Study: NCT02935686

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 26 at risk

Adverse event: Nausea (Solicited)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 26 at risk

Adverse event: Chills (Solicited)
Serious: no
Organ System: General disorders
Frequency: 12 affected / 26 at risk

Adverse event: Erythema (Solicited)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Fatigue (Solicited)
Serious: no
Organ System: General disorders
Frequency: 19 affected / 26 at risk

Adverse event: Pain/Tenderness (Solicited)
Serious: no
Organ System: General disorders
Frequency: 24 affected / 26 at risk

Adverse event: Pyrexia (Solicited)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Swelling/Induration (Solicited)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 26 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 26 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 26 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: Myalgia (Solicited)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Headache (Solicited)
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 26 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Miscarriage of partner
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 100 at risk

Adverse event: Nausea (Solicited)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 100 at risk

Adverse event: Chills (Solicited)
Serious: no
Organ System: General disorders
Frequency: 48 affected / 100 at risk

Adverse event: Erythema (Solicited)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 100 at risk

Adverse event: Fatigue (Solicited)
Serious: no
Organ System: General disorders
Frequency: 78 affected / 100 at risk

Adverse event: Pain/Tenderness (Solicited)
Serious: no
Organ System: General disorders
Frequency: 94 affected / 100 at risk

Adverse event: Pyrexia (Solicited)
Serious: no
Organ System: General disorders
Frequency: 15 affected / 100 at risk

Adverse event: Swelling/Induration (Solicited)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 100 at risk

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 100 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 100 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 100 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 100 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 100 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 100 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 100 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 100 at risk

Adverse event: Myalgia (Solicited)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 68 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 100 at risk

Adverse event: Headache (Solicited)
Serious: no
Organ System: Nervous system disorders
Frequency: 69 affected / 100 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 100 at risk

Adverse event: Nausea (Solicited)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 26 at risk

Adverse event: Chills (Solicited)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Erythema (Solicited)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Fatigue (Solicited)
Serious: no
Organ System: General disorders
Frequency: 18 affected / 26 at risk

Adverse event: Pain/Tenderness (Solicited)
Serious: no
Organ System: General disorders
Frequency: 16 affected / 26 at risk

Adverse event: Pyrexia (Solicited)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 26 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Myalgia (Solicited)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Headache (Solicited)
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 26 at risk

Adverse event: Death neonatal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 41 at risk

Adverse event: Miscarriage of partner
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 41 at risk

Adverse event: Nausea (Solicited)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 41 at risk

Adverse event: Chills (Solicited)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 41 at risk

Adverse event: Erythema (Solicited)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 41 at risk

Adverse event: Fatigue (Solicited)
Serious: no
Organ System: General disorders
Frequency: 26 affected / 41 at risk

Adverse event: Pain/Tenderness (Solicited)
Serious: no
Organ System: General disorders
Frequency: 34 affected / 41 at risk

Adverse event: Pyrexia (Solicited)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Swelling/Induration (Solicited)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 41 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Myalgia (Solicited)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Headache (Solicited)
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 41 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 13 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nausea (Solicited)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Chills (Solicited)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 13 at risk

Adverse event: Fatigue (Solicited)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 13 at risk

Adverse event: Pain/Tenderness (Solicited)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 13 at risk

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Headache (Solicited)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 13 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk