Study: NCT00343642

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Participant had a syncopal episode (felt to be vasovagal) after a bowel movement at home. Participant had a history of vasovagal syncope before the trial. She fell and hit her head during the syncope and fully recovered. Was hospitalized overnight.
Frequency: 1 affected / 19 at risk

Adverse event: Crohn's flare up
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject presented with abdominal pain, diarrhea, nausea and vomiting felt to be either a Crohn's flare or a viral infection. She was hospitalized for 3 days. A colonoscopy revealed active Crohn's disease confirming a flare.
Frequency: 1 affected / 19 at risk

Adverse event: Cardio vascular and Pulmonary symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 19 at risk

Adverse event: Allergy symptoms
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 19 at risk

Adverse event: Squamous cell skin cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 19 at risk

Adverse event: GenitoUrinary symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 19 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 19 at risk

Adverse event: Abnormal exam due to URI
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 19 at risk

Adverse event: Joint pain/ MSK problems
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 19 at risk

Adverse event: Neurological symptoms
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 19 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Infection- URI
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 19 at risk

Adverse event: Nausea/Vomitting
Serious: no
Organ System: General disorders
Frequency: 9 affected / 19 at risk

Adverse event: Abnormal abdominal exam
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 19 at risk

Adverse event: Extraintestinal Symptoms of IBD other than arthritis /arthralgia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Psychiatric symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 19 at risk

Adverse event: GERD symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 19 at risk

Adverse event: Infection-Lip Herpes
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 19 at risk

Adverse event: Diarrhea/Frequent BM
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 19 at risk

Adverse event: Infection- Shingles
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Abdominal discomfort+pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 19 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 19 at risk

Adverse event: Infection- Genital
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Skin lesions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 19 at risk

Adverse event: Decrease in Appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 19 at risk

Adverse event: Gas/Flatus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 19 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 19 at risk

Adverse event: Change of bowel habit
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Urgency - Bowel
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Rectal tenesmus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hernia - abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Abnormal ear exam
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 19 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject had cough fever and headache and was given Tamiflu for possible influenza. He developed nausea, vomiting possibly due to Tamiflu or infection and a fever of 103 degrees Fahrenheit. He was hospitalized for 3 days for IV fluids and antibiotics.
Frequency: 1 affected / 19 at risk

Adverse event: Cardio vascular and Pulmonary symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 19 at risk

Adverse event: Endocrine signs and symptoms
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 19 at risk

Adverse event: Allergy symptoms
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 19 at risk

Adverse event: Abnormal Heart exam
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Tooth issues
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: GenitoUrinary symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 19 at risk

Adverse event: Fractures
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 19 at risk

Adverse event: Abnormal exam due to URI
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 19 at risk

Adverse event: Joint pain/ MSK problems
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 19 at risk

Adverse event: Neurological symptoms
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 19 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 19 at risk

Adverse event: Infection- URI
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 19 at risk

Adverse event: Nausea/Vomitting
Serious: no
Organ System: General disorders
Frequency: 4 affected / 19 at risk

Adverse event: Eye symptoms
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 19 at risk

Adverse event: Abnormal abdominal exam
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 19 at risk

Adverse event: Extraintestinal Symptoms of IBD other than arthritis /arthralgia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 19 at risk

Adverse event: Psychiatric symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 19 at risk

Adverse event: Infection-UTI
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: GERD symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 19 at risk

Adverse event: Infection- HPV
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Diarrhea/Frequent BM
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 19 at risk

Adverse event: Perianal and Rectal pain/discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 19 at risk

Adverse event: Infection- Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Infection- Shingles
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Abdominal discomfort+pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 19 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: Surgeries
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 19 at risk

Adverse event: Skin lesions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 19 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 19 at risk

Adverse event: Gas/Flatus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 19 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Weight Decline
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Change of bowel habit
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Urgency - Bowel
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Polymyalgia rheumatica
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Rectal tenesmus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Portal hypertension
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Cardio vascular and Pulmonary symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 16 at risk

Adverse event: Endocrine signs and symptoms
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 16 at risk

Adverse event: Allergy symptoms
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 16 at risk

Adverse event: Abnormal Heart exam
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 16 at risk

Adverse event: Tooth issues
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: GenitoUrinary symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 16 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Joint pain/ MSK problems
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 16 at risk

Adverse event: Infection- GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Neurological symptoms
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 16 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Infection- URI
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 16 at risk

Adverse event: Nausea/Vomitting
Serious: no
Organ System: General disorders
Frequency: 4 affected / 16 at risk

Adverse event: Eye symptoms
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 16 at risk

Adverse event: Abnormal abdominal exam
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 16 at risk

Adverse event: Extraintestinal Symptoms of IBD other than arthritis /arthralgia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 16 at risk

Adverse event: Psychiatric symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 16 at risk

Adverse event: Infection-UTI
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 16 at risk

Adverse event: Diarrhea/Frequent BM
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 16 at risk

Adverse event: Perianal and Rectal pain/discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Infection- Shingles
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Abdominal discomfort+pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 16 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Skin lesions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Gas/Flatus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 16 at risk

Adverse event: Weight Decline
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Urgency - Bowel
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 16 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Abnormal ear exam
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 16 at risk

Adverse event: Abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk