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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126020431 | 12602043 | 1 | I | 20160721 | 20160728 | 20160728 | EXP | US-ASTELLAS-2016US028249 | ASTELLAS | GWERTZMAN R, COREY H, ROBERTI I. AUTOIMMUNE POLYGLANDULAR SYNDROME TYPE I CAN HAVE SIGNIFICANT KIDNEY DISEASE IN CHILDREN INCLUDING RECURRENCE IN RENAL ALLOGRAFT - A REPORT OF TWO CASES. CLINICAL NEPHROLOGY. 2016;85(6):358-63 | 16.00 | YR | M | Y | 0.00000 | 20160728 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126020431 | 12602043 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0.1 MG/KG, TWICE DAILY | U | 50708 | .1 | MG/KG | FORMULATION UNKNOWN | BID | |||||
| 126020431 | 12602043 | 2 | C | BASILIXIMAB | BASILIXIMAB | 1 | Unknown | U | 0 | 20 | MG | FORMULATION UNKNOWN | BID | ||||||
| 126020431 | 12602043 | 3 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | U | 0 | 300 | MG/M**2 | FORMULATION UNKNOWN | BID | ||||||
| 126020431 | 12602043 | 4 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 2 MG/KG, ONCE DAILY X 2 MONTHS | U | 0 | 2 | MG/KG | FORMULATION UNKNOWN | QD | |||||
| 126020431 | 12602043 | 5 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126020431 | 12602043 | 6 | C | SULFAMETHOXAZOLE-TRIMETHOPRIM (SMZ) | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126020431 | 12602043 | 7 | C | VALGANCICLOVIR. | VALGANCICLOVIR | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126020431 | 12602043 | 1 | Renal transplant |
| 126020431 | 12602043 | 2 | Renal transplant |
| 126020431 | 12602043 | 3 | Renal transplant |
| 126020431 | 12602043 | 4 | Renal transplant |
| 126020431 | 12602043 | 5 | Renal transplant |
| 126020431 | 12602043 | 6 | Renal transplant |
| 126020431 | 12602043 | 7 | Renal transplant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126020431 | 12602043 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126020431 | 12602043 | Acute kidney injury | |
| 126020431 | 12602043 | Adrenocortical insufficiency acute | |
| 126020431 | 12602043 | Oesophageal candidiasis | |
| 126020431 | 12602043 | Oral candidiasis | |
| 126020431 | 12602043 | Pneumonia | |
| 126020431 | 12602043 | Tubulointerstitial nephritis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |