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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97284195 | 9728419 | 5 | F | 20131010 | 20160803 | 20131204 | 20160808 | EXP | CN-ASTELLAS-2013JP013281 | ASTELLAS | 21.75 | YR | F | Y | 59.00000 | KG | 20160808 | CN | CN | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97284195 | 9728419 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 12 | MG | 1M4101B | 204096 | 6 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 97284195 | 9728419 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 12 | MG | 204096 | 5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 97284195 | 9728419 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 12 | MG | 204096 | 4 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 97284195 | 9728419 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 12 | MG | 204096 | 3.5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 97284195 | 9728419 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 12 | MG | 204096 | 3 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 97284195 | 9728419 | 6 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 12 | MG | 204096 | 2.5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 97284195 | 9728419 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 12 | MG | 204096 | 1.5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 97284195 | 9728419 | 8 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 12 | MG | 204096 | 1 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 97284195 | 9728419 | 9 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 0.5 MG, ONCE DAILY | 12 | MG | 204096 | .5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||
| 97284195 | 9728419 | 10 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 0.5 MG, EVERY 12 HOURS | 12 | MG | 204096 | MODIFIED-RELEASE CAPSULE, HARD | Q12H | ||||||
| 97284195 | 9728419 | 11 | SS | ATG-FRESENIUS | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Intravenous (not otherwise specified) | 600 | MG | 0 | 120 | MG | INJECTION | QD | |||||
| 97284195 | 9728419 | 12 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | U | 0 | 500 | MG | PER ORAL NOS | BID | ||||||
| 97284195 | 9728419 | 13 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 1 | G | INJECTION | QD | |||||||
| 97284195 | 9728419 | 14 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0.2 G, ONCE DAILY | 0 | .2 | G | INJECTION | QD | ||||||
| 97284195 | 9728419 | 15 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 40 | MG | INJECTION | QD | |||||||
| 97284195 | 9728419 | 16 | SS | PREDNISOLONE ACETATE. | PREDNISOLONE ACETATE | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 97284195 | 9728419 | 17 | C | CYCLOSPORIN A | CYCLOSPORINE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 97284195 | 9728419 | 18 | C | CEFUROXIME SODIUM. | CEFUROXIME SODIUM | 1 | Intravenous (not otherwise specified) | 6 G DAILY, TWICE DAILY | U | 0 | INJECTION | BID | |||||||
| 97284195 | 9728419 | 19 | C | GANCICLOVIR. | GANCICLOVIR | 1 | Intravenous (not otherwise specified) | 0.25 G DAILY, UNKNOWN FREQ. | U | 0 | INJECTION | ||||||||
| 97284195 | 9728419 | 20 | C | ALPROSTADIL. | ALPROSTADIL | 1 | Intravenous (not otherwise specified) | 10 UG DAILY, UNKNOWN FREQ. | U | 0 | INJECTION | ||||||||
| 97284195 | 9728419 | 21 | C | MEROPENEM. | MEROPENEM | 1 | Intravenous (not otherwise specified) | 2 G DAILY, EVERY 12 HOURS | U | 0 | INJECTION | Q12H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 97284195 | 9728419 | 1 | Renal transplant |
| 97284195 | 9728419 | 11 | Renal transplant |
| 97284195 | 9728419 | 12 | Renal transplant |
| 97284195 | 9728419 | 13 | Renal transplant |
| 97284195 | 9728419 | 16 | Renal transplant |
| 97284195 | 9728419 | 17 | Renal transplant |
| 97284195 | 9728419 | 18 | Pyrexia |
| 97284195 | 9728419 | 19 | Pyrexia |
| 97284195 | 9728419 | 20 | Thrombolysis |
| 97284195 | 9728419 | 21 | Infection prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 97284195 | 9728419 | OT |
| 97284195 | 9728419 | DS |
| 97284195 | 9728419 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 97284195 | 9728419 | Blood creatinine increased | |
| 97284195 | 9728419 | Complications of transplanted kidney | |
| 97284195 | 9728419 | Pneumonia cytomegaloviral | |
| 97284195 | 9728419 | Renal artery thrombosis | |
| 97284195 | 9728419 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 97284195 | 9728419 | 1 | 20130831 | 20130901 | 0 | |
| 97284195 | 9728419 | 2 | 20130902 | 20130902 | 0 | |
| 97284195 | 9728419 | 3 | 20130903 | 20130912 | 0 | |
| 97284195 | 9728419 | 4 | 20130913 | 20130923 | 0 | |
| 97284195 | 9728419 | 5 | 20130924 | 20131002 | 0 | |
| 97284195 | 9728419 | 6 | 20131003 | 20131010 | 0 | |
| 97284195 | 9728419 | 7 | 20131011 | 20131013 | 0 | |
| 97284195 | 9728419 | 8 | 20131014 | 20131024 | 0 | |
| 97284195 | 9728419 | 9 | 20131025 | 20131028 | 0 | |
| 97284195 | 9728419 | 10 | 20131029 | 20131030 | 0 | |
| 97284195 | 9728419 | 11 | 20130830 | 20130903 | 0 | |
| 97284195 | 9728419 | 12 | 20130830 | 0 | ||
| 97284195 | 9728419 | 13 | 20130830 | 20130830 | 0 | |
| 97284195 | 9728419 | 14 | 20130831 | 20130831 | 0 | |
| 97284195 | 9728419 | 15 | 20130901 | 20130904 | 0 | |
| 97284195 | 9728419 | 16 | 20130905 | 0 | ||
| 97284195 | 9728419 | 18 | 20131010 | 20131011 | 0 | |
| 97284195 | 9728419 | 19 | 20131010 | 20131024 | 0 | |
| 97284195 | 9728419 | 20 | 20131120 | 20131122 | 0 | |
| 97284195 | 9728419 | 21 | 20131120 | 20131122 | 0 |