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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125219601 | 12521960 | 1 | I | 20150907 | 20160108 | 20160701 | 20160701 | EXP | DE-ASTELLAS-2016US000900 | ASTELLAS | 28.00 | YR | F | Y | 107.00000 | KG | 20160701 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125219601 | 12521960 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 8 (UNITS NOT REPORTED), ONCE DAILY | 204096 | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||||||
| 125219601 | 12521960 | 2 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 0 | 500 | MG | FORMULATION UNKNOWN | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125219601 | 12521960 | 1 | Immunosuppression |
| 125219601 | 12521960 | 2 | Immunosuppression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125219601 | 12521960 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125219601 | 12521960 | Abortion spontaneous | |
| 125219601 | 12521960 | 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 |
|---|---|---|---|---|---|---|
| 125219601 | 12521960 | 1 | 20111124 | 0 | ||
| 125219601 | 12521960 | 2 | 20110826 | 20150823 | 0 |