Study: NCT01650558

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 22 affected / 500 at risk

Adverse event: Pregnancy, puerperium and perinatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 500 at risk

Adverse event: Nervousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 500 at risk

Adverse event: Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 500 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 500 at risk

Adverse event: Neoplasms
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 500 at risk

Adverse event: Surgical and medical
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 500 at risk

Adverse event: General
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 500 at risk

Adverse event: Reproductive system
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 500 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 500 at risk

Adverse event: Blood
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 500 at risk

Adverse event: Psychiatric
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 500 at risk

Adverse event: Eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 500 at risk

Adverse event: Cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hepatobiliary
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 500 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 500 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 414 affected / 500 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 304 affected / 500 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 298 affected / 500 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 248 affected / 500 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 256 affected / 500 at risk

Adverse event: Blood
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 240 affected / 500 at risk

Adverse event: Nervousness
Serious: no
Organ System: Nervous system disorders
Frequency: 217 affected / 500 at risk

Adverse event: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 140 affected / 500 at risk

Adverse event: Eye
Serious: no
Organ System: Eye disorders
Frequency: 122 affected / 500 at risk

Adverse event: Reproductive system
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 85 affected / 500 at risk

Adverse event: Injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 85 affected / 500 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 59 affected / 500 at risk

Adverse event: Vascular
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 500 at risk

Adverse event: Pregnancy, puerperium and perinatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 17 affected / 500 at risk

Adverse event: Metabolism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 500 at risk

Adverse event: Ear and labyrinth
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 18 affected / 500 at risk

Adverse event: Neoplasms
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 15 affected / 500 at risk

Adverse event: Cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 500 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 500 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 500 at risk

Adverse event: Surgical and medical
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 500 at risk

Adverse event: Hepatobiliary
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 500 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 500 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 32 affected / 500 at risk

Adverse event: Pregnancy, puerperium and perinatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 26 affected / 500 at risk

Adverse event: Nervousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 500 at risk

Adverse event: Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 500 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 500 at risk

Adverse event: Neoplasms
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 500 at risk

Adverse event: Surgical and medical
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 500 at risk

Adverse event: General
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 500 at risk

Adverse event: Reproductive system
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 500 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 500 at risk

Adverse event: Blood
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Psychiatric
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 500 at risk

Adverse event: Eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 500 at risk

Adverse event: Metabolism
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 500 at risk

Adverse event: Cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 428 affected / 500 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 267 affected / 500 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 307 affected / 500 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 243 affected / 500 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 223 affected / 500 at risk

Adverse event: Blood
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 222 affected / 500 at risk

Adverse event: Nervousness
Serious: no
Organ System: Nervous system disorders
Frequency: 209 affected / 500 at risk

Adverse event: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 133 affected / 500 at risk

Adverse event: Eye
Serious: no
Organ System: Eye disorders
Frequency: 130 affected / 500 at risk

Adverse event: Reproductive system
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 94 affected / 500 at risk

Adverse event: Injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 82 affected / 500 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 65 affected / 500 at risk

Adverse event: Vascular
Serious: no
Organ System: Vascular disorders
Frequency: 29 affected / 500 at risk

Adverse event: Pregnancy, puerperium and perinatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 27 affected / 500 at risk

Adverse event: Metabolism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 500 at risk

Adverse event: Ear and labyrinth
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 24 affected / 500 at risk

Adverse event: Neoplasms
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 23 affected / 500 at risk

Adverse event: Cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 500 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 17 affected / 500 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 500 at risk

Adverse event: Surgical and medical
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 500 at risk

Adverse event: Hepatobiliary
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 500 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 500 at risk

Adverse event: Congenital, familial and genetic
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 500 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 40 affected / 499 at risk

Adverse event: Pregnancy, puerperium and perinatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 29 affected / 499 at risk

Adverse event: Nervousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 499 at risk

Adverse event: Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 499 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 499 at risk

Adverse event: Neoplasms
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 9 affected / 499 at risk

Adverse event: Surgical and medical
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 499 at risk

Adverse event: General
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 499 at risk

Adverse event: Reproductive system
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 499 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 499 at risk

Adverse event: Blood
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 499 at risk

Adverse event: Psychiatric
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 499 at risk

Adverse event: Eye
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 499 at risk

Adverse event: Vascular
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 499 at risk

Adverse event: Metabolism
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 499 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 499 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 443 affected / 499 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 312 affected / 499 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 278 affected / 499 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 291 affected / 499 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 264 affected / 499 at risk

Adverse event: Blood
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 205 affected / 499 at risk

Adverse event: Nervousness
Serious: no
Organ System: Nervous system disorders
Frequency: 224 affected / 499 at risk

Adverse event: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 138 affected / 499 at risk

Adverse event: Eye
Serious: no
Organ System: Eye disorders
Frequency: 126 affected / 499 at risk

Adverse event: Reproductive system
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 93 affected / 499 at risk

Adverse event: Injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 79 affected / 499 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 59 affected / 499 at risk

Adverse event: Vascular
Serious: no
Organ System: Vascular disorders
Frequency: 31 affected / 499 at risk

Adverse event: Pregnancy, puerperium and perinatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 29 affected / 499 at risk

Adverse event: Metabolism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 499 at risk

Adverse event: Ear and labyrinth
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 18 affected / 499 at risk

Adverse event: Neoplasms
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 16 affected / 499 at risk

Adverse event: Cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 499 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 19 affected / 499 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 499 at risk

Adverse event: Surgical and medical
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 499 at risk

Adverse event: Hepatobiliary
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 499 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 499 at risk

Adverse event: Congenital, familial and genetic
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 499 at risk