | US-MYLANLABS-2014M1014132 | MYLAN | 0.00 | Y | 0.00000 | 20160729 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106986032 | 10698603 | 1 | PS | CYTARABINE. | CYTARABINE | 1 | Intrathecal | UNK, | Y | U | 200914 | ||||||||
| 106986032 | 10698603 | 2 | SS | MYLOTARG | GEMTUZUMAB OZOGAMICIN | 1 | Intravenous (not otherwise specified) | 1.1 MG, UNK | Y | U | 0 | 1.1 | MG |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 106986032 | 10698603 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 106986032 | 10698603 | Alanine aminotransferase increased | |
| 106986032 | 10698603 | Anaemia | |
| 106986032 | 10698603 | Aspartate aminotransferase increased | |
| 106986032 | 10698603 | Hypokalaemia | |
| 106986032 | 10698603 | Platelet 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 |
|---|---|---|---|---|---|---|
| 106986032 | 10698603 | 1 | 20141015 | 20141015 | 0 | |
| 106986032 | 10698603 | 2 | 20141030 | 20141030 | 0 |