Study: NCT03008460

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Diagnostic finding at colonoscopy, reported as non-related TEAE and related to the indication for colonoscopy.
Frequency: 2 affected / 124 at risk

Adverse event: Intestinal polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Intestinal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 90 affected / 124 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 67 affected / 124 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 64 affected / 124 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 124 at risk

Adverse event: Crohn's disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diagnostic finding at colonoscopy, reported as non-related TEAE and related to the indication for colonoscopy.
Frequency: 9 affected / 124 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 124 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diagnostic finding at colonoscopy, reported as non-related TEAE and related to the indication for colonoscopy.
Frequency: 1 affected / 124 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 124 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 124 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Diagnostic finding at colonoscopy, reported as non-related TEAE and related to the indication for colonoscopy.
Frequency: 1 affected / 117 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 117 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 84 affected / 117 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 77 affected / 117 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 64 affected / 117 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 117 at risk

Adverse event: Crohn's disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diagnostic finding at colonoscopy, reported as non-related TEAE and related to the indication for colonoscopy.
Frequency: 2 affected / 117 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 117 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diagnostic finding at colonoscopy, reported as non-related TEAE and related to the indication for colonoscopy.
Frequency: 6 affected / 117 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 117 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 117 at risk