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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127160012 | 12716001 | 2 | F | 20160429 | 20160824 | 20160906 | 20160906 | EXP | PHHY2016GR117018 | NOVARTIS | 5.70 | YR | M | Y | 0.00000 | 20160906 | CN | GR | GR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127160012 | 12716001 | 1 | PS | CICLOSPORIN | CYCLOSPORINE | 1 | Unknown | 4 MG/KG, UNK (FROM DAY 1) | U | 50574 | 4 | MG/KG | |||||||
| 127160012 | 12716001 | 2 | SS | ARACYTIN | CYTARABINE | 1 | Unknown | 0 | SOLUTION FOR INJECTION | ||||||||||
| 127160012 | 12716001 | 3 | SS | IDARUBICIN HCL | IDARUBICIN HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 127160012 | 12716001 | 4 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | 1000 MG/M2 (1 GR/M2), UNK | U | 0 | 1000 | MG/M**2 | |||||||
| 127160012 | 12716001 | 5 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | 3.10 MG/M2, UNK (DAY +1 AND +3) | U | 0 | 3.1 | MG/M**2 | |||||||
| 127160012 | 12716001 | 6 | SS | CLOFARABINE | CLOFARABINE | 1 | Unknown | U | 0 | ||||||||||
| 127160012 | 12716001 | 7 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | U | 0 | ||||||||||
| 127160012 | 12716001 | 8 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Unknown | U | 0 | ||||||||||
| 127160012 | 12716001 | 9 | SS | ERWINASE//ASPARAGINASE | ASPARAGINASE ERWINIA CHRYSANTHEMI | 1 | Unknown | 0 | |||||||||||
| 127160012 | 12716001 | 10 | SS | ONCOVIN | VINCRISTINE SULFATE | 1 | Unknown | 0 | |||||||||||
| 127160012 | 12716001 | 11 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 0 | |||||||||||
| 127160012 | 12716001 | 12 | SS | FLUDARA | FLUDARABINE PHOSPHATE | 1 | Unknown | 30 MG/KG, (1 X 5 DAYS) | U | 0 | 30 | MG/KG | |||||||
| 127160012 | 12716001 | 13 | SS | BUSILVEX | BUSULFAN | 1 | Unknown | 1.1 MG/KG, UNK (16 DOSES) | U | 0 | 1.1 | MG/KG | |||||||
| 127160012 | 12716001 | 14 | SS | THIOTEPA. | THIOTEPA | 1 | Unknown | 5 MG/KG, (X 2 X 1 DAY) | U | 0 | 5 | MG/KG | |||||||
| 127160012 | 12716001 | 15 | SS | ATG//ANTITHYMOCYTE IMMUNOGLOBULIN | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Unknown | 7.5 MG/KG, UNK (TOTAL DOSE) | U | 0 | 7.5 | MG/KG | |||||||
| 127160012 | 12716001 | 16 | SS | FLUDARABIN | FLUDARABINE PHOSPHATE | 1 | Unknown | U | 0 | ||||||||||
| 127160012 | 12716001 | 17 | SS | 6-MERCAPTOPURINE MONOHYDRATE | MERCAPTOPURINE | 1 | Unknown | UNK UNK, QD | U | 0 | QD | ||||||||
| 127160012 | 12716001 | 18 | SS | ASPARAGINASE MEDAC | ASPARAGINASE | 1 | Unknown | U | 0 | ||||||||||
| 127160012 | 12716001 | 19 | SS | ONCASPAR | PEGASPARGASE | 1 | Unknown | U | 0 | ||||||||||
| 127160012 | 12716001 | 20 | SS | TARGOCID | TEICOPLANIN | 1 | Unknown | U | 0 | ||||||||||
| 127160012 | 12716001 | 21 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
| 127160012 | 12716001 | 22 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 127160012 | 12716001 | 23 | SS | ASPARAGINASE | ASPARAGINASE | 1 | Unknown | UNK | U | 0 | |||||||||
| 127160012 | 12716001 | 24 | SS | VINCRISTINE | VINCRISTINE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127160012 | 12716001 | 1 | Graft versus host disease |
| 127160012 | 12716001 | 2 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 3 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 4 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 6 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 7 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 8 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 9 | Product used for unknown indication |
| 127160012 | 12716001 | 10 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 11 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 12 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 13 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 14 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 15 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 16 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 17 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 18 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 19 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 20 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 21 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 22 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 23 | Acute lymphocytic leukaemia |
| 127160012 | 12716001 | 24 | Acute lymphocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127160012 | 12716001 | HO |
| 127160012 | 12716001 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127160012 | 12716001 | Acute lymphocytic leukaemia recurrent | |
| 127160012 | 12716001 | Bacterial sepsis | |
| 127160012 | 12716001 | Bone marrow leukaemic cell infiltration | |
| 127160012 | 12716001 | Epstein-Barr virus infection | |
| 127160012 | 12716001 | Febrile neutropenia | |
| 127160012 | 12716001 | Hepatosplenomegaly | |
| 127160012 | 12716001 | Hypersensitivity | |
| 127160012 | 12716001 | Platelet count increased | |
| 127160012 | 12716001 | Pseudomonal sepsis | |
| 127160012 | 12716001 | Serratia 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 |
|---|---|---|---|---|---|---|
| 127160012 | 12716001 | 17 | 20150310 | 0 | ||
| 127160012 | 12716001 | 22 | 20140612 | 0 | ||
| 127160012 | 12716001 | 23 | 20140612 | 0 | ||
| 127160012 | 12716001 | 24 | 20140612 | 0 |