Study: NCT00112359

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 84 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 84 at risk

Adverse event: Rales
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 84 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 84 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 84 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 84 at risk

Adverse event: Exercise tolerance decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 84 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 84 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 84 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Use of accessory respiratory muscles
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 84 at risk

Adverse event: Oxygen saturation decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 84 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 84 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Productive cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 84 at risk

Adverse event: Pulmonary function test decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 84 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 84 at risk

Adverse event: Respiratory tract congestion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Sinus congestion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Sputum discoloured
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 84 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 84 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 84 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 84 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 84 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 84 at risk

Adverse event: Rales
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 84 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 84 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 84 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 84 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 84 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 84 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 84 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 84 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 84 at risk

Adverse event: Pulmonary function test decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 84 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 84 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 84 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 84 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 84 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 84 at risk

Adverse event: Blood glucose increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 80 at risk

Adverse event: Breath sounds abnormal
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: C-reactive protein increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 80 at risk

Adverse event: Rales
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 80 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Erythema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Productive cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Pulmonary function test decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 80 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Tachypnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 80 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 80 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 80 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 38 affected / 80 at risk

Adverse event: Rales
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 80 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 80 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 80 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 80 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 80 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 80 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 80 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 80 at risk

Adverse event: Pulmonary function test decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 80 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 80 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 80 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 80 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 80 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 80 at risk