Study: NCT00931242

Adverse event: Sepsis 2nd to Atopic Dermatitis
Serious: yes
Organ System: Infections and infestations
Notes: This patient was in the screening phase of the trial and never received study medication. The subject was not eligible to enroll in trial due to the infection and flare of dermatitis.
Frequency: 1 affected / 12 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: routine questioning at visit
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: routine questioning at visit
Frequency: 2 affected / 12 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: routine questioning at visit
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: routine questioning at visit
Frequency: 2 affected / 12 at risk

Adverse event: asymptomatic sinus arrythmia per EKG
Serious: no
Organ System: Cardiac disorders
Notes: routine EKG
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: routine questioning at visit
Frequency: 1 affected / 12 at risk

Adverse event: soft stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: routine questioning at visit
Frequency: 1 affected / 12 at risk

Adverse event: dermatitis flare
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: routine questioning at visit
Frequency: 4 affected / 12 at risk

Adverse event: foot fracture after mechanical fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Chills
Serious: no
Organ System: Nervous system disorders
Notes: routine questioning at visit
Frequency: 1 affected / 12 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: routine questioning at visit
Frequency: 1 affected / 12 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: routine questioning at visit
Frequency: 1 affected / 12 at risk

Adverse event: facial irritation from ketoconazole
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: routine questioning at visit
Frequency: 1 affected / 12 at risk

Adverse event: Ectropion
Serious: no
Organ System: Eye disorders
Notes: routine questioning at visit
Frequency: 1 affected / 12 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: routine questioning at visit
Frequency: 1 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: routine questioning at visit
Frequency: 2 affected / 12 at risk

Adverse event: atopic blepharoconjunctivitis
Serious: no
Organ System: Eye disorders
Notes: routine questioning at visit
Frequency: 1 affected / 12 at risk

Adverse event: Meibomian gland dysfunction
Serious: no
Organ System: Eye disorders
Notes: routine questioning at visits
Frequency: 1 affected / 12 at risk

Adverse event: myalgias
Serious: no
Organ System: Nervous system disorders
Notes: routine questioning at visits
Frequency: 1 affected / 12 at risk

Adverse event: Chills
Serious: no
Organ System: Nervous system disorders
Notes: routine questioning at visits
Frequency: 1 affected / 12 at risk

Adverse event: lower back pain 2nd to motor vehicle accident (minor)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: routine questioning at visits
Frequency: 1 affected / 12 at risk

Adverse event: b12 deficiency
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: pcp screening
Frequency: 1 affected / 12 at risk

Adverse event: increase in number of stools
Serious: no
Organ System: Gastrointestinal disorders
Notes: routine questioning at visits
Frequency: 1 affected / 12 at risk

Adverse event: hair dye allergy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: routine questioning at visits
Frequency: 1 affected / 12 at risk

Adverse event: Diverticulum intestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: screening colonoscopy
Frequency: 1 affected / 12 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Notes: screening colonoscopy
Frequency: 1 affected / 12 at risk

Adverse event: scraped shin from mechanical injury
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: routine questioning at visits
Frequency: 1 affected / 12 at risk

Adverse event: nodules in breasts
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: physical examination (routine)
Frequency: 1 affected / 12 at risk

Adverse event: MSSA skin infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: routine questioning at visits
Frequency: 1 affected / 12 at risk