Study: NCT00951561

Adverse event: Pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 102 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 102 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 102 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 102 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Colposcopy
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 102 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 102 at risk

Adverse event: Cryptosporidiosis infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Daytime hypersomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Dental infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Dental pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 102 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 102 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Elevated blood pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 102 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Generalized body aches
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Giardia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: A single device-related adverse event, headache, occurred during the study and the relationship to the device was deemed "possible".
Frequency: 10 affected / 102 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 102 at risk

Adverse event: Insect bite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 102 at risk

Adverse event: Hypobarism
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 102 at risk

Adverse event: Peridontal surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 102 at risk

Adverse event: Poison ivy reaction
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Rash
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Tendon pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Ankle pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 102 at risk

Adverse event: Labial biopsy
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 102 at risk

Adverse event: Root canal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Cyst
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 102 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Strep throat
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 102 at risk

Adverse event: Sunburn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Swollen bruised right eye
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Twisted back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 102 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 102 at risk