Study: NCT02630953

Adverse event: Heel and Back Pain
Serious: no
Organ System: General disorders
Notes: Participant reported pain in her heels which continued through the night and began to bother her back. She stated that she suffers from ingrown toenails and speculated that this condition may exacerbate the foot pain.
Frequency: 1 affected / 97 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1. Participant reported that she twisted her knee while standing in her kitchen. She stated that this injury was not related to the study.
2. We received a completed adverse event form reporting that the participant has had knee pain
Frequency: 2 affected / 97 at risk

Adverse event: Limb injury
Serious: no
Organ System: General disorders
Notes: We received a completed adverse event form reporting that the participant hurt her leg when standing on top of a gallon jug and that she scratched and bruised her leg.
Frequency: 1 affected / 97 at risk

Adverse event: Biopsy breast
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Participant had a minor biopsy to remove a small sample from her left breast.
Frequency: 1 affected / 97 at risk

Adverse event: Toe Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Participant reported feeling pain in her big toe. She stated that the pain is due to a bunion on her foot that she has had for the past 20 years. She sees her physician regularly and they have not advised her to discontinue physical activity.
Frequency: 1 affected / 102 at risk

Adverse event: Infected Bladder
Serious: no
Organ System: Renal and urinary disorders
Notes: Participant stating that she just had surgery for an infected bladder. Her physician had instructed her to do no extraneous physical activity until further notice. Participant was put on medical hold until she could receive clearance.
Frequency: 1 affected / 102 at risk

Adverse event: Hip Pain and Rash
Serious: no
Organ System: General disorders
Notes: Participant reporting that she had a rash on her leg and minor pain in her left hip but that she no longer feels any pain.
Frequency: 1 affected / 102 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1. Participant had a pain in her leg when playing basketball and Zumba.
2. Participant's legs were bothering her with pain after 1 mile of fast walking.
Frequency: 2 affected / 102 at risk

Adverse event: Lumbar spinal stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Participant reported having lumbar spinal stenosis. The participant is confident that the pain/sciatica was not brought on by the exercise in the study and says the walking has actually been helpful.
Frequency: 1 affected / 102 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: We received a completed adverse event from this participant stating pain in her foot.
Frequency: 1 affected / 102 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1. We received a completed adverse event from this participant stating that she has knee pain.
2. We received a completed adverse event form reporting that the participant had pain in her right knee what she ran.
Frequency: 2 affected / 102 at risk

Adverse event: Stroke (unrelated to study)
Serious: no
Organ System: Cardiac disorders
Notes: Participant informed our staff member via phone that her daughter in the study had suffered a stroke last month while at school and thus she felt like it was necessary for her and her daughter withdraw from the study.
Frequency: 1 affected / 102 at risk