Study: NCT00704912

Adverse event: Abnormal uterine bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Episode of abnormal uterine bleeding leading to ER visit
Frequency: 1 affected / 50 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Ectopic pregnancy requiring surgery
Frequency: 1 affected / 50 at risk

Adverse event: Preterm delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Preterm delivery of twins at 20 weeks: 1 live birth and 1 IUFD secondary to infection
Frequency: 1 affected / 50 at risk

Adverse event: Steatorrhea/Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Phase I Intervention
Frequency: 6 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 15 affected / 50 at risk

Adverse event: Upper Respiratory Infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Phase I Intervention
Frequency: 8 affected / 50 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 6 affected / 50 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase I Intervention
Frequency: 1 affected / 50 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 5 affected / 50 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase I Intervention
Frequency: 1 affected / 50 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Phase I Intervention
Frequency: 6 affected / 50 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Notes: Phase I Intervention
Frequency: 3 affected / 50 at risk

Adverse event: Gas/Bloating
Serious: no
Organ System: Gastrointestinal disorders
Notes: Phase I Intervention
Frequency: 2 affected / 50 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Phase I Intervention
Frequency: 1 affected / 50 at risk

Adverse event: Vaginitis/Vulvitis
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase I Intervention
Frequency: 1 affected / 50 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase I Intervention
Frequency: 2 affected / 50 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 4 affected / 50 at risk

Adverse event: Dizziness/Vertigo
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 3 affected / 50 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 1 affected / 50 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Phase I Intervention
Frequency: 1 affected / 50 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Phase I Intervention
Frequency: 2 affected / 50 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 2 affected / 50 at risk

Adverse event: Tachycardia
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 1 affected / 50 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase II Ovulation Induction
Frequency: 7 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Phase II Ovulation Induction
Frequency: 4 affected / 44 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase II Ovulation Induction
Frequency: 5 affected / 44 at risk

Adverse event: Hot flush
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase II Ovulation Induction
Frequency: 4 affected / 44 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: General disorders
Notes: Phase II Ovulation Induction
Frequency: 5 affected / 44 at risk

Adverse event: Upper Respiratory Infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Phase II Ovulation Induction
Frequency: 2 affected / 44 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Notes: Phase II Ovulation Induction
Frequency: 3 affected / 44 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase II Ovulation Induction
Frequency: 1 affected / 44 at risk

Adverse event: Gas/Bloating
Serious: no
Organ System: Gastrointestinal disorders
Notes: Phase II Ovulation Induction
Frequency: 4 affected / 44 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Phase II Ovulation Induction
Frequency: 2 affected / 44 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Phase II Ovulation Induction
Frequency: 2 affected / 44 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: Phase II Ovulation Induction
Frequency: 2 affected / 44 at risk

Adverse event: Visual Changes
Serious: no
Organ System: General disorders
Notes: Phase II Ovulation Induction
Frequency: 1 affected / 44 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 4 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 3 affected / 16 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 3 affected / 16 at risk

Adverse event: Breast pain
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 2 affected / 16 at risk

Adverse event: Mood swings
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 16 at risk

Adverse event: Constipation
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 16 at risk

Adverse event: Hot flush
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 2 affected / 16 at risk

Adverse event: Spotting in pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 16 at risk

Adverse event: Hypertension
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 16 at risk

Adverse event: Vaginitis/Vulvitis
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 16 at risk

Adverse event: Vaginal Dryness/Pain
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 16 at risk

Adverse event: Vomiting
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 16 at risk

Adverse event: Urinary tract infection in pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 16 at risk

Adverse event: Gas/Bloating
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 16 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 16 at risk

Adverse event: Pre-eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 4 affected / 16 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 3 affected / 16 at risk

Adverse event: Preterm Delivery
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 3 affected / 16 at risk

Adverse event: Premature rupture of membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 3 affected / 16 at risk

Adverse event: Upper Respiratory Infections
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 3 affected / 16 at risk

Adverse event: Placental Abnormalities
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 16 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 16 at risk

Adverse event: Dental, other
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 16 at risk

Adverse event: Cervical incompetence
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 16 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 16 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 16 at risk

Adverse event: Edema localized
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 16 at risk

Adverse event: Glycosuria
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 16 at risk

Adverse event: Pregnancy-induced Hypertension
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Delivery and Postpartum
Frequency: 2 affected / 16 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Delivery and Postpartum
Frequency: 1 affected / 16 at risk

Adverse event: Postpartum infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Delivery and Postpartum
Frequency: 1 affected / 16 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: After 20 weeks pregnancy in fetus through neonatal period
Frequency: 2 affected / 12 at risk

Adverse event: Intrauterine growth restriction
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: After 20 weeks pregnancy in fetus through neonatal period
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 14 affected / 49 at risk

Adverse event: Upper Respiratory Infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Phase I Intervention
Frequency: 8 affected / 49 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 7 affected / 49 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase I Intervention
Frequency: 10 affected / 49 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 1 affected / 49 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase I Intervention
Frequency: 8 affected / 49 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Phase I Intervention
Frequency: 1 affected / 49 at risk

Adverse event: Abnormal uterine bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase I Intervention
Frequency: 4 affected / 49 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Notes: Phase I Intervention
Frequency: 3 affected / 49 at risk

Adverse event: Gas/Bloating
Serious: no
Organ System: Gastrointestinal disorders
Notes: Phase I Intervention
Frequency: 2 affected / 49 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Phase I Intervention
Frequency: 3 affected / 49 at risk

Adverse event: Vaginitis/Vulvitis
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase I Intervention
Frequency: 4 affected / 49 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase I Intervention
Frequency: 3 affected / 49 at risk

Adverse event: Dizziness/Vertigo
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 2 affected / 49 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 2 affected / 49 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Phase I Intervention
Frequency: 1 affected / 49 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase II Ovulation Induction
Frequency: 12 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Phase II Ovulation Induction
Frequency: 6 affected / 44 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase II Ovulation Induction
Frequency: 7 affected / 44 at risk

Adverse event: Hot flush
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase II Ovulation Induction
Frequency: 6 affected / 44 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: General disorders
Notes: Phase II Ovulation Induction
Frequency: 3 affected / 44 at risk

Adverse event: Upper Respiratory Infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Phase II Ovulation Induction
Frequency: 5 affected / 44 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Notes: Phase II Ovulation Induction
Frequency: 3 affected / 44 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase II Ovulation Induction
Frequency: 6 affected / 44 at risk

Adverse event: Gas/Bloating
Serious: no
Organ System: Gastrointestinal disorders
Notes: Phase II Ovulation Induction
Frequency: 1 affected / 44 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Phase II Ovulation Induction
Frequency: 2 affected / 44 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Phase II Ovulation Induction
Frequency: 1 affected / 44 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: Phase II Ovulation Induction
Frequency: 3 affected / 44 at risk

Adverse event: Vaginal Dryness/Pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase II Ovulation Induction
Frequency: 3 affected / 44 at risk

Adverse event: Rash
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 8 at risk

Adverse event: Pre-eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 8 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 8 at risk

Adverse event: Placental Abnormalities
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 8 at risk

Adverse event: Dizziness/Vertigo
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 8 at risk

Adverse event: Perinatal depression
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Delivery and Postpartum
Frequency: 1 affected / 8 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: After 20 weeks pregnancy in fetus through neonatal period
Frequency: 1 affected / 5 at risk

Adverse event: Perforated appendix
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Postpartum hospitalization for perforated appendix
Frequency: 1 affected / 50 at risk

Adverse event: Steatorrhea/Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Phase I Intervention
Frequency: 12 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 18 affected / 50 at risk

