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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126743031 | 12674303 | 1 | I | 20130913 | 20160822 | 20160822 | EXP | IN-SANOFI-AVENTIS-2013SA091952 | AVENTIS | 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 | 3.00 | YR | C | M | Y | 0.00000 | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126743031 | 12674303 | 1 | PS | FLUDARABINE PHOSPHATE. | FLUDARABINE PHOSPHATE | 1 | Unknown | UNK | 20038 | ||||||||||
| 126743031 | 12674303 | 2 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | ON DAY +3,+4 | UNK | 0 | 50 | MG/KG | |||||||
| 126743031 | 12674303 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | ON DAY +3,+4 | UNK | 0 | 50 | MG/KG | |||||||
| 126743031 | 12674303 | 4 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | IN ORAL SUSPENSION OR TABLET FORM | UNK | 0 | 15 | MG/KG | TID | ||||||
| 126743031 | 12674303 | 5 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | IN ORAL SUSPENSION OR TABLET FORM | UNK | 0 | 15 | MG/KG | TID | ||||||
| 126743031 | 12674303 | 6 | SS | ALEMTUZUMAB | ALEMTUZUMAB | 1 | Unknown | UNKNOWN | 103948 | .2 | MG/KG | QD | |||||||
| 126743031 | 12674303 | 7 | SS | ALEMTUZUMAB | ALEMTUZUMAB | 1 | Unknown | UNKNOWN | 103948 | .2 | MG/KG | QD | |||||||
| 126743031 | 12674303 | 8 | SS | ALEMTUZUMAB | ALEMTUZUMAB | 1 | Unknown | UNK | 103948 | .2 | MG/KG | QD | |||||||
| 126743031 | 12674303 | 9 | SS | ALEMTUZUMAB | ALEMTUZUMAB | 1 | Unknown | UNK | 103948 | .2 | MG/KG | QD | |||||||
| 126743031 | 12674303 | 10 | SS | ALEMTUZUMAB | ALEMTUZUMAB | 1 | Unknown | UNK | 103948 | 10 | MG | ||||||||
| 126743031 | 12674303 | 11 | SS | ALEMTUZUMAB | ALEMTUZUMAB | 1 | Unknown | UNK | 103948 | 10 | MG | ||||||||
| 126743031 | 12674303 | 12 | SS | TREOSULFAN | TREOSULFAN | 1 | Unknown | UNK | 0 | ||||||||||
| 126743031 | 12674303 | 13 | SS | THIOTEPA. | THIOTEPA | 1 | Unknown | UNK | 0 | ||||||||||
| 126743031 | 12674303 | 14 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | IN TWO DIVIDED DOSES | UNK | 0 | 3 | MG/KG | |||||||
| 126743031 | 12674303 | 15 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | IN TWO DIVIDED DOSES | UNK | 0 | 3 | MG/KG | |||||||
| 126743031 | 12674303 | 16 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | UNK | 0 | ||||||||||
| 126743031 | 12674303 | 17 | SS | ETANERCEPT | ETANERCEPT | 1 | Unknown | UNK | 0 | ||||||||||
| 126743031 | 12674303 | 18 | SS | SIROLIMUS. | SIROLIMUS | 1 | Unknown | UNK | 0 | ||||||||||
| 126743031 | 12674303 | 19 | SS | BUDESONIDE. | BUDESONIDE | 1 | Oral | UNK | 0 | ||||||||||
| 126743031 | 12674303 | 20 | SS | RITUXIMAB | RITUXIMAB | 1 | Unknown | 2 DOSES | UNK | 0 | /wk | ||||||||
| 126743031 | 12674303 | 21 | SS | INFLIXIMAB | INFLIXIMAB | 1 | Unknown | UNK | 0 | 5 | MG/KG | 1X | |||||||
| 126743031 | 12674303 | 22 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | 0 | .5 | MG/KG | ||||||||||
| 126743031 | 12674303 | 23 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | 0 | ||||||||||||
| 126743031 | 12674303 | 24 | C | IMMUNOGLOBULIN | HUMAN IMMUNOGLOBULIN G | 1 | Oral | ORAL AND INTRAVENOUS | 0 | ||||||||||
| 126743031 | 12674303 | 25 | C | IMMUNOGLOBULIN | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | ORAL AND INTRAVENOUS | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126743031 | 12674303 | 1 | Bone marrow conditioning regimen |
| 126743031 | 12674303 | 2 | Bone marrow conditioning regimen |
| 126743031 | 12674303 | 3 | Prophylaxis against graft versus host disease |
| 126743031 | 12674303 | 4 | Bone marrow conditioning regimen |
| 126743031 | 12674303 | 5 | Prophylaxis against graft versus host disease |
| 126743031 | 12674303 | 6 | Graft versus host disease |
| 126743031 | 12674303 | 7 | Bone marrow conditioning regimen |
| 126743031 | 12674303 | 8 | Graft versus host disease |
| 126743031 | 12674303 | 9 | Bone marrow conditioning regimen |
| 126743031 | 12674303 | 10 | Graft versus host disease |
| 126743031 | 12674303 | 11 | Bone marrow conditioning regimen |
| 126743031 | 12674303 | 12 | Bone marrow conditioning regimen |
| 126743031 | 12674303 | 13 | Bone marrow conditioning regimen |
| 126743031 | 12674303 | 14 | Bone marrow conditioning regimen |
| 126743031 | 12674303 | 15 | Prophylaxis against graft versus host disease |
| 126743031 | 12674303 | 16 | Graft versus host disease |
| 126743031 | 12674303 | 17 | Graft versus host disease |
| 126743031 | 12674303 | 18 | Graft versus host disease |
| 126743031 | 12674303 | 19 | Graft versus host disease |
| 126743031 | 12674303 | 20 | Graft versus host disease |
| 126743031 | 12674303 | 21 | Graft versus host disease |
| 126743031 | 12674303 | 22 | Graft versus host disease |
| 126743031 | 12674303 | 23 | Graft versus host disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126743031 | 12674303 | OT |
| 126743031 | 12674303 | LT |
| 126743031 | 12674303 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126743031 | 12674303 | Adenovirus infection | |
| 126743031 | 12674303 | Drug ineffective | |
| 126743031 | 12674303 | Epstein-Barr virus infection | |
| 126743031 | 12674303 | Pneumonia cytomegaloviral | |
| 126743031 | 12674303 | Respiratory distress | |
| 126743031 | 12674303 | Rotavirus infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |