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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127046522 | 12704652 | 2 | F | 20160825 | 20160831 | 20160901 | EXP | PHHY2016AU118266 | SANDOZ | DWYER KM, CARROLL R, HILL P, BATEMAN S, BAKER C, LANGHAM RG ET AL.. REFRACTORY VASCULAR REJECTION IN A HAND ALLOGRAFT IN THE PRESENCE OF ANTIBODIES AGAINST ANGIOTENSIN II (TYPE 1) RECEPTOR. TRANSPLANTATION. 2016;100 (7S):S419 | 69.00 | YR | M | Y | 0.00000 | 20160901 | OT | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127046522 | 12704652 | 1 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Unknown | 540 MG, BID | U | 0 | 540 | MG | BID | ||||||
| 127046522 | 12704652 | 2 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | U | 0 | |||||||||||
| 127046522 | 12704652 | 3 | PS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 1.5 MG, BID | U | 65461 | 1.5 | MG | BID | ||||||
| 127046522 | 12704652 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 1 MG, BID | U | 65461 | 1 | MG | BID | ||||||
| 127046522 | 12704652 | 5 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 5 MG, QD | U | 0 | 5 | MG | QD | ||||||
| 127046522 | 12704652 | 6 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | U | 0 | |||||||||||
| 127046522 | 12704652 | 7 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127046522 | 12704652 | 1 | Organ transplant |
| 127046522 | 12704652 | 2 | Immunosuppressant drug therapy |
| 127046522 | 12704652 | 3 | Organ transplant |
| 127046522 | 12704652 | 4 | Immunosuppressant drug therapy |
| 127046522 | 12704652 | 5 | Organ transplant |
| 127046522 | 12704652 | 6 | Immunosuppressant drug therapy |
| 127046522 | 12704652 | 7 | Transplant rejection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127046522 | 12704652 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127046522 | 12704652 | Product use issue | |
| 127046522 | 12704652 | Transplant rejection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |