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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126912982 | 12691298 | 2 | F | 20160823 | 20160826 | 20160902 | EXP | IT-SA-2016SA153197 | AVENTIS | 51.00 | YR | A | M | Y | 0.00000 | 20160902 | OT | IT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126912982 | 12691298 | 1 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 24 HOUR AFTER TRANSPLANTATION | U | UNK | 0 | 15 | MG/M**2 | ||||||
| 126912982 | 12691298 | 2 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | ON DAY 3,6 AND 11 | U | UNK | 0 | 10 | MG/M**2 | ||||||
| 126912982 | 12691298 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Intravenous (not otherwise specified) | UNK | 0 | 2 | MG/KG | QD | |||||||
| 126912982 | 12691298 | 4 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Intravenous (not otherwise specified) | UNK | 0 | 1 | G | TID | |||||||
| 126912982 | 12691298 | 5 | PS | THYMOGLOBULIN | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Unknown | ON DAY 3 AND 2 | U | UNK | 103869 | 2.5 | MG/KG | ||||||
| 126912982 | 12691298 | 6 | SS | CYCLOSPORIN A | CYCLOSPORINE | 1 | Unknown | U | UNK | 0 | 1.5 | MG/KG | BID | ||||||
| 126912982 | 12691298 | 7 | SS | BUDESONIDE. | BUDESONIDE | 1 | Oral | UNK | 0 | 3 | MG | TID | |||||||
| 126912982 | 12691298 | 8 | C | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | DAY 1-5 | 0 | 30 | MG/M**2 | QD | ||||||||
| 126912982 | 12691298 | 9 | C | CYTARABINE. | CYTARABINE | 1 | DAYS 1-5 | 0 | 2000 | MG/M**2 | QD | ||||||||
| 126912982 | 12691298 | 10 | C | IDARUBICIN | IDARUBICIN | 1 | DAYS 1-3 | 0 | 10 | MG/M**2 | QD | ||||||||
| 126912982 | 12691298 | 11 | C | BUSULFAN. | BUSULFAN | 1 | DAYS 7 TO 4) | 0 | 3.2 | MG/KG | QD | ||||||||
| 126912982 | 12691298 | 12 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | DAYS 3 AND 2 | 0 | 60 | MG/KG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126912982 | 12691298 | 1 | Prophylaxis against graft versus host disease |
| 126912982 | 12691298 | 2 | Prophylaxis against graft versus host disease |
| 126912982 | 12691298 | 3 | Graft versus host disease |
| 126912982 | 12691298 | 4 | Graft versus host disease |
| 126912982 | 12691298 | 5 | Prophylaxis against graft versus host disease |
| 126912982 | 12691298 | 6 | Prophylaxis against graft versus host disease |
| 126912982 | 12691298 | 7 | Graft versus host disease |
| 126912982 | 12691298 | 8 | Chemotherapy |
| 126912982 | 12691298 | 9 | Chemotherapy |
| 126912982 | 12691298 | 10 | Chemotherapy |
| 126912982 | 12691298 | 11 | Bone marrow conditioning regimen |
| 126912982 | 12691298 | 12 | Bone marrow conditioning regimen |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126912982 | 12691298 | HO |
| 126912982 | 12691298 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126912982 | 12691298 | Abdominal pain | |
| 126912982 | 12691298 | Acute graft versus host disease | |
| 126912982 | 12691298 | Condition aggravated | |
| 126912982 | 12691298 | Diarrhoea | |
| 126912982 | 12691298 | Drug ineffective | |
| 126912982 | 12691298 | Histology abnormal | |
| 126912982 | 12691298 | Mucosal inflammation | |
| 126912982 | 12691298 | Rash maculo-papular | |
| 126912982 | 12691298 | Therapeutic response decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |