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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126229981 | 12622998 | 1 | I | 20140901 | 20160728 | 20160804 | 20160804 | EXP | PHHY2016ES104794 | SANDOZ | 61.00 | YR | F | Y | 0.00000 | 20160804 | OT | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126229981 | 12622998 | 1 | PS | ADOPORT | TACROLIMUS | 1 | Oral | 0.5 | U | 65461 | HARD-GELATIN CAPSULE | ||||||||
| 126229981 | 12622998 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 5 MG, QD | U | 0 | 5 | MG | QD | ||||||
| 126229981 | 12622998 | 3 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | 1G/5ML | Y | 0 | 1 | G | POWDER FOR ORAL SUSPENSION | ||||||
| 126229981 | 12622998 | 4 | C | ATORVASTATINE//ATORVASTATIN | 2 | Oral | 20 MG, QD | U | 0 | 20 | MG | QD | |||||||
| 126229981 | 12622998 | 5 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 20 MG, QD | U | 0 | 20 | MG | QD | ||||||
| 126229981 | 12622998 | 6 | C | COLISTIN | COLISTIN | 1 | Respiratory (inhalation) | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126229981 | 12622998 | 1 | Renal transplant |
| 126229981 | 12622998 | 2 | Renal transplant |
| 126229981 | 12622998 | 3 | Renal transplant |
| 126229981 | 12622998 | 4 | Product used for unknown indication |
| 126229981 | 12622998 | 5 | Product used for unknown indication |
| 126229981 | 12622998 | 6 | Respiratory therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126229981 | 12622998 | OT |
| 126229981 | 12622998 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126229981 | 12622998 | Cytomegalovirus infection | |
| 126229981 | 12622998 | Renal tuberculosis |
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 |
|---|---|---|---|---|---|---|
| 126229981 | 12622998 | 3 | 20141120 | 0 | ||
| 126229981 | 12622998 | 6 | 20141014 | 0 |