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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105639474 | 10563947 | 4 | F | 20140926 | 20160912 | 20141104 | 20160916 | EXP | JP-SA-2014SA148303 | AVENTIS | 12.00 | YR | T | M | Y | 0.00000 | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105639474 | 10563947 | 1 | PS | EVOLTRA | CLOFARABINE | 1 | Intravenous (not otherwise specified) | EVOLTRA (20 MG) | Y | UNKNOWN | 21673 | 52 | MG/M**2 | SOLUTION FOR INFUSION | QD | ||||
| 105639474 | 10563947 | 2 | SS | EVOLTRA | CLOFARABINE | 1 | Intravenous (not otherwise specified) | Y | UNKNOWN | 21673 | 60 | MG | SOLUTION FOR INFUSION | QD | |||||
| 105639474 | 10563947 | 3 | SS | EVOLTRA | CLOFARABINE | 1 | Intravenous (not otherwise specified) | Y | UNKNOWN | 21673 | 60 | MG | SOLUTION FOR INFUSION | QD | |||||
| 105639474 | 10563947 | 4 | SS | EVOLTRA | CLOFARABINE | 1 | Intravenous (not otherwise specified) | Y | UNKNOWN | 21673 | 60 | MG | SOLUTION FOR INFUSION | QD | |||||
| 105639474 | 10563947 | 5 | SS | EVOLTRA | CLOFARABINE | 1 | Intravenous (not otherwise specified) | Y | UNKNOWN | 21673 | 60 | MG | SOLUTION FOR INFUSION | QD | |||||
| 105639474 | 10563947 | 6 | SS | EVOLTRA | CLOFARABINE | 1 | Intravenous (not otherwise specified) | Y | UNKNOWN | 21673 | 60 | MG | SOLUTION FOR INFUSION | QD | |||||
| 105639474 | 10563947 | 7 | SS | VORICONAZOLE. | VORICONAZOLE | 1 | DOSE: 180 MG BID (I.V.) OR 200 MG/DAY, BID (P.O.) | U | UNKNOWN | 0 | BID | ||||||||
| 105639474 | 10563947 | 8 | SS | MICAFUNGIN | MICAFUNGIN | 1 | Unknown | U | UNKNOWN | 0 | 225 | MG | QD | ||||||
| 105639474 | 10563947 | 9 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | 1000 | MG/M**2 | |||||||
| 105639474 | 10563947 | 10 | SS | LEUKERIN | MERCAPTOPURINE | 1 | Oral | U | UNKNOWN | 0 | 60 | MG/M**2 | |||||||
| 105639474 | 10563947 | 11 | SS | LEUKERIN | MERCAPTOPURINE | 1 | Oral | U | UNKNOWN | 0 | 60 | MG/M**2 | |||||||
| 105639474 | 10563947 | 12 | SS | CYLOCIDE | CYTARABINE | 1 | 25 MG/M2 OR BODY??IV OR INTRASEPTAL | U | UNKNOWN | 0 | |||||||||
| 105639474 | 10563947 | 13 | SS | CYLOCIDE | CYTARABINE | 1 | 25 MG/M2 OR BODY??IV OR INTRASEPTAL | U | UNKNOWN | 0 | |||||||||
| 105639474 | 10563947 | 14 | SS | CYLOCIDE | CYTARABINE | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | 75 | MG/M**2 | |||||||
| 105639474 | 10563947 | 15 | SS | CYLOCIDE | CYTARABINE | 1 | Intradiscal (intraspinal) | DOSE: 25 MG/BODY | U | UNKNOWN | 0 | 25 | MG | ||||||
| 105639474 | 10563947 | 16 | SS | CYLOCIDE | CYTARABINE | 1 | Intradiscal (intraspinal) | DOSE: 25 MG/BODY | U | UNKNOWN | 0 | 25 | MG | ||||||
| 105639474 | 10563947 | 17 | SS | CYLOCIDE | CYTARABINE | 1 | Intradiscal (intraspinal) | DOSE: 25 MG/BODY | U | UNKNOWN | 0 | 25 | MG | ||||||
| 105639474 | 10563947 | 18 | SS | CYLOCIDE | CYTARABINE | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | 75 | MG/M**2 | |||||||
| 105639474 | 10563947 | 19 | SS | CYLOCIDE | CYTARABINE | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 0 | 75 | MG/M**2 | |||||||
| 105639474 | 10563947 | 20 | C | PENTCILLIN | PIPERACILLIN SODIUM | 1 | Intravenous (not otherwise specified) | 0 | 2 | G | |||||||||
| 105639474 | 10563947 | 21 | C | METHOTREXATE. | METHOTREXATE | 1 | 12.5 MG/BODY INTRASPINAL | 0 | 12.5 | MG | |||||||||
| 105639474 | 10563947 | 22 | C | METHOTREXATE. | METHOTREXATE | 1 | 12.5 MG/BODY INTRASPINAL | 0 | 12.5 | MG | |||||||||
| 105639474 | 10563947 | 23 | C | METHOTREXATE. | METHOTREXATE | 1 | 12.5 MG/BODY INTRASPINAL | 0 | 12.5 | MG | |||||||||
| 105639474 | 10563947 | 24 | C | METHOTREXATE. | METHOTREXATE | 1 | 12.5 MG/BODY INTRASPINAL | 0 | 12.5 | MG | |||||||||
| 105639474 | 10563947 | 25 | C | METHOTREXATE. | METHOTREXATE | 1 | 12.5 MG/BODY INTRASPINAL | 0 | 12.5 | MG | |||||||||
| 105639474 | 10563947 | 26 | C | METHOTREXATE. | METHOTREXATE | 1 | 12.5 MG/BODY INTRASPINAL | 0 | 12.5 | MG | |||||||||
| 105639474 | 10563947 | 27 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | 25 MG/BODY INTRASPINAL | 0 | 25 | MG | |||||||||
| 105639474 | 10563947 | 28 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | 25 MG/BODY INTRASPINAL | 0 | 25 | MG | |||||||||
| 105639474 | 10563947 | 29 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | 25 MG/BODY INTRASPINAL | 0 | 25 | MG | |||||||||
| 105639474 | 10563947 | 30 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | 25 MG/BODY INTRASPINAL | 0 | 25 | MG | |||||||||
| 105639474 | 10563947 | 31 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | 25 MG/BODY INTRASPINAL | 0 | 25 | MG | |||||||||
| 105639474 | 10563947 | 32 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | 25 MG/BODY INTRASPINAL | 0 | 25 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 105639474 | 10563947 | 1 | Acute lymphocytic leukaemia recurrent |
| 105639474 | 10563947 | 2 | Acute lymphocytic leukaemia recurrent |
| 105639474 | 10563947 | 3 | Acute lymphocytic leukaemia recurrent |
| 105639474 | 10563947 | 4 | Acute lymphocytic leukaemia recurrent |
| 105639474 | 10563947 | 5 | Acute lymphocytic leukaemia recurrent |
| 105639474 | 10563947 | 6 | Acute lymphocytic leukaemia recurrent |
| 105639474 | 10563947 | 9 | Acute lymphocytic leukaemia recurrent |
| 105639474 | 10563947 | 10 | Acute lymphocytic leukaemia recurrent |
| 105639474 | 10563947 | 11 | Acute lymphocytic leukaemia recurrent |
| 105639474 | 10563947 | 12 | Acute lymphocytic leukaemia recurrent |
| 105639474 | 10563947 | 13 | Acute lymphocytic leukaemia recurrent |
| 105639474 | 10563947 | 14 | Acute lymphocytic leukaemia recurrent |
| 105639474 | 10563947 | 15 | Acute lymphocytic leukaemia recurrent |
| 105639474 | 10563947 | 16 | Acute lymphocytic leukaemia recurrent |
| 105639474 | 10563947 | 17 | Acute lymphocytic leukaemia recurrent |
| 105639474 | 10563947 | 18 | Acute lymphocytic leukaemia recurrent |
| 105639474 | 10563947 | 19 | Acute lymphocytic leukaemia recurrent |
| 105639474 | 10563947 | 20 | Pancreatitis chronic |
| 105639474 | 10563947 | 21 | Acute lymphocytic leukaemia |
| 105639474 | 10563947 | 22 | Acute lymphocytic leukaemia |
| 105639474 | 10563947 | 23 | Acute lymphocytic leukaemia |
| 105639474 | 10563947 | 24 | Acute lymphocytic leukaemia |
| 105639474 | 10563947 | 25 | Acute lymphocytic leukaemia |
| 105639474 | 10563947 | 26 | Acute lymphocytic leukaemia |
| 105639474 | 10563947 | 27 | Acute lymphocytic leukaemia |
| 105639474 | 10563947 | 28 | Acute lymphocytic leukaemia |
| 105639474 | 10563947 | 29 | Acute lymphocytic leukaemia |
| 105639474 | 10563947 | 30 | Acute lymphocytic leukaemia |
| 105639474 | 10563947 | 31 | Acute lymphocytic leukaemia |
| 105639474 | 10563947 | 32 | Acute lymphocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 105639474 | 10563947 | OT |
| 105639474 | 10563947 | HO |
| 105639474 | 10563947 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 105639474 | 10563947 | Cystitis viral | |
| 105639474 | 10563947 | Hypercalcaemia | |
| 105639474 | 10563947 | Liver disorder | |
| 105639474 | 10563947 | Lymphocyte count decreased | |
| 105639474 | 10563947 | Pancreatitis | |
| 105639474 | 10563947 | Renal impairment |
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 |
|---|---|---|---|---|---|---|
| 105639474 | 10563947 | 1 | 20140923 | 20140925 | 0 | |
| 105639474 | 10563947 | 2 | 20141013 | 20141016 | 0 | |
| 105639474 | 10563947 | 3 | 20150514 | 20150518 | 0 | |
| 105639474 | 10563947 | 4 | 20141113 | 20141116 | 0 | |
| 105639474 | 10563947 | 5 | 20150806 | 20150810 | 0 | |
| 105639474 | 10563947 | 6 | 20150212 | 20150215 | 0 | |
| 105639474 | 10563947 | 7 | 20140823 | 20150813 | 0 | |
| 105639474 | 10563947 | 8 | 20140817 | 20150115 | 0 | |
| 105639474 | 10563947 | 9 | 20141208 | 20141208 | 0 | |
| 105639474 | 10563947 | 10 | 20141208 | 0 | ||
| 105639474 | 10563947 | 11 | 201412 | 20141225 | 0 | |
| 105639474 | 10563947 | 12 | 20141020 | 20141020 | 0 | |
| 105639474 | 10563947 | 13 | 20141118 | 20141118 | 0 | |
| 105639474 | 10563947 | 14 | 20141219 | 20141223 | 0 | |
| 105639474 | 10563947 | 15 | 20150217 | 20150217 | 0 | |
| 105639474 | 10563947 | 16 | 20150520 | 20150520 | 0 | |
| 105639474 | 10563947 | 17 | 20150812 | 20150812 | 0 | |
| 105639474 | 10563947 | 18 | 20141208 | 20141208 | 0 | |
| 105639474 | 10563947 | 19 | 20141213 | 20141216 | 0 | |
| 105639474 | 10563947 | 20 | 20140910 | 20140925 | 0 | |
| 105639474 | 10563947 | 21 | 20141020 | 20141020 | 0 | |
| 105639474 | 10563947 | 22 | 20141118 | 20141118 | 0 | |
| 105639474 | 10563947 | 23 | 20141208 | 20141208 | 0 | |
| 105639474 | 10563947 | 24 | 20150217 | 20150217 | 0 | |
| 105639474 | 10563947 | 25 | 20150520 | 20150520 | 0 | |
| 105639474 | 10563947 | 26 | 20150812 | 20150812 | 0 | |
| 105639474 | 10563947 | 27 | 20141020 | 20141020 | 0 | |
| 105639474 | 10563947 | 28 | 20141118 | 20141118 | 0 | |
| 105639474 | 10563947 | 29 | 20141208 | 20141208 | 0 | |
| 105639474 | 10563947 | 30 | 20150217 | 20150217 | 0 | |
| 105639474 | 10563947 | 31 | 20150520 | 20150520 | 0 | |
| 105639474 | 10563947 | 32 | 20150812 | 20150812 | 0 |