Study: NCT03229057

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastroenteritis resulting in dehydration
Frequency: 1 affected / 79 at risk

Adverse event: Surgery
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Exploratory laparoscopy for severe lower abdominal pain
Frequency: 1 affected / 79 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 79 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 79 at risk

Adverse event: Abdominal Pain/Cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 79 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 79 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 79 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 79 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 79 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 79 at risk

Adverse event: Vaginal Bleeding/Spotting
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 19 affected / 79 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 15 affected / 79 at risk

Adverse event: Breast Symptoms
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Breast tenderness/pain/swelling
Frequency: 7 affected / 79 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 79 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 79 at risk

Adverse event: Mood Swings/Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 79 at risk

Adverse event: Joint/muscle pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 79 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 79 at risk

Adverse event: COVID infection/symptoms after exposure
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 79 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 79 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Hospitalization for sever depression
Frequency: 1 affected / 81 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Pregnancy with miscarriage at 20 weeks, 5 days
Frequency: 1 affected / 81 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Ongoing bleeding despite medical management. Admitted for blood transfusion and D\&C.
Frequency: 1 affected / 81 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 81 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 81 at risk

Adverse event: Abdominal Pain/Cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 81 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 81 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 81 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 81 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 81 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 81 at risk

Adverse event: Vaginal Bleeding/Spotting
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 81 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 81 at risk

Adverse event: Breast Symptoms
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Breast tenderness/pain/swelling
Frequency: 2 affected / 81 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 81 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 81 at risk

Adverse event: Mood Swings/Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 81 at risk

Adverse event: Joint/muscle pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 81 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 81 at risk

Adverse event: COVID infection/symptoms after exposure
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 81 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 81 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Gall bladder attack with surgery
Frequency: 1 affected / 80 at risk

Adverse event: Medical intervention
Serious: yes
Organ System: Nervous system disorders
Notes: Headache/vision problems diagnosed to be idiopathic intracranial hypertension
Frequency: 1 affected / 80 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Cholecystectomy
Frequency: 1 affected / 80 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 80 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 80 at risk

Adverse event: Abdominal Pain/Cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 80 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 80 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 80 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 80 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 80 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 80 at risk

Adverse event: Vaginal Bleeding/Spotting
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 80 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 80 at risk

Adverse event: Breast Symptoms
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Breast tenderness/pain/swelling
Frequency: 5 affected / 80 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 80 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 80 at risk

Adverse event: Mood Swings/Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 80 at risk

Adverse event: Joint/muscle pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 80 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 80 at risk

Adverse event: COVID infection/symptoms after exposure
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 80 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 80 at risk