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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124203663 | 12420366 | 3 | F | 20160830 | 20160531 | 20160906 | EXP | PHHY2016IN072429 | NOVARTIS | JAISWAL SR, ZAMAN S, CHAKRABARTI A, SEHRAWAT A, BANSAL S, GUPTA M ET AL.. T CELL COSTIMULATION BLOCKADE FOR HYPERACUTE STEROID REFRACTORY GRAFT VERSUS-HOST DISEASE IN CHILDREN UNDERGOING HAPLOIDENTICAL TRANSPLANTATION. TRANSPLANT IMMUNOLOGY. 2016;1-6 | 4.00 | YR | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124203663 | 12420366 | 1 | PS | CICLOSPORIN | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | 3 MG/KG, TWO DIVIDED DOSES | 50574 | 3 | MG/KG | ||||||||
| 124203663 | 12420366 | 2 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | 50574 | ||||||||||||
| 124203663 | 12420366 | 3 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | 50574 | ||||||||||||
| 124203663 | 12420366 | 4 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 15 MG/KG, QD | 0 | 15 | MG/KG | QD | |||||||
| 124203663 | 12420366 | 5 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | 0 | ||||||||||||
| 124203663 | 12420366 | 6 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 50 MG/KG, UNK | 0 | 50 | MG/KG | ||||||||
| 124203663 | 12420366 | 7 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | 0 | ||||||||||||
| 124203663 | 12420366 | 8 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | 0 | ||||||||||||
| 124203663 | 12420366 | 9 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | 30 MG/M2, UNK | 0 | 30 | MG/M**2 | ||||||||
| 124203663 | 12420366 | 10 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | 0 | ||||||||||||
| 124203663 | 12420366 | 11 | SS | MELPHALAN | MELPHALAN | 1 | Unknown | 140 MG/M2, UNK | 0 | 140 | MG/M**2 | ||||||||
| 124203663 | 12420366 | 12 | SS | MELPHALAN | MELPHALAN | 1 | 0 | ||||||||||||
| 124203663 | 12420366 | 13 | SS | BUSULFAN. | BUSULFAN | 1 | Unknown | 0.8 MG/KG, SIX HOURLY FOR 12 DOSES | 0 | .8 | MG/KG | Q6H | |||||||
| 124203663 | 12420366 | 14 | SS | BUSULFAN. | BUSULFAN | 1 | 0 | ||||||||||||
| 124203663 | 12420366 | 15 | C | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 10 MG/KG, BID | 0 | 10 | MG/KG | BID | |||||||
| 124203663 | 12420366 | 16 | C | URSODEOXYCHOLIC ACID | URSODIOL | 1 | Unknown | 15 MG/KG, QD | 0 | 15 | MG/KG | QD | |||||||
| 124203663 | 12420366 | 17 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Unknown | UNK | 0 | ||||||||||
| 124203663 | 12420366 | 18 | C | AMPHOTERICIN | AMPHOTERICIN B | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124203663 | 12420366 | 1 | Stem cell transplant |
| 124203663 | 12420366 | 2 | Prophylaxis against graft versus host disease |
| 124203663 | 12420366 | 3 | Immunosuppressant drug therapy |
| 124203663 | 12420366 | 4 | Prophylaxis against graft versus host disease |
| 124203663 | 12420366 | 5 | Immunosuppressant drug therapy |
| 124203663 | 12420366 | 6 | Stem cell transplant |
| 124203663 | 12420366 | 7 | Prophylaxis against graft versus host disease |
| 124203663 | 12420366 | 8 | Immunosuppressant drug therapy |
| 124203663 | 12420366 | 9 | Bone marrow conditioning regimen |
| 124203663 | 12420366 | 10 | Acute lymphocytic leukaemia |
| 124203663 | 12420366 | 11 | Bone marrow conditioning regimen |
| 124203663 | 12420366 | 12 | Acute lymphocytic leukaemia |
| 124203663 | 12420366 | 13 | Bone marrow conditioning regimen |
| 124203663 | 12420366 | 14 | Acute lymphocytic leukaemia |
| 124203663 | 12420366 | 15 | Product used for unknown indication |
| 124203663 | 12420366 | 16 | Product used for unknown indication |
| 124203663 | 12420366 | 17 | Prophylaxis |
| 124203663 | 12420366 | 18 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124203663 | 12420366 | LT |
| 124203663 | 12420366 | OT |
| 124203663 | 12420366 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124203663 | 12420366 | Acute graft versus host disease in intestine | |
| 124203663 | 12420366 | Acute graft versus host disease in liver | |
| 124203663 | 12420366 | Acute graft versus host disease in skin | |
| 124203663 | 12420366 | Bacterial infection | |
| 124203663 | 12420366 | Cytomegalovirus infection | |
| 124203663 | 12420366 | Histiocytosis haematophagic | |
| 124203663 | 12420366 | Rotavirus infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |