Study: NCT00271219

Adverse event: Abnormal fetal health
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Mothers only
Frequency: 3 affected / 89 at risk

Adverse event: cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 89 at risk

Adverse event: gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Illicit drug use
Serious: yes
Organ System: Psychiatric disorders
Notes: Mothers only
Frequency: 1 affected / 89 at risk

Adverse event: obstetrical
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 89 at risk

Adverse event: psychological
Serious: yes
Organ System: Psychiatric disorders
Notes: Mothers only
Frequency: 1 affected / 89 at risk

Adverse event: psychosocial
Serious: yes
Organ System: Social circumstances
Notes: Mothers only
Frequency: 1 affected / 89 at risk

Adverse event: respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: sexually transmitted diseases
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Abnormal fetal health
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Mothers only
Frequency: 6 affected / 89 at risk

Adverse event: abnormal appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 89 at risk

Adverse event: abnormal laboratory values
Serious: no
Organ System: General disorders
Frequency: 10 affected / 89 at risk

Adverse event: blood-borne disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 89 at risk

Adverse event: cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 89 at risk

Adverse event: endocrinologic
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 89 at risk

Adverse event: eye, ear, nose, or throat problems
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 12 affected / 89 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 89 at risk

Adverse event: gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 89 at risk

Adverse event: genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 23 affected / 89 at risk

Adverse event: hematopoietic or lymphatic symptoms
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 89 at risk

Adverse event: Illicit drug use
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 89 at risk

Adverse event: dental problems
Serious: no
Organ System: General disorders
Frequency: 22 affected / 89 at risk

Adverse event: musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 89 at risk

Adverse event: neuromuscular
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 89 at risk

Adverse event: neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 89 at risk

Adverse event: obstetrical
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 29 affected / 89 at risk

Adverse event: postsurgical
Serious: no
Organ System: Surgical and medical procedures
Frequency: 16 affected / 89 at risk

Adverse event: psychological
Serious: no
Organ System: Psychiatric disorders
Notes: Mothers only
Frequency: 24 affected / 89 at risk

Adverse event: psychosocial
Serious: no
Organ System: Social circumstances
Notes: Mothers only
Frequency: 4 affected / 89 at risk

Adverse event: respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 89 at risk

Adverse event: sexually transmitted diseases
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 89 at risk

Adverse event: skin conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 89 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Nervous system disorders
Notes: Mothers only
Frequency: 24 affected / 89 at risk

Adverse event: somatic
Serious: no
Organ System: Nervous system disorders
Notes: Mothers only
Frequency: 19 affected / 89 at risk

Adverse event: other AE
Serious: no
Organ System: General disorders
Frequency: 4 affected / 89 at risk

Adverse event: gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 86 at risk

Adverse event: Illicit drug use
Serious: yes
Organ System: Psychiatric disorders
Notes: Mothers only
Frequency: 1 affected / 86 at risk

Adverse event: obstetrical
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 86 at risk

Adverse event: skin conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Sleep disorder
Serious: yes
Organ System: Nervous system disorders
Notes: Mothers only
Frequency: 1 affected / 86 at risk

Adverse event: other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 86 at risk

Adverse event: Abnormal fetal health
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Mothers only
Frequency: 4 affected / 86 at risk

Adverse event: abnormal laboratory values
Serious: no
Organ System: General disorders
Frequency: 8 affected / 86 at risk

Adverse event: blood-borne disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 86 at risk

Adverse event: cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 86 at risk

Adverse event: endocrinologic
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 86 at risk

Adverse event: eye, ear, nose, or throat problems
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 15 affected / 86 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 86 at risk

Adverse event: gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 86 at risk

Adverse event: genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 86 at risk

Adverse event: hematopoietic or lymphatic symptoms
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 86 at risk

Adverse event: Illicit drug use
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 86 at risk

Adverse event: dental problems
Serious: no
Organ System: General disorders
Frequency: 15 affected / 86 at risk

Adverse event: musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 28 affected / 86 at risk

Adverse event: neuromuscular
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 86 at risk

Adverse event: neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 86 at risk

Adverse event: obstetrical
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 23 affected / 86 at risk

Adverse event: postsurgical
Serious: no
Organ System: Surgical and medical procedures
Frequency: 8 affected / 86 at risk

Adverse event: psychological
Serious: no
Organ System: Psychiatric disorders
Notes: Mothers only
Frequency: 21 affected / 86 at risk

Adverse event: psychosocial
Serious: no
Organ System: Social circumstances
Notes: Mothers only
Frequency: 5 affected / 86 at risk

Adverse event: respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 86 at risk

Adverse event: sexually transmitted diseases
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 86 at risk

Adverse event: skin conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 86 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Nervous system disorders
Notes: Mothers only
Frequency: 20 affected / 86 at risk

Adverse event: somatic
Serious: no
Organ System: Nervous system disorders
Notes: Mothers only
Frequency: 9 affected / 86 at risk

Adverse event: other AE
Serious: no
Organ System: General disorders
Frequency: 3 affected / 86 at risk

Adverse event: cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 73 at risk

Adverse event: obstetrical
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 73 at risk

Adverse event: respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 73 at risk

Adverse event: other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 73 at risk

Adverse event: abnormal appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 73 at risk

Adverse event: cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 73 at risk

Adverse event: endocrinologic
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 73 at risk

Adverse event: eye, ear, nose, or throat problems
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 73 at risk

Adverse event: gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 73 at risk

Adverse event: genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 73 at risk

Adverse event: hematopoietic or lymphatic symptoms
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 73 at risk

Adverse event: Illicit drug use
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 73 at risk

Adverse event: dental problems
Serious: no
Organ System: General disorders
Frequency: 1 affected / 73 at risk

Adverse event: musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 73 at risk

Adverse event: obstetrical
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 73 at risk

Adverse event: postsurgical
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 73 at risk

Adverse event: respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 73 at risk

Adverse event: sexually transmitted diseases
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: skin conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 73 at risk

Adverse event: other AE
Serious: no
Organ System: General disorders
Frequency: 2 affected / 73 at risk

Adverse event: cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 58 at risk

Adverse event: musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 58 at risk

Adverse event: neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 58 at risk

Adverse event: obstetrical
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 58 at risk

Adverse event: postsurgical
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 58 at risk

Adverse event: other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: abnormal appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: blood-borne disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 58 at risk

Adverse event: cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 58 at risk

Adverse event: endocrinologic
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 58 at risk

Adverse event: eye, ear, nose, or throat problems
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 58 at risk

Adverse event: gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 58 at risk

Adverse event: hematopoietic or lymphatic symptoms
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 58 at risk

Adverse event: Illicit drug use
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 58 at risk

Adverse event: dental problems
Serious: no
Organ System: General disorders
Frequency: 2 affected / 58 at risk

Adverse event: musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 58 at risk

Adverse event: obstetrical
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 58 at risk

Adverse event: respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 58 at risk

Adverse event: sexually transmitted diseases
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: skin conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 58 at risk

Adverse event: other AE
Serious: no
Organ System: General disorders
Frequency: 3 affected / 58 at risk