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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125288271 | 12528827 | 1 | I | 20160309 | 20160620 | 20160705 | 20160705 | EXP | US-SA-2016SA121796 | AVENTIS | 69.00 | YR | E | M | Y | 88.10000 | KG | 20160705 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125288271 | 12528827 | 1 | PS | FLUDARA | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | UNKNOWN | 20038 | 63 | MG | QD | |||||||
| 125288271 | 12528827 | 2 | C | MYLOTARG | GEMTUZUMAB OZOGAMICIN | 1 | ROUTE: IVPB | 0 | 6.3 | MG | QD | ||||||||
| 125288271 | 12528827 | 3 | C | CYTARABINE. | CYTARABINE | 1 | Intravenous (not otherwise specified) | 0 | 2100 | MG | QD | ||||||||
| 125288271 | 12528827 | 4 | C | IDARUBICIN | IDARUBICIN | 1 | 0 | 10.5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125288271 | 12528827 | 1 | Acute myeloid leukaemia |
| 125288271 | 12528827 | 3 | Acute myeloid leukaemia |
| 125288271 | 12528827 | 4 | Acute myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125288271 | 12528827 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125288271 | 12528827 | Escherichia bacteraemia | |
| 125288271 | 12528827 | Febrile neutropenia |
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 |
|---|---|---|---|---|---|---|
| 125288271 | 12528827 | 1 | 20160227 | 20160229 | 0 | |
| 125288271 | 12528827 | 2 | 20160302 | 20160302 | 0 | |
| 125288271 | 12528827 | 3 | 20160228 | 20160301 | 0 | |
| 125288271 | 12528827 | 4 | 20160228 | 20160301 | 0 |