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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113083746 | 11308374 | 6 | F | 20140622 | 20160722 | 20150724 | 20160729 | EXP | PHJP2015JP012280 | NOVARTIS | SAKIYAMA K, YOSHIDA T, GOTO Y, KIMURA M. A CASE OF RECURRENT BREAST CANCER DEVELOPED MELAENA, INTERSTITIAL PNEUMONIA AND STOMATITIS IN SPITE OF REMARKABLE EFFECT OF COMBINATION THERAPY WITH EVEROLIMUS AND EXEMESTANE. THE 24TH ANNUAL MEETING OF THE JAPANESE BREAST CANCER SOCIETY. 2015 | 80.00 | YR | F | Y | 0.00000 | 20160729 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113083746 | 11308374 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | 490 | MG | Y | 22334 | 10 | MG | TABLET | QD | |||
| 113083746 | 11308374 | 2 | SS | EXEMESTANE. | EXEMESTANE | 1 | Oral | 25 MG, QD | Y | 0 | 25 | MG | QD | ||||||
| 113083746 | 11308374 | 3 | C | FULVESTRANT | FULVESTRANT | 1 | Unknown | 500 MG, UNK | U | 0 | 500 | MG | |||||||
| 113083746 | 11308374 | 4 | C | ERIBULIN MESILATE | ERIBULIN | 1 | Unknown | 1.4 MG/M2, UNK | Y | 0 | 1.4 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113083746 | 11308374 | 1 | Breast cancer recurrent |
| 113083746 | 11308374 | 2 | Breast cancer recurrent |
| 113083746 | 11308374 | 3 | Chest wall mass |
| 113083746 | 11308374 | 4 | Pleural effusion |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113083746 | 11308374 | OT |
| 113083746 | 11308374 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113083746 | 11308374 | Abdominal pain | |
| 113083746 | 11308374 | Cough | |
| 113083746 | 11308374 | Diarrhoea | |
| 113083746 | 11308374 | Dyspnoea | |
| 113083746 | 11308374 | Fatigue | |
| 113083746 | 11308374 | Feeding disorder | |
| 113083746 | 11308374 | Haematochezia | |
| 113083746 | 11308374 | Haemoglobin decreased | |
| 113083746 | 11308374 | Interstitial lung disease | |
| 113083746 | 11308374 | Malnutrition | |
| 113083746 | 11308374 | Melaena | |
| 113083746 | 11308374 | Pyrexia | |
| 113083746 | 11308374 | Stomatitis | |
| 113083746 | 11308374 | 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 |
|---|---|---|---|---|---|---|
| 113083746 | 11308374 | 1 | 20140605 | 20140723 | 0 | |
| 113083746 | 11308374 | 2 | 20140605 | 201410 | 0 |