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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127760111 | 12776011 | 1 | I | 2013 | 20160916 | 20160923 | 20160923 | EXP | FR-ASTELLAS-2016US036644 | ASTELLAS | 16.26 | YR | F | Y | 0.00000 | 20160923 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127760111 | 12776011 | 1 | PS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Oral | 50708 | 4.5 | MG | FORMULATION UNKNOWN | BID | |||||||
| 127760111 | 12776011 | 2 | SS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Oral | 50708 | 4.5 | MG | FORMULATION UNKNOWN | BID | |||||||
| 127760111 | 12776011 | 3 | SS | CERTICAN | EVEROLIMUS | 1 | Oral | 0 | 3.75 | MG | FORMULATION UNKNOWN | BID | |||||||
| 127760111 | 12776011 | 4 | SS | CERTICAN | EVEROLIMUS | 1 | Oral | 0 | 3.75 | MG | FORMULATION UNKNOWN | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127760111 | 12776011 | 1 | Organ transplant |
| 127760111 | 12776011 | 3 | Organ transplant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127760111 | 12776011 | HO |
| 127760111 | 12776011 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127760111 | 12776011 | Acute kidney injury | |
| 127760111 | 12776011 | Back pain | |
| 127760111 | 12776011 | Cholestasis | |
| 127760111 | 12776011 | Clostridium difficile infection | |
| 127760111 | 12776011 | Colitis | |
| 127760111 | 12776011 | Conjunctivitis | |
| 127760111 | 12776011 | Ear infection | |
| 127760111 | 12776011 | Epstein-Barr virus associated lymphoproliferative disorder | |
| 127760111 | 12776011 | Epstein-Barr virus infection | |
| 127760111 | 12776011 | Flank pain | |
| 127760111 | 12776011 | Gastric ulcer | |
| 127760111 | 12776011 | Malnutrition | |
| 127760111 | 12776011 | Off label use | |
| 127760111 | 12776011 | Overdose | |
| 127760111 | 12776011 | Pain in extremity | |
| 127760111 | 12776011 | Pancreatitis acute | |
| 127760111 | 12776011 | Pruritus | |
| 127760111 | 12776011 | Rash macular | |
| 127760111 | 12776011 | Renal tubular necrosis | |
| 127760111 | 12776011 | Sputum abnormal |
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 |
|---|---|---|---|---|---|---|
| 127760111 | 12776011 | 1 | 201306 | 0 | ||
| 127760111 | 12776011 | 3 | 201306 | 0 |