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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126628242 | 12662824 | 2 | F | 20160531 | 20160830 | 20160818 | 20160906 | EXP | GB-PFIZER INC-2016384175 | PFIZER | 6.00 | YR | M | Y | 0.00000 | 20160906 | MD | GB | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126628242 | 12662824 | 1 | PS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | 10 MG/M2 | U | 11719 | 10 | MG/M**2 | ||||||||
| 126628242 | 12662824 | 2 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | 10 MG/M2 | U | 11719 | 10 | MG/M**2 | ||||||||
| 126628242 | 12662824 | 3 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | 4 MG/KG (FROM DAY -1) | U | 0 | 4 | MG/KG | ||||||||
| 126628242 | 12662824 | 4 | SS | BUSILVEX | BUSULFAN | 1 | 1.1 MG/KG X 16 DOSES | U | 0 | 1.1 | MG/KG | ||||||||
| 126628242 | 12662824 | 5 | SS | FLUDARA | FLUDARABINE PHOSPHATE | 1 | 30 MG/KG X 1 X 5 DAYS | U | 0 | 30 | MG/KG | ||||||||
| 126628242 | 12662824 | 6 | SS | TEPADINA | THIOTEPA | 1 | 5 MG/KG X 2 X 1 DAY | U | 0 | 5 | MG/KG | BID | |||||||
| 126628242 | 12662824 | 7 | SS | ATG /00575401/ | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | 7.5 MG/KG TOTAL DOSE | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126628242 | 12662824 | 1 | Prophylaxis against graft versus host disease |
| 126628242 | 12662824 | 3 | Prophylaxis against graft versus host disease |
| 126628242 | 12662824 | 4 | Acute lymphocytic leukaemia |
| 126628242 | 12662824 | 5 | Acute lymphocytic leukaemia |
| 126628242 | 12662824 | 7 | Acute lymphocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126628242 | 12662824 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126628242 | 12662824 | Epstein-Barr virus infection | |
| 126628242 | 12662824 | Febrile neutropenia | |
| 126628242 | 12662824 | Leukaemia recurrent |
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 |
|---|---|---|---|---|---|---|
| 126628242 | 12662824 | 1 | 20160420 | 0 | ||
| 126628242 | 12662824 | 2 | 20160422 | 0 | ||
| 126628242 | 12662824 | 3 | 20160418 | 0 | ||
| 126628242 | 12662824 | 4 | 20160307 | 0 | ||
| 126628242 | 12662824 | 5 | 20160307 | 0 | ||
| 126628242 | 12662824 | 6 | 20160307 | 0 | ||
| 126628242 | 12662824 | 7 | 20160307 | 0 |