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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124203583 | 12420358 | 3 | F | 20160830 | 20160531 | 20160906 | EXP | PHHY2016IN072415 | NOVARTIS | 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):675-82 | 10.00 | YR | F | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124203583 | 12420358 | 1 | PS | CICLOSPORIN | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | 3 MG/KG, IN TWO DIVIDED DOSES | 50574 | 3 | MG/KG | ||||||||
| 124203583 | 12420358 | 2 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | 50574 | ||||||||||||
| 124203583 | 12420358 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 50 MG/KG, UNK | 0 | 50 | MG/KG | ||||||||
| 124203583 | 12420358 | 4 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | 0 | ||||||||||||
| 124203583 | 12420358 | 5 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 15 MG/KG, TID | 0 | 15 | MG/KG | TID | |||||||
| 124203583 | 12420358 | 6 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | 0 | ||||||||||||
| 124203583 | 12420358 | 7 | C | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | 30 MG/M2, UNK | 0 | 30 | MG/M**2 | ||||||||
| 124203583 | 12420358 | 8 | C | BUSULFAN. | BUSULFAN | 1 | Unknown | 0.8 MG/KG, Q6H | 0 | .8 | MG/KG | Q6H | |||||||
| 124203583 | 12420358 | 9 | C | MELPHALAN | MELPHALAN | 1 | Unknown | 140 MG/M2, UNK | 0 | 140 | MG/M**2 | ||||||||
| 124203583 | 12420358 | 10 | C | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 10 MG/KG, BID | 0 | 10 | MG/KG | BID | |||||||
| 124203583 | 12420358 | 11 | C | URSODEOXYCHOLIC ACID | URSODIOL | 1 | Unknown | 15 MG/KG, QD | 0 | 15 | MG/KG | QD | |||||||
| 124203583 | 12420358 | 12 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Unknown | UNK | 0 | ||||||||||
| 124203583 | 12420358 | 13 | C | AMPHOTERICIN | AMPHOTERICIN B | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124203583 | 12420358 | 1 | Prophylaxis against graft versus host disease |
| 124203583 | 12420358 | 2 | Immunosuppressant drug therapy |
| 124203583 | 12420358 | 3 | Prophylaxis against graft versus host disease |
| 124203583 | 12420358 | 4 | Immunosuppressant drug therapy |
| 124203583 | 12420358 | 5 | Prophylaxis against graft versus host disease |
| 124203583 | 12420358 | 6 | Immunosuppressant drug therapy |
| 124203583 | 12420358 | 7 | Bone marrow conditioning regimen |
| 124203583 | 12420358 | 8 | Bone marrow conditioning regimen |
| 124203583 | 12420358 | 9 | Bone marrow conditioning regimen |
| 124203583 | 12420358 | 10 | Product used for unknown indication |
| 124203583 | 12420358 | 11 | Product used for unknown indication |
| 124203583 | 12420358 | 12 | Prophylaxis |
| 124203583 | 12420358 | 13 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124203583 | 12420358 | OT |
| 124203583 | 12420358 | DE |
| 124203583 | 12420358 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124203583 | 12420358 | Acute graft versus host disease in intestine | |
| 124203583 | 12420358 | Acute graft versus host disease in liver | |
| 124203583 | 12420358 | Acute graft versus host disease in skin | |
| 124203583 | 12420358 | Adenovirus infection | |
| 124203583 | 12420358 | Chronic graft versus host disease | |
| 124203583 | 12420358 | Cytomegalovirus infection | |
| 124203583 | 12420358 | Histiocytosis haematophagic |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |