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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126334331 | 12633433 | 1 | I | 20160724 | 20160802 | 20160808 | 20160808 | EXP | PHHY2016BR107807 | NOVARTIS | 23.00 | YR | F | Y | 71.50000 | KG | 20160808 | MD | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126334331 | 12633433 | 1 | PS | CERTICAN | EVEROLIMUS | 1 | Oral | 3 MG, QD (2 DF OF 1MG AND 2 DF OF 0.5 MG, QD) | 12 | MG | Y | 21560 | 3 | MG | TABLET | QD | |||
| 126334331 | 12633433 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 7 MG (4MG IN THE MORNING AND 3 MG AT NIGHT, AFTER 12HRS) | U | 0 | 7 | MG | |||||||
| 126334331 | 12633433 | 3 | C | TIMOGLOBULINA | 2 | Unknown | 4.5 MG, (3MG + 1.5MG) | Y | 0 | 4.5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126334331 | 12633433 | 1 | Renal transplant |
| 126334331 | 12633433 | 2 | Renal transplant |
| 126334331 | 12633433 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126334331 | 12633433 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126334331 | 12633433 | Off label use | |
| 126334331 | 12633433 | Submaxillary gland enlargement |
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 |
|---|---|---|---|---|---|---|
| 126334331 | 12633433 | 1 | 20160724 | 20160728 | 0 |