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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125837252 | 12583725 | 2 | F | 20130319 | 20160720 | 20160722 | 20160727 | EXP | CA-ASTELLAS-2013US003359 | ASTELLAS | 35.14 | YR | M | Y | 0.00000 | 20160727 | MD | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125837252 | 12583725 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 515 | MG | 204096 | 5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 125837252 | 12583725 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 515 | MG | U | 204096 | 10 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 125837252 | 12583725 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 515 | MG | U | 204096 | 6 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 125837252 | 12583725 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 515 | MG | U | 204096 | 3 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 125837252 | 12583725 | 5 | C | KIVEXA | ABACAVIR SULFATELAMIVUDINE | 1 | Oral | 600/300 MG, UID/QD | U | 0 | 600 | MG | TABLET | QD | |||||
| 125837252 | 12583725 | 6 | C | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Oral | U | 0 | 360 | MG | FORMULATION UNKNOWN | BID | ||||||
| 125837252 | 12583725 | 7 | C | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Oral | U | 0 | 720 | MG | FORMULATION UNKNOWN | BID | ||||||
| 125837252 | 12583725 | 8 | C | PANTOLOC /01263204/ | PANTOPRAZOLE SODIUM | 1 | Unknown | U | 0 | 40 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125837252 | 12583725 | 9 | C | APO-PREDNISONE | PREDNISONE | 1 | Oral | U | 0 | 10 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125837252 | 12583725 | 10 | C | APO-PREDNISONE | PREDNISONE | 1 | Oral | U | 0 | 5 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125837252 | 12583725 | 11 | C | ISENTRESS | RALTEGRAVIR POTASSIUM | 1 | Oral | U | 0 | 400 | MG | FORMULATION UNKNOWN | BID | ||||||
| 125837252 | 12583725 | 12 | C | ALTACE | RAMIPRIL | 1 | Oral | U | 0 | 5 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125837252 | 12583725 | 13 | C | ALTACE | RAMIPRIL | 1 | Oral | U | 0 | 10 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125837252 | 12583725 | 14 | C | SEPTRA | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 800/160 MG, 3XWEEKLY | U | 0 | 800 | MG | FORMULATION UNKNOWN | TIW | |||||
| 125837252 | 12583725 | 15 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Unknown | U | 0 | 5 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125837252 | 12583725 | 16 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Oral | U | 0 | 5 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125837252 | 12583725 | 17 | C | PROTOPIC | TACROLIMUS | 1 | Topical | 0.1 %, AS NEEDED | U | 0 | .1 | PCT | OINTMENT | ||||||
| 125837252 | 12583725 | 18 | C | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | Oral | 0.8 MG, AT BEDTIME | U | 0 | .8 | MG | MODIFIED-RELEASE TABLET | QD | |||||
| 125837252 | 12583725 | 19 | C | VITAMIN D /00107901/ | ERGOCALCIFEROL | 1 | Unknown | U | 0 | 1000 | IU | FORMULATION UNKNOWN | QD | ||||||
| 125837252 | 12583725 | 20 | C | SUBLINOX | ZOLPIDEM TARTRATE | 1 | Oral | U | 0 | 10 | MG | FORMULATION UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125837252 | 12583725 | 1 | Renal transplant |
| 125837252 | 12583725 | 2 | Prophylaxis against transplant rejection |
| 125837252 | 12583725 | 5 | Product used for unknown indication |
| 125837252 | 12583725 | 6 | Renal transplant |
| 125837252 | 12583725 | 8 | Product used for unknown indication |
| 125837252 | 12583725 | 9 | Renal transplant |
| 125837252 | 12583725 | 11 | Product used for unknown indication |
| 125837252 | 12583725 | 12 | Product used for unknown indication |
| 125837252 | 12583725 | 14 | Product used for unknown indication |
| 125837252 | 12583725 | 15 | Product used for unknown indication |
| 125837252 | 12583725 | 16 | Product used for unknown indication |
| 125837252 | 12583725 | 17 | Product used for unknown indication |
| 125837252 | 12583725 | 18 | Product used for unknown indication |
| 125837252 | 12583725 | 19 | Product used for unknown indication |
| 125837252 | 12583725 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125837252 | 12583725 | OT |
| 125837252 | 12583725 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125837252 | 12583725 | Kidney transplant rejection | |
| 125837252 | 12583725 | Renal transplant failure |
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 |
|---|---|---|---|---|---|---|
| 125837252 | 12583725 | 1 | 20121207 | 20130320 | 0 | |
| 125837252 | 12583725 | 2 | 20130321 | 0 |