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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125419141 | 12541914 | 1 | I | 20141009 | 20160701 | 20160708 | 20160708 | EXP | IT-MINISAL02-365657 | IT-MYLANLABS-2016M1027962 | MYLAN | 0.00 | Y | 0.00000 | 20160708 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125419141 | 12541914 | 1 | PS | CAPECITABINE. | CAPECITABINE | 1 | UNK | 90943 | |||||||||||
| 125419141 | 12541914 | 2 | SS | CAPECITABINE. | CAPECITABINE | 1 | Intravenous (not otherwise specified) | UNK | 90943 | ||||||||||
| 125419141 | 12541914 | 3 | SS | HERCEPTIN | TRASTUZUMAB | 1 | UNK | U | 0 | ||||||||||
| 125419141 | 12541914 | 4 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Intravenous (not otherwise specified) | UNK | U | 0 | |||||||||
| 125419141 | 12541914 | 5 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Subcutaneous | UNK | U | 0 | |||||||||
| 125419141 | 12541914 | 6 | SS | NAVELBINE | VINORELBINE TARTRATE | 1 | UNK | 0 | |||||||||||
| 125419141 | 12541914 | 7 | SS | NAVELBINE | VINORELBINE TARTRATE | 1 | Subcutaneous | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125419141 | 12541914 | 1 | Breast cancer stage IV |
| 125419141 | 12541914 | 3 | Breast cancer stage IV |
| 125419141 | 12541914 | 6 | Breast cancer stage IV |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125419141 | 12541914 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125419141 | 12541914 | Dysphonia | |
| 125419141 | 12541914 | Necrosis | |
| 125419141 | 12541914 | Periodontal disease | |
| 125419141 | 12541914 | Pleural effusion | |
| 125419141 | 12541914 | Toxicity to various agents | |
| 125419141 | 12541914 | Vocal cord paralysis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |