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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 75513943 | 7551394 | 3 | F | 20100807 | 20160824 | 20100824 | 20160824 | EXP | PHHO2010GB12079 | NOVARTIS | 49.37 | YR | F | Y | 68.00000 | KG | 20160824 | MD | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 75513943 | 7551394 | 1 | PS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Oral | UNK | 0 | ||||||||||
| 75513943 | 7551394 | 2 | SS | COMPARATOR VINORELBINE | VINORELBINE TARTRATE | 1 | Intravenous (not otherwise specified) | 44 MG, UNK | 0 | 44 | MG | ||||||||
| 75513943 | 7551394 | 3 | SS | COMPARATOR TRASTUZUMAB | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | 270 MG, UNK | 0 | 270 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 75513943 | 7551394 | 1 | Breast cancer metastatic |
| 75513943 | 7551394 | 2 | Breast cancer metastatic |
| 75513943 | 7551394 | 3 | Breast cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 75513943 | 7551394 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 75513943 | 7551394 | Abdominal pain | |
| 75513943 | 7551394 | Haematemesis | |
| 75513943 | 7551394 | Neutropenia | |
| 75513943 | 7551394 | Stomatitis |
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 |
|---|---|---|---|---|---|---|
| 75513943 | 7551394 | 1 | 20100802 | 0 | ||
| 75513943 | 7551394 | 2 | 20100802 | 0 | ||
| 75513943 | 7551394 | 3 | 20100802 | 0 |