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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1114039422 | 11140394 | 22 | F | 2014 | 20160711 | 20150527 | 20160720 | EXP | CA-ROCHE-1382044 | ROCHE | 63.32 | YR | F | Y | 43.00000 | KG | 20160720 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1114039422 | 11140394 | 1 | PS | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | 1 | Intravenous (not otherwise specified) | 125427 | 160 | MG | |||||||||
| 1114039422 | 11140394 | 2 | SS | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | 1 | Intravenous (not otherwise specified) | 125427 | 162 | MG | |||||||||
| 1114039422 | 11140394 | 3 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Unknown | 103792 | |||||||||||
| 1114039422 | 11140394 | 4 | SS | XELODA | CAPECITABINE | 1 | Oral | 20896 | |||||||||||
| 1114039422 | 11140394 | 5 | SS | TAMOXIFEN | TAMOXIFEN | 1 | Unknown | 0 | |||||||||||
| 1114039422 | 11140394 | 6 | SS | TAXOTERE | DOCETAXEL | 1 | Unknown | U | 0 | ||||||||||
| 1114039422 | 11140394 | 7 | SS | TAXOL | PACLITAXEL | 1 | Unknown | 0 | |||||||||||
| 1114039422 | 11140394 | 8 | SS | VINORELBINE | VINORELBINEVINORELBINE TARTRATE | 1 | Unknown | 0 | |||||||||||
| 1114039422 | 11140394 | 9 | C | SENOKOT | SENNOSIDES | 1 | 0 | ||||||||||||
| 1114039422 | 11140394 | 10 | C | TYLENOL | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 1114039422 | 11140394 | 11 | C | GRAVOL | DIMENHYDRINATE | 1 | Oral | 0 | 50 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1114039422 | 11140394 | 1 | HER-2 positive breast cancer |
| 1114039422 | 11140394 | 3 | Breast cancer |
| 1114039422 | 11140394 | 4 | Breast cancer |
| 1114039422 | 11140394 | 5 | Breast cancer |
| 1114039422 | 11140394 | 6 | Breast cancer |
| 1114039422 | 11140394 | 7 | Breast cancer |
| 1114039422 | 11140394 | 8 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1114039422 | 11140394 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1114039422 | 11140394 | Abdominal pain | |
| 1114039422 | 11140394 | Alanine aminotransferase increased | |
| 1114039422 | 11140394 | Aspartate aminotransferase increased | |
| 1114039422 | 11140394 | Blood alkaline phosphatase increased | |
| 1114039422 | 11140394 | Blood calcium decreased | |
| 1114039422 | 11140394 | Blood chloride decreased | |
| 1114039422 | 11140394 | Blood creatinine decreased | |
| 1114039422 | 11140394 | Blood glucose increased | |
| 1114039422 | 11140394 | Blood lactate dehydrogenase increased | |
| 1114039422 | 11140394 | Blood pressure increased | |
| 1114039422 | 11140394 | Blood sodium decreased | |
| 1114039422 | 11140394 | Blood urea decreased | |
| 1114039422 | 11140394 | Blood uric acid decreased | |
| 1114039422 | 11140394 | Body temperature decreased | |
| 1114039422 | 11140394 | Body temperature increased | |
| 1114039422 | 11140394 | Cellulitis | |
| 1114039422 | 11140394 | Cough | |
| 1114039422 | 11140394 | Dental caries | |
| 1114039422 | 11140394 | Diarrhoea | |
| 1114039422 | 11140394 | Dizziness | |
| 1114039422 | 11140394 | Drug ineffective | |
| 1114039422 | 11140394 | Dyspnoea | |
| 1114039422 | 11140394 | Eosinophil count increased | |
| 1114039422 | 11140394 | Eosinophil percentage increased | |
| 1114039422 | 11140394 | Gastrooesophageal reflux disease | |
| 1114039422 | 11140394 | Gingival bleeding | |
| 1114039422 | 11140394 | Haematocrit decreased | |
| 1114039422 | 11140394 | Haemoglobin decreased | |
| 1114039422 | 11140394 | Heart rate decreased | |
| 1114039422 | 11140394 | Heart rate increased | |
| 1114039422 | 11140394 | Hypertension | |
| 1114039422 | 11140394 | Infusion related reaction | |
| 1114039422 | 11140394 | Injection site extravasation | |
| 1114039422 | 11140394 | Lipase increased | |
| 1114039422 | 11140394 | Lymphocyte count decreased | |
| 1114039422 | 11140394 | Malignant neoplasm progression | |
| 1114039422 | 11140394 | Monocyte count increased | |
| 1114039422 | 11140394 | Monocyte percentage increased | |
| 1114039422 | 11140394 | Nasopharyngitis | |
| 1114039422 | 11140394 | Nausea | |
| 1114039422 | 11140394 | Peripheral swelling | |
| 1114039422 | 11140394 | Platelet count decreased | |
| 1114039422 | 11140394 | Red blood cell count decreased | |
| 1114039422 | 11140394 | Red blood cell count increased | |
| 1114039422 | 11140394 | Red cell distribution width increased | |
| 1114039422 | 11140394 | Stomatitis | |
| 1114039422 | 11140394 | Stress | |
| 1114039422 | 11140394 | Tooth disorder | |
| 1114039422 | 11140394 | Toothache |
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 |
|---|---|---|---|---|---|---|
| 1114039422 | 11140394 | 1 | 20141112 | 20160622 | 0 | |
| 1114039422 | 11140394 | 2 | 20150318 | 0 | ||
| 1114039422 | 11140394 | 3 | 20060101 | 20141104 | 0 | |
| 1114039422 | 11140394 | 4 | 20130802 | 201404 | 0 | |
| 1114039422 | 11140394 | 6 | 20050101 | 20060101 | 0 | |
| 1114039422 | 11140394 | 7 | 201303 | 201308 | 0 |