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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125112162 | 12511216 | 2 | F | 20160705 | 20160629 | 20160711 | EXP | PHJP2016JP016647 | NOVARTIS | 72.00 | YR | F | Y | 0.00000 | 20160711 | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125112162 | 12511216 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, BID | Y | 22334 | 5 | MG | TABLET | BID | |||||
| 125112162 | 12511216 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | Y | 22334 | 5 | MG | TABLET | QD | |||||
| 125112162 | 12511216 | 3 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, UNK | Y | 22334 | 10 | MG | TABLET | ||||||
| 125112162 | 12511216 | 4 | SS | EXEMESTANE. | EXEMESTANE | 1 | Unknown | 25 MG, UNK | Y | 0 | 25 | MG | |||||||
| 125112162 | 12511216 | 5 | SS | EXEMESTANE. | EXEMESTANE | 1 | Unknown | 25 MG, UNK | Y | 0 | 25 | MG | |||||||
| 125112162 | 12511216 | 6 | C | INSULIN | INSULIN NOS | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125112162 | 12511216 | 1 | Breast cancer recurrent |
| 125112162 | 12511216 | 4 | Breast cancer recurrent |
| 125112162 | 12511216 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125112162 | 12511216 | HO |
| 125112162 | 12511216 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125112162 | 12511216 | Blood glucose increased | |
| 125112162 | 12511216 | Dyspnoea | |
| 125112162 | 12511216 | Erythema | |
| 125112162 | 12511216 | Face oedema | |
| 125112162 | 12511216 | General physical health deterioration | |
| 125112162 | 12511216 | Glycosylated haemoglobin increased | |
| 125112162 | 12511216 | Inflammation | |
| 125112162 | 12511216 | Malignant neoplasm progression | |
| 125112162 | 12511216 | Metastases to bone | |
| 125112162 | 12511216 | Oedema | |
| 125112162 | 12511216 | Oedema peripheral | |
| 125112162 | 12511216 | Organising pneumonia | |
| 125112162 | 12511216 | Pruritus | |
| 125112162 | 12511216 | Pyrexia | |
| 125112162 | 12511216 | Rash | |
| 125112162 | 12511216 | Renal impairment | |
| 125112162 | 12511216 | Stomatitis | |
| 125112162 | 12511216 | Urticaria |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |