Study: NCT00116558

Adverse event: ALS Progression
Serious: yes
Organ System: Nervous system disorders
Notes: Dates: 5/5/2007 5/25/2007 Status: Resolved Reason for Qualifying: Are other conditions which represent significant hazards Intensity: Moderate Relationship to study: Unrelated Description: Treatment and Evaluation of ALS Progression
Frequency: 1 affected / 153 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 5/11/2008 5/12/2008 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Mild Relationship to study: Unrelated Description: Aspiration
Frequency: 1 affected / 153 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 6/10/2007 6/19/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to Study: Unrelated Description: Presumed Aspiration Pneumonia
Frequency: 1 affected / 153 at risk

Adverse event: Bladder malignancy/UTI
Serious: yes
Organ System: Renal and urinary disorders
Notes: Dates: 8/22/2007 9/5/2007 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Possible bladder malignancy and UTI
Frequency: 1 affected / 153 at risk

Adverse event: Blood Clot
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 8/21/2005 9/1/2005 Status:Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to study: Unrelated Description: Blood Clot Behind right knee
Frequency: 1 affected / 153 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Dates: 4/4/2006 4/4/2006 Status: Resolved Reason for Qualifying: Resulting in death Intensity: Severe Relationship to Study: Unrelated Description: Cardiac Arrest
Frequency: 1 affected / 153 at risk

Adverse event: Colonic Bleed
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Dates: 1/15/2007 1/29/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship: Unrelated Description: Left Colonic Bleed
Frequency: 1 affected / 153 at risk

Adverse event: Concussion
Serious: yes
Organ System: Nervous system disorders
Notes: Dates: 2/7/2007 2/7/2007 Status: Resolved Reason for Qualifying: Life-threatening Intensity: Moderate Relationship to Study: Unrelated Description: Concussion as result of Automobile Accident
Frequency: 1 affected / 153 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Dates: 6/2/2006 6/2/2006 Status: Resolved Reason for Qualifying: Resulting in death Intensity: Severe Relationship to Study: Unrelated Description: No Information Given
Frequency: 14 affected / 153 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 5/21/2007 5/27/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to Study: Unrelated Description: Difficulty breathing due to Sialorrhea
Frequency: 1 affected / 153 at risk

Adverse event: Dislodged PEG Tube
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Dates: 6/30/2007 Status: Continuing at discontinuation Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Dislodged PEG Tube and Respiratory Distress
Frequency: 1 affected / 153 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Dates: 8/24/2005 8/29/2005 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to Study: Unrelated Description: Distended Abdomen
Frequency: 1 affected / 153 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Dates: 3/11/2008 3/11/2008 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Dysphagia
Frequency: 3 affected / 153 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 4/9/2007 Status: Continuing at discontinuation Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Increased Dyspnea
Frequency: 1 affected / 153 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Dates: 7/23/2007 8/10/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to Study: Unrelated Description: Diagnosed as failure to thrive
Frequency: 1 affected / 153 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dates: 4/25/2006 5/4/2006 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to study: Unrelated Description: Left Hip Fracture Resulting From Fall
Frequency: 1 affected / 153 at risk

Adverse event: Hypokalemia, hypomagnesia, and antythmia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Dates: 12/15/2007 12/17/2007 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Hypokalemia, hypomagnesia, and antythmia
Frequency: 1 affected / 153 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Dates: 10/3/2007 10/11/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Severe infection
Frequency: 2 affected / 153 at risk

Adverse event: Irregular Heartbeat
Serious: yes
Organ System: Cardiac disorders
Notes: Dates: 1/18/2008 2/17/2008 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Irregular Heartbeat
Frequency: 2 affected / 153 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Dates: 9/9/2007 11/4/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Debridement and Closure of Laceration
Frequency: 1 affected / 153 at risk

Adverse event: Liver Cancer Diagnosis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Dates: 11/4/2005 Status: Continuing at discontinuation Reason for Qualifying: Are other conditions which represent significant hazards Intensity: Severe Relationship to Study: Unrelated Description: Liver Cancer Diagnosis
Frequency: 1 affected / 153 at risk

