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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125824902 | 12582490 | 2 | F | 2011 | 20160726 | 20160722 | 20160728 | EXP | JP-ASTELLAS-2016JP009296AA | ASTELLAS | 76.35 | YR | F | Y | 29.00000 | KG | 20160728 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125824902 | 12582490 | 1 | PS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Oral | 0.8 MG, TWICE DAILY | 50708 | .8 | MG | GRANULES | BID | ||||||
| 125824902 | 12582490 | 2 | SS | PIRESPA | PIRFENIDONE | 1 | Oral | U | 0 | 200 | MG | TABLET | TID | ||||||
| 125824902 | 12582490 | 3 | SS | PIRESPA | PIRFENIDONE | 1 | Oral | U | 0 | 400 | MG | TABLET | TID | ||||||
| 125824902 | 12582490 | 4 | SS | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | U | 0 | 10 | MG | TABLET | QD | ||||||
| 125824902 | 12582490 | 5 | C | URSO | URSODIOL | 1 | Oral | 200 MG IN THE MORNING, 100 MG IN THE EVENING, TWICE DAILY | U | 0 | TABLET | BID | |||||||
| 125824902 | 12582490 | 6 | C | ASTOMIN /00426502/ | DIMEMORFAN PHOSPHATE | 1 | Oral | U | 0 | 10 | MG | TABLET | TID | ||||||
| 125824902 | 12582490 | 7 | C | SELBEX | TEPRENONE | 1 | Oral | U | 0 | 50 | MG | CAPSULE | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125824902 | 12582490 | 1 | Liver transplant |
| 125824902 | 12582490 | 2 | Idiopathic pulmonary fibrosis |
| 125824902 | 12582490 | 4 | Idiopathic pulmonary fibrosis |
| 125824902 | 12582490 | 5 | Hepatitis C |
| 125824902 | 12582490 | 6 | Pulmonary fibrosis |
| 125824902 | 12582490 | 7 | Gastritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125824902 | 12582490 | OT |
| 125824902 | 12582490 | HO |
| 125824902 | 12582490 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125824902 | 12582490 | Alanine aminotransferase increased | |
| 125824902 | 12582490 | Aspartate aminotransferase increased | |
| 125824902 | 12582490 | Decreased appetite | |
| 125824902 | 12582490 | Idiopathic pulmonary fibrosis | |
| 125824902 | 12582490 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 125824902 | 12582490 | 1 | 20160210 | 0 | ||
| 125824902 | 12582490 | 2 | 20140929 | 20141030 | 0 | |
| 125824902 | 12582490 | 3 | 20141031 | 20160210 | 0 | |
| 125824902 | 12582490 | 4 | 20141114 | 20160210 | 0 | |
| 125824902 | 12582490 | 5 | 20160210 | 0 | ||
| 125824902 | 12582490 | 6 | 20160210 | 0 | ||
| 125824902 | 12582490 | 7 | 20160210 | 0 |