Study: NCT00754065

Adverse event: Pharyngitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 191 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 191 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 191 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 191 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 191 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 191 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 191 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 191 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 3 affected / 191 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 191 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 191 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 191 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 191 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 191 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 191 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 191 at risk

Adverse event: Bacterial vulvovaginitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 191 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 191 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 191 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 191 at risk

Adverse event: White blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 5 affected / 191 at risk

Adverse event: Human papilloma virus test positive
Serious: no
Organ System: Investigations
Frequency: 10 affected / 191 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 191 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 191 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 191 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 191 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 56 affected / 191 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 191 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 191 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 191 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 191 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 20 affected / 191 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 191 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 23 affected / 191 at risk

Adverse event: Cervical dysplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 22 affected / 191 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 18 affected / 191 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 191 at risk

Adverse event: Menstruation delayed
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 191 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 31 affected / 191 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 46 affected / 191 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 191 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 191 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 191 at risk

Adverse event: Diabetes insipidus
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 204 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 204 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 204 at risk

Adverse event: Migraine with aura
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 204 at risk

Adverse event: Speech disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 204 at risk

Adverse event: Disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 204 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 204 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 204 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 204 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 204 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 204 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 204 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 5 affected / 204 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 204 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 204 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 204 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 204 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 204 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 204 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 204 at risk

Adverse event: Bacterial vulvovaginitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 204 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 204 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 204 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 204 at risk

Adverse event: White blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 5 affected / 204 at risk

Adverse event: Human papilloma virus test positive
Serious: no
Organ System: Investigations
Frequency: 7 affected / 204 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 204 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 204 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 204 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 204 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 50 affected / 204 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 204 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 204 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 204 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 204 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 204 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 27 affected / 204 at risk

Adverse event: Cervical dysplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 20 affected / 204 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 17 affected / 204 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 204 at risk

Adverse event: Menstruation delayed
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 204 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 25 affected / 204 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 47 affected / 204 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 204 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 204 at risk