Study: NCT03700320

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 196 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 196 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 196 at risk

Adverse event: Colon cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 196 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 196 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 196 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 196 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 196 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 196 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 196 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 196 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 196 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 196 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 196 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 196 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 196 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 543 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 543 at risk

Adverse event: Beta haemolytic streptococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Coronavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 543 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 543 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 543 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 543 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 543 at risk

Adverse event: Adenocarcinoma of colon
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 543 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 543 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 543 at risk

Adverse event: Neuroendocrine carcinoma metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 543 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Number of participants at risk are female participants as this adverse event is specific to females.
Frequency: 1 affected / 479 at risk

Adverse event: Cervical radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 543 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 543 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 543 at risk

Adverse event: Status migrainosus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 543 at risk

Adverse event: Transient global amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 543 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 543 at risk

Adverse event: Suicidal behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 543 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 543 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Number of participants at risk are female participants as this adverse event is specific to females.
Frequency: 1 affected / 479 at risk

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Number of participants at risk are female participants as this adverse event is specific to females.
Frequency: 1 affected / 479 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Lung perforation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Victim of crime
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 543 at risk

Adverse event: Victim of homicide
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 543 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 543 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 543 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 543 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 56 affected / 543 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 543 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 543 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 543 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 543 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 543 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 543 at risk