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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126927591 | 12692759 | 1 | I | 20160530 | 20160829 | 20160829 | EXP | IN-MLMSERVICE-20160810-0390355-7 | IN-ACCORD-043458 | ACCORD | JAISWAL SR, CHAKRABARTI A, CHATTERJEE S, RAY K, CHAKRABARTI S. HAPLOIDENTICAL TRANSPLANTATION IN CHILDREN WITH UNMANIPULATED PERIPHERAL BLOOD STEM CELL GRAFT: THE NEED TO LOOK BEYOND POST-TRANSPLANTATION CYCLOPHOSPHAMIDE IN YOUNGER CHILDREN. PEDIATRIC TRANSPLANTATION. 2016; 20(5): 675-682. | 5.00 | YR | C | M | Y | 0.00000 | 20160829 | MD | IN | IN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126927591 | 12692759 | 1 | PS | MYCOPHENOLIC ACID. | MYCOPHENOLIC ACID | 1 | IN ORAL SUSPENSION OR TABLET FORM | 65416 | 15 | MG/KG | TID | ||||||||
| 126927591 | 12692759 | 2 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | TWO DIVIDED DOSES | 0 | 3 | MG/KG | ||||||||
| 126927591 | 12692759 | 3 | SS | CYCLOPHOSPHAMIDE/CYCLOPHOSPHAMIDE MONOHYDRATE | CYCLOPHOSPHAMIDE | 1 | ON DAYS 3 AND 4 | 0 | 50 | MG/KG | |||||||||
| 126927591 | 12692759 | 4 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | FOR FIVE DAYS FROM DAY 6 | 0 | 30 | MG/M**2 | |||||||||
| 126927591 | 12692759 | 5 | SS | BUSULFAN. | BUSULFAN | 1 | FOR 12 DOSES | 0 | .8 | MG/KG | Q6H | ||||||||
| 126927591 | 12692759 | 6 | SS | MELPHALAN | MELPHALAN | 1 | ON DAY 1 | 0 | 140 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126927591 | 12692759 | 1 | Prophylaxis against graft versus host disease |
| 126927591 | 12692759 | 2 | Prophylaxis against graft versus host disease |
| 126927591 | 12692759 | 3 | Prophylaxis against graft versus host disease |
| 126927591 | 12692759 | 4 | Acute lymphocytic leukaemia |
| 126927591 | 12692759 | 5 | Acute lymphocytic leukaemia |
| 126927591 | 12692759 | 6 | Acute lymphocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126927591 | 12692759 | LT |
| 126927591 | 12692759 | OT |
| 126927591 | 12692759 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126927591 | 12692759 | Acute graft versus host disease | |
| 126927591 | 12692759 | Aspergillus infection | |
| 126927591 | 12692759 | Drug ineffective | |
| 126927591 | 12692759 | Pneumonia cytomegaloviral |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |