Study: NCT01541917

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalized for evaluation of abdominal pain.
Frequency: 1 affected / 144 at risk

Adverse event: Arthritis flare
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Admitted to hospital for management of arthritis flare
Frequency: 1 affected / 144 at risk

Adverse event: Hospitalized for management of Crohn's disease flare
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 144 at risk

Adverse event: Hospitalized for suicidal thoughts
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 144 at risk

Adverse event: Skin system findings (psoriasis, rash)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 144 at risk

Adverse event: Injury (e.g., sprain, fracture)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 144 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 144 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 144 at risk

Adverse event: Blood disorder/problems
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 144 at risk

Adverse event: Dizziness and/or fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 144 at risk

Adverse event: Arthritis flare
Serious: no
Organ System: Immune system disorders
Frequency: 13 affected / 144 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 144 at risk

Adverse event: Suicidal thoughts
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 144 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalized for evaluation of abdominal pain.
Frequency: 3 affected / 145 at risk

Adverse event: Hospitalized for macrophage activation syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 145 at risk

Adverse event: Hospitalized for appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 145 at risk

Adverse event: Skin system findings (psoriasis, rash)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 145 at risk

Adverse event: Injury (e.g., sprain, fracture)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 145 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 145 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 145 at risk

Adverse event: Blood disorder/problems
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 145 at risk

Adverse event: Dizziness and/or fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 145 at risk

Adverse event: Arthritis flare
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 145 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 145 at risk

Adverse event: Suicidal thoughts
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 145 at risk