Study: NCT00127439

Adverse event: Dizziness
Serious: no
Organ System: Vascular disorders
Notes: Dizziness upon standing; circulatory
Frequency: 1 affected / 9 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin abrasion
Frequency: 4 affected / 9 at risk

Adverse event: Loss of balance/fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Loss of balance that took subject to the floor, no injury
Frequency: 1 affected / 9 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Knee and foot pain
Frequency: 2 affected / 9 at risk

Adverse event: Colored urine
Serious: no
Organ System: Renal and urinary disorders
Notes: Blood tinged urine
Frequency: 1 affected / 9 at risk

Adverse event: Muscle soreness (leg)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pulled back muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Occurred over weekend; unrelated
Frequency: 1 affected / 9 at risk

Adverse event: Catheter loosens and comes off during training
Serious: no
Organ System: General disorders
Notes: Urine spillage due to incident.
Frequency: 1 affected / 9 at risk

Adverse event: Hospitalized
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Participant hospitalized with elevated temperature and elevated blood pressure. Diagnosed with sepsis in bloodstream; hospitalized over weekend, self-report.
Frequency: 1 affected / 10 at risk

Adverse event: Hospitalized
Serious: yes
Organ System: Infections and infestations
Notes: Infected wound at base of sacrum.
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Vascular disorders
Notes: Dizziness upon standing; circulatory
Frequency: 1 affected / 10 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin abrasion
Frequency: 4 affected / 10 at risk

Adverse event: Loss of balance/fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Loss of balance that took subject to the floor, no injury
Frequency: 1 affected / 10 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Knee and foot pain
Frequency: 2 affected / 10 at risk

Adverse event: Colored urine
Serious: no
Organ System: Renal and urinary disorders
Notes: Blood tinged urine
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: muscle pain groin
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

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

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

Adverse event: Not feeling well
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk