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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126679352 | 12667935 | 2 | F | 20160830 | 20160819 | 20160906 | EXP | IN-SA-2016SA152320 | AVENTIS | 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. PEDIATR TRANSPLANTATION. 2016;20(5):675-82. DOI: 10.1111/PETR.12724 | 4.00 | YR | C | M | Y | 0.00000 | 20160906 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126679352 | 12667935 | 1 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | ON DAYS 3 AND 4 | UNK | 0 | 50 | MG/KG | |||||||
| 126679352 | 12667935 | 2 | PS | FLUDARABINE PHOSPHATE. | FLUDARABINE PHOSPHATE | 1 | Unknown | FOR 5 DAYS FROM DAY 6 | UNK | 20038 | 30 | MG/M**2 | QD | ||||||
| 126679352 | 12667935 | 3 | SS | FLUDARABINE PHOSPHATE. | FLUDARABINE PHOSPHATE | 1 | Unknown | FOR 5 DAYS FROM DAY 6 | UNK | 20038 | 30 | MG/M**2 | QD | ||||||
| 126679352 | 12667935 | 4 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | IN ORAL SUSPENSION OR TABLET FORM | UNK | 0 | 15 | MG/KG | TID | ||||||
| 126679352 | 12667935 | 5 | SS | BUSULFAN. | BUSULFAN | 1 | Unknown | FOR 12 DOSES | UNK | 0 | .8 | MG/KG | Q6H | ||||||
| 126679352 | 12667935 | 6 | SS | BUSULFAN. | BUSULFAN | 1 | Unknown | FOR 12 DOSES | UNK | 0 | .8 | MG/KG | Q6H | ||||||
| 126679352 | 12667935 | 7 | SS | MELPHALAN | MELPHALAN | 1 | Unknown | ON DAY 1 | UNK | 0 | 140 | MG/M**2 | /cycle | ||||||
| 126679352 | 12667935 | 8 | SS | MELPHALAN | MELPHALAN | 1 | Unknown | ON DAY 1 | UNK | 0 | 140 | MG/M**2 | /cycle | ||||||
| 126679352 | 12667935 | 9 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | UNK | 0 | BID | |||||||||
| 126679352 | 12667935 | 10 | C | LEVETIRACETAM. | LEVETIRACETAM | 1 | 0 | 10 | MG/KG | BID | |||||||||
| 126679352 | 12667935 | 11 | C | URSODEOXYCHOLIC ACID | URSODIOL | 1 | THREE DIVIDED DOSES WAS STARTED FROM DAY 7 AND CONTINUED FOR 30 DAYS POST-TRANSPLANT | 0 | TID | ||||||||||
| 126679352 | 12667935 | 12 | C | ACYCLOVIR. | ACYCLOVIR | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126679352 | 12667935 | 1 | Prophylaxis against graft versus host disease |
| 126679352 | 12667935 | 2 | Acute lymphocytic leukaemia |
| 126679352 | 12667935 | 3 | Bone marrow conditioning regimen |
| 126679352 | 12667935 | 4 | Prophylaxis against graft versus host disease |
| 126679352 | 12667935 | 5 | Acute lymphocytic leukaemia |
| 126679352 | 12667935 | 6 | Bone marrow conditioning regimen |
| 126679352 | 12667935 | 7 | Acute lymphocytic leukaemia |
| 126679352 | 12667935 | 8 | Bone marrow conditioning regimen |
| 126679352 | 12667935 | 9 | Prophylaxis against graft versus host disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126679352 | 12667935 | DE |
| 126679352 | 12667935 | OT |
| 126679352 | 12667935 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126679352 | 12667935 | Acute graft versus host disease | |
| 126679352 | 12667935 | Bacterial infection | |
| 126679352 | 12667935 | Cytomegalovirus infection | |
| 126679352 | 12667935 | Drug ineffective | |
| 126679352 | 12667935 | Histiocytosis haematophagic | |
| 126679352 | 12667935 | Rotavirus infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |