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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126923972 | 12692397 | 2 | F | 20160824 | 20160828 | 20160830 | EXP | PHHY2016IT115212 | SANDOZ | MAFFINI E, GIACCONE L, FESTUCCIA M, BRUNELLO L, BUONDONNO I, FERRERO D ET AL. RUXOLITINIB IN STEROID REFRACTORY GRAFT-VS.-HOST DISEASE: A CASE REPORT. JOURNAL OF HEMATOLOGY AND ONCOLOGY. 2016;9(1):ARTICLE NUMBER 67. | 51.00 | YR | M | Y | 0.00000 | 20160830 | COUNTRY NOT SPECIFIED | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126923972 | 12692397 | 1 | PS | CICLOSPORIN | CYCLOSPORINE | 1 | Unknown | 1.5 MG/KG, BID FROM DAY -1 | U | 65017 | 1.5 | MG/KG | BID | ||||||
| 126923972 | 12692397 | 2 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | Oral | UNK | U | 65017 | |||||||||
| 126923972 | 12692397 | 3 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | Unknown | (1.5 MG/KG TWICE DAILY, FROM DAY -1) | U | 65017 | 1.5 | MG/KG | BID | ||||||
| 126923972 | 12692397 | 4 | SS | RUXOLITINIB | RUXOLITINIB | 1 | Oral | 5 MG, BID ON DAY 33 | Y | 0 | 5 | MG | BID | ||||||
| 126923972 | 12692397 | 5 | SS | RUXOLITINIB | RUXOLITINIB | 1 | Oral | 5 MG, QD ON DAY 100 | Y | 0 | 5 | MG | QD | ||||||
| 126923972 | 12692397 | 6 | SS | RUXOLITINIB | RUXOLITINIB | 1 | Oral | 5 MG, QD ON DAY 107 | Y | 0 | 5 | MG | |||||||
| 126923972 | 12692397 | 7 | SS | RUXOLITINIB | RUXOLITINIB | 1 | Oral | 5 MG, QD ON DAY 113 | Y | 0 | 5 | MG | QD | ||||||
| 126923972 | 12692397 | 8 | SS | BUDESONIDE. | BUDESONIDE | 1 | Oral | 3 MG, TID ON DAY 28 | U | 0 | 3 | MG | TID | ||||||
| 126923972 | 12692397 | 9 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 15 MG/M2, 24 H AFTER TRANSPLANT | U | 0 | 15 | MG/M**2 | |||||||
| 126923972 | 12692397 | 10 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 10 MG/M2, ON DAYS 3, 6, AND 11 | U | 0 | 10 | MG/M**2 | |||||||
| 126923972 | 12692397 | 11 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Intravenous (not otherwise specified) | 1 G, TID ON DAY 29 | Y | 0 | 1 | G | TID | ||||||
| 126923972 | 12692397 | 12 | SS | THYMOGLOBULIN | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Unknown | 2.5 MG/KG, ON DAYS -3 AND -2 | U | 0 | 2.5 | MG/KG | |||||||
| 126923972 | 12692397 | 13 | SS | THYMOGLOBULIN | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126923972 | 12692397 | 1 | Stem cell transplant |
| 126923972 | 12692397 | 2 | Prophylaxis against graft versus host disease |
| 126923972 | 12692397 | 4 | Acute graft versus host disease in intestine |
| 126923972 | 12692397 | 8 | Graft versus host disease in gastrointestinal tract |
| 126923972 | 12692397 | 9 | Stem cell transplant |
| 126923972 | 12692397 | 10 | Prophylaxis against graft versus host disease |
| 126923972 | 12692397 | 11 | Graft versus host disease in gastrointestinal tract |
| 126923972 | 12692397 | 12 | Stem cell transplant |
| 126923972 | 12692397 | 13 | Prophylaxis against graft versus host disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126923972 | 12692397 | HO |
| 126923972 | 12692397 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126923972 | 12692397 | Abdominal pain | |
| 126923972 | 12692397 | Acute graft versus host disease in intestine | |
| 126923972 | 12692397 | Diarrhoea | |
| 126923972 | 12692397 | Drug ineffective | |
| 126923972 | 12692397 | General physical health deterioration | |
| 126923972 | 12692397 | Pancytopenia | |
| 126923972 | 12692397 | Product use issue |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |