Study: NCT01080716

Adverse event: Diarrheic stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 2 affected / 13 at risk

Adverse event: Water stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 2 affected / 13 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 1 affected / 13 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Mild
Frequency: 8 affected / 13 at risk

Adverse event: Tenderness at digit of left foot
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Moderate
Frequency: 1 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 1 affected / 13 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 1 affected / 13 at risk

Adverse event: Urticaria
Serious: no
Organ System: Immune system disorders
Notes: Mild
Frequency: 1 affected / 13 at risk

Adverse event: Insomnia (sleep difficulty)
Serious: no
Organ System: Psychiatric disorders
Notes: Mild
Frequency: 1 affected / 13 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Mild
Frequency: 3 affected / 13 at risk

Adverse event: Diarrheic stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 4 affected / 6 at risk

Adverse event: Water stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 2 affected / 6 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Mild
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Mild
Frequency: 2 affected / 6 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Moderate
Frequency: 1 affected / 6 at risk

Adverse event: Abrasion wound at peri-anal
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Mild
Frequency: 1 affected / 6 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Mild
Frequency: 2 affected / 6 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 1 affected / 6 at risk

Adverse event: Myalgia at back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain (epigastrium)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 1 affected / 6 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Mild
Frequency: 1 affected / 6 at risk

Adverse event: Pruritus at left thigh
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain (generalized)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 1 affected / 6 at risk

Adverse event: Rectal tenesmus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 1 affected / 6 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Mild
Frequency: 1 affected / 6 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Mild
Frequency: 1 affected / 6 at risk

Adverse event: Diarrheic stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 4 affected / 10 at risk

Adverse event: Water stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Mild
Frequency: 4 affected / 10 at risk

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

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 1 affected / 10 at risk

Adverse event: Insomnia (sleep difficulty)
Serious: no
Organ System: Psychiatric disorders
Notes: Mild
Frequency: 2 affected / 10 at risk

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

Adverse event: Myalgia at back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 1 affected / 10 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Mild
Frequency: 2 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Mild
Frequency: 2 affected / 10 at risk

Adverse event: Rectal tenesmus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 1 affected / 10 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Mild
Frequency: 3 affected / 10 at risk

Adverse event: Nasal swelling
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Mild
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia at neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Moderate
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Mild
Frequency: 4 affected / 10 at risk

Adverse event: Dysentery
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 3 affected / 10 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Moderate
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Mild
Frequency: 3 affected / 10 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Mild
Frequency: 2 affected / 10 at risk

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

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

Adverse event: Herpes (lip)
Serious: no
Organ System: Infections and infestations
Notes: Mild
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain (whole)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 1 affected / 10 at risk

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

Adverse event: Diarrheic stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 2 affected / 10 at risk

Adverse event: Water stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 6 affected / 10 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Mild
Frequency: 2 affected / 10 at risk

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

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 5 affected / 10 at risk

Adverse event: Insomnia (sleep difficulty)
Serious: no
Organ System: Psychiatric disorders
Notes: Mild
Frequency: 1 affected / 10 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Mild
Frequency: 3 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Mild
Frequency: 3 affected / 10 at risk

Adverse event: Rectal tenesmus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 2 affected / 10 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Mild
Frequency: 2 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Mild
Frequency: 4 affected / 10 at risk

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

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

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Mild
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain (whole)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 1 affected / 10 at risk

Adverse event: High ALT
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 1 affected / 10 at risk

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

Adverse event: Tendonitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Mild
Frequency: 1 affected / 10 at risk

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

Adverse event: Increased bowel sound
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 1 affected / 10 at risk

Adverse event: Anal abscess
Serious: no
Organ System: Gastrointestinal disorders
Notes: Moderate
Frequency: 1 affected / 10 at risk

Adverse event: Shigella infection
Serious: no
Organ System: Infections and infestations
Notes: Severe
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia at right shoulder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 1 affected / 10 at risk