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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117476423 | 11747642 | 3 | F | 20150216 | 20160809 | 20151117 | 20160816 | EXP | FR-ASTELLAS-2015US038561 | ASTELLAS | 53.00 | YR | F | Y | 56.00000 | KG | 20160816 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117476423 | 11747642 | 1 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0 | 4.5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||||
| 117476423 | 11747642 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0 | 4 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||||
| 117476423 | 11747642 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0 | 3.5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||||
| 117476423 | 11747642 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0 | 2.5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||||
| 117476423 | 11747642 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0 | 5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||||
| 117476423 | 11747642 | 6 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0 | 10 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||||
| 117476423 | 11747642 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0 | 3 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||||
| 117476423 | 11747642 | 8 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0 | 3.5 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||||
| 117476423 | 11747642 | 9 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | U | 0 | 3 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | ||||||
| 117476423 | 11747642 | 10 | PS | VESICARE | SOLIFENACIN SUCCINATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 21518 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117476423 | 11747642 | 1 | Liver transplant |
| 117476423 | 11747642 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117476423 | 11747642 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117476423 | 11747642 | Arthralgia | |
| 117476423 | 11747642 | Autoimmune hepatitis | |
| 117476423 | 11747642 | Blood immunoglobulin G increased | |
| 117476423 | 11747642 | Genital herpes | |
| 117476423 | 11747642 | Headache | |
| 117476423 | 11747642 | Thrombocytopenia | |
| 117476423 | 11747642 | Tremor | |
| 117476423 | 11747642 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 117476423 | 11747642 | 1 | 20150214 | 0 | ||
| 117476423 | 11747642 | 2 | 20150227 | 0 | ||
| 117476423 | 11747642 | 3 | 20150306 | 0 | ||
| 117476423 | 11747642 | 4 | 20150402 | 0 | ||
| 117476423 | 11747642 | 5 | 20150409 | 0 | ||
| 117476423 | 11747642 | 6 | 20150505 | 0 | ||
| 117476423 | 11747642 | 8 | 20150915 | 0 | ||
| 117476423 | 11747642 | 9 | 20151222 | 0 |