Study: NCT04623242

Adverse event: General disorders
Serious: yes
Organ System: General disorders
Notes: To maintain blinding to participants' genetic status and assigned treatment, SAEs reported at the arm/group level are included under the General disorders SOC; all other SOCs are reported in the Combined Blinded Group.
Frequency: 12 affected / 52 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 4 affected / 52 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 8 affected / 52 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: Eye disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 12 affected / 52 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 33 affected / 52 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 50 affected / 52 at risk

Adverse event: Immune system disorders
Serious: no
Organ System: Immune system disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 5 affected / 52 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 36 affected / 52 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 16 affected / 52 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 7 affected / 52 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 30 affected / 52 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 6 affected / 52 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 41 affected / 52 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 22 affected / 52 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 5 affected / 52 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 7 affected / 52 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 24 affected / 52 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 23 affected / 52 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 8 affected / 52 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 39 affected / 52 at risk

Adverse event: Social Circumstances
Serious: no
Organ System: Social circumstances
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 3 affected / 52 at risk

Adverse event: General disorders
Serious: yes
Organ System: General disorders
Notes: To maintain blinding to participants' genetic status and assigned treatment, SAEs reported at the arm/group level are included under the General disorders SOC; all other SOCs are reported in the Combined Blinded Group.
Frequency: 13 affected / 52 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 1 affected / 52 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 6 affected / 52 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: Eye disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 2 affected / 52 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 35 affected / 52 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 31 affected / 52 at risk

Adverse event: Immune system disorders
Serious: no
Organ System: Immune system disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 8 affected / 52 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 35 affected / 52 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 12 affected / 52 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 6 affected / 52 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 28 affected / 52 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 5 affected / 52 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 38 affected / 52 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 29 affected / 52 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 4 affected / 52 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 6 affected / 52 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 22 affected / 52 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 18 affected / 52 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 5 affected / 52 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 41 affected / 52 at risk

Adverse event: Social Circumstances
Serious: no
Organ System: Social circumstances
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 3 affected / 52 at risk

Adverse event: General disorders
Serious: yes
Organ System: General disorders
Notes: To maintain blinding to participants' genetic status and assigned treatment, SAEs reported at the arm/group level are included under the General disorders SOC; all other SOCs are reported in the Combined Blinded Group.
Frequency: 12 affected / 89 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 9 affected / 89 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 11 affected / 89 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: Eye disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 9 affected / 89 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 48 affected / 89 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 54 affected / 89 at risk

Adverse event: Immune system disorders
Serious: no
Organ System: Immune system disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 8 affected / 89 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 52 affected / 89 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 30 affected / 89 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 14 affected / 89 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 52 affected / 89 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 4 affected / 89 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 58 affected / 89 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 29 affected / 89 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 6 affected / 89 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 8 affected / 89 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 33 affected / 89 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 29 affected / 89 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 13 affected / 89 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 62 affected / 89 at risk

Adverse event: Social Circumstances
Serious: no
Organ System: Social circumstances
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 5 affected / 89 at risk

Adverse event: General disorders
Serious: yes
Organ System: General disorders
Notes: To maintain blinding to participants' genetic status and assigned treatment, SAEs reported at the arm/group level are included under the General disorders SOC; all other SOCs are reported in the Combined Blinded Group.
Frequency: 10 affected / 69 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 27 affected / 69 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 25 affected / 69 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: In order to maintain blinding to participants' genetic status and assigned treatment, this AE is reported by system organ class.
Frequency: 30 affected / 69 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Notes: To maintain blinding to participants' genetic status and assigned treatment, SAEs reported at the arm/group level are included under the General disorders SOC; all other SOCs are reported in the Combined Blinded Group.
Frequency: 7 affected / 262 at risk

Adverse event: General disorders
Serious: yes
Organ System: General disorders
Notes: To maintain blinding to participants' genetic status and assigned treatment, SAEs reported at the arm/group level are included under the General disorders SOC; all other SOCs are reported in the Combined Blinded Group.
Frequency: 3 affected / 262 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Notes: To maintain blinding to participants' genetic status and assigned treatment, SAEs reported at the arm/group level are included under the General disorders SOC; all other SOCs are reported in the Combined Blinded Group.
Frequency: 9 affected / 262 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: To maintain blinding to participants' genetic status and assigned treatment, SAEs reported at the arm/group level are included under the General disorders SOC; all other SOCs are reported in the Combined Blinded Group.
Frequency: 14 affected / 262 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: To maintain blinding to participants' genetic status and assigned treatment, SAEs reported at the arm/group level are included under the General disorders SOC; all other SOCs are reported in the Combined Blinded Group.
Frequency: 6 affected / 262 at risk

Adverse event: Neoplasms benign, malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: To maintain blinding to participants' genetic status and assigned treatment, SAEs reported at the arm/group level are included under the General disorders SOC; all other SOCs are reported in the Combined Blinded Group.
Frequency: 3 affected / 262 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Notes: To maintain blinding to participants' genetic status and assigned treatment, SAEs reported at the arm/group level are included under the General disorders SOC; all other SOCs are reported in the Combined Blinded Group.
Frequency: 11 affected / 262 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: To maintain blinding to participants' genetic status and assigned treatment, SAEs reported at the arm/group level are included under the General disorders SOC; all other SOCs are reported in the Combined Blinded Group.
Frequency: 4 affected / 262 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Notes: To maintain blinding to participants' genetic status and assigned treatment, SAEs reported at the arm/group level are included under the General disorders SOC; all other SOCs are reported in the Combined Blinded Group.
Frequency: 3 affected / 262 at risk

Adverse event: Reproductive system and breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: To maintain blinding to participants' genetic status and assigned treatment, SAEs reported at the arm/group level are included under the General disorders SOC; all other SOCs are reported in the Combined Blinded Group.
Frequency: 2 affected / 262 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: To maintain blinding to participants' genetic status and assigned treatment, SAEs reported at the arm/group level are included under the General disorders SOC; all other SOCs are reported in the Combined Blinded Group.
Frequency: 2 affected / 262 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: To maintain blinding to participants' genetic status and assigned treatment, SAEs reported at the arm/group level are included under the General disorders SOC; all other SOCs are reported in the Combined Blinded Group.
Frequency: 2 affected / 262 at risk