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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125354482 | 12535448 | 2 | F | 201602 | 20160831 | 20160707 | 20160907 | EXP | PHHY2016FR091062 | NOVARTIS | 78.68 | YR | F | Y | 60.00000 | KG | 20160907 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125354482 | 12535448 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | 860 | MG | N | 22334 | 5 | MG | QD | ||||
| 125354482 | 12535448 | 2 | C | EXEMESTANE. | EXEMESTANE | 1 | Oral | 25 MG, UNK | U | 0 | 25 | MG | |||||||
| 125354482 | 12535448 | 3 | C | BISOPROLOL | BISOPROLOL | 1 | Oral | 1.25 MG, UNK | U | 0 | 1.25 | MG | |||||||
| 125354482 | 12535448 | 4 | C | XGEVA | DENOSUMAB | 1 | Subcutaneous | 100 MG, UNK | U | 0 | 100 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125354482 | 12535448 | 1 | Breast cancer metastatic |
| 125354482 | 12535448 | 2 | Product used for unknown indication |
| 125354482 | 12535448 | 3 | Hypertension |
| 125354482 | 12535448 | 4 | Metastases to bone |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125354482 | 12535448 | OT |
| 125354482 | 12535448 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125354482 | 12535448 | Gastrointestinal angiodysplasia haemorrhagic | |
| 125354482 | 12535448 | General physical health deterioration | |
| 125354482 | 12535448 | Iron deficiency anaemia | |
| 125354482 | 12535448 | Melaena | |
| 125354482 | 12535448 | 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 |
|---|---|---|---|---|---|---|
| 125354482 | 12535448 | 1 | 20151211 | 20160601 | 0 | |
| 125354482 | 12535448 | 2 | 20151217 | 0 |