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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125478382 | 12547838 | 2 | F | 20160622 | 20160829 | 20160712 | 20160902 | PER | PHEH2016US016975 | NOVARTIS | 58.17 | YR | F | Y | 55.70000 | KG | 20160902 | MD | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125478382 | 12547838 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 7.5 MG, QD | Y | F0026 | 22334 | 7.5 | MG | QD | |||||
| 125478382 | 12547838 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | Y | 22334 | 5 | MG | QD | ||||||
| 125478382 | 12547838 | 3 | SS | XGEVA | DENOSUMAB | 1 | Subcutaneous | UNK UNK, QMO | 0 | /month | |||||||||
| 125478382 | 12547838 | 4 | SS | AROMASIN | EXEMESTANE | 1 | Unknown | 25 MG, QD | 0 | 25 | MG | QD | |||||||
| 125478382 | 12547838 | 5 | SS | EMLA | LIDOCAINEPRILOCAINE | 1 | Topical | UNK UNK, PRN | 0 | ||||||||||
| 125478382 | 12547838 | 6 | C | HERCEPTIN | TRASTUZUMAB | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125478382 | 12547838 | 1 | Breast cancer |
| 125478382 | 12547838 | 3 | Breast cancer |
| 125478382 | 12547838 | 4 | Breast cancer |
| 125478382 | 12547838 | 5 | Product used for unknown indication |
| 125478382 | 12547838 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125478382 | 12547838 | Dry throat | |
| 125478382 | 12547838 | Dysphagia | |
| 125478382 | 12547838 | Dysphonia | |
| 125478382 | 12547838 | Headache | |
| 125478382 | 12547838 | Intraocular pressure increased | |
| 125478382 | 12547838 | Oropharyngeal pain | |
| 125478382 | 12547838 | Pharyngeal oedema |
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 |
|---|---|---|---|---|---|---|
| 125478382 | 12547838 | 1 | 20160622 | 20160625 | 0 |