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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125832611 | 12583261 | 1 | I | 20160310 | 20160420 | 20160722 | 20160722 | EXP | PHHY2016CO055867 | NOVARTIS | 48.67 | YR | F | Y | 84.00000 | KG | 20160722 | CN | COUNTRY NOT SPECIFIED | CO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125832611 | 12583261 | 1 | PS | TYKERB | LAPATINIB DITOSYLATE | 1 | Oral | 250 MG, TID (3 TABLES) | 22059 | 250 | MG | TABLET | TID | ||||||
| 125832611 | 12583261 | 2 | SS | TYKERB | LAPATINIB DITOSYLATE | 1 | Oral | 250 MG, TID (3 TABLETS) | 22059 | 250 | MG | TABLET | TID | ||||||
| 125832611 | 12583261 | 3 | C | TRASTUZUMAB | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 440 MG, QMO ( (EVERY 21 DAYS) | U | 0 | 440 | MG | SOLUTION FOR INJECTION | /month |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125832611 | 12583261 | 1 | Breast cancer |
| 125832611 | 12583261 | 3 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125832611 | 12583261 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125832611 | 12583261 | Dental caries | |
| 125832611 | 12583261 | Discomfort | |
| 125832611 | 12583261 | Haemorrhage | |
| 125832611 | 12583261 | Hypersensitivity | |
| 125832611 | 12583261 | Hypoaesthesia | |
| 125832611 | 12583261 | Insomnia | |
| 125832611 | 12583261 | Laceration | |
| 125832611 | 12583261 | Pruritus | |
| 125832611 | 12583261 | Rash | |
| 125832611 | 12583261 | Sciatica | |
| 125832611 | 12583261 | Speech disorder | |
| 125832611 | 12583261 | Stomatitis | |
| 125832611 | 12583261 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 125832611 | 12583261 | 1 | 20160307 | 0 | ||
| 125832611 | 12583261 | 2 | 20160421 | 20160718 | 0 |