Study: NCT01687712

Adverse event: Accessory auricle
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 549 at risk

Adverse event: Foetal chromosome abnormality
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 549 at risk

Adverse event: Mosaicism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 549 at risk

Adverse event: Polydactyly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 549 at risk

Adverse event: Trisomy 13
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 549 at risk

Adverse event: Trisomy 15
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 549 at risk

Adverse event: Trisomy 21
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 549 at risk

Adverse event: Turner's syndrome
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 549 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 549 at risk

Adverse event: Death neonatal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 549 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 549 at risk

Adverse event: Procedural pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 549 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 549 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 549 at risk

Adverse event: Cervical incompetence
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 549 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 549 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 549 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 549 at risk

Adverse event: Heterotopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 549 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 549 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 549 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 549 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 549 at risk

Adverse event: Prolonged labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 549 at risk

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 549 at risk

Adverse event: Abortion induced
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 549 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 549 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 549 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 549 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 549 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 549 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 549 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 549 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 549 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 549 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 549 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 549 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 549 at risk

Adverse event: Abdominal tenderness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 549 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 549 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 549 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 549 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 549 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 549 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 549 at risk

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 549 at risk

Adverse event: Glossodynia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 549 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 549 at risk

Adverse event: Lip pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 549 at risk

Adverse event: Intra-abdominal fluid collection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 549 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 549 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 549 at risk

Adverse event: Adverse drug reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 549 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 549 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 1 affected / 549 at risk

Adverse event: Discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 549 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 549 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 6 affected / 549 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 82 affected / 549 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 3 affected / 549 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 549 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 7 affected / 549 at risk

Adverse event: Injection site scab
Serious: no
Organ System: General disorders
Frequency: 2 affected / 549 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 8 affected / 549 at risk

Adverse event: Injection site vesicles
Serious: no
Organ System: General disorders
Frequency: 3 affected / 549 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 2 affected / 549 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 549 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 549 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 549 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 549 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 549 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 549 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 549 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 549 at risk

Adverse event: Salpingitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 549 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 549 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 549 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 549 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 549 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 549 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 549 at risk

Adverse event: Post procedural discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 39 affected / 549 at risk

Adverse event: Post procedural haematuria
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 549 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 549 at risk

Adverse event: Procedural hypertension
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 549 at risk

Adverse event: Procedural nausea
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 549 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 105 affected / 549 at risk

Adverse event: Procedural vomiting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 549 at risk

Adverse event: Blood oestrogen increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 549 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 549 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 549 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 549 at risk

Adverse event: Infertility tests
Serious: no
Organ System: Investigations
Frequency: 1 affected / 549 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 549 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 549 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 549 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 549 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 549 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 549 at risk

Adverse event: Limb discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 549 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 549 at risk

Adverse event: Muscle tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 549 at risk

Adverse event: Musculoskeletal discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 549 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 549 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 549 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 549 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 549 at risk

Adverse event: Leiomyoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 549 at risk

Adverse event: Uterine leiomyoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 549 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 549 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 549 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 145 affected / 549 at risk

Adverse event: Hyperaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 549 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 549 at risk

Adverse event: Migraine with aura
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 549 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 549 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 549 at risk

Adverse event: Retinal migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 549 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 549 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 549 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 549 at risk

Adverse event: Abortion early
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 43 affected / 549 at risk

Adverse event: Abortion spontaneous
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 549 at risk

Adverse event: Cervical incompetence
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 549 at risk

Adverse event: Ectopic pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 549 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 549 at risk

Adverse event: Haemorrhage in pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 549 at risk

Adverse event: Placenta praevia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 549 at risk

Adverse event: Subchorionic haematoma
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 549 at risk

Adverse event: Subchorionic haemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 549 at risk

Adverse event: Vanishing twin syndrome
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 549 at risk

Adverse event: Morning sickness
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 549 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 549 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 549 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 549 at risk

Adverse event: Mood altered
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 549 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 549 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 549 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 549 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 549 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 549 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 549 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 549 at risk

Adverse event: Adnexa uteri pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 549 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 549 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 12 affected / 549 at risk

Adverse event: Cervical discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 549 at risk

Adverse event: Cervical polyp
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 549 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 549 at risk

Adverse event: Fallopian tube cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 549 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 549 at risk

Adverse event: Nipple pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 549 at risk

Adverse event: Ovarian cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 549 at risk

Adverse event: Ovarian enlargement
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 549 at risk

Adverse event: Ovarian hyperstimulation syndrome
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Note: This includes subjects who were at risk of OHSS as well those who had actual OHSS.
Frequency: 16 affected / 549 at risk

Adverse event: Pelvic discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 549 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 549 at risk

Adverse event: Uterine cervix stenosis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 549 at risk

Adverse event: Uterine haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 549 at risk

Adverse event: Uterine pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 549 at risk

Adverse event: Uterine polyp
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 549 at risk

Adverse event: Uterine spasm
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 549 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 549 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 14 affected / 549 at risk

Adverse event: Vaginal odour
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 549 at risk

Adverse event: Vulvovaginal discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 549 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 549 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 549 at risk

Adverse event: Dry throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 549 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 549 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 549 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 549 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 549 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 549 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 549 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 549 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 549 at risk

Adverse event: Blood blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 549 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 549 at risk

Adverse event: Ingrowing nail
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 549 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 549 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 549 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 549 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 549 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 549 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 549 at risk

Adverse event: Skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 549 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 549 at risk

Adverse event: Abortion induced
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 549 at risk

Adverse event: Sinus operation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 549 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 549 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 549 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 549 at risk

Adverse event: Foetal heart rate deceleration abnormality
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 551 at risk

Adverse event: Cardiac septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 551 at risk

Adverse event: Cleft palate
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 551 at risk

Adverse event: Congenital skin dimples
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 551 at risk

Adverse event: Cytogenetic abnormality
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 551 at risk

Adverse event: Foetal chromosome abnormality
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 551 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 551 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 551 at risk

Adverse event: Trisomy 15
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 551 at risk

Adverse event: Trisomy 22
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 551 at risk

Adverse event: Trisomy 9
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 551 at risk

Adverse event: Death neonatal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 551 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 551 at risk

Adverse event: Cholestasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 551 at risk

Adverse event: Post procedural haematuria
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 551 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 551 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 551 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 551 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 551 at risk

Adverse event: Hyperemesis gravidarum
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 551 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 551 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 551 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 551 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 551 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 551 at risk

Adverse event: Umbilical cord abnormality
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 551 at risk

Adverse event: Ovarian hyperstimulation syndrome
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Note: This includes subjects who were at risk of OHSS as well those who had actual OHSS.
Frequency: 2 affected / 551 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 551 at risk

Adverse event: Ear discomfort
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 551 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 551 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 551 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 551 at risk

Adverse event: Asthenopia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 551 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 551 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 551 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 551 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 551 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 551 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 551 at risk

Adverse event: Abdominal tenderness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 551 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 551 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 551 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 551 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 551 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 551 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 551 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 551 at risk

Adverse event: Hypoaesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 551 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 551 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 551 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 551 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 551 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 551 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 1 affected / 551 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 8 affected / 551 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 76 affected / 551 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 2 affected / 551 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 2 affected / 551 at risk

Adverse event: Injection site inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 551 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 551 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 551 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 7 affected / 551 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 4 affected / 551 at risk

Adverse event: Injection site vesicles
Serious: no
Organ System: General disorders
Frequency: 4 affected / 551 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 551 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 551 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 551 at risk

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 551 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 551 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 551 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 551 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 551 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 551 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 551 at risk

Adverse event: Genital herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 551 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 551 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 551 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 551 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 551 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 551 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 551 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 551 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 551 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 551 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 551 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 551 at risk

Adverse event: Post procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 551 at risk

Adverse event: Post procedural discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 36 affected / 551 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 551 at risk

Adverse event: Procedural hypertension
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 551 at risk

Adverse event: Procedural nausea
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 551 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 89 affected / 551 at risk

Adverse event: Procedural vomiting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 551 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 551 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 551 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 551 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 551 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 551 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 551 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 551 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 551 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 551 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 551 at risk

Adverse event: Musculoskeletal discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 551 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 551 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 551 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 551 at risk

Adverse event: Uterine leiomyoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 551 at risk

Adverse event: Aphonia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 551 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 551 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 551 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 127 affected / 551 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 551 at risk

Adverse event: Nerve compression
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 551 at risk

Adverse event: Poor quality sleep
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 551 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 551 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 551 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 551 at risk

Adverse event: Tension headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 551 at risk

Adverse event: Abortion early
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 60 affected / 551 at risk

Adverse event: Abortion spontaneous
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 551 at risk

Adverse event: Ectopic pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 551 at risk

Adverse event: Haemorrhage in pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 551 at risk

Adverse event: Hyperemesis gravidarum
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 551 at risk

Adverse event: Subchorionic haematoma
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 551 at risk

Adverse event: Subchorionic haemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 551 at risk

Adverse event: Vanishing twin syndrome
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 551 at risk

Adverse event: Morning sickness
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 551 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 551 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 551 at risk

Adverse event: Emotional disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 551 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 551 at risk

Adverse event: Mood altered
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 551 at risk

Adverse event: Nightmare
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 551 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 551 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 551 at risk

Adverse event: Adnexa uteri pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 551 at risk

Adverse event: Breast mass
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 551 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 551 at risk

Adverse event: Coital bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 551 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 551 at risk

Adverse event: Hypomenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 551 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 551 at risk

Adverse event: Nipple pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 551 at risk

Adverse event: Ovarian enlargement
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 551 at risk

Adverse event: Ovarian hyperstimulation syndrome
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Note: This includes subjects who were at risk of OHSS as well those who had actual OHSS.
Frequency: 12 affected / 551 at risk

Adverse event: Pelvic discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 10 affected / 551 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 551 at risk

Adverse event: Uterine pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 551 at risk

Adverse event: Uterine polyp
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 551 at risk

Adverse event: Uterine spasm
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 551 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 551 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 19 affected / 551 at risk

Adverse event: Vulvovaginal discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 551 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 551 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 551 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 551 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 551 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 551 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 551 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 551 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 551 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 551 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 551 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 551 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 551 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 551 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 551 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 551 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 551 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 551 at risk

Adverse event: Swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 551 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 551 at risk

Adverse event: Diastolic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 551 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 551 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 551 at risk

Adverse event: Acute fatty liver of pregnancy
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 109 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 109 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 109 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 109 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 109 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 109 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 109 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 109 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 109 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 109 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 109 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 109 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 109 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 109 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 11 affected / 109 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 109 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 109 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 109 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 109 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 109 at risk

Adverse event: Bacterial vulvovaginitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 109 at risk

Adverse event: Post procedural discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 109 at risk

Adverse event: Procedural nausea
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 109 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 109 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 109 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 109 at risk

Adverse event: Limb discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 109 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 109 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 109 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 109 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 109 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 109 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 109 at risk

Adverse event: Abortion early
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 18 affected / 109 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 109 at risk

Adverse event: Adnexa uteri pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 109 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 109 at risk

Adverse event: Ovarian hyperstimulation syndrome
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Note: This includes subjects who were at risk of OHSS as well those who had actual OHSS.
Frequency: 3 affected / 109 at risk

Adverse event: Pelvic discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 109 at risk

Adverse event: Uterine polyp
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 109 at risk

Adverse event: Uterine spasm
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 109 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 109 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 109 at risk

Adverse event: Paranasal sinus discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 109 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 109 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 109 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 109 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 109 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 109 at risk

Adverse event: Trisomy 17
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 120 at risk

Adverse event: Trisomy 21
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 120 at risk

Adverse event: Haemoperitoneum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 120 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 120 at risk

Adverse event: Vanishing twin syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 120 at risk

Adverse event: Ovarian hyperstimulation syndrome
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Note: This includes subjects who were at risk of OHSS as well those who had actual OHSS.
Frequency: 1 affected / 120 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 120 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 120 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 120 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 120 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 120 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 120 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 120 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 120 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 120 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 120 at risk

Adverse event: Infected bite
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Post procedural discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 120 at risk

Adverse event: Procedural nausea
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 120 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 120 at risk

Adverse event: Heart rate increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 120 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 120 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 120 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Abortion early
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 16 affected / 120 at risk

Adverse event: Abortion spontaneous
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 120 at risk

Adverse event: Ectopic pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 120 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 120 at risk

Adverse event: Cervical discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 120 at risk

Adverse event: Ovarian hyperstimulation syndrome
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Note: This includes subjects who were at risk of OHSS as well those who had actual OHSS.
Frequency: 2 affected / 120 at risk

Adverse event: Uterine spasm
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 120 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 120 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 120 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 120 at risk

Adverse event: Turner's syndrome
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 28 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 28 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 28 at risk

Adverse event: Transverse presentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 28 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Post procedural discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 28 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Abortion early
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 28 at risk

Adverse event: Abortion spontaneous
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 28 at risk

Adverse event: Cervical incompetence
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 28 at risk

Adverse event: Ectopic pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 28 at risk

Adverse event: Premature rupture of membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 28 at risk

Adverse event: Retained placenta or membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 28 at risk

Adverse event: Adnexa uteri pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 28 at risk

Adverse event: Pelvic discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 28 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 28 at risk

Adverse event: Uterine dilation and curettage
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 28 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Post procedural discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 24 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 24 at risk

Adverse event: Abortion early
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 24 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk