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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125524042 | 12552404 | 2 | F | 20150216 | 20160822 | 20160713 | 20160826 | EXP | ES-ASTELLAS-2016US026035 | ASTELLAS | 60.19 | YR | F | Y | 0.00000 | 20160826 | CN | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125524042 | 12552404 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | 50708 | FORMULATION UNKNOWN | |||||||||
| 125524042 | 12552404 | 2 | SS | INOTUZUMAB OZOGAMICIN | INOTUZUMAB OZOGAMICIN | 1 | 0 | ||||||||||||
| 125524042 | 12552404 | 3 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | UNK, UNKNOWN FREQ. | 0 | FORMULATION UNKNOWN | |||||||||
| 125524042 | 12552404 | 4 | SS | VINCRISTINE | VINCRISTINE | 1 | Unknown | UNK, UNKNOWN FREQ. | 0 | FORMULATION UNKNOWN | |||||||||
| 125524042 | 12552404 | 5 | SS | FLUDARABINE PHOSPHATE. | FLUDARABINE PHOSPHATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | 0 | FORMULATION UNKNOWN | |||||||||
| 125524042 | 12552404 | 6 | SS | FLUDARABINE PHOSPHATE. | FLUDARABINE PHOSPHATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | 0 | FORMULATION UNKNOWN | |||||||||
| 125524042 | 12552404 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | 0 | FORMULATION UNKNOWN | |||||||||
| 125524042 | 12552404 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | 0 | FORMULATION UNKNOWN | |||||||||
| 125524042 | 12552404 | 9 | SS | G-CSF | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | 0 | FORMULATION UNKNOWN | |||||||||
| 125524042 | 12552404 | 10 | SS | MELPHALAN | MELPHALAN | 1 | Unknown | UNK, UNKNOWN FREQ. | 0 | FORMULATION UNKNOWN | |||||||||
| 125524042 | 12552404 | 11 | SS | RAPAMYCIN | SIROLIMUS | 1 | Unknown | UNK, UNKNOWN FREQ. | 0 | FORMULATION UNKNOWN | |||||||||
| 125524042 | 12552404 | 12 | C | ASPARAGINASE | ASPARAGINASE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 125524042 | 12552404 | 13 | C | IDARUBICIN | IDARUBICIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 125524042 | 12552404 | 14 | C | BLINATUMOMAB | BLINATUMOMAB | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125524042 | 12552404 | 1 | Prophylaxis against graft versus host disease |
| 125524042 | 12552404 | 3 | Acute lymphocytic leukaemia |
| 125524042 | 12552404 | 4 | Acute lymphocytic leukaemia recurrent |
| 125524042 | 12552404 | 5 | Acute lymphocytic leukaemia recurrent |
| 125524042 | 12552404 | 7 | Acute lymphocytic leukaemia recurrent |
| 125524042 | 12552404 | 9 | Acute lymphocytic leukaemia recurrent |
| 125524042 | 12552404 | 10 | Bone marrow conditioning regimen |
| 125524042 | 12552404 | 11 | Prophylaxis against graft versus host disease |
| 125524042 | 12552404 | 12 | Acute lymphocytic leukaemia recurrent |
| 125524042 | 12552404 | 13 | Acute lymphocytic leukaemia recurrent |
| 125524042 | 12552404 | 14 | Acute lymphocytic leukaemia recurrent |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125524042 | 12552404 | OT |
| 125524042 | 12552404 | DE |
| 125524042 | 12552404 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125524042 | 12552404 | Acute lymphocytic leukaemia | |
| 125524042 | 12552404 | Disease progression | |
| 125524042 | 12552404 | Disease recurrence | |
| 125524042 | 12552404 | Graft versus host disease | |
| 125524042 | 12552404 | Off label use | |
| 125524042 | 12552404 | Pleural effusion |
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 |
|---|---|---|---|---|---|---|
| 125524042 | 12552404 | 1 | 201505 | 20151108 | 0 | |
| 125524042 | 12552404 | 3 | 20141001 | 0 | ||
| 125524042 | 12552404 | 4 | 20141117 | 0 | ||
| 125524042 | 12552404 | 5 | 20141001 | 0 | ||
| 125524042 | 12552404 | 6 | 201505 | 0 | ||
| 125524042 | 12552404 | 7 | 20141117 | 0 | ||
| 125524042 | 12552404 | 8 | 20160408 | 0 | ||
| 125524042 | 12552404 | 9 | 20141001 | 0 | ||
| 125524042 | 12552404 | 10 | 201505 | 0 | ||
| 125524042 | 12552404 | 11 | 201505 | 20160323 | 0 | |
| 125524042 | 12552404 | 12 | 20141117 | 0 | ||
| 125524042 | 12552404 | 13 | 20141001 | 0 | ||
| 125524042 | 12552404 | 14 | 20150414 | 20150512 | 0 |