Study: NCT03323658

Adverse event: Motion sickness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Rash/papulopustular(w/o pustules) at site application
Frequency: 1 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Burning sensation on rash at site application
Frequency: 3 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Rash/maculo/papular at site application
Frequency: 3 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Itching/pruritis at site application
Frequency: 8 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Erythema/redness (non-painful) at application site
Frequency: 1 affected / 10 at risk

Adverse event: Tired(Fatigue)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Sun burn/rash macular without papules (includes itching) at application site
Frequency: 1 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Tingling sensation at site application
Frequency: 1 affected / 10 at risk

Adverse event: Tongue Swelling/soreness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Fine maculopapular rash at application site
Frequency: 2 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Rash (papular) at application site (20%)
Frequency: 1 affected / 10 at risk

Adverse event: Allergic reaction, small itchy lump on right arm at allergy shot injection site
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk

Adverse event: Reproductive System and Breast Disorders-Other, Specify
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Vaginal itchiness
Frequency: 1 affected / 10 at risk

Adverse event: Cough/Coughing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Rash/papulopustular (w/o pustules) of sternum and not at site application
Frequency: 1 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Itching of upper outer quadrant of left breast, not at application site
Frequency: 1 affected / 10 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Burning sensation on skin underneath and on the side of breast (not at application site)
Frequency: 1 affected / 10 at risk

Adverse event: Rash Maculopapular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Maculopapular rash on sides of right breast (not site of application)
Frequency: 1 affected / 10 at risk

Adverse event: Skin and Subcutaneous Tissue Disorders - Other, Specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erythema/redness (non-painful) along bra wire line (not at application site)
Frequency: 1 affected / 10 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Skin and Subcutaneous Tissue Disorders - Other, Specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Burning sensation on skin underneath and on the side of breast (not at application site)
Frequency: 1 affected / 10 at risk

Adverse event: Skin and Subcutaneous Tissue Disorders - Other, Specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash papulopustular (without pustules) of sternum and not at application site
Frequency: 1 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Rash/maculo/papular at site application
Frequency: 2 affected / 4 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Itching/pruritis at site application
Frequency: 1 affected / 4 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Maculopapular rash with intermittent pruritus at site application
Frequency: 1 affected / 4 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Erythema/redness (non-painful) at application site
Frequency: 1 affected / 4 at risk

Adverse event: Tired(Fatigue)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Dryness at application site
Frequency: 1 affected / 4 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Redness with some mild intermittent rash over approximately 60% of left chest including superior aspect of left breast to below left clavicle "entire application site"
Frequency: 1 affected / 4 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Redness with faint rash over left chest including superior aspect of left breast
Frequency: 1 affected / 4 at risk

Adverse event: Dermatitis (blistering)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Sleep disturbance/insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Cough/Coughing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Rash Maculopapular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Maculopapular rash with intermittent pruritus (not at site application)
Frequency: 1 affected / 4 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Rash/maculo/papular at site application
Frequency: 3 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Itching/pruritis at site application
Frequency: 7 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Erythema/redness (non-painful) at application site
Frequency: 2 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Rash (painless erythema) over 50-75% of application area
Frequency: 1 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Rash (painless erythema) less than 50% of application area
Frequency: 1 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Occasional warm sensation inside upper portion of right breast on some days of gel application
Frequency: 1 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Small red bumps/dots on the left breast at application site.
Frequency: 1 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Rash Acneiform, single red raised spot, with few small scattered spots at application site
Frequency: 1 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Raw Blister-like area on left breast at site of steri-strip from biopsy procedure
Frequency: 1 affected / 10 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Tin (metallic) taste in mouth approximately 2 hours after applying gel
Frequency: 1 affected / 10 at risk

Adverse event: Reproductive System and Breast Disorders-Other, Specify
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Heaviness (fullness) in right breast
Frequency: 1 affected / 10 at risk

Adverse event: Skin and Subcutaneous Tissue Disorders- Other, Specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Singular pale red patch, same location above bilateral breast that may be related to the use of the tank top (not at application site)
Frequency: 1 affected / 10 at risk

Adverse event: Skin and Subcutaneous Tissue Disorders - Other, Specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness/burning irritation on skin from pre-biopsy cleansing scrub
Frequency: 1 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Erythema (intermittent) small reddened area at application site
Frequency: 1 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Erythema (redness) on left breast at site of steri-strips from biopsy procedure
Frequency: 1 affected / 10 at risk

Adverse event: General Disorders and Administration Site Conditions-Other, Specify
Serious: no
Organ System: General disorders
Notes: Rash on upper medial portion of right breast at the application site
Frequency: 1 affected / 10 at risk