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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127626421 | 12762642 | 1 | I | 20160819 | 20160825 | 20160920 | 20160920 | EXP | IT-OTSUKA-2016_022317 | OTSUKA | 0.00 | M | Y | 100.00000 | KG | 20160920 | MD | IT | IT |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127626421 | 12762642 | 1 | PS | BUSULFAN. | BUSULFAN | 1 | Intravenous (not otherwise specified) | 260 MG DAILY | 520 | MG | D | U | 20954 | 260 | MG | INJECTION | QD | ||
127626421 | 12762642 | 2 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 60 MG DAILY | 300 | MG | D | 0 | 60 | MG | QD | ||||
127626421 | 12762642 | 3 | SS | ANTI-HUMANLYMPHOZYTEN-GLOBULIN | THYMOCYTE IMMUNE GLOBULIN NOS | 1 | Intravenous (not otherwise specified) | 820 MG DAILY | 2460 | MG | D | 0 | 820 | MG | QD |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
127626421 | 12762642 | 1 | Bone marrow conditioning regimen |
127626421 | 12762642 | 2 | Bone marrow conditioning regimen |
127626421 | 12762642 | 3 | Bone marrow conditioning regimen |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
127626421 | 12762642 | LT |
127626421 | 12762642 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
127626421 | 12762642 | Acute respiratory distress syndrome |
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 |
---|---|---|---|---|---|---|
127626421 | 12762642 | 1 | 20160729 | 20160730 | 0 | |
127626421 | 12762642 | 2 | 20160727 | 20160731 | 0 | |
127626421 | 12762642 | 3 | 20160729 | 20160731 | 0 |