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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123006562 | 12300656 | 2 | F | 20160810 | 20160425 | 20160817 | EXP | CA-ASTELLAS-2016US015407 | ASTELLAS | DYBA J, TINMOUTH A, BREDESON C, MATTHEWS J, ALLAN DS. ELTROMBOPAG AFTER ALLOGENEIC HAEMATOPOIETIC CELL TRANSPLANTATION IN A CASE OF POOR GRAFT FUNCTION AND SYSTEMATIC REVIEW OF THE LITERATURE. TRANSFUSION MEDICINE. 2016;6(3):202-7 | 56.00 | YR | F | Y | 0.00000 | 20160817 | MD | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123006562 | 12300656 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 50708 | FORMULATION UNKNOWN | ||||||||
| 123006562 | 12300656 | 2 | C | ANTITHYMOCYTE IMMUNOGLOBULIN | THYMOCYTE IMMUNE GLOBULIN NOS | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 123006562 | 12300656 | 3 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 50 MG/KG, ONCE DAILY FOR 4 DAYS | U | 0 | 50 | MG/KG | FORMULATION UNKNOWN | QD | |||||
| 123006562 | 12300656 | 4 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. (ON DAYS 1, 3, 6 AND 11) | U | 0 | FORMULATION UNKNOWN | ||||||||
| 123006562 | 12300656 | 5 | C | BUSULFAN. | BUSULFAN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123006562 | 12300656 | 1 | Stem cell transplant |
| 123006562 | 12300656 | 2 | Stem cell transplant |
| 123006562 | 12300656 | 3 | Bone marrow conditioning regimen |
| 123006562 | 12300656 | 4 | Stem cell transplant |
| 123006562 | 12300656 | 5 | Bone marrow conditioning regimen |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123006562 | 12300656 | OT |
| 123006562 | 12300656 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123006562 | 12300656 | Anaemia | |
| 123006562 | 12300656 | Aspergillus infection | |
| 123006562 | 12300656 | Bacteraemia | |
| 123006562 | 12300656 | Bacterial infection | |
| 123006562 | 12300656 | Cytomegalovirus infection | |
| 123006562 | 12300656 | Infection | |
| 123006562 | 12300656 | Off label use | |
| 123006562 | 12300656 | Pneumonia | |
| 123006562 | 12300656 | Subdural haematoma | |
| 123006562 | 12300656 | Thrombocytopenia | |
| 123006562 | 12300656 | Transplant dysfunction |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |