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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125618491 | 12561849 | 1 | I | 20160706 | 20160715 | 20160715 | EXP | US-SA-2016SA126296 | AVENTIS | SIVARAJ D, GREEN M M, CIFTCI A M, ZAHID M F, JOHNS A A, ROSS M ET AL. CAN WE CURE LIGHT CHAIN DEPOSITION DISEASE OF THE KIDNEYS? A REVIEW AND CASE REPORT OF A PATIENT TREATED WITH A TRIPLE TRANSPLANT APPROACH. CLINICAL LYMPHOMA, MYELOMA + LEUKEMIA. 2016 JUN; 16(6):95-100. DOI: 10.1016/J.CLML.2016.03.002 | 43.00 | YR | A | F | Y | 0.00000 | 20160715 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125618491 | 12561849 | 1 | PS | ALEMTUZUMAB | ALEMTUZUMAB | 1 | Intravenous (not otherwise specified) | UNKNOWN | 103948 | 20 | MG | QD | |||||||
| 125618491 | 12561849 | 2 | SS | FLUDARABINE PHOSPHATE. | FLUDARABINE PHOSPHATE | 1 | Unknown | UNKNOWN | 20038 | 30 | MG/M**2 | QD | |||||||
| 125618491 | 12561849 | 3 | SS | FLUDARABINE PHOSPHATE. | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | UNKNOWN | 20038 | 25 | MG/M**2 | QD | |||||||
| 125618491 | 12561849 | 4 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | UNKNOWN | 0 | 950 | MG | QD | |||||||
| 125618491 | 12561849 | 5 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | Y | UNKNOWN | 0 | |||||||||
| 125618491 | 12561849 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | Y | U | UNKNOWN | 0 | ||||||||
| 125618491 | 12561849 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | Y | U | UNKNOWN | 0 | ||||||||
| 125618491 | 12561849 | 8 | SS | THALIDOMIDE | THALIDOMIDE | 1 | Unknown | Y | UNKNOWN | 0 | |||||||||
| 125618491 | 12561849 | 9 | C | MELPHALAN | MELPHALAN | 1 | 0 | ||||||||||||
| 125618491 | 12561849 | 10 | C | MELPHALAN | MELPHALAN | 1 | Intravenous (not otherwise specified) | 0 | 70 | MG/M**2 | QD | ||||||||
| 125618491 | 12561849 | 11 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125618491 | 12561849 | 12 | C | FK 506 | TACROLIMUS | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125618491 | 12561849 | 1 | Bone marrow conditioning regimen |
| 125618491 | 12561849 | 2 | Bone marrow conditioning regimen |
| 125618491 | 12561849 | 3 | Bone marrow conditioning regimen |
| 125618491 | 12561849 | 4 | Bone marrow conditioning regimen |
| 125618491 | 12561849 | 5 | Immune tolerance induction |
| 125618491 | 12561849 | 6 | Immunomodulatory therapy |
| 125618491 | 12561849 | 7 | Immunomodulatory therapy |
| 125618491 | 12561849 | 8 | Immune tolerance induction |
| 125618491 | 12561849 | 9 | Chemotherapy |
| 125618491 | 12561849 | 10 | Chemotherapy |
| 125618491 | 12561849 | 11 | Immunomodulatory therapy |
| 125618491 | 12561849 | 12 | Immunomodulatory therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125618491 | 12561849 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125618491 | 12561849 | Cytomegalovirus infection | |
| 125618491 | 12561849 | Fluid overload | |
| 125618491 | 12561849 | Graft versus host disease | |
| 125618491 | 12561849 | Off label use | |
| 125618491 | 12561849 | Renal failure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125618491 | 12561849 | 1 | 200612 | 200612 | 0 | |
| 125618491 | 12561849 | 2 | 200612 | 200612 | 0 | |
| 125618491 | 12561849 | 3 | 2007 | 2007 | 0 | |
| 125618491 | 12561849 | 4 | 200612 | 200612 | 0 | |
| 125618491 | 12561849 | 10 | 2007 | 2007 | 0 |