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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127164961 | 12716496 | 1 | I | 20160830 | 20160906 | 20160906 | EXP | PHHY2016IN120186 | 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 | 2.00 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127164961 | 12716496 | 1 | PS | CICLOSPORIN | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | 3 MG/KG, IN 2 DIVIDED DOSES | 50574 | 3 | MG/KG | ||||||||
| 127164961 | 12716496 | 2 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | 50574 | ||||||||||||
| 127164961 | 12716496 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 50 MG/KG, ON DAYS 3 AND 4, UKN | 0 | 50 | MG/KG | ||||||||
| 127164961 | 12716496 | 4 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | 0 | ||||||||||||
| 127164961 | 12716496 | 5 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 15 MG/KG, TID | 0 | 15 | MG/KG | TID | |||||||
| 127164961 | 12716496 | 6 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127164961 | 12716496 | 1 | Stem cell transplant |
| 127164961 | 12716496 | 2 | Prophylaxis against graft versus host disease |
| 127164961 | 12716496 | 3 | Stem cell transplant |
| 127164961 | 12716496 | 4 | Prophylaxis against graft versus host disease |
| 127164961 | 12716496 | 5 | Stem cell transplant |
| 127164961 | 12716496 | 6 | Prophylaxis against graft versus host disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127164961 | 12716496 | DE |
| 127164961 | 12716496 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127164961 | 12716496 | Acute graft versus host disease in intestine | |
| 127164961 | 12716496 | Acute graft versus host disease in liver | |
| 127164961 | 12716496 | Acute graft versus host disease in skin | |
| 127164961 | 12716496 | Aspergillus infection | |
| 127164961 | 12716496 | Cytomegalovirus infection | |
| 127164961 | 12716496 | Multiple organ dysfunction syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |