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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124073763 | 12407376 | 3 | F | 20131216 | 20160922 | 20160526 | 20160929 | EXP | PHHY2016FR005904 | NOVARTIS | 57.06 | YR | M | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124073763 | 12407376 | 1 | SS | CERTICAN | EVEROLIMUS | 1 | Oral | 7.5 MG, QD | 255 | MG | Y | 0 | 7.5 | MG | QD | ||||
| 124073763 | 12407376 | 2 | SS | CERTICAN | EVEROLIMUS | 1 | Oral | 6 MG, QD | 255 | MG | Y | 0 | 6 | MG | QD | ||||
| 124073763 | 12407376 | 3 | SS | CERTICAN | EVEROLIMUS | 1 | Oral | 7.5 MG, QD | 255 | MG | Y | 0 | 7.5 | MG | QD | ||||
| 124073763 | 12407376 | 4 | SS | CERTICAN | EVEROLIMUS | 1 | Oral | 4.5 MG, QD | 255 | MG | Y | 0 | 4.5 | MG | QD | ||||
| 124073763 | 12407376 | 5 | PS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Unknown | 720 MG, QD | 24480 | MG | Y | 50791 | 720 | MG | QD | ||||
| 124073763 | 12407376 | 6 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | 24480 | MG | Y | 50791 | |||||||||
| 124073763 | 12407376 | 7 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | 2 MG, QD | Y | 0 | 2 | MG | QD | ||||||
| 124073763 | 12407376 | 8 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | 2.5 MG, QD | Y | 0 | 2.5 | MG | QD | ||||||
| 124073763 | 12407376 | 9 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | 3 MG, QD | Y | 0 | 3 | MG | QD | ||||||
| 124073763 | 12407376 | 10 | C | ADVAGRAF | TACROLIMUS | 1 | Unknown | 3 MG, QD | 0 | 3 | MG | QD | |||||||
| 124073763 | 12407376 | 11 | C | ADVAGRAF | TACROLIMUS | 1 | Unknown | 4 MG, QD | 0 | 4 | MG | QD | |||||||
| 124073763 | 12407376 | 12 | C | ADVAGRAF | TACROLIMUS | 1 | Unknown | 3.5 MG, QD | 0 | 3.5 | MG | QD | |||||||
| 124073763 | 12407376 | 13 | C | ADVAGRAF | TACROLIMUS | 1 | Unknown | 3 MG, QD | 0 | 3 | MG | QD | |||||||
| 124073763 | 12407376 | 14 | C | ADVAGRAF | TACROLIMUS | 1 | Unknown | 3 MG, QD | 0 | 3 | MG | QD | |||||||
| 124073763 | 12407376 | 15 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | 2 G, QD | 0 | 2 | G | QD | |||||||
| 124073763 | 12407376 | 16 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | 1.5 G, QD | 0 | 1.5 | G | QD | |||||||
| 124073763 | 12407376 | 17 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | 1 G, QD | 0 | 1 | G | QD | |||||||
| 124073763 | 12407376 | 18 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | 2 G, QD | 0 | 2 | G | QD | |||||||
| 124073763 | 12407376 | 19 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | 1 G, QD | 0 | 1 | G | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124073763 | 12407376 | 1 | Liver transplant |
| 124073763 | 12407376 | 2 | Immunosuppressant drug therapy |
| 124073763 | 12407376 | 5 | Liver transplant |
| 124073763 | 12407376 | 6 | Immunosuppressant drug therapy |
| 124073763 | 12407376 | 7 | Immunosuppressant drug therapy |
| 124073763 | 12407376 | 10 | Immunosuppressant drug therapy |
| 124073763 | 12407376 | 15 | Immunosuppressant drug therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124073763 | 12407376 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124073763 | 12407376 | Anaemia | |
| 124073763 | 12407376 | Cholestasis | |
| 124073763 | 12407376 | Cough | |
| 124073763 | 12407376 | Hepatic necrosis | |
| 124073763 | 12407376 | Infection | |
| 124073763 | 12407376 | Pancytopenia | |
| 124073763 | 12407376 | Peritonitis | |
| 124073763 | 12407376 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 124073763 | 12407376 | 1 | 20131113 | 20131218 | 0 | |
| 124073763 | 12407376 | 2 | 20131220 | 20140103 | 0 | |
| 124073763 | 12407376 | 3 | 20140103 | 20140120 | 0 | |
| 124073763 | 12407376 | 4 | 20140121 | 20140122 | 0 | |
| 124073763 | 12407376 | 5 | 20131113 | 20140123 | 0 | |
| 124073763 | 12407376 | 7 | 20140123 | 20140126 | 0 | |
| 124073763 | 12407376 | 8 | 20140127 | 20140127 | 0 | |
| 124073763 | 12407376 | 9 | 20140128 | 20140130 | 0 | |
| 124073763 | 12407376 | 10 | 20140131 | 20140213 | 0 | |
| 124073763 | 12407376 | 11 | 20140214 | 20140521 | 0 | |
| 124073763 | 12407376 | 12 | 20140522 | 20141126 | 0 | |
| 124073763 | 12407376 | 13 | 20141127 | 20150129 | 0 | |
| 124073763 | 12407376 | 14 | 20150130 | 0 | ||
| 124073763 | 12407376 | 15 | 20140123 | 20140129 | 0 | |
| 124073763 | 12407376 | 16 | 20140130 | 20140130 | 0 | |
| 124073763 | 12407376 | 17 | 20140131 | 20140211 | 0 | |
| 124073763 | 12407376 | 18 | 20140212 | 20140312 | 0 | |
| 124073763 | 12407376 | 19 | 20140313 | 0 |