Study: NCT00089752

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: TOOTH DISORDER VOMITING No relation to study
Frequency: 1 affected / 121 at risk

Adverse event: Cardiac
Serious: yes
Organ System: Cardiac disorders
Notes: Arrhythmia, palpitations General cardiac Chest pain No relation to study
Frequency: 1 affected / 121 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: SOFT TISSUE FRACTURE No relation to study
Frequency: 2 affected / 121 at risk

Adverse event: Pain
Serious: yes
Organ System: Nervous system disorders
Notes: HEADACHE - No relation to study
Frequency: 1 affected / 121 at risk

Adverse event: Constitutional Symptoms
Serious: yes
Organ System: General disorders
Notes: Pyrexia - No relation to study
Frequency: 1 affected / 121 at risk

Adverse event: Rhinitis Allergic nos/ Allergy Other-Possibly related to study
Serious: no
Organ System: Immune system disorders
Notes: MedDRA codes provided in the CTC AE (Publish date: December 12, 2003) correspond with MedDRA 6.0
Frequency: 27 affected / 121 at risk

Adverse event: Dermatology/Skin - Possibly related to study
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mask irritation of the skin Dermatitis exfoliative nos Dermatology/skin - other Ecchymosis
Frequency: 20 affected / 121 at risk

Adverse event: Constitutional Symptoms
Serious: no
Organ System: General disorders
Notes: Fatigue - Possibly related to study Insomnia
Frequency: 4 affected / 121 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal distention- Possibly related to study Constipation Diarrhea nos Dry mouth- Possibly related to study Dyspepsia Gastrointestinal - other Nausea - Possibly related to study Vomiting nos
Frequency: 15 affected / 121 at risk

Adverse event: Infection - Not related to study
Serious: no
Organ System: Infections and infestations
Notes: Sinus infection Upper aerodigestive Upper airway Not study related
Frequency: 14 affected / 121 at risk

Adverse event: Musculoskeletal/Soft Tissue- Not related to study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Upper extremity/function Soft tissue
Frequency: 7 affected / 121 at risk

Adverse event: Neurology - Not related to study
Serious: no
Organ System: Nervous system disorders
Notes: Anxiety Dizziness Neurology-other
Frequency: 7 affected / 121 at risk

Adverse event: Pain- possibly related to study
Serious: no
Organ System: General disorders
Notes: Arthralgia, back pain, chest wall pain, facial pain,headache, neck pain, oral pain, pain - other, pain in extremity, pharyngolary pain, sinus pain, stomach discomfort, toothache
Frequency: 47 affected / 121 at risk

Adverse event: Pulmonary/Upper Respiratory - Possibly related to study
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Bronchospasm Cough, Nasal cavity/paranasal sinus pulmonary/upