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Table 3 Incidence of treatment-related serious adverse events in the main adjuvant aromatase inhibitor trials[71]

From: Status of adjuvant endocrine therapy for breast cancer

Study Arms numberaMSK: % (comparative P value)b Arms numberaBMD (T-score): % (comparative P value)b Arms numberaCV events: % (comparative P value) Arms numberaGynae: % (comparative Pvalue) Arms numberaHot flashes : % (comparative P value)
ATAC A versus T 6,241 A versus T (5 years) 197 A versus T 6,186 A versus T (5 years) 6,186 A versus T (5 years) 6,186
  Arthralgia: 35.6 versus 29.4 (<0.0001) LS: −6.1 versus +2.8 (<0.0001) Ischemic CV event: 4.1 versus 3.4 (0.1) Gynecologic eventd: 3.0 versus 10.0 (<0.0001) 35.7 versus 40.9 (<0.0001)
    Ischemic CerebroV event: 2.0 versus 2.8 (0.03) Vaginal bleeding. 5.4 versus 10.2 (<0.0001)  
  CTS: 3.0 versus 1.0 (<0.0001) Hip: −7.2 versus +0.7 (<0.0001) Venous TE event: 2.8 versus 4.5 (0.0004) Vaginal discharge: 3.5 versus 13.2 (<0.0001)  
    DVT event: 1.6 versus 2.4 (0.02) Reduced libido: 1.0 versus 0.4 (<0.0001)  
    CV deathc: 2.0 versus 2.0 (NR)   
    CerebroV deathc: 0.8 versus 0.9 (NR)   
    Hypercholesterolemia: 9.0 versus 3.0 (<0.0001)   
BIG 1-98 L versus T 8,028 (4,992)a NA L versus T 4,895 L versus T (6 years) 3,074 L versus T (6 years) 3,074
  Arthralgia: 20.0 versus 13.5 (<0.001)   Cardiac event: 5.5 versus 5.0 (0.48) Vaginal bleeding: 5.1 versus 9.9 (<0.001) 37.7 versus 42.9 (NR)
  Myalgia: 7.1 versus 6.1 (0.19)   CerebroV accident or TIA: 1.4 versus 1.4 (0.90) Night sweating: 15.6 versus 19.4 (NR)  
    TE event: 2.0 versus 3.8 (<0.001)   
    Hypercholesterolemia: 50.6 versus 24.6 (<0.001)   
TEAM E versus T 9,779 E versus T (1 year) 161 E versus T 9,779 E versus T (2.75 years) 9,779 NA
  Arthralgia: 17.9 versus 9.2 (≤0.001) LS: −2.8 versus +0.5 (0.0008) Ischemic CV event/MI: 0.8 versus 0.7 (NR) Endometrial hyperplasia: 0.0 versus 2.0 (<0.0001)  
     Vaginal hemorrhage: 1.6 versus 3.1 (<0.0001)  
   Hip: −2.2 versus +0.4 (0.04)    
     Vaginal discharge: 2.3 versus 6.8 (<0.0001)  
   FN: +0.3 versus −1.8 (0.414)   Vaginal infection: 0.7 versus 2.2 (<0.0001)  
MA.17 L versus placebo 5,187 L versus placebo 226 L versus placebo 5,187 L versus placebo (2.5 years) 5,187 L versus placebo 5,187
  Arthralgia: 25.0 versus 21.0 (<0.001) LS: −5.4 versus −0.7 (0.008) CV disease: 5.8 versus 5.6 (0.76) Vaginal bleeding: 6 versus 8 (0.005) 58 versus 54 (0.003)
  Arthritis: 6.0 versus 5.0 (0.07) Hip: −3.6 versus −0.7 (0.044) MI: 0.3 versus 0.4 (NR) Stroke/TIA: 0.7 versus 0.6 (NR) Vaginal dryness: 6 versus 5 (0.26)  
  Myalgia: 15.0 versus 12.0 (0.0041)   TE event: 0.4 versus 0.2 (NR) Hypercholesterolemia: 16 versus 16 (0.79)   
  1. aPatients analyzed; bvalues represent T-score change from baseline; cdata from 100-month analysis, n = 6,241; dincludes endometrial hyperplasia and neoplasia, cervical neoplasm, and enlarged uterine fibroids. A, anastrozole; ATAC, Arimidex, Tamoxifen, Alone or in Combination; BIG, Breast International Group; BMD, bone mineral density; CerebroV, cerebrovascular; CTS, carpal tunnel syndrome; CV, cardiovascular; DVT, deep vein thromboembolic; E, exemestane; FN, femoral neck; L, letrozole; LS, lumbar spine; MI, myocardial infarction; MSK, musculoskeletal; NA, not available; NR, not reported; T, tamoxifen; TE, thromboembolic; TEAM, Tamoxifen Exemestane Adjuvant Multinational; TIA, transient ischemic attack.