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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121558825 | 12155882 | 5 | F | 20151001 | 20160809 | 20160307 | 20160823 | EXP | FR-ASTELLAS-2015US024963 | ASTELLAS | 31.00 | YR | M | Y | 0.00000 | 20160823 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121558825 | 12155882 | 1 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 5 MG, DAILY, 1 HOUR BEFORE OR 2 HOURS AFTER MEAL | U | 0 | 5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 121558825 | 12155882 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 0 | 6 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||||
| 121558825 | 12155882 | 3 | PS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Oral | 5 MG, DAILY | 50708 | 5 | MG | FORMULATION UNKNOWN | QD | ||||||
| 121558825 | 12155882 | 4 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Oral | 0 | 360 | MG | FORMULATION UNKNOWN | BID | |||||||
| 121558825 | 12155882 | 5 | SS | SOLUPRED /00016201/ | PREDNISOLONE | 1 | Oral | 10 MG, EVERY OTHER DAY, ALTERNATE WITH 5 MG EVERY OTHER DAY | 0 | 10 | MG | FORMULATION UNKNOWN | QOD | ||||||
| 121558825 | 12155882 | 6 | SS | SOLUPRED /00016201/ | PREDNISOLONE | 1 | Oral | 5 MG, EVERY OTHER DAY, ALTERNATE WITH 10 MG EVERY OTHER DAY | 0 | 5 | MG | FORMULATION UNKNOWN | QOD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121558825 | 12155882 | 1 | Renal transplant |
| 121558825 | 12155882 | 3 | Renal transplant |
| 121558825 | 12155882 | 4 | Renal transplant |
| 121558825 | 12155882 | 5 | Renal transplant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121558825 | 12155882 | HO |
| 121558825 | 12155882 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121558825 | 12155882 | Faeces soft | |
| 121558825 | 12155882 | Influenza like illness | |
| 121558825 | 12155882 | Leukocytosis | |
| 121558825 | 12155882 | Pneumothorax spontaneous | |
| 121558825 | 12155882 | Transplant rejection |
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 |
|---|---|---|---|---|---|---|
| 121558825 | 12155882 | 1 | 20150619 | 0 | ||
| 121558825 | 12155882 | 2 | 20150701 | 0 | ||
| 121558825 | 12155882 | 4 | 20150609 | 0 | ||
| 121558825 | 12155882 | 5 | 20150930 | 0 | ||
| 121558825 | 12155882 | 6 | 20150930 | 0 |