The Safety Rates Drug Report

Member Login
2004.Q1    2004.Q2    2004.Q3    2004.Q4    2005.Q1    2005.Q2    2005.Q3    2005.Q4    2006.Q1    2006.Q2    2006.Q3    2006.Q4    2007.Q1    2007.Q2    2007.Q3    2007.Q4    2008.Q1    2008.Q2    2008.Q3    2008.Q4    2009.Q1    2009.Q2    2009.Q3    2009.Q4    2010.Q1    2010.Q2    2010.Q3    2010.Q4    2011.Q1    2011.Q2    2011.Q3    2011.Q4    2012.Q1    2012.Q2    2012.Q3    2012.Q4    2013.Q1    2013.Q2    2013.Q3    2013.Q4    2014.Q1    2014.Q2    2014.Q3    2014.Q4    2015.Q1    2015.Q2    2015.Q3    2015.Q4    2016.Q1    2016.Q2    2016.Q3   

Drug     Injury     Quarter    

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
125762761 12576276 1 I 20160707 20160720 20160720 EXP JP-ACTAVIS-2016-15683 ACTAVIS WATANABE K, SATO M, YAMAMOTO M, IKARASHI M, HAGIO K, TOMIOKA N ET AL. SAFETY AND TOLERANCE OF DOSE-DENSE EPIRUBICIN AND CYCLOPHOSPHAMIDE (EC) WITH PEGFILGRASTIM FOR JAPANESE PATIENTS WITH EARLY BREAST CANCER. GAN TO KAGAKU RYOHO. CANCER + CHEMOTHERAPY. 2016;43(4):435-438. 50.00 YR F Y 0.00000 20160720 MD JP JP

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
125762761 12576276 1 PS Paclitaxel (Unknown) PACLITAXEL 1 Unknown 80 MG/M2, CYCLICAL (SCHEDULED WEEKLY FOR 12 CONSECUTIVE WEEKS) UNCONFIRMED 90130 80 MG/M**2 UNK
125762761 12576276 2 SS Epirubicin (Unknown) EPIRUBICIN 1 Unknown 90 MG/M2, CYCLICAL (FOUR CYCLES OF 2 WEEKS EACH) UNCONFIRMED 0 90 MG/M**2 UNK
125762761 12576276 3 SS PEGFILGRASTIM PEGFILGRASTIM 1 Subcutaneous 3.6 MG, CYCLICAL 0 3.6 MG
125762761 12576276 4 SS CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE 1 Unknown 600 MG/M2, CYCLICAL (FOUR CYCLES OF 2 WEEKS EACH) 0 600 MG/M**2

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125762761 12576276 1 Breast cancer
125762761 12576276 2 Breast cancer
125762761 12576276 3 Breast cancer
125762761 12576276 4 Breast cancer

Outcome of event

Event ID CASEID OUTC COD
125762761 12576276 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
125762761 12576276 Neutropenia
125762761 12576276 Pneumonia

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

Therapies reported

no results found