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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124251192 | 12425119 | 2 | F | 20150610 | 20160830 | 20160601 | 20160906 | EXP | PHHY2016FR074640 | NOVARTIS | 67.50 | YR | M | Y | 0.00000 | 20160906 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124251192 | 12425119 | 1 | PS | CERTICAN | EVEROLIMUS | 1 | Oral | 1.5 MG, QD | 288 | MG | Y | 21560 | 1.5 | MG | QD | ||||
| 124251192 | 12425119 | 2 | SS | CERTICAN | EVEROLIMUS | 1 | Oral | 2 MG, QD | 288 | MG | Y | 21560 | 2 | MG | QD | ||||
| 124251192 | 12425119 | 3 | SS | CERTICAN | EVEROLIMUS | 1 | 288 | MG | Y | 21560 | |||||||||
| 124251192 | 12425119 | 4 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Unknown | 720 MG, QD | 553320 | MG | Y | 0 | 720 | MG | QD | ||||
| 124251192 | 12425119 | 5 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Unknown | 540 MG, QD | 553320 | MG | Y | 0 | 540 | MG | QD | ||||
| 124251192 | 12425119 | 6 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Unknown | 720 MG, QD | 553320 | MG | Y | 0 | 720 | MG | QD | ||||
| 124251192 | 12425119 | 7 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Unknown | 720 MG, QD | 553320 | MG | Y | 0 | 720 | MG | QD | ||||
| 124251192 | 12425119 | 8 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Unknown | 360 MG, QD | 553320 | MG | Y | 0 | 360 | MG | QD | ||||
| 124251192 | 12425119 | 9 | SS | CORTANCYL | PREDNISONE | 1 | Unknown | 2.5 MG, QD | 9992 | MG | 0 | 2.5 | MG | QD | |||||
| 124251192 | 12425119 | 10 | SS | CORTANCYL | PREDNISONE | 1 | Unknown | 10 MG, QD | 9992 | MG | 0 | 10 | MG | QD | |||||
| 124251192 | 12425119 | 11 | SS | CORTANCYL | PREDNISONE | 1 | Unknown | 60 MG, QD | 9992 | MG | 0 | 60 | MG | QD | |||||
| 124251192 | 12425119 | 12 | SS | CORTANCYL | PREDNISONE | 1 | Unknown | 40 MG, QD | 9992 | MG | 0 | 40 | MG | QD | |||||
| 124251192 | 12425119 | 13 | SS | CORTANCYL | PREDNISONE | 1 | Unknown | 30 MG, QD | 9992 | MG | 0 | 30 | MG | QD | |||||
| 124251192 | 12425119 | 14 | SS | CORTANCYL | PREDNISONE | 1 | Unknown | 20 MG, QD | 9992 | MG | 0 | 20 | MG | QD | |||||
| 124251192 | 12425119 | 15 | SS | CORTANCYL | PREDNISONE | 1 | Unknown | 10 MG, QD | 9992 | MG | 0 | 10 | MG | QD | |||||
| 124251192 | 12425119 | 16 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | 2 MG, QD | 1471 | MG | Y | 0 | 2 | MG | QD | ||||
| 124251192 | 12425119 | 17 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | 3 MG, QD | 1471 | MG | Y | 0 | 3 | MG | QD | ||||
| 124251192 | 12425119 | 18 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | 2.5 MG, QD | 1471 | MG | Y | 0 | 2.5 | MG | QD | ||||
| 124251192 | 12425119 | 19 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | 3 MG, QD | 1471 | MG | Y | 0 | 3 | MG | QD | ||||
| 124251192 | 12425119 | 20 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | 2.5 MG, QD | 1471 | MG | Y | 0 | 2.5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124251192 | 12425119 | 1 | Prophylaxis against transplant rejection |
| 124251192 | 12425119 | 2 | Liver transplant |
| 124251192 | 12425119 | 3 | Immunosuppressant drug therapy |
| 124251192 | 12425119 | 4 | Immunosuppressant drug therapy |
| 124251192 | 12425119 | 5 | Liver transplant |
| 124251192 | 12425119 | 9 | Immunosuppressant drug therapy |
| 124251192 | 12425119 | 16 | Immunosuppressant drug therapy |
| 124251192 | 12425119 | 17 | Liver transplant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124251192 | 12425119 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124251192 | 12425119 | Back pain | |
| 124251192 | 12425119 | Hypothyroidism | |
| 124251192 | 12425119 | Myopathy | |
| 124251192 | 12425119 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 124251192 | 12425119 | 1 | 20150116 | 20150416 | 0 | |
| 124251192 | 12425119 | 2 | 20150417 | 20150701 | 0 | |
| 124251192 | 12425119 | 4 | 20130315 | 20131210 | 0 | |
| 124251192 | 12425119 | 5 | 20131211 | 20141030 | 0 | |
| 124251192 | 12425119 | 6 | 20150116 | 20150701 | 0 | |
| 124251192 | 12425119 | 7 | 20150702 | 20150804 | 0 | |
| 124251192 | 12425119 | 8 | 20150805 | 20151119 | 0 | |
| 124251192 | 12425119 | 9 | 20130824 | 20140717 | 0 | |
| 124251192 | 12425119 | 10 | 20140718 | 20140801 | 0 | |
| 124251192 | 12425119 | 11 | 20140802 | 20140918 | 0 | |
| 124251192 | 12425119 | 12 | 20140919 | 20141003 | 0 | |
| 124251192 | 12425119 | 13 | 20141004 | 20141030 | 0 | |
| 124251192 | 12425119 | 14 | 20141031 | 20150701 | 0 | |
| 124251192 | 12425119 | 15 | 20150702 | 0 | ||
| 124251192 | 12425119 | 16 | 20131211 | 20140722 | 0 | |
| 124251192 | 12425119 | 17 | 20130615 | 20131210 | 0 | |
| 124251192 | 12425119 | 18 | 20140723 | 20140804 | 0 | |
| 124251192 | 12425119 | 19 | 20140805 | 20141030 | 0 | |
| 124251192 | 12425119 | 20 | 20141031 | 20150115 | 0 |