Study: NCT03292731

Adverse event: SAEs unrelated to drug therapy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAEs unrelated to drug therapy- these were related to hospital admission for pregnancy related issues
Frequency: 19 affected / 65 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 53 affected / 65 at risk

Adverse event: Headache
Serious: no
Organ System: Vascular disorders
Frequency: 24 affected / 65 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 65 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 65 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 65 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 65 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 65 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 65 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Subject had suicidal ideation and was removed from study and drug stopped
Frequency: 1 affected / 66 at risk

Adverse event: SAEs unrelated to drug therapy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAEs unrelated to drug therapy- these were related to hospital admission for pregnancy related issues
Frequency: 16 affected / 66 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 57 affected / 66 at risk

Adverse event: Headache
Serious: no
Organ System: Vascular disorders
Frequency: 21 affected / 66 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 66 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 66 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 66 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 66 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 66 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 66 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Subject had suicidal ideation and was removed from study and drug stopped
Frequency: 1 affected / 131 at risk

Adverse event: SAEs unrelated to drug therapy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAEs unrelated to drug therapy- these were related to hospital admission for pregnancy related issues
Frequency: 35 affected / 131 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 110 affected / 131 at risk

Adverse event: Headache
Serious: no
Organ System: Vascular disorders
Frequency: 43 affected / 131 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 131 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 131 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 131 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 131 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 131 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 131 at risk