Study: NCT02516202

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Lobular carcinoma in left breast
Frequency: 1 affected / 102 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Lymphoma confirmed by lab tests
Frequency: 1 affected / 102 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Infiltrating ductal carcinoma left breast
Frequency: 1 affected / 102 at risk

Adverse event: Increased vaginal secretions
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Counted in participants who did not report moderate-severe vaginal secretions at baseline
Frequency: 14 affected / 92 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Counted in participants who did not report moderate-severe vaginal itching at baseline
Frequency: 6 affected / 75 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Counted in participants who did not report moderate-severe breast tenderness at baseline
Frequency: 3 affected / 97 at risk

Adverse event: Skin rash outside the vagina
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Counted in participants who did not report moderate-severe skin rash outside the vagina at baseline
Frequency: 4 affected / 96 at risk

Adverse event: Body rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Counted in participants who did not report moderate-severe body rash at baseline
Frequency: 2 affected / 95 at risk

Adverse event: Hospitalization for dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Admitted to hospital for ongoing gastrointestinal symptoms. Admitted again 6 days later with dehydration diagnosis.
Frequency: 1 affected / 100 at risk

Adverse event: Increased vaginal secretions
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Counted in participants who did not report moderate-severe vaginal secretions at baseline
Frequency: 16 affected / 99 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Counted in participants who did not report moderate-severe vaginal itching at baseline
Frequency: 6 affected / 79 at risk

Adverse event: Vaginal spotting or bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Counted in participants who did not report moderate-severe vaginal spotting or bleeding at baseline
Frequency: 1 affected / 99 at risk

Adverse event: Body rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Counted in participants who did not report moderate-severe body rash at baseline
Frequency: 1 affected / 97 at risk

Adverse event: Hospitalization for back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Participant reported increasing back pain, worsening spinal stenosis, required surgery
Frequency: 1 affected / 100 at risk

Adverse event: Increased vaginal secretions
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Counted in participants who did not report moderate-severe vaginal secretions at baseline
Frequency: 14 affected / 96 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Counted in participants who did not report moderate-severe vaginal itching at baseline
Frequency: 6 affected / 84 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Counted in participants who did not report moderate-severe breast tenderness at baseline
Frequency: 2 affected / 96 at risk

Adverse event: Skin rash outside the vagina
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Counted in participants who did not report moderate-severe skin rash outside the vagina at baseline
Frequency: 1 affected / 97 at risk

Adverse event: Body rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Counted in participants who did not report moderate-severe body rash at baseline
Frequency: 5 affected / 98 at risk