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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127761161 | 12776116 | 1 | I | 2013 | 20160914 | 20160923 | 20160923 | EXP | US-BAXTER-2016BAX048241 | BAXTER | 56.00 | YR | F | Y | 0.00000 | 20160923 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127761161 | 12776116 | 1 | PS | CYCLOPHOSPHAMIDE FOR INJECTION, USP | CYCLOPHOSPHAMIDE | 1 | Unknown | CYCLE 1, HYPER CVAD REGIMEN | D | 40745 | POWDER FOR SOLUTION FOR INJECTION | /cycle | |||||||
| 127761161 | 12776116 | 2 | SS | IFOSFAMIDE FOR INJECTION | IFOSFAMIDE | 1 | Unknown | ONE CYCLE | D | 19763 | POWDER FOR SOLUTION FOR INFUSION | /cycle | |||||||
| 127761161 | 12776116 | 3 | SS | vincristine | VINCRISTINE | 1 | Unknown | CYCLE 1, HYPER CVAD REGIMEN | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 4 | SS | vincristine | VINCRISTINE | 1 | Unknown | 1 CYCLE, IFOSFAMIDE CONTAINING REGIMEN | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 5 | SS | vincristine | VINCRISTINE | 1 | Unknown | 24 CYCLES OF POMP MAINTENANCE | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 6 | SS | doxorubicin | DOXORUBICIN | 1 | Unknown | CYCLE 1, HYPER CVAD REGIMEN | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 7 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | CYCLE 1, HYPER CVAD REGIMEN | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 8 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | CYCLE 1, HYPER CVAD REGIMEN | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 9 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | CYCLE 2, HYPER CVAD REGIMEN | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 10 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 1 CYCLE, IFOSFAMIDE CONTAINING REGIMEN | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 11 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 24 CYCLES OF POMP MAINTENANCE | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 12 | SS | CYTARABINE. | CYTARABINE | 1 | Intrathecal | CYCLE 1, HYPER CVAD REGIMEN | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 13 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | CYCLE 2, HYPER CVAD REGIMEN | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 14 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | FLAG ARM | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 15 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | FLAG ARM | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 16 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | FLAG ARM | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 17 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | FLAG ARM | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 18 | SS | granulocyte colony-stimulating factor | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Unknown | FLAG ARM | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 19 | SS | granulocyte colony-stimulating factor | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Unknown | FLAG ARM | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 20 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | 1 CYCLE, IFOSFAMIDE CONTAINING REGIMEN | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 21 | SS | pegaspargase | PEGASPARGASE | 1 | Unknown | 1 CYCLE, IFOSFAMIDE CONTAINING REGIMEN | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 22 | SS | MERCAPTOPURINE. | MERCAPTOPURINE | 1 | Unknown | 24 CYCLES OF POMP MAINTENANCE | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 23 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 24 CYCLES OF POMP MAINTENANCE | D | 0 | /cycle | ||||||||
| 127761161 | 12776116 | 24 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | EVERY 6 HOURS AS NEEDED | 0 | 25 | MG | TABLET | Q6H | ||||||
| 127761161 | 12776116 | 25 | C | ZOVIRAX | ACYCLOVIR | 1 | Oral | 1 TABLET | 0 | TABLET | BID | ||||||||
| 127761161 | 12776116 | 26 | C | ZYLOPRIM | ALLOPURINOL | 1 | Oral | 3 TABLETS WITH FOOD | 0 | TABLET | QD | ||||||||
| 127761161 | 12776116 | 27 | C | CEFTIN | CEFUROXIME AXETIL | 1 | Oral | 2 TABLETS | 0 | TABLET | Q12H | ||||||||
| 127761161 | 12776116 | 28 | C | TEMOVATE | CLOBETASOL PROPIONATE | 1 | Topical | 0 | OINTMENT | BID | |||||||||
| 127761161 | 12776116 | 29 | C | DIFLUCAN | FLUCONAZOLE | 1 | Oral | 2 TABLETS | 0 | TABLET | QD | ||||||||
| 127761161 | 12776116 | 30 | C | ATIVAN | LORAZEPAM | 1 | Oral | 1 TABLET EVERY 4 HOURS AS NEEDED | 0 | TABLET | Q4H | ||||||||
| 127761161 | 12776116 | 31 | C | TOPROL XL | METOPROLOL SUCCINATE | 1 | Oral | EXTENDED RELEASE TABLET, 0.5 TABS BY MOUTH | 0 | TABLET | QD | ||||||||
| 127761161 | 12776116 | 32 | C | ROXICODONE | OXYCODONE HYDROCHLORIDE | 1 | Oral | 1 TABLET EVERY 4 HOURS AS NEEDED | 0 | TABLET | Q4H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127761161 | 12776116 | 1 | B-cell type acute leukaemia |
| 127761161 | 12776116 | 2 | Malignant neoplasm progression |
| 127761161 | 12776116 | 3 | B-cell type acute leukaemia |
| 127761161 | 12776116 | 4 | Malignant neoplasm progression |
| 127761161 | 12776116 | 5 | Chemotherapy |
| 127761161 | 12776116 | 6 | B-cell type acute leukaemia |
| 127761161 | 12776116 | 7 | B-cell type acute leukaemia |
| 127761161 | 12776116 | 8 | B-cell type acute leukaemia |
| 127761161 | 12776116 | 9 | Malignant neoplasm progression |
| 127761161 | 12776116 | 10 | Chemotherapy |
| 127761161 | 12776116 | 12 | B-cell type acute leukaemia |
| 127761161 | 12776116 | 16 | B-cell type acute leukaemia |
| 127761161 | 12776116 | 18 | B-cell type acute leukaemia |
| 127761161 | 12776116 | 20 | Malignant neoplasm progression |
| 127761161 | 12776116 | 21 | Malignant neoplasm progression |
| 127761161 | 12776116 | 22 | Chemotherapy |
| 127761161 | 12776116 | 23 | Chemotherapy |
| 127761161 | 12776116 | 24 | Hypersensitivity |
| 127761161 | 12776116 | 25 | Product used for unknown indication |
| 127761161 | 12776116 | 26 | Product used for unknown indication |
| 127761161 | 12776116 | 27 | Product used for unknown indication |
| 127761161 | 12776116 | 28 | Product used for unknown indication |
| 127761161 | 12776116 | 29 | Product used for unknown indication |
| 127761161 | 12776116 | 30 | Anxiety |
| 127761161 | 12776116 | 31 | Product used for unknown indication |
| 127761161 | 12776116 | 32 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127761161 | 12776116 | HO |
| 127761161 | 12776116 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127761161 | 12776116 | Acute lymphocytic leukaemia recurrent | |
| 127761161 | 12776116 | Blood bilirubin increased | |
| 127761161 | 12776116 | Malignant neoplasm progression |
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 |
|---|---|---|---|---|---|---|
| 127761161 | 12776116 | 1 | 20130727 | 20130912 | 0 | |
| 127761161 | 12776116 | 2 | 20130912 | 20131115 | 0 | |
| 127761161 | 12776116 | 3 | 20130727 | 20130912 | 0 | |
| 127761161 | 12776116 | 4 | 20130912 | 20131115 | 0 | |
| 127761161 | 12776116 | 5 | 20131218 | 20151116 | 0 | |
| 127761161 | 12776116 | 6 | 20130727 | 20130912 | 0 | |
| 127761161 | 12776116 | 7 | 20130727 | 20130912 | 0 | |
| 127761161 | 12776116 | 8 | 20130727 | 20130912 | 0 | |
| 127761161 | 12776116 | 9 | 20130727 | 20130912 | 0 | |
| 127761161 | 12776116 | 10 | 20130912 | 20131115 | 0 | |
| 127761161 | 12776116 | 11 | 20131218 | 20151116 | 0 | |
| 127761161 | 12776116 | 12 | 20130727 | 20130912 | 0 | |
| 127761161 | 12776116 | 13 | 20130727 | 20130912 | 0 | |
| 127761161 | 12776116 | 14 | 20130911 | 0 | ||
| 127761161 | 12776116 | 15 | 20130912 | 0 | ||
| 127761161 | 12776116 | 16 | 20130911 | 0 | ||
| 127761161 | 12776116 | 17 | 20130912 | 0 | ||
| 127761161 | 12776116 | 18 | 20130911 | 0 | ||
| 127761161 | 12776116 | 19 | 20130912 | 0 | ||
| 127761161 | 12776116 | 20 | 20130912 | 20131115 | 0 | |
| 127761161 | 12776116 | 21 | 20130912 | 20131115 | 0 | |
| 127761161 | 12776116 | 22 | 20131218 | 20151116 | 0 | |
| 127761161 | 12776116 | 23 | 20131218 | 20151116 | 0 |