Adverse event: Upper Respiratory Infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Phase I Intervention
Frequency: 13 affected / 50 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 9 affected / 50 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase I Intervention
Frequency: 6 affected / 50 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 10 affected / 50 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase I Intervention
Frequency: 3 affected / 50 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Phase I Intervention
Frequency: 4 affected / 50 at risk

Adverse event: Abnormal uterine bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase I Intervention
Frequency: 6 affected / 50 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Notes: Phase I Intervention
Frequency: 3 affected / 50 at risk

Adverse event: Gas/Bloating
Serious: no
Organ System: Gastrointestinal disorders
Notes: Phase I Intervention
Frequency: 5 affected / 50 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Phase I Intervention
Frequency: 4 affected / 50 at risk

Adverse event: Vaginitis/Vulvitis
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase I Intervention
Frequency: 1 affected / 50 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase I Intervention
Frequency: 1 affected / 50 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 1 affected / 50 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 3 affected / 50 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Phase I Intervention
Frequency: 3 affected / 50 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Phase I Intervention
Frequency: 3 affected / 50 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 3 affected / 50 at risk

Adverse event: Tachycardia
Serious: no
Organ System: General disorders
Notes: Phase I Intervention
Frequency: 3 affected / 50 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase II Ovulation Induction
Frequency: 13 affected / 43 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Phase II Ovulation Induction
Frequency: 12 affected / 43 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase II Ovulation Induction
Frequency: 9 affected / 43 at risk

Adverse event: Hot flush
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase II Ovulation Induction
Frequency: 3 affected / 43 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: General disorders
Notes: Phase II Ovulation Induction
Frequency: 5 affected / 43 at risk

Adverse event: Upper Respiratory Infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Phase II Ovulation Induction
Frequency: 5 affected / 43 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Notes: Phase II Ovulation Induction
Frequency: 2 affected / 43 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Phase II Ovulation Induction
Frequency: 1 affected / 43 at risk

Adverse event: Gas/Bloating
Serious: no
Organ System: Gastrointestinal disorders
Notes: Phase II Ovulation Induction
Frequency: 3 affected / 43 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Phase II Ovulation Induction
Frequency: 3 affected / 43 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Phase II Ovulation Induction
Frequency: 3 affected / 43 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: Phase II Ovulation Induction
Frequency: 1 affected / 43 at risk

Adverse event: Visual Changes
Serious: no
Organ System: General disorders
Notes: Phase II Ovulation Induction
Frequency: 3 affected / 43 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 14 at risk

Adverse event: Fatigue
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 14 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 14 at risk

Adverse event: Breast pain
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 2 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 14 at risk

Adverse event: Mood swings
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 14 at risk

Adverse event: Constipation
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 14 at risk

Adverse event: Spotting in pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 14 at risk

Adverse event: Dizziness/Vertigo
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 14 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: First trimester
Frequency: 1 affected / 14 at risk

Adverse event: Pre-eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 2 affected / 14 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 2 affected / 14 at risk

Adverse event: Biliary tract disorder
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 14 at risk

Adverse event: Breast mass
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 14 at risk

Adverse event: Vaginitis/Vulvitis
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 14 at risk

Adverse event: Urinary tract infection in pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 14 at risk

Adverse event: Amniotic cavity infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 14 at risk

Adverse event: Pruritus
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 14 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Phase III After Conception: Second and Third trimester
Frequency: 1 affected / 14 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: After 20 weeks pregnancy in fetus through neonatal period
Frequency: 4 affected / 12 at risk

Adverse event: Intrauterine growth restriction
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: After 20 weeks pregnancy in fetus through neonatal period
Frequency: 1 affected / 12 at risk

Adverse event: Neonatal infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: After 20 weeks pregnancy in fetus through neonatal period
Frequency: 1 affected / 12 at risk

Adverse event: Other complication of infant after delivery
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: After 20 weeks pregnancy in fetus through neonatal period
Frequency: 1 affected / 12 at risk