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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126049462 | 12604946 | 2 | F | 20160712 | 20160801 | 20160728 | 20160808 | EXP | IT-BAXALTA-2016BLT005304 | BAXALTA | 59.69 | YR | F | Y | 0.00000 | 20160808 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126049462 | 12604946 | 1 | PS | ONCASPAR | PEGASPARGASE | 1 | Intravenous (not otherwise specified) | 1570 IU, 1X A DAY | 1570 | IU | U | UNKNOWN | 103411 | 1570 | IU | INJECTION | QD | ||
| 126049462 | 12604946 | 2 | SS | IDARUBICIN | IDARUBICIN | 1 | Intravenous (not otherwise specified) | 14.13 MG, 1X A DAY | 14 | MG | U | 0 | 14.13 | MG | QD | ||||
| 126049462 | 12604946 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 1570 MG, 1X A DAY | 1570 | MG | U | 0 | 1570 | MG | QD | ||||
| 126049462 | 12604946 | 4 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 7.85 MG, 2X A DAY | 16 | MG | U | 0 | 7.85 | MG | BID | ||||
| 126049462 | 12604946 | 5 | SS | MERCAPTOPURINE. | MERCAPTOPURINE | 1 | Oral | 50 MG, 2X A DAY | 800 | MG | U | 0 | 50 | MG | BID | ||||
| 126049462 | 12604946 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 8 MG, 2X A DAY | 64 | MG | U | 0 | 8 | MG | BID | ||||
| 126049462 | 12604946 | 7 | SS | CYTARABINE. | CYTARABINE | 1 | Subcutaneous | 117.75 MG, 1X A DAY | 471 | MG | U | 0 | 117.75 | MG | QD | ||||
| 126049462 | 12604946 | 8 | C | ACICLOVIR | ACYCLOVIR | 1 | Unknown | 400 MG, 2X A DAY | 0 | 400 | MG | BID | |||||||
| 126049462 | 12604946 | 9 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Unknown | 200 MG, 1X A DAY | 0 | 200 | MG | QD | |||||||
| 126049462 | 12604946 | 10 | C | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Unknown | 500 MG, 1X A DAY | 0 | 500 | MG | QD | |||||||
| 126049462 | 12604946 | 11 | C | FILGRASTIM | FILGRASTIM | 1 | Unknown | 30, 1 VIAL, 1X A DAY | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126049462 | 12604946 | 1 | Acute lymphocytic leukaemia |
| 126049462 | 12604946 | 2 | Acute lymphocytic leukaemia |
| 126049462 | 12604946 | 3 | Acute lymphocytic leukaemia |
| 126049462 | 12604946 | 4 | Acute lymphocytic leukaemia |
| 126049462 | 12604946 | 5 | Acute lymphocytic leukaemia |
| 126049462 | 12604946 | 6 | Acute lymphocytic leukaemia |
| 126049462 | 12604946 | 7 | Acute lymphocytic leukaemia |
| 126049462 | 12604946 | 8 | Infection prophylaxis |
| 126049462 | 12604946 | 9 | Infection prophylaxis |
| 126049462 | 12604946 | 10 | Infection prophylaxis |
| 126049462 | 12604946 | 11 | Evidence based treatment |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126049462 | 12604946 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126049462 | 12604946 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 126049462 | 12604946 | 1 | 20160707 | 20160707 | 0 | |
| 126049462 | 12604946 | 2 | 20160630 | 20160630 | 0 | |
| 126049462 | 12604946 | 3 | 20160630 | 20160630 | 0 | |
| 126049462 | 12604946 | 4 | 20160630 | 20160630 | 0 | |
| 126049462 | 12604946 | 5 | 20160630 | 20160707 | 0 | |
| 126049462 | 12604946 | 6 | 20160701 | 20160704 | 0 | |
| 126049462 | 12604946 | 7 | 20160701 | 20160704 | 0 |