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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125816461 | 12581646 | 1 | I | 20151112 | 20160722 | 20160722 | PER | US-STRIDES ARCOLAB LIMITED-2015SP001778 | STRIDES | 0.00 | Y | 0.00000 | 20160722 | OT | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125816461 | 12581646 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 1 G, BID | 90055 | 1 | G | ||||||||
| 125816461 | 12581646 | 2 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | 10 MG, QD | 0 | 10 | MG | |||||||||
| 125816461 | 12581646 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | 3 MG, BID | 0 | 3 | MG | |||||||||
| 125816461 | 12581646 | 4 | SS | LIALDA | MESALAMINE | 1 | 2.5 G, QD | 0 | 2.5 | G |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125816461 | 12581646 | 1 | Liver transplant |
| 125816461 | 12581646 | 2 | Immunosuppression |
| 125816461 | 12581646 | 3 | Immunosuppression |
| 125816461 | 12581646 | 4 | Colitis ulcerative |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125816461 | 12581646 | Exposure during pregnancy |
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 |
|---|---|---|---|---|---|---|
| 125816461 | 12581646 | 1 | 2006 | 20151105 | 0 | |
| 125816461 | 12581646 | 2 | 2006 | 0 | ||
| 125816461 | 12581646 | 3 | 2006 | 0 | ||
| 125816461 | 12581646 | 4 | 2006 | 0 |