Study: NCT03220737

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 165 at risk

Adverse event: Intentional overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 165 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 165 at risk

Adverse event: Swelling
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 165 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 62 affected / 165 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited Day 1 - 8
Frequency: 74 affected / 165 at risk

Adverse event: Lack of Appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited Day 1 - 8
Frequency: 48 affected / 165 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Solicited Day 1 - 8
Frequency: 67 affected / 165 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 6 affected / 165 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 37 affected / 165 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 9 affected / 165 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Solicited Day 1 - 8
Frequency: 3 affected / 165 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unsolicited Day 29
Frequency: 4 affected / 165 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Unsolicited Day 29
Frequency: 4 affected / 165 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unsolicited Day 29
Frequency: 1 affected / 165 at risk

Adverse event: Loose Stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited Day 29
Frequency: 23 affected / 165 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited Day 29
Frequency: 7 affected / 165 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 4 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited Day 1 - 8
Frequency: 11 affected / 24 at risk

Adverse event: Lack of Appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited Day 1 - 8
Frequency: 3 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Solicited Day 1 - 8
Frequency: 9 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 1 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 6 affected / 24 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unsolicited Day 29
Frequency: 1 affected / 24 at risk

Adverse event: Loose Stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited Day 29
Frequency: 5 affected / 24 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited Day 29
Frequency: 1 affected / 24 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 43 affected / 157 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited Day 1 - 8
Frequency: 41 affected / 157 at risk

Adverse event: Lack of Appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited Day 1 - 8
Frequency: 24 affected / 157 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Solicited Day 1 - 8
Frequency: 55 affected / 157 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 22 affected / 157 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 7 affected / 157 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Solicited Day 1 - 8
Frequency: 5 affected / 157 at risk

Adverse event: Loose Stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited Day 29
Frequency: 18 affected / 157 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 6 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited Day 1 - 8
Frequency: 6 affected / 25 at risk

Adverse event: Lack of Appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited Day 1 - 8
Frequency: 5 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Solicited Day 1 - 8
Frequency: 8 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 4 affected / 25 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Solicited Day 1 - 8
Frequency: 1 affected / 25 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unsolicited Day 29
Frequency: 1 affected / 25 at risk

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Notes: Unsolicited Day 29
Frequency: 1 affected / 25 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Unsolicited Day 29
Frequency: 1 affected / 25 at risk

Adverse event: Rectal tenesmus
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited Day 29
Frequency: 1 affected / 25 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unsolicited Day 29
Frequency: 1 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited Day 29
Frequency: 2 affected / 25 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited Day 29
Frequency: 1 affected / 25 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 25 affected / 146 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited Day 1 - 8
Frequency: 13 affected / 146 at risk

Adverse event: Lack of Appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited Day 1 - 8
Frequency: 28 affected / 146 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Solicited Day 1 - 8
Frequency: 45 affected / 146 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 1 affected / 146 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 10 affected / 146 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 2 affected / 146 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Solicited Day 1 - 8
Frequency: 3 affected / 146 at risk

Adverse event: Lack of Appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unsolicited Day 29
Frequency: 3 affected / 146 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Unsolicited Day 29
Frequency: 5 affected / 146 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited Day 29
Frequency: 3 affected / 146 at risk

Adverse event: Loose Stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited Day 29
Frequency: 8 affected / 146 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited Day 29
Frequency: 6 affected / 146 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited Day 29
Frequency: 3 affected / 146 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited Day 29
Frequency: 3 affected / 146 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited Day 29
Frequency: 1 affected / 146 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 4 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Solicited Day 1 - 8
Frequency: 2 affected / 26 at risk

Adverse event: Lack of Appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited Day 1 - 8
Frequency: 3 affected / 26 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Solicited Day 1 - 8
Frequency: 6 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 1 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 4 affected / 26 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited Day 1 - 8
Frequency: 3 affected / 26 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Solicited Day 1 - 8
Frequency: 1 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited Day 29
Frequency: 1 affected / 26 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unsolicited Day 29
Frequency: 1 affected / 26 at risk

Adverse event: Loose Stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited Day 29
Frequency: 2 affected / 26 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited Day 29
Frequency: 3 affected / 26 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited Day 29
Frequency: 1 affected / 26 at risk