Adverse event: Loculated right pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 7/27/2007 8/2/2007 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Loculated right pleural effusion and possible Pneumonia
Frequency: 1 affected / 153 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Dates: 8/30/2007 8/31/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Apparent Myocardial Infarction
Frequency: 1 affected / 153 at risk

Adverse event: PEG Procedure Complications
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Dates: 5/11/2006 5/12/2006 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to study: Unrelated Description: Complications from PEG Procedure
Frequency: 2 affected / 153 at risk

Adverse event: Peg Replacement
Serious: yes
Organ System: Surgical and medical procedures
Notes: Dates: 3/14/2008 3/18/2008 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Mild Relationship to study: Unrelated Description: PEG replacement
Frequency: 2 affected / 153 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 3/6/2008 3/19/2008 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Pneumonia
Frequency: 4 affected / 153 at risk

Adverse event: Pulmonary Emboli and pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 9/3/2006 10/5/2006 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Pulmonary emboli and pneumonia
Frequency: 1 affected / 153 at risk

Adverse event: Respiratory Complications
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 10/7/2006 10/7/2006 Status: Resolved Reason for Qualifying: Resulting in death Intensity: Severe Relationship to study: Unrelated Description: Respiratory Complications
Frequency: 2 affected / 153 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 9/28/2007 9/28/2007 Status: Resolved Reason for qualifying: Requiring or prolonging Hospitalization Intensity: Severe Relationship to study: Unrelated Description: continued respiratory decline
Frequency: 2 affected / 153 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Dates: 10/3/2007 10/11/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Severe Sepsis around PEG Tube
Frequency: 1 affected / 153 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 10/2/2006 Status: Continuing at discontinuation Reason for Qualifying: Are other conditions which represent significant hazards Intensity: Severe Relationship: Unrelated Description: Shortness of breath
Frequency: 2 affected / 153 at risk

Adverse event: Subarachroid Hemmorrhage and Contusion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Dates: 3/14/2007 3/16/2007 Status: Resolved Reason for Qualifying: Resulting in death Severe Relationship to Study: Unrelated Description: Sub-arachnoid Haemmorrhage and Contusion Resulting from fall
Frequency: 1 affected / 153 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Dates: 6/11/2007 6/11/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Subdural Hematoma from fall
Frequency: 1 affected / 153 at risk

Adverse event: Transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Dates: 9/6/2007 9/23/2007 Status: Resolved Reason for Qualifying: Resulting in death Intensity: Severe Relationship to study: Unrelated Description Small bowel obstruction, transitional cell carcinoma
Frequency: 1 affected / 153 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dates: 3/20/2007 Status: Unresolved at 48 Weeks Description: Abdominal distension Intensity: moderate Relationship to study: possible
Frequency: 3 affected / 153 at risk

Adverse event: Abnormal Lab
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Dates: 5/2/2006 8/21/2006 Status: Resolved Description: Abnormal Lab Intensity: mild Relationship to study: not related
Frequency: 8 affected / 153 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Dates: 4/17/2007 4/22/2007 Status: Ended Description: Allergy Intensity: mild Relationship to study: not related
Frequency: 2 affected / 153 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dates: 9/6/2006 Status: Ended Description: Ankle Sprain Intensity: moderate Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dates: 3/27/2007 Status: Unresolved at 48 Weeks Description: Arthritis Intensity: mild Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dates:: 6/3/2006 Status: Unresolved at 48 weeks Description: Back Pain Intensity: moderate Relationship to study: not related
Frequency: 4 affected / 153 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dates: 4/1/2008 Status: Unresolved at 48 Weeks Description: Blister Intensity: mild Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Blood Clot
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 1/28/2008 Status: Unresolved at 48 Weeks Description: Blood Clot Intensity: moderate Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 1/20/2008 2/10/2008 Status: Ended Description: Bronchitis Intensity: moderate Relationship to study: possible
Frequency: 4 affected / 153 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dates: 5/11/2006 5/11/2006 Status:Ended Description: Bruise Intensity: mild Relationship to study: not related
Frequency: 2 affected / 153 at risk

Adverse event: Burning sensation
Serious: no
Organ System: General disorders
Notes: Dates: 7/23/2007 Status: Continuing Description: PAIN Burning Sensation Intensity: severe Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Notes: Dates: 8/9/2007 8/15/2007 Status: Ended Description: Cold Intensity: mild Relationship to study: not related
Frequency: 7 affected / 153 at risk

Adverse event: Colon Polyp
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Dates: 2/1/2006 2/1/2006 Status: Ended Description: Colon Polyp Intensity: mild Relationship: not related
Frequency: 1 affected / 153 at risk

Adverse event: Concussion
Serious: no
Organ System: Nervous system disorders
Notes: Dates: 2/6/2006 2/6/2006 Status: Ended Description: Concussion Intensity: severe Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Congestion
Serious: no
Organ System: Immune system disorders
Notes: Dates: 7/21/2006 7/31/2006 Status: Resolved Description: Congestion Intensity: moderate Relationship to study: not related
Frequency: 2 affected / 153 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Dates: 7/3/2007 7/8/2007 Status: Ended Description: Conjunctivitis Intensity: mild Relationship to study: not related
Frequency: 2 affected / 153 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dates: 2/1/2006 6/1/2006 Status: Resolved Description: Constipation Intensity: moderate Relationship to study: not likely
Frequency: 8 affected / 153 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dates: 7/4/2007 7/4/2007 Status: Ended Description: Contusion Intensity: mild Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 9/7/2006 Status: Ended Description: Cough Intensity: moderate Relationship: not related
Frequency: 1 affected / 153 at risk

Adverse event: Decreased Rectal Tone
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dates: 6/4/2007 Status: Continuing Description: Decreased Rectal Tone Intensity: moderate Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dates: 3/5/2008 Description: Dehydration Intensity: mild Relationship to study: not likely
Frequency: 1 affected / 153 at risk

Adverse event: Dental
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dates: 4/17/2006 Status: Ended Description: Dental Intensity: moderate Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dates: 3/1/2008 Status: Unresolved at 48 Weeks Description: Dermatitis Intensity: mild Relationship to study: possible
Frequency: 1 affected / 153 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dates: 2/10/2007 2/10/2007 Status: Ended Description: Diarrhea Intensity: mild Relationship to study: not related
Frequency: 4 affected / 153 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dates: 10/15/2006 11/14/2006 Status: Resolved Description: Diverticulitis Intensity: severe Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Dates: 1/15/2006 Status: Ended Description: Dizziness Intensity: moderate Relationship to study: not related
Frequency: 3 affected / 153 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: Dates: 10/15/2007 Description:Dry Eye Intensity: mild Relationship to study: probable
Frequency: 1 affected / 153 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dates: 6/15/2006 Status: Unresolved at 48 Weeks Description: Dysphagia Intensity: mild Relationship to study: not likely
Frequency: 1 affected / 153 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Notes: Dates: 10/1/2006 10/26/2006 Status: Resolved Description: Ear Infection Intensity: mild Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Dates: 10/24/2006 Status: Unresolved at 48 Weeks Description: Edema Intensity: mild Relationship to study: not likely
Frequency: 7 affected / 153 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Notes: Dates: 4/13/2007 4/13/2007 Status: Ended Description: Fall Intensity: mild Relationship to study: not related
Frequency: 8 affected / 153 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Dates: 11/1/2005 Status: Unresolved at Discontinuation Description: Fatigue Intensity: severe Relationship to study: not related
Frequency: 5 affected / 153 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dates: 1/18/2007 3/29/2007 Status: Resolved Description: Fracture Intensity: mild Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dates: 9/25/2006 10/2/2006 Status: Ended Description: Gastritis Intensity: severe Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Hallucination
Serious: no
Organ System: Nervous system disorders
Notes: Dates: 9/13/2006 9/16/2006 Status: Ended Description: Hallucination Intensity: moderate Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Dates: 1/18/2006 3/1/2006 Status: Ended Description: Headache Intensity: mild Relationship to study: not related
Frequency: 2 affected / 153 at risk

Adverse event: Hypercapnia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Dates: 11/6/2006 Status: Continuing Description: Hypercarbia Intensity: mild Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Dates: 1/11/2008 Status: Unresolved at 48 Weeks Description: Hypertension Intensity: mild Relationship to study: not likely
Frequency: 1 affected / 153 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Dates: 11/4/2006 11/4/2006 Status: Ended Description: Hypotension Intensity: mild Relationship to Study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Dates: 10/26/2007 11/4/2007 Status: Ended Description: Infection Intensity: mild Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dates: 6/30/2007 7/13/2007 Status: Ended Description: Knee Sprain Intensity: moderate Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dates: 2/5/2007 2/5/2007 Status: Ended Description: Laceration Intensity: mild Relationship to study: not related
Frequency: 2 affected / 153 at risk

Adverse event: Lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dates: 3/30/2007 5/7/2007 Status: Ended Description: Lesion Intensity: mild Relationship to study: definite
Frequency: 1 affected / 153 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 11/1/2007 Status: Continuing Description: Nosebleed Intensity: mild Relationship to study: probable
Frequency: 1 affected / 153 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dates: 9/4/2006 Status: Unresolved at 48 Weeks Description: Osteopenia Intensity: mild Relationship to study: not likely
Frequency: 1 affected / 153 at risk

Adverse event: PEG
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dates: 6/29/2006 7/1/2006 Status: Ended Description: PEG Intensity: moderate Relationship to study: not related
Frequency: 3 affected / 153 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Dates: 11/20/2006 12/18/2006 Status: Resolved Description: Pain Intensity: moderate Relationship to study: not related
Frequency: 4 affected / 153 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 11/1/2007 Status: Unresolved at 48 Weeks Description: Pneumonia Intensity: moderate Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Post Nasal Drip
Serious: no
Organ System: Immune system disorders
Notes: Dates: 3/31/2006 Status: Unresolved at 48 Weeks Description: Post Nasal Drip Intensity: severe Relationship to study: not related
Frequency: 2 affected / 153 at risk

Adverse event: Pressure Sores
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dates: 11/28/2006 11/30/2006 Status: Resolved Description: Pressure Sores Intensity: mild Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: RADS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 1/17/2007 4/30/2007 Status: Ended Description: RADS Intensity: mild Relationship: not related
Frequency: 1 affected / 153 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dates: 8/15/2005 Status: Unresolved at 48 Weeks Description: Rash Intensity: mild Relationship to study: not likely
Frequency: 4 affected / 153 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 2/25/2007 2/25/2007 Status: Ended Description: Shortness of Breath Intensity: moderate Relationship to study: not related
Frequency: 2 affected / 153 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dates: 1/23/2006 1/25/2006 Status: Ended Description: Shoulder Pain Intensity: severe Relationship to study: not related
Frequency: 3 affected / 153 at risk

Adverse event: Salivary hypersecretion
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dates: 2/10/2006 Status: Unresolved at 48 Weeks Description: Sialorrhea Intensity: mild Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Dates: 4/1/2007 4/7/2007 Status: Ended Description: Sinus Infection Severity: moderate Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Notes: Dates: 10/12/2006 Status: Unresolved at 48 Weeks Description: Sore Throat Intensity: mild Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Spasm (Respiratory)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 1/19/2007 1/19/2007 Status: Resolved Description: Spasm Intensity: mild Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dates: 4/29/2006 5/1/2006 Status: Ended Description: Stomach Upset Intensity: mild Relationship to study: not related
Frequency: 3 affected / 153 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Dates: 3/14/2006 3/24/2006 Status: Ended Description: UTI Intensity: moderate Relationship to study: not related
Frequency: 4 affected / 153 at risk

Adverse event: Urgent Bowel Movements
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dates: 2/1/2006 Status: Unresolved at Discontinuation Description: Urgent Bowel Movements Intensity: mild Relationship to study: possible
Frequency: 1 affected / 153 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Dates: 6/11/2007 6/24/2007 Status: Ended Description: Urinary Frequency Intensity: moderate Relationship to study: not likely
Frequency: 1 affected / 153 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dates: 10/18/2005 10/18/2005 Status: Ended Description: Vomiting Intensity: mild Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Asthenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dates: 2/1/2006 Status: Unresolved at Discontinuation Description: Weakness Intensity: mild Relationship to study: not related
Frequency: 3 affected / 153 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Notes: Dates: 8/8/2005 3/13/2006 Status: Ended Description: Weight Loss Intensity: moderate Relationship to study: not related
Frequency: 1 affected / 153 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dates: 11/6/2006 Status: Resolved Description: Wheezing Intensity: moderate Relationship to study: not related
Frequency: 1 affected / 153 at risk