[Lani]

Patient-reported side effect AI
Studied
Incidence of clinically significant symptoms
at any time point during study period (%)
Odds ratio (OR) or
P-value for comparison
In favor of
AI Tamoxifen (or placebo as indicated)


Vasomotor symptoms
Hot flashes ANA 26.6 28.5 – ANA
EXE 46.0 44.7 OR = 1.10 TAM
LET 22.0 17.0 (PLA) P = 0.0002 PLA


Cold sweats ANA 7.7 9.1 – ANA
EXE 19.4 16.4 OR = 1.22 TAM

Night sweats ANA 17.8 21.3 – ANA
EXE 32.2 34.8 OR = 0.85 EXE
LET 17.0 14.0 (PLA) P = 0.047 PLA

Sleeping difficulties ANA 19.0 18.8 – –
EXE 34.6 34.5 OR = 1.12 TAM
LET 29.0 26.0 (PLA) P = 0.047 PLA

Neuropsychiatric symptoms
Lightheaded (dizzy) feeling ANA 3.1 5.4 – ANA
EXE 11.4 12.0 OR = 0.69 EXE

Headaches ANA 5.1 5.0 – TAM
EXE 18.3 15.0 OR = 1.38 TAM

Mood swings ANA 10.3 11.3 – ANA
EXE 20.8 19.8 OR = 1.02 –

Irritability ANA 8.7 9.1 – ANA
EXE 16.6 15.0 OR = 1.03 –

Lack of energy ANA 15.9 18.3 – ANA
EXE 37.7 34.1 OR = 1.17 TAM

Nervous feeling ANA 6.6 8.6 – ANA
EXE 19.7 19.8 OR = 0.93 EXE

Gastrointestinal symptoms
Weight gain ANA 22.6 20.6 – TAM
EXE 46.7 48.1 OR = 0.96 –
LET 21.0 22.0 (PLA) P = 0.45 –

Diarrhea ANA 3.1 1.3 – TAM
EXE 6.6 7.2 OR = 0.87 EXE

Bloated feeling ANA 10.4 10.9 – –
EXE 23.5 28.0 OR = 0.79 EXE

Nausea ANA 1.2 2.2 – ANA
EXE 5.2 4.8 OR = 1.21 TAM

Gynecologic symptoms
Vaginal discharge ANA 1.2 5.2 – ANA
EXE 7.6 17.1 OR = 0.25 EXE

Vaginal itching/irritation ANA 3.4 5.0 ANA
EXE 9.3 12.6 OR = 0.65 EXE

Vaginal dryness ANA 18.5 9.1 – TAM
EXE 23.5 26.3 OR = 1.14 TAM
LET 22.0 19.0 (PLA) P = 0.016 PLA

Pain or discomfort with
intercourse
ANA 17.3 8.1 – TAM
EXE 14.9 15.0 OR = 0.96 –
123... continued

Patient-reported side effect AI
Studied
Incidence of clinically significant symptoms at
any time point during study period (%)
Odds ratio (OR) or
P-value for comparison
In favor of
AI Tamoxifen (or placebo as indicated)

Lost interest in sex ANA 34.0 26.1 – TAM
EXE 41.2 45.4 OR = 1.03 –

Breast sensitivity/tenderness ANA 12.0 11.6 – TAM
EXE 19.4 22.5 OR = 1.16 TAM

Abbreviations: TAM = tamoxifen; ANA = anastrozole for 5 years in the ATAC trial [22]; EXE = exemestane for 2 years in the IES [24];
LET = letrozole for 2 years in the MA.17 trial [25]; PLA = placebo; OR = odds ratio. Note: letrozole also had significantly higher ‘‘Bodily
Pain’’
Breast Cancer Res Treat