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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121624952 | 12162495 | 2 | F | 20150710 | 20160912 | 20160309 | 20160919 | EXP | FR-ASTELLAS-2016US008234 | ASTELLAS | 50.00 | YR | F | Y | 0.00000 | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121624952 | 12162495 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 19 MG, DAILY DOSE | 1028 | MG | D | 204096 | 19 | MG | MODIFIED-RELEASE CAPSULE, HARD | ||||
| 121624952 | 12162495 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 21 MG, DAILY | 1028 | MG | D | 204096 | 21 | MG | MODIFIED-RELEASE CAPSULE, HARD | ||||
| 121624952 | 12162495 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 20 MG, DAILY | 1028 | MG | D | 204096 | 20 | MG | MODIFIED-RELEASE CAPSULE, HARD | ||||
| 121624952 | 12162495 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 15 MG, DAILY | 1028 | MG | D | 204096 | 15 | MG | MODIFIED-RELEASE CAPSULE, HARD | ||||
| 121624952 | 12162495 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 1028 | MG | D | 204096 | 16 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 121624952 | 12162495 | 6 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 1028 | MG | U | 204096 | 6 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 121624952 | 12162495 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 5 MG, DAILY | 1028 | MG | 204096 | 5 | MG | MODIFIED-RELEASE CAPSULE, HARD | |||||
| 121624952 | 12162495 | 8 | SS | CERTICAN | EVEROLIMUS | 1 | Oral | 204 | MG | D | 0 | 3 | MG | FORMULATION UNKNOWN | BID | ||||
| 121624952 | 12162495 | 9 | SS | CERTICAN | EVEROLIMUS | 1 | Oral | 204 | MG | 0 | 2 | MG | FORMULATION UNKNOWN | BID | |||||
| 121624952 | 12162495 | 10 | SS | CORTANCYL | PREDNISONE | 1 | Oral | D | 0 | 10 | MG | FORMULATION UNKNOWN | QD | ||||||
| 121624952 | 12162495 | 11 | SS | CORTANCYL | PREDNISONE | 1 | Oral | D | 0 | 5 | MG | FORMULATION UNKNOWN | QD | ||||||
| 121624952 | 12162495 | 12 | C | BISOPROLOL | BISOPROLOL | 1 | Unknown | 2.5 MG, DAILY | D | U | 0 | 2.5 | MG | FORMULATION UNKNOWN | |||||
| 121624952 | 12162495 | 13 | C | BISOPROLOL | BISOPROLOL | 1 | Oral | D | U | 0 | 2.5 | MG | FORMULATION UNKNOWN | BID | |||||
| 121624952 | 12162495 | 14 | C | BISOPROLOL | BISOPROLOL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 121624952 | 12162495 | 15 | C | CAPTOPRIL. | CAPTOPRIL | 1 | Unknown | D | U | 0 | 4 | MG | FORMULATION UNKNOWN | ||||||
| 121624952 | 12162495 | 16 | C | CAPTOPRIL. | CAPTOPRIL | 1 | Unknown | 25 MG, DAILY | D | U | 0 | 25 | MG | FORMULATION UNKNOWN | |||||
| 121624952 | 12162495 | 17 | C | CAPTOPRIL. | CAPTOPRIL | 1 | Unknown | D | U | 0 | 50 | MG | FORMULATION UNKNOWN | ||||||
| 121624952 | 12162495 | 18 | C | CAPTOPRIL. | CAPTOPRIL | 1 | Oral | D | U | 0 | 50 | MG | FORMULATION UNKNOWN | BID | |||||
| 121624952 | 12162495 | 19 | C | CAPTOPRIL. | CAPTOPRIL | 1 | Oral | D | U | 0 | 50 | MG | FORMULATION UNKNOWN | TID | |||||
| 121624952 | 12162495 | 20 | C | INEXIUM /01479302/ | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | D | U | 0 | 40 | MG | FORMULATION UNKNOWN | QD | |||||
| 121624952 | 12162495 | 21 | C | ZELTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | Oral | D | U | 0 | 1500 | MG | FORMULATION UNKNOWN | TID | |||||
| 121624952 | 12162495 | 22 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | D | U | 0 | 400 | MG | FORMULATION UNKNOWN | QD | |||||
| 121624952 | 12162495 | 23 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 2000 MG, DAILY | D | U | 0 | 2000 | MG | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121624952 | 12162495 | 1 | Immunosuppression |
| 121624952 | 12162495 | 8 | Immunosuppression |
| 121624952 | 12162495 | 10 | Immunosuppression |
| 121624952 | 12162495 | 12 | Hypertension |
| 121624952 | 12162495 | 15 | Hypertension |
| 121624952 | 12162495 | 20 | Prophylaxis |
| 121624952 | 12162495 | 21 | Prophylaxis |
| 121624952 | 12162495 | 22 | Prophylaxis |
| 121624952 | 12162495 | 23 | Immunosuppressant drug therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121624952 | 12162495 | OT |
| 121624952 | 12162495 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121624952 | 12162495 | Hepatic function abnormal | |
| 121624952 | 12162495 | Hypogammaglobulinaemia | |
| 121624952 | 12162495 | Pyelonephritis | |
| 121624952 | 12162495 | Tachycardia | |
| 121624952 | 12162495 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 121624952 | 12162495 | 1 | 20150119 | 0 | ||
| 121624952 | 12162495 | 2 | 20150207 | 20150402 | 0 | |
| 121624952 | 12162495 | 3 | 20150403 | 20150417 | 0 | |
| 121624952 | 12162495 | 4 | 20150417 | 20150619 | 0 | |
| 121624952 | 12162495 | 5 | 20150620 | 20150709 | 0 | |
| 121624952 | 12162495 | 6 | 20150710 | 20160106 | 0 | |
| 121624952 | 12162495 | 7 | 20160107 | 0 | ||
| 121624952 | 12162495 | 8 | 20150619 | 20150722 | 0 | |
| 121624952 | 12162495 | 9 | 20151028 | 0 | ||
| 121624952 | 12162495 | 10 | 20150417 | 0 | ||
| 121624952 | 12162495 | 11 | 20150930 | 0 | ||
| 121624952 | 12162495 | 12 | 201501 | 201503 | 0 | |
| 121624952 | 12162495 | 13 | 20150306 | 0 | ||
| 121624952 | 12162495 | 15 | 201502 | 201503 | 0 | |
| 121624952 | 12162495 | 16 | 201503 | 201503 | 0 | |
| 121624952 | 12162495 | 17 | 201503 | 201506 | 0 | |
| 121624952 | 12162495 | 18 | 20150605 | 0 | ||
| 121624952 | 12162495 | 19 | 20150619 | 0 | ||
| 121624952 | 12162495 | 20 | 20150116 | 0 | ||
| 121624952 | 12162495 | 21 | 20150115 | 0 | ||
| 121624952 | 12162495 | 22 | 20150119 | 0 | ||
| 121624952 | 12162495 | 23 | 201501 | 201504 | 0 |