Study: NCT03308968

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 277 at risk

Adverse event: Congenital diaphragmatic hernia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 277 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 277 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 277 at risk

Adverse event: Peritonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 277 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 277 at risk

Adverse event: Thoracic vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 277 at risk

Adverse event: Blood pressure increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 277 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 277 at risk

Adverse event: Thyroid adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 277 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: This is a gender-specific AE. Only female participants were at risk.
Frequency: 1 affected / 231 at risk

Adverse event: Vulval cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: This is a gender-specific AE. Only female participants were at risk.
Frequency: 1 affected / 231 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 277 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 277 at risk

Adverse event: Intermenstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: This is a gender-specific AE. Only female participants were at risk.
Frequency: 1 affected / 231 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 24 affected / 277 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 16 affected / 277 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 277 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 277 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 277 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 277 at risk

Adverse event: Anorectal polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 276 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 276 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 276 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 276 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 276 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 276 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 276 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 276 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 276 at risk

Adverse event: International normalised ratio abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 276 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 276 at risk

Adverse event: Intracranial aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 276 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 276 at risk

Adverse event: Dysmenorrhoea
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: This is a gender-specific AE. Only female participants were at risk.
Frequency: 1 affected / 229 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: This is a gender-specific AE. Only female participants were at risk.
Frequency: 1 affected / 229 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 31 affected / 276 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 19 affected / 276 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 276 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 276 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 276 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 276 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 285 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 285 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 285 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 285 at risk

Adverse event: Respiratory fume inhalation disorder
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 285 at risk

Adverse event: Angiomyxoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 285 at risk

Adverse event: Multiple sclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 285 at risk

Adverse event: Optic neuritis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 285 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 285 at risk

Adverse event: Endometriosis
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: This is a gender-specific AE. Only female participants were at risk.
Frequency: 1 affected / 240 at risk

Adverse event: Menometrorrhagia
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: This is a gender-specific AE. Only female participants were at risk.
Frequency: 1 affected / 240 at risk

Adverse event: Vocal cord thickening
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 285 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 32 affected / 285 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 18 affected / 285 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 285 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 285 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 285 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 285 at risk