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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125303344 | 12530334 | 4 | F | 2014 | 20160624 | 20160706 | 20160708 | EXP | US-ACTAVIS-2016-10832 | ACTAVIS | 0.00 | F | Y | 0.00000 | 20160708 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125303344 | 12530334 | 1 | SS | Tamoxifen Citrate (Actavis Laboratories FL) | TAMOXIFEN CITRATE | 1 | Unknown | UNK | Y | UNKNOWN | 0 | UNK | |||||||
| 125303344 | 12530334 | 2 | SS | Tamoxifen Citrate (Actavis Laboratories FL) | TAMOXIFEN CITRATE | 1 | Y | 0 | UNK | ||||||||||
| 125303344 | 12530334 | 3 | SS | Carboplatin (Watson Laboratories) | CARBOPLATIN | 1 | Unknown | 6 CYCLES | UNKNOWN | 0 | UNK | ||||||||
| 125303344 | 12530334 | 4 | PS | Doxorubicin Hydrochloride (Actavis Inc) | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | 4 CYCLES | UNKNOWN | 203622 | UNK | ||||||||
| 125303344 | 12530334 | 5 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Unknown | UNK | U | UNKNOWN | 0 | ||||||||
| 125303344 | 12530334 | 6 | SS | HERCEPTIN | TRASTUZUMAB | 1 | U | 0 | |||||||||||
| 125303344 | 12530334 | 7 | SS | PERTUZUMAB | PERTUZUMAB | 1 | Unknown | UNK | U | UNKNOWN | 0 | ||||||||
| 125303344 | 12530334 | 8 | SS | PERTUZUMAB | PERTUZUMAB | 1 | U | 0 | |||||||||||
| 125303344 | 12530334 | 9 | SS | CYCLOPHOSPHAMIDE MONOHYDRATE | CYCLOPHOSPHAMIDE | 1 | Unknown | 4 CYCLES | UNKNOWN | 0 | |||||||||
| 125303344 | 12530334 | 10 | SS | TAXOL | PACLITAXEL | 1 | Unknown | 1 CYCLE | UNKNOWN | 0 | |||||||||
| 125303344 | 12530334 | 11 | SS | TAXOTERE | DOCETAXEL | 1 | Unknown | 1 CYCLE | UNKNOWN | 0 | |||||||||
| 125303344 | 12530334 | 12 | SS | TAXOTERE | DOCETAXEL | 1 | Unknown | 6 CYCLES | UNKNOWN | 0 | |||||||||
| 125303344 | 12530334 | 13 | SS | ARIMIDEX | ANASTROZOLE | 1 | Unknown | UNK | UNKNOWN | 0 | |||||||||
| 125303344 | 12530334 | 14 | SS | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | 1 | Unknown | UNK | UNKNOWN | 0 | |||||||||
| 125303344 | 12530334 | 15 | SS | FASLODEX | FULVESTRANT | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 125303344 | 12530334 | 16 | SS | XELODA | CAPECITABINE | 1 | Unknown | UNK | UNKNOWN | 0 | |||||||||
| 125303344 | 12530334 | 17 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 125303344 | 12530334 | 18 | C | CALCIUM + D3 /00944201/ | CALCIUM CARBONATECHOLECALCIFEROL | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 125303344 | 12530334 | 19 | C | VITAMINS NOS | VITAMINS | 1 | Unknown | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125303344 | 12530334 | 1 | Breast cancer recurrent |
| 125303344 | 12530334 | 2 | HER-2 positive breast cancer |
| 125303344 | 12530334 | 3 | Breast cancer recurrent |
| 125303344 | 12530334 | 5 | Breast cancer recurrent |
| 125303344 | 12530334 | 6 | HER-2 positive breast cancer |
| 125303344 | 12530334 | 7 | Breast cancer recurrent |
| 125303344 | 12530334 | 8 | HER-2 positive breast cancer |
| 125303344 | 12530334 | 9 | Breast cancer metastatic |
| 125303344 | 12530334 | 10 | Breast cancer metastatic |
| 125303344 | 12530334 | 11 | Breast cancer metastatic |
| 125303344 | 12530334 | 12 | Breast cancer recurrent |
| 125303344 | 12530334 | 13 | Disease progression |
| 125303344 | 12530334 | 14 | Disease progression |
| 125303344 | 12530334 | 15 | Disease progression |
| 125303344 | 12530334 | 16 | Disease progression |
| 125303344 | 12530334 | 17 | Product used for unknown indication |
| 125303344 | 12530334 | 18 | Product used for unknown indication |
| 125303344 | 12530334 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125303344 | 12530334 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125303344 | 12530334 | Breast cancer recurrent | |
| 125303344 | 12530334 | Hypoaesthesia oral | |
| 125303344 | 12530334 | Malignant neoplasm progression | |
| 125303344 | 12530334 | Neuropathy peripheral |
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 |
|---|---|---|---|---|---|---|
| 125303344 | 12530334 | 1 | 20131210 | 20140520 | 0 | |
| 125303344 | 12530334 | 4 | 20111108 | 201201 | 0 | |
| 125303344 | 12530334 | 5 | 20131228 | 0 | ||
| 125303344 | 12530334 | 7 | 20140116 | 0 | ||
| 125303344 | 12530334 | 9 | 20111108 | 201201 | 0 | |
| 125303344 | 12530334 | 10 | 20120208 | 0 | ||
| 125303344 | 12530334 | 13 | 20140520 | 0 | ||
| 125303344 | 12530334 | 14 | 20140520 | 0 | ||
| 125303344 | 12530334 | 16 | 201602 | 0 |