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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126780891 | 12678089 | 1 | I | 20140620 | 20140704 | 20160823 | 20160823 | EXP | JP-SA-2014SA090715 | AVENTIS | NISHIKAWA T, ABEMATSU T, NAKAGAWA S, KURAUCHI K, KODAMA Y, TANABE T ET ALL. CLOFARABINE-BASED COMBINATION CHEMOTHERAPY FOR RECURRENT AND REFRACTORY CHILDHOOD HEMATOLOGICAL TUMOUR. THE JAPANESE JOURNAL OF CLINICAL HEMATOLOGY/; THE 5THKYUSHU REGIONAL MEETING OF THE JAPANESE SOCIETY OF HEMATOLOGY (14 MARCH, 2015)/FUKUOKA CITY, FUKUOKA PREFECTURE 56(5)522/(MAY 2015). | 12.00 | YR | T | M | Y | 0.00000 | 20160823 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126780891 | 12678089 | 1 | PS | EVOLTRA | CLOFARABINE | 1 | Intravenous (not otherwise specified) | UNKNOWN | 21673 | 40 | MG/M**2 | SOLUTION FOR INFUSION | QD | ||||||
| 126780891 | 12678089 | 2 | SS | EVOLTRA | CLOFARABINE | 1 | Intravenous (not otherwise specified) | UNKNOWN | 21673 | 40 | MG/M**2 | SOLUTION FOR INFUSION | QD | ||||||
| 126780891 | 12678089 | 3 | SS | DECADRON | DEXAMETHASONE | 1 | Oral | UNKNOWN | 0 | 10 | MG/M**2 | QD | |||||||
| 126780891 | 12678089 | 4 | SS | DECADRON | DEXAMETHASONE | 1 | Oral | UNKNOWN | 0 | 10 | MG/M**2 | QD | |||||||
| 126780891 | 12678089 | 5 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | 0 | 150 | MG/M**2 | QD | ||||||||
| 126780891 | 12678089 | 6 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | 0 | 150 | MG/M**2 | QD | ||||||||
| 126780891 | 12678089 | 7 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 0 | 400 | MG/M**2 | QD | ||||||||
| 126780891 | 12678089 | 8 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 0 | 400 | MG/M**2 | QD | ||||||||
| 126780891 | 12678089 | 9 | C | METHOTREXATE. | METHOTREXATE | 1 | ROUTE: INTRASPINAL INJECTION | 0 | 12 | MG | |||||||||
| 126780891 | 12678089 | 10 | C | METHOTREXATE. | METHOTREXATE | 1 | ROUTE: INTRASPINAL INJECTION | 0 | 12 | MG | |||||||||
| 126780891 | 12678089 | 11 | C | METHOTREXATE. | METHOTREXATE | 1 | ROUTE: INTRASPINAL INJECTION | 0 | 12 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126780891 | 12678089 | 1 | Acute lymphocytic leukaemia recurrent |
| 126780891 | 12678089 | 2 | Acute lymphocytic leukaemia recurrent |
| 126780891 | 12678089 | 3 | Acute lymphocytic leukaemia |
| 126780891 | 12678089 | 4 | Acute lymphocytic leukaemia |
| 126780891 | 12678089 | 5 | Acute lymphocytic leukaemia recurrent |
| 126780891 | 12678089 | 6 | Acute lymphocytic leukaemia recurrent |
| 126780891 | 12678089 | 7 | Acute lymphocytic leukaemia recurrent |
| 126780891 | 12678089 | 8 | Acute lymphocytic leukaemia recurrent |
| 126780891 | 12678089 | 9 | Acute lymphocytic leukaemia recurrent |
| 126780891 | 12678089 | 10 | Acute lymphocytic leukaemia recurrent |
| 126780891 | 12678089 | 11 | Acute lymphocytic leukaemia recurrent |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126780891 | 12678089 | HO |
| 126780891 | 12678089 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126780891 | 12678089 | Alanine aminotransferase increased | |
| 126780891 | 12678089 | Anaemia | |
| 126780891 | 12678089 | Aspartate aminotransferase increased | |
| 126780891 | 12678089 | Febrile neutropenia | |
| 126780891 | 12678089 | Lip swelling | |
| 126780891 | 12678089 | Mucous membrane disorder | |
| 126780891 | 12678089 | Platelet count decreased | |
| 126780891 | 12678089 | White blood cell 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 |
|---|---|---|---|---|---|---|
| 126780891 | 12678089 | 1 | 20140619 | 20140623 | 0 | |
| 126780891 | 12678089 | 2 | 20140717 | 20140721 | 0 | |
| 126780891 | 12678089 | 3 | 20140619 | 20140623 | 0 | |
| 126780891 | 12678089 | 4 | 20140717 | 20140721 | 0 | |
| 126780891 | 12678089 | 5 | 20140619 | 20140623 | 0 | |
| 126780891 | 12678089 | 6 | 20140717 | 20140721 | 0 | |
| 126780891 | 12678089 | 7 | 20140619 | 20140623 | 0 | |
| 126780891 | 12678089 | 8 | 20140717 | 20140721 | 0 | |
| 126780891 | 12678089 | 9 | 20140721 | 20140721 | 0 | |
| 126780891 | 12678089 | 10 | 20140716 | 20140716 | 0 | |
| 126780891 | 12678089 | 11 | 20140618 | 20140618 | 0 |