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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127350991 | 12735099 | 1 | I | 20160808 | 20160912 | 20160912 | EXP | PL-ASTELLAS-2016US031232 | ASTELLAS | 70.00 | YR | M | Y | 0.00000 | 20160912 | OT | GB | PL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127350991 | 12735099 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | 50708 | FORMULATION UNKNOWN | |||||||||
| 127350991 | 12735099 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | KEPT AT A TARGET TROUGH LEVEL } 9 NG/ML | U | 50708 | FORMULATION UNKNOWN | ||||||||
| 127350991 | 12735099 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | KEPT AT A TARGET TROUGH LEVEL { 6 NG/ML | U | 50708 | FORMULATION UNKNOWN | ||||||||
| 127350991 | 12735099 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | KEPT AT A TARGET TROUGH LEVEL OF 3.3 TO 4.2 NG/ML | U | 50708 | FORMULATION UNKNOWN | ||||||||
| 127350991 | 12735099 | 5 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | U | 0 | 2000 | MG | FORMULATION UNKNOWN | |||||||
| 127350991 | 12735099 | 6 | SS | BASILIXIMAB | BASILIXIMAB | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127350991 | 12735099 | 7 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | U | 0 | 250 | MG | FORMULATION UNKNOWN | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127350991 | 12735099 | 1 | Renal transplant |
| 127350991 | 12735099 | 5 | Renal transplant |
| 127350991 | 12735099 | 6 | Renal transplant |
| 127350991 | 12735099 | 7 | Renal transplant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127350991 | 12735099 | OT |
| 127350991 | 12735099 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127350991 | 12735099 | BK virus infection | |
| 127350991 | 12735099 | Basal cell carcinoma | |
| 127350991 | 12735099 | Delayed graft function | |
| 127350991 | 12735099 | Kidney transplant rejection | |
| 127350991 | 12735099 | Pneumonia bacterial | |
| 127350991 | 12735099 | Polyomavirus-associated nephropathy |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |