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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126628421 | 12662842 | 1 | I | 20160628 | 20160818 | 20160818 | EXP | US-STRIDES ARCOLAB LIMITED-2016SP008917 | STRIDES | ODDIS CV, SCIURBA FC, ELMAGD KA, STARZL TE.. TACROLIMUS IN REFRACTORY POLYMYOSITIS WITH INTERSTITIAL LUNG DISEASE. LANCET. 1999;353(9166):1762-1763 | 0.00 | Y | 0.00000 | 20160818 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126628421 | 12662842 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 0.075 MG/KG, QD IN TWICE DAILY DOSES | 90687 | ||||||||||
| 126628421 | 12662842 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | 90687 | ||||||||||||
| 126628421 | 12662842 | 3 | C | PREDNISONE. | PREDNISONE | 1 | UNK | 0 | |||||||||||
| 126628421 | 12662842 | 4 | C | PREDNISONE. | PREDNISONE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126628421 | 12662842 | 1 | Polymyositis |
| 126628421 | 12662842 | 2 | Dermatomyositis |
| 126628421 | 12662842 | 3 | Polymyositis |
| 126628421 | 12662842 | 4 | Dermatomyositis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126628421 | 12662842 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126628421 | 12662842 | Accelerated hypertension | |
| 126628421 | 12662842 | Renal impairment |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |