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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105254854 | 10525485 | 4 | F | 2014 | 20160912 | 20141017 | 20160919 | EXP | FR-ASTELLAS-2014US014990 | ASTELLAS | 65.95 | YR | M | Y | 0.00000 | 20160919 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105254854 | 10525485 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | UNK, UNKNOWN FREQ. | U | 204096 | MODIFIED-RELEASE CAPSULE, HARD | ||||||||
| 105254854 | 10525485 | 2 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Oral | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 105254854 | 10525485 | 3 | SS | CORTANCYL | PREDNISONE | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 105254854 | 10525485 | 4 | C | HYDROCORTISONE HEMISUCCINATE | HYDROCORTISONE HEMISUCCINATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 105254854 | 10525485 | 1 | Prophylaxis against transplant rejection |
| 105254854 | 10525485 | 2 | Prophylaxis against transplant rejection |
| 105254854 | 10525485 | 3 | Prophylaxis against transplant rejection |
| 105254854 | 10525485 | 4 | Prophylaxis against transplant rejection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 105254854 | 10525485 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 105254854 | 10525485 | Intra-abdominal fluid collection | |
| 105254854 | 10525485 | Klebsiella infection | |
| 105254854 | 10525485 | Perirenal haematoma | |
| 105254854 | 10525485 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 105254854 | 10525485 | 1 | 20140310 | 20140415 | 0 | |
| 105254854 | 10525485 | 2 | 20140310 | 20140605 | 0 | |
| 105254854 | 10525485 | 3 | 20140310 | 20140530 | 0 | |
| 105254854 | 10525485 | 4 | 20140531 | 0 |