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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118882269 | 11888226 | 9 | F | 20151116 | 20160905 | 20160105 | 20160913 | EXP | PHHY2015FR171709 | NOVARTIS | 57.88 | YR | M | Y | 0.00000 | 20160913 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118882269 | 11888226 | 1 | PS | CERTICAN | EVEROLIMUS | 1 | Oral | UNK | U | 21560 | |||||||||
| 118882269 | 11888226 | 2 | SS | CERTICAN | EVEROLIMUS | 1 | U | 21560 | |||||||||||
| 118882269 | 11888226 | 3 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Oral | 1440 MG, QD | 1306080 | MG | Y | 0 | 1440 | MG | QD | ||||
| 118882269 | 11888226 | 4 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | 1306080 | MG | Y | 0 | |||||||||
| 118882269 | 11888226 | 5 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | 6 MG, QD | Y | 0 | 6 | MG | QD | ||||||
| 118882269 | 11888226 | 6 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | 5.5 MG, QD | Y | 0 | 5.5 | MG | QD | ||||||
| 118882269 | 11888226 | 7 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | 5 MG, QD | Y | 0 | 5 | MG | QD | ||||||
| 118882269 | 11888226 | 8 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | 4.5 MG, QD | Y | 0 | 4.5 | MG | QD | ||||||
| 118882269 | 11888226 | 9 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Oral | 4 MG, QD | Y | 0 | 4 | MG | QD | ||||||
| 118882269 | 11888226 | 10 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | 3.5 MG, QD | Y | 0 | 3.5 | MG | QD | ||||||
| 118882269 | 11888226 | 11 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | UNK | Y | 0 | |||||||||
| 118882269 | 11888226 | 12 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Oral | 0.5 MG, BID | Y | 0 | .5 | MG | BID | ||||||
| 118882269 | 11888226 | 13 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Oral | 1 MG, BID, IN EVENING | Y | 0 | 1 | MG | BID | ||||||
| 118882269 | 11888226 | 14 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Oral | 6 MG, QD | Y | 0 | 6 | MG | QD | ||||||
| 118882269 | 11888226 | 15 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | 500 MG, UNK | U | 0 | 500 | MG | |||||||
| 118882269 | 11888226 | 16 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | 250 MG, UNK | U | 0 | 250 | MG | |||||||
| 118882269 | 11888226 | 17 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | 500 MG, UNK | U | 0 | 500 | MG | |||||||
| 118882269 | 11888226 | 18 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Unknown | 500 MG, BID | U | 0 | 500 | MG | BID | ||||||
| 118882269 | 11888226 | 19 | C | SIMULECT | BASILIXIMAB | 1 | Unknown | U | 0 | ||||||||||
| 118882269 | 11888226 | 20 | C | CORTANCYL | PREDNISONE | 1 | Unknown | 1 MG, QD | Y | 0 | 1 | MG | QD | ||||||
| 118882269 | 11888226 | 21 | C | CORTANCYL | PREDNISONE | 1 | Unknown | 2 MG, QD | Y | 0 | 2 | MG | QD | ||||||
| 118882269 | 11888226 | 22 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 350 MG, UNK | U | 0 | 350 | MG | |||||||
| 118882269 | 11888226 | 23 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 20 MG, UNK | U | 0 | 20 | MG | |||||||
| 118882269 | 11888226 | 24 | C | INEXIUM//ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Unknown | 20 MG, QD | U | 0 | 20 | MG | QD | ||||||
| 118882269 | 11888226 | 25 | C | VIREAD | TENOFOVIR DISOPROXIL FUMARATE | 1 | Unknown | 1 DF, QD | U | 0 | 1 | DF | TABLET | QD | |||||
| 118882269 | 11888226 | 26 | C | KARDEGIC | ASPIRIN LYSINE | 1 | Unknown | 75 MG, QD | U | 0 | 75 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118882269 | 11888226 | 1 | Liver transplant |
| 118882269 | 11888226 | 2 | Immunosuppressant drug therapy |
| 118882269 | 11888226 | 3 | Liver transplant |
| 118882269 | 11888226 | 4 | Immunosuppressant drug therapy |
| 118882269 | 11888226 | 5 | Immunosuppressant drug therapy |
| 118882269 | 11888226 | 15 | Immunosuppressant drug therapy |
| 118882269 | 11888226 | 19 | Immunosuppressant drug therapy |
| 118882269 | 11888226 | 20 | Immunosuppressant drug therapy |
| 118882269 | 11888226 | 22 | Immunosuppressant drug therapy |
| 118882269 | 11888226 | 24 | Product used for unknown indication |
| 118882269 | 11888226 | 25 | Product used for unknown indication |
| 118882269 | 11888226 | 26 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118882269 | 11888226 | OT |
| 118882269 | 11888226 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118882269 | 11888226 | Acute kidney injury | |
| 118882269 | 11888226 | Asthenia | |
| 118882269 | 11888226 | Biliary anastomosis complication | |
| 118882269 | 11888226 | Chills | |
| 118882269 | 11888226 | Cholangitis | |
| 118882269 | 11888226 | Cholestasis | |
| 118882269 | 11888226 | Decreased appetite | |
| 118882269 | 11888226 | Device occlusion | |
| 118882269 | 11888226 | Diarrhoea | |
| 118882269 | 11888226 | Hallucination | |
| 118882269 | 11888226 | Hepatic artery stenosis | |
| 118882269 | 11888226 | Infectious pleural effusion | |
| 118882269 | 11888226 | Jaundice | |
| 118882269 | 11888226 | Klebsiella infection | |
| 118882269 | 11888226 | Liver graft loss | |
| 118882269 | 11888226 | Oliguria | |
| 118882269 | 11888226 | Pancreatitis | |
| 118882269 | 11888226 | Pancytopenia | |
| 118882269 | 11888226 | Septic shock | |
| 118882269 | 11888226 | Somnolence | |
| 118882269 | 11888226 | Type 1 diabetes mellitus | |
| 118882269 | 11888226 | Weight 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 |
|---|---|---|---|---|---|---|
| 118882269 | 11888226 | 3 | 20130706 | 20151229 | 0 | |
| 118882269 | 11888226 | 5 | 20130913 | 20140115 | 0 | |
| 118882269 | 11888226 | 6 | 20140116 | 20140116 | 0 | |
| 118882269 | 11888226 | 7 | 20140117 | 20140210 | 0 | |
| 118882269 | 11888226 | 8 | 20140211 | 20140211 | 0 | |
| 118882269 | 11888226 | 9 | 20140212 | 20151214 | 0 | |
| 118882269 | 11888226 | 10 | 20151215 | 20151229 | 0 | |
| 118882269 | 11888226 | 11 | 20151230 | 20160111 | 0 | |
| 118882269 | 11888226 | 12 | 20160112 | 0 | ||
| 118882269 | 11888226 | 13 | 20160113 | 0 | ||
| 118882269 | 11888226 | 14 | 20160426 | 0 | ||
| 118882269 | 11888226 | 15 | 20151230 | 20160102 | 0 | |
| 118882269 | 11888226 | 16 | 20160103 | 20160104 | 0 | |
| 118882269 | 11888226 | 17 | 20160107 | 20160112 | 0 | |
| 118882269 | 11888226 | 18 | 20160114 | 0 | ||
| 118882269 | 11888226 | 20 | 20131222 | 20140105 | 0 | |
| 118882269 | 11888226 | 21 | 20131207 | 20131221 | 0 | |
| 118882269 | 11888226 | 22 | 20160107 | 20160107 | 0 | |
| 118882269 | 11888226 | 23 | 20160108 | 0 |