Study: NCT00227370

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Cytomegalovirus colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 66 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Lung transplant rejection
Serious: yes
Organ System: Immune system disorders
Frequency: 5 affected / 66 at risk

Adverse event: Transplant rejection
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 66 at risk

Adverse event: GASTROINTESTINAL DISORDERS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 66 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 66 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: CARDIAC DISORDERS
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 66 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 66 at risk

Adverse event: Opportunistic Infections, all organ systems
Serious: yes
Organ System: Infections and infestations
Frequency: 31 affected / 66 at risk

Adverse event: Opportunistic Infections, all organ systems, mild
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 66 at risk

Adverse event: Opportunistic Infections, all organ systems, moderate
Serious: yes
Organ System: Infections and infestations
Frequency: 17 affected / 66 at risk

Adverse event: Opportunistic Infections, all organ systems, severe
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 66 at risk

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 66 at risk

Adverse event: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 38 affected / 66 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 66 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 66 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 66 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 66 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 66 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 66 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 66 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 66 at risk

Adverse event: Lung infiltration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 66 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 66 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 66 at risk

Adverse event: Fatigue
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 66 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 66 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 66 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 66 at risk

Adverse event: Malaise
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 66 at risk

Adverse event: Oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 66 at risk

Adverse event: Chills
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 66 at risk

Adverse event: Generalised oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 66 at risk

Adverse event: GASTROINTESTINAL DISORDERS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 66 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 66 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 66 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 66 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 66 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 66 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 66 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 66 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 66 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 66 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 66 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 66 at risk

Adverse event: Sepsis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 66 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 66 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 66 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 66 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 66 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 66 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 66 at risk

Adverse event: Pulmonary function test decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 66 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 66 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 66 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 66 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Lung transplant rejection
Serious: no
Organ System: Immune system disorders
Frequency: 18 affected / 66 at risk

Adverse event: Transplant rejection
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 66 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 66 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 66 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 66 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 66 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 66 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 66 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 66 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 66 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 66 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 66 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 66 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 66 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 66 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 66 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 66 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 66 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 66 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 70 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Bronchostenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Lung infiltration
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 70 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Lung transplant rejection
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 70 at risk

Adverse event: Transplant rejection
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 70 at risk

Adverse event: GASTROINTESTINAL DISORDERS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 70 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Immune system disorders
Frequency: 9 affected / 70 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 70 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 70 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: CARDIAC DISORDERS
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 70 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 70 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Opportunistic Infections, all organ systems
Serious: yes
Organ System: Infections and infestations
Frequency: 32 affected / 70 at risk

Adverse event: Opportunistic Infections, all organ systems, mild
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 70 at risk

Adverse event: Opportunistic Infections, all organ systems, moderate
Serious: yes
Organ System: Infections and infestations
Frequency: 17 affected / 70 at risk

Adverse event: Opportunistic Infections, all organ systems, severe
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 70 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 70 at risk

Adverse event: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 42 affected / 70 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 70 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 70 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 70 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 70 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 70 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 70 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 70 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 70 at risk

Adverse event: Lung infiltration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 70 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 70 at risk

Adverse event: Bronchostenosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 70 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 70 at risk

Adverse event: Fatigue
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 70 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 70 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 70 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 70 at risk

Adverse event: Malaise
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 70 at risk

Adverse event: Oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 70 at risk

Adverse event: Chills
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Asthenia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 70 at risk

Adverse event: GASTROINTESTINAL DISORDERS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 70 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 70 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 70 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 70 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 70 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 70 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 70 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 70 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 70 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 70 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 70 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 70 at risk

Adverse event: Sepsis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 70 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 70 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 70 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 70 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 70 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 70 at risk

Adverse event: Pulmonary function test decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 70 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 70 at risk

Adverse event: Breath sounds abnormal
Serious: no
Organ System: Investigations
Frequency: 4 affected / 70 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 70 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 70 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 70 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 70 at risk

Adverse event: Lung transplant rejection
Serious: no
Organ System: Immune system disorders
Frequency: 18 affected / 70 at risk

Adverse event: Transplant rejection
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 70 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 70 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 70 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 70 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 70 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 70 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 70 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 70 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 70 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 70 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 70 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 70 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 70 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 70 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 70 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 70 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 70 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 70 at risk