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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126247961 | 12624796 | 1 | I | 20160510 | 20160726 | 20160805 | 20160805 | EXP | PHHY2016CN104488 | NOVARTIS | 44.99 | YR | M | Y | 0.00000 | 20160805 | MD | CN | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126247961 | 12624796 | 1 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Oral | 1440 MG, QD | Y | 0 | 1440 | MG | QD | ||||||
| 126247961 | 12624796 | 2 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Oral | 1260 MG, QD | Y | 0 | 1260 | MG | QD | ||||||
| 126247961 | 12624796 | 3 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Oral | 900 MG, QD | Y | 0 | 900 | MG | QD | ||||||
| 126247961 | 12624796 | 4 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Oral | 720 MG, QD | Y | 0 | 720 | MG | QD | ||||||
| 126247961 | 12624796 | 5 | PS | BASILIXIMAB | BASILIXIMAB | 1 | Unknown | 20 MG, QD | Y | 103764 | 20 | MG | SOLUTION FOR INJECTION | QD | |||||
| 126247961 | 12624796 | 6 | SS | BASILIXIMAB | BASILIXIMAB | 1 | Y | 103764 | SOLUTION FOR INJECTION | ||||||||||
| 126247961 | 12624796 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 5.5 MG, QD | 0 | 5.5 | MG | CAPSULE | QD | ||||||
| 126247961 | 12624796 | 8 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 6 MG, QD | 0 | 6 | MG | CAPSULE | QD | ||||||
| 126247961 | 12624796 | 9 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 4.5 MG, QD | 0 | 4.5 | MG | CAPSULE | QD | ||||||
| 126247961 | 12624796 | 10 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 3.5 MG, QD | 0 | 3.5 | MG | CAPSULE | QD | ||||||
| 126247961 | 12624796 | 11 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 1000 MG, QD | 1000 | MG | Y | 0 | 1000 | MG | QD | ||||
| 126247961 | 12624796 | 12 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | 1000 | MG | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126247961 | 12624796 | 1 | Renal transplant |
| 126247961 | 12624796 | 5 | Renal transplant |
| 126247961 | 12624796 | 6 | Immunosuppressant drug therapy |
| 126247961 | 12624796 | 7 | Renal transplant |
| 126247961 | 12624796 | 8 | Immunosuppressant drug therapy |
| 126247961 | 12624796 | 11 | Renal transplant |
| 126247961 | 12624796 | 12 | Immunosuppressant drug therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126247961 | 12624796 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126247961 | 12624796 | Abdominal pain upper | |
| 126247961 | 12624796 | Alanine aminotransferase increased | |
| 126247961 | 12624796 | Aspartate aminotransferase increased | |
| 126247961 | 12624796 | Blood creatinine increased | |
| 126247961 | 12624796 | Blood glucose increased | |
| 126247961 | 12624796 | Blood triglycerides increased | |
| 126247961 | 12624796 | Blood urea increased | |
| 126247961 | 12624796 | Haemoglobin decreased | |
| 126247961 | 12624796 | High density lipoprotein decreased | |
| 126247961 | 12624796 | Lymphocyte count decreased | |
| 126247961 | 12624796 | Neutrophil count increased | |
| 126247961 | 12624796 | Platelet count decreased | |
| 126247961 | 12624796 | Urine analysis abnormal | |
| 126247961 | 12624796 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 126247961 | 12624796 | 1 | 20160510 | 20160510 | 0 | |
| 126247961 | 12624796 | 2 | 20160511 | 20160601 | 0 | |
| 126247961 | 12624796 | 3 | 20160530 | 20160601 | 0 | |
| 126247961 | 12624796 | 4 | 20160602 | 0 | ||
| 126247961 | 12624796 | 5 | 20160510 | 20160510 | 0 | |
| 126247961 | 12624796 | 7 | 20160510 | 20160524 | 0 | |
| 126247961 | 12624796 | 8 | 20160525 | 20160526 | 0 | |
| 126247961 | 12624796 | 9 | 20160527 | 20160531 | 0 | |
| 126247961 | 12624796 | 10 | 20160603 | 0 | ||
| 126247961 | 12624796 | 11 | 20160509 | 20160509 | 0 |