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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120519293 | 12051929 | 3 | F | 20160806 | 20160824 | 20160209 | 20160829 | PER | PHEH2016US002916 | NOVARTIS | 72.88 | YR | F | Y | 0.00000 | 20160830 | CN | COUNTRY NOT SPECIFIED | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120519293 | 12051929 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | Y | 22334 | 10 | MG | TABLET | QD | |||||
| 120519293 | 12051929 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 7.5 MG, QD | Y | 22334 | 7.5 | MG | TABLET | QD | |||||
| 120519293 | 12051929 | 3 | C | CAPECITABINE. | CAPECITABINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 120519293 | 12051929 | 4 | C | ALEVE | NAPROXEN SODIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 120519293 | 12051929 | 5 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 120519293 | 12051929 | 6 | C | NEXIUM I.V. | ESOMEPRAZOLE SODIUM | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120519293 | 12051929 | 1 | Nipple neoplasm |
| 120519293 | 12051929 | 3 | Product used for unknown indication |
| 120519293 | 12051929 | 4 | Product used for unknown indication |
| 120519293 | 12051929 | 5 | Product used for unknown indication |
| 120519293 | 12051929 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120519293 | 12051929 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120519293 | 12051929 | Cough | |
| 120519293 | 12051929 | Decreased appetite | |
| 120519293 | 12051929 | Diarrhoea | |
| 120519293 | 12051929 | Dizziness | |
| 120519293 | 12051929 | Dyspnoea | |
| 120519293 | 12051929 | Frequent bowel movements | |
| 120519293 | 12051929 | Hyperhidrosis | |
| 120519293 | 12051929 | Oral pain | |
| 120519293 | 12051929 | Pollakiuria | |
| 120519293 | 12051929 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 120519293 | 12051929 | 2 | 20160112 | 0 |