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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126490303 | 12649030 | 3 | F | 20150514 | 20160902 | 20160812 | 20160909 | EXP | PHHO2015AU008833 | NOVARTIS | 52.25 | YR | F | Y | 59.60000 | KG | 20160909 | MD | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126490303 | 12649030 | 1 | PS | LDE 225 | ERISMODEGIB | 1 | Oral | DOSE BLINDED | 205266 | CAPSULE | |||||||||
| 126490303 | 12649030 | 2 | SS | LDE 225 | ERISMODEGIB | 1 | Oral | DOSE BLINDED | 205266 | CAPSULE | |||||||||
| 126490303 | 12649030 | 3 | SS | SIROLIMUS. | SIROLIMUS | 1 | Oral | 1 MG, OO | 0 | 1 | MG | ||||||||
| 126490303 | 12649030 | 4 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 5 MG, OO | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126490303 | 12649030 | 1 | Basal cell carcinoma |
| 126490303 | 12649030 | 3 | Renal transplant |
| 126490303 | 12649030 | 4 | Renal transplant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126490303 | 12649030 | DS |
| 126490303 | 12649030 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126490303 | 12649030 | Dyspnoea | |
| 126490303 | 12649030 | Lower respiratory tract infection | |
| 126490303 | 12649030 | Pleural effusion | |
| 126490303 | 12649030 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 126490303 | 12649030 | 1 | 20120628 | 20150514 | 0 | |
| 126490303 | 12649030 | 2 | 20150518 | 0 | ||
| 126490303 | 12649030 | 3 | 1981 | 0 | ||
| 126490303 | 12649030 | 4 | 1981 | 0 |