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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 81185092 | 8118509 | 2 | F | 20110729 | 20121018 | 20110902 | 20121029 | EXP | FR-GENZYME-CLOF-1001759 | GENZYME | 23.77 | YR | F | Y | 66.00000 | KG | 20121029 | CN | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 81185092 | 8118509 | 1 | PS | Evoltra | 1 | INTRAVENOUS | 53 MG, UNK | U | UNKNOWN | 21673 | Solution for infusion | ||||||||
| 81185092 | 8118509 | 2 | SS | CYTARABINE | 1 | INTRAVENOUS | 1750 MG, UNK | U | UNKNOWN | 0 | |||||||||
| 81185092 | 8118509 | 3 | SS | FILGRASTIM | 1 | INTRAVENOUS | 330 MCG, UNK | U | UNKNOWN | 0 | |||||||||
| 81185092 | 8118509 | 4 | C | ORAL CONTRACEPTIVE NOS | 1 | ORAL | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 81185092 | 8118509 | 1 | Acute myeloid leukaemia |
| 81185092 | 8118509 | 2 | Acute myeloid leukaemia |
| 81185092 | 8118509 | 3 | Acute myeloid leukaemia |
| 81185092 | 8118509 | 4 | Metrorrhagia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 81185092 | 8118509 | HO |
| 81185092 | 8118509 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 81185092 | 8118509 | Axillary vein thrombosis | |
| 81185092 | 8118509 | Subclavian artery stenosis | |
| 81185092 | 8118509 | Subclavian vein thrombosis |
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 |
|---|---|---|---|---|---|---|
| 81185092 | 8118509 | 1 | 20110713 | 20110717 | 0 | |
| 81185092 | 8118509 | 2 | 20110712 | 20110716 | 0 | |
| 81185092 | 8118509 | 3 | 20110712 | 20110717 | 0 |