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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125662622 | 12566262 | 2 | F | 20160325 | 20160908 | 20160718 | 20160916 | EXP | US-ASTELLAS-2016US012317 | ASTELLAS | 54.63 | YR | F | Y | 0.00000 | 20160916 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125662622 | 12566262 | 1 | SS | ASP0113 | INVESTIGATIONAL PRODUCT | 1 | Intramuscular | D | 0 | INJECTION | |||||||||
| 125662622 | 12566262 | 2 | SS | ASP0113 | INVESTIGATIONAL PRODUCT | 1 | Intramuscular | D | 0 | INJECTION | |||||||||
| 125662622 | 12566262 | 3 | SS | ASP0113 | INVESTIGATIONAL PRODUCT | 1 | Intramuscular | D | 0 | INJECTION | |||||||||
| 125662622 | 12566262 | 4 | SS | ASP0113 | INVESTIGATIONAL PRODUCT | 1 | Intramuscular | D | 0 | INJECTION | |||||||||
| 125662622 | 12566262 | 5 | SS | ASP0113 | INVESTIGATIONAL PRODUCT | 1 | Intramuscular | D | 0 | INJECTION | |||||||||
| 125662622 | 12566262 | 6 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | U | 50708 | 3 | MG | CAPSULE | QD | ||||||
| 125662622 | 12566262 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | U | 50708 | 2 | MG | CAPSULE | BID | ||||||
| 125662622 | 12566262 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | 5 | MG | TABLET | QD | ||||||
| 125662622 | 12566262 | 9 | SS | PREDNISONE. | PREDNISONE | 1 | 0 | TABLET | |||||||||||
| 125662622 | 12566262 | 10 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 125662622 | 12566262 | 11 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | 0 | FORMULATION UNKNOWN | |||||||||||
| 125662622 | 12566262 | 12 | C | INSULIN GLARGINE | INSULIN GLARGINE | 1 | Unknown | 20 IU, NIGHTLY | D | U | 0 | 20 | IU | FORMULATION UNKNOWN | |||||
| 125662622 | 12566262 | 13 | C | INSULIN GLARGINE | INSULIN GLARGINE | 1 | Unknown | 24 IU, ONCE DAILY (EVERY MORNING) | D | U | 0 | 24 | IU | FORMULATION UNKNOWN | QD | ||||
| 125662622 | 12566262 | 14 | C | COUMADIN | WARFARIN SODIUM | 1 | Oral | D | U | 0 | 2 | MG | TABLET | QD | |||||
| 125662622 | 12566262 | 15 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | D | U | 0 | 500 | MG | TABLET | BID | |||||
| 125662622 | 12566262 | 16 | C | METOCLOPRAMIDE. | METOCLOPRAMIDE | 1 | Oral | D | U | 0 | 5 | MG | TABLET | TID | |||||
| 125662622 | 12566262 | 17 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | D | U | 0 | 20 | MG | CAPSULE | QD | |||||
| 125662622 | 12566262 | 18 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 112 MCG, ONCE DAILY | D | U | 0 | TABLET | QD | ||||||
| 125662622 | 12566262 | 19 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 20 MG, ONCE DAILY (ONCE DAILY) | D | U | 0 | 20 | MG | TABLET | QD | ||||
| 125662622 | 12566262 | 20 | C | GLIMEPIRIDE. | GLIMEPIRIDE | 1 | Oral | D | U | 0 | 2 | MG | TABLET | BID | |||||
| 125662622 | 12566262 | 21 | C | INSULIN LISPRO | INSULIN LISPRO | 1 | Subcutaneous | 1-10 IU, THRICE DAILY | D | U | 0 | INJECTION | TID | ||||||
| 125662622 | 12566262 | 22 | C | KEFLEX | CEPHALEXIN | 1 | Oral | D | U | 0 | 500 | MG | CAPSULE | QD | |||||
| 125662622 | 12566262 | 23 | C | LYRICA | PREGABALIN | 1 | Unknown | D | U | 0 | 75 | MG | CAPSULE | BID | |||||
| 125662622 | 12566262 | 24 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Unknown | D | U | 0 | 1000 | IU | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125662622 | 12566262 | 1 | Immunisation |
| 125662622 | 12566262 | 6 | Renal transplant |
| 125662622 | 12566262 | 7 | Immunosuppression |
| 125662622 | 12566262 | 8 | Renal transplant |
| 125662622 | 12566262 | 9 | Immunosuppression |
| 125662622 | 12566262 | 10 | Renal transplant |
| 125662622 | 12566262 | 11 | Immunosuppression |
| 125662622 | 12566262 | 12 | Product used for unknown indication |
| 125662622 | 12566262 | 14 | Product used for unknown indication |
| 125662622 | 12566262 | 15 | BK virus infection |
| 125662622 | 12566262 | 16 | Product used for unknown indication |
| 125662622 | 12566262 | 17 | Product used for unknown indication |
| 125662622 | 12566262 | 18 | Product used for unknown indication |
| 125662622 | 12566262 | 19 | Product used for unknown indication |
| 125662622 | 12566262 | 20 | Product used for unknown indication |
| 125662622 | 12566262 | 21 | Product used for unknown indication |
| 125662622 | 12566262 | 22 | Product used for unknown indication |
| 125662622 | 12566262 | 23 | Product used for unknown indication |
| 125662622 | 12566262 | 24 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125662622 | 12566262 | OT |
| 125662622 | 12566262 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125662622 | 12566262 | Acute kidney injury | |
| 125662622 | 12566262 | Acute myocardial infarction | |
| 125662622 | 12566262 | Atrioventricular block complete | |
| 125662622 | 12566262 | Cardiac arrest | |
| 125662622 | 12566262 | Pneumonia | |
| 125662622 | 12566262 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 125662622 | 12566262 | 1 | 20140821 | 20140821 | 0 | |
| 125662622 | 12566262 | 2 | 20140919 | 20140919 | 0 | |
| 125662622 | 12566262 | 3 | 20141015 | 20141015 | 0 | |
| 125662622 | 12566262 | 4 | 20141113 | 20141113 | 0 | |
| 125662622 | 12566262 | 5 | 20150120 | 20150120 | 0 | |
| 125662622 | 12566262 | 6 | 20160211 | 0 | ||
| 125662622 | 12566262 | 8 | 20141002 | 0 | ||
| 125662622 | 12566262 | 12 | 20150805 | 0 | ||
| 125662622 | 12566262 | 15 | 20150825 | 0 | ||
| 125662622 | 12566262 | 16 | 20160209 | 0 | ||
| 125662622 | 12566262 | 17 | 20130425 | 0 | ||
| 125662622 | 12566262 | 18 | 20110222 | 0 | ||
| 125662622 | 12566262 | 19 | 20140725 | 0 | ||
| 125662622 | 12566262 | 20 | 20150407 | 0 | ||
| 125662622 | 12566262 | 21 | 20140725 | 0 | ||
| 125662622 | 12566262 | 23 | 20140919 | 0 |