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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125301051 | 12530105 | 1 | I | 20160511 | 20160512 | 20160706 | 20160706 | EXP | DE-TEVA-662893ISR | TEVA | 63.00 | YR | M | Y | 82.00000 | KG | 20160706 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125301051 | 12530105 | 1 | PS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 60.4 MILLIGRAM DAILY; | 76349 | ||||||||||
| 125301051 | 12530105 | 2 | SS | BUSULFAN (PIERRE FABRE) | BUSULFAN | 1 | Intravenous (not otherwise specified) | 65.4 MILLIGRAM DAILY; | 0 | ||||||||||
| 125301051 | 12530105 | 3 | C | ATG | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 817 MILLIGRAM DAILY; | 0 |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125301051 | 12530105 | DE |
| 125301051 | 12530105 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125301051 | 12530105 | Sepsis | |
| 125301051 | 12530105 | Venoocclusive liver disease |
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 |
|---|---|---|---|---|---|---|
| 125301051 | 12530105 | 1 | 20160505 | 20160509 | 0 | |
| 125301051 | 12530105 | 2 | 20160507 | 20160508 | 0 | |
| 125301051 | 12530105 | 3 | 20160507 | 20160509 | 0 |