TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00619060

Adverse event: Burning
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dryness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Burning
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dryness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 22 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 22 at risk

Adverse event: Flaking
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 22 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Migraine
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk
Study: NCT00619112

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 28 affected / 60 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 60 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 60 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 60 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 60 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 60 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 60 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 60 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 60 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 60 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 60 at risk
Study: NCT00619190

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 21 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 21 at risk

Adverse event: Appetite Increased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Appetite Decreased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 21 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 21 at risk

Adverse event: Encopresis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 21 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 21 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: General disorders
Frequency: 5 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 21 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 9 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 9 at risk

Adverse event: Nightmare
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Allergies
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Mouth Sores
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk
Study: NCT00619229

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 18 at risk

Adverse event: Choroidal neovascularisation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 18 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 18 at risk

Adverse event: Vitreous opacities
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Blood pressure decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk
Study: NCT00619255

Adverse event: Suicide ideation
Serious: no
Organ System: Psychiatric disorders
Notes: PHQ-9 Score of \>0
Frequency: 14 affected / 59 at risk

Adverse event: Suicide ideation
Serious: no
Organ System: Psychiatric disorders
Notes: PHQ-9 Score of \>0
Frequency: 13 affected / 61 at risk
Study: NCT00619307

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 59 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 59 at risk

Adverse event: Influenza-like illness
Serious: no
Organ System: General disorders
Frequency: 39 affected / 59 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 59 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 59 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 59 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 59 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 59 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 57 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 57 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 57 at risk

Adverse event: Influenza-like illness
Serious: no
Organ System: General disorders
Frequency: 38 affected / 57 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 57 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 57 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 57 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 57 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 57 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 57 at risk
Study: NCT00619502

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 130 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 130 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 130 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 35 affected / 130 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 56 affected / 130 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 26 affected / 130 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 51 affected / 130 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 29 affected / 130 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 40 affected / 130 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 130 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 29 affected / 130 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 124 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 50 affected / 124 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 67 affected / 124 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 36 affected / 124 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 61 affected / 124 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 36 affected / 124 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 43 affected / 124 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 124 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 35 affected / 124 at risk
Study: NCT00619684

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 18 at risk

Adverse event: Influenza - H1N1
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Fever, hypoxia, neuralgia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 18 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 18 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 18 at risk

Adverse event: Asthenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Skin tightness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Jaw popping
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk
Study: NCT00619762

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: On POD 7, Mediport was placed. During placement, a pneumothorax occurred. A chest tube was placed to reinflate lung and was removed 5 days later. Event was not considered related to device \& resolved without sequelae on POD 12.
Frequency: 1 affected / 17 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: On POD 21, erythema of lower breast flap was noted \& antibiotics initiated. After 2 wk course of antibiotics, erythema had resolved \& antibiotics discontinued. Event was considered possibly related to device \& resolved without sequelae on POD 36.
Frequency: 1 affected / 17 at risk

Adverse event: post operative bleeding
Serious: yes
Organ System: Vascular disorders
Notes: After breast reconstruction, severe bleeding was noted while in recovery rm. Subject returned to OR for control of bleeding by ligation of small artery. Event was not considered to be related to device \& resolved without sequelae on day of surgery.
Frequency: 1 affected / 17 at risk

Adverse event: Breast deformity
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: On POD 229, subject noted to have significant deformity of breast/lack of subcutaneous tissue.Subject received fat grafting.Event was not considered related to device \& subject recovered without sequelae.
Frequency: 1 affected / 17 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Infection of breast flap on POD 53 that was possibly related to device and resolved without sequelae Infection of breast flap on POD 37 that ws possibly Resolved to device and resolved without sequelae
Frequency: 2 affected / 29 at risk
Study: NCT00619827

Adverse event: Ear pruritus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 45 at risk

Adverse event: Oral pruritus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 45 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 45 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 44 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 44 at risk
Study: NCT00619892

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 13 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 13 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 13 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 13 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 13 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 13 at risk

Adverse event: Derealisation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 13 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 13 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 13 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 13 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 13 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 13 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Muscle Aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 13 at risk

Adverse event: Weight increased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk
Study: NCT00619918

Adverse event: ICU admission
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patients requiring admission or transfer to the PICU or NICU
Frequency: 4 affected / 231 at risk

Adverse event: Worsening cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Parent or provider perception of worsening cough
Frequency: 1 affected / 231 at risk

Adverse event: ICU admission
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patients requiring admission or transfer to the PICU or NICU
Frequency: 6 affected / 216 at risk

Adverse event: Worsening cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Parent or provider perception of worsening cough
Frequency: 2 affected / 216 at risk
Study: NCT00619983

Adverse event: Osteomyelitis
Serious: no
Organ System: Infections and infestations
Notes: subject experienced osteomyelitis of of second phalange
Frequency: 1 affected / 5 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: Subject experienced chest pain and was hospitalized. Serial ECGs and troponins were negative for myocardial injury
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: subject experienced nausea
Frequency: 1 affected / 6 at risk
Study: NCT00620022

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 83 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 83 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 83 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 83 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 84 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 84 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 84 at risk
Study: NCT00620191

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk