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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126436971 | 12643697 | 1 | I | 20160804 | 20160811 | 20160811 | EXP | FR-ASTELLAS-2016US030693 | ASTELLAS | MORELON E, PETRUZZO P, KANITAKIS J, GAZARIAN A, TESTELIN S, DEVAUCHELLE B, ET AL. CHRONIC REJECTION IN VASCULARIZED COMPOSITE ALLOTRANSPLANTATION. TRANSPLANTATION. 2016;100(7S):S420 | 0.00 | M | Y | 0.00000 | 20160811 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126436971 | 12643697 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 50708 | FORMULATION UNKNOWN | ||||||||
| 126436971 | 12643697 | 2 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126436971 | 12643697 | 3 | C | ATG /00575401/ | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126436971 | 12643697 | 1 | Transplant |
| 126436971 | 12643697 | 2 | Transplant |
| 126436971 | 12643697 | 3 | Transplant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126436971 | 12643697 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126436971 | 12643697 | Extremity necrosis | |
| 126436971 | 12643697 | Off label use | |
| 126436971 | 12643697 | Peripheral artery thrombosis | |
| 126436971 | 12643697 | Transplant rejection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |