Study: NCT00976352

Adverse event: Right-sided spontaneous pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3 at risk

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

Adverse event: respiratory symthomps
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough, Increased secretions, cold symptoms, desaturation, oxygen requirement,Increased work of breathing, wheezing and Diminished breath sounds
Frequency: 3 affected / 3 at risk

Adverse event: fever, bacteremia, Dehydration
Serious: no
Organ System: General disorders
Notes: fever, bacteremia, Dehydration
Frequency: 3 affected / 3 at risk

Adverse event: Pulmonary and chest problems
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: lung contusion, chest problems,
Frequency: 1 affected / 3 at risk

Adverse event: Reflux and Diarrhea, G-tube problems
Serious: no
Organ System: Gastrointestinal disorders
Notes: change to bowel and bladder regimen, Reflux and Diarrhea, stomach virus, G-tube problems, Abdominal abscess
Frequency: 3 affected / 3 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: pain, cramps
Frequency: 2 affected / 3 at risk

Adverse event: Skin issue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling, rash,
Frequency: 2 affected / 3 at risk

Adverse event: ear infection and fluids
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3 at risk

Adverse event: Contracturs and scoliosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypokalemia and Hypoglycemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: urinary issues
Serious: no
Organ System: Renal and urinary disorders
Notes: Increased difficulty urinating, positional; infections
Frequency: 1 affected / 3 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Bilateral pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: Right upper lobe collapse with respiratory distress and Clostridium difficile gastritis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The subject was hospitalized 10 months post-dosing during the first occurrence of this SAE. The same subject was hospitalized 11 months post-dosing for an acute episode of desaturation, right upper lobe collapse, recurrent gastritis.
Frequency: 1 affected / 9 at risk

Adverse event: Bacteremia accompanied by fever
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Occurred 3 months post dosing. This unexpected event was determined to be unrelated to the test article and study procedures.
Frequency: 1 affected / 9 at risk

Adverse event: Desaturation Episode
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hospitalization: dehydration, increased work of breathing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hospitalization: dehydration, increased work of breathing
Frequency: 1 affected / 9 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 9 at risk

Adverse event: hospitalization, worsening CHF, pulmonary edema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: hospitalization, worsening CHF, pulmonary edema
Frequency: 1 affected / 9 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: Pneumothorax/Capnothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 9 at risk

Adverse event: respiratory symthomps
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough, Increased secretions, cold symptoms, desaturation, oxygen requirement,Increased work of breathing, wheezing and Diminished breath sounds
Frequency: 7 affected / 9 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: fever, bacteremia, Dehydration
Serious: no
Organ System: General disorders
Notes: fever, bacteremia, Dehydration
Frequency: 5 affected / 9 at risk

Adverse event: Pulmonary and chest problems
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: lung contusion, chest problems,
Frequency: 2 affected / 9 at risk

Adverse event: Reflux and Diarrhea, G-tube problems
Serious: no
Organ System: Gastrointestinal disorders
Notes: change to bowel and bladder regimen, Reflux and Diarrhea, stomach virus, G-tube problems, Abdominal abscess
Frequency: 4 affected / 9 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: pain, cramps
Frequency: 4 affected / 9 at risk

Adverse event: Skin issue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling, rash,
Frequency: 3 affected / 9 at risk

Adverse event: Trachestomy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: ear infection and fluids
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 9 at risk

Adverse event: Eye infection
Serious: no
Organ System: Eye disorders
Notes: chalazion
Frequency: 1 affected / 9 at risk

Adverse event: Contracturs and scoliosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

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

Adverse event: urinary issues
Serious: no
Organ System: Renal and urinary disorders
Notes: Increased difficulty urinating, positional; infections
Frequency: 2 affected / 9 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk