Study: NCT01101438

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1816 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 191 affected / 1816 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 179 affected / 1816 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 288 affected / 1816 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 819 affected / 1816 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 174 affected / 1816 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 155 affected / 1816 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 121 affected / 1816 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 560 affected / 1816 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 139 affected / 1816 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 143 affected / 1816 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 811 affected / 1816 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 250 affected / 1816 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 127 affected / 1816 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 90 affected / 1816 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 171 affected / 1816 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 182 affected / 1816 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 80 affected / 1816 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 389 affected / 1816 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 86 affected / 1816 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 211 affected / 1816 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 90 affected / 1816 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 226 affected / 1816 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 328 affected / 1816 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 150 affected / 1816 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 95 affected / 1816 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 304 affected / 1816 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 484 affected / 1816 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 251 affected / 1816 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 243 affected / 1816 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 417 affected / 1816 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 111 affected / 1816 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 99 affected / 1816 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 159 affected / 1816 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 165 affected / 1816 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 194 affected / 1816 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 716 affected / 1816 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 207 affected / 1816 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 171 affected / 1816 at risk

Adverse event: Retinal vascular disorder
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1816 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1816 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 146 affected / 1816 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 151 affected / 1816 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 226 affected / 1816 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 354 affected / 1816 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 141 affected / 1816 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 145 affected / 1816 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 114 affected / 1816 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 297 affected / 1816 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 100 affected / 1816 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 130 affected / 1816 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 797 affected / 1816 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 276 affected / 1816 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 138 affected / 1816 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 156 affected / 1816 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 81 affected / 1816 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 84 affected / 1816 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 93 affected / 1816 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 427 affected / 1816 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 99 affected / 1816 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 189 affected / 1816 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 102 affected / 1816 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 248 affected / 1816 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 332 affected / 1816 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 145 affected / 1816 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 61 affected / 1816 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 325 affected / 1816 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 517 affected / 1816 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 241 affected / 1816 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 242 affected / 1816 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 380 affected / 1816 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 145 affected / 1816 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 99 affected / 1816 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 171 affected / 1816 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 170 affected / 1816 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 159 affected / 1816 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 706 affected / 1816 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 227 affected / 1816 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 178 affected / 1816 at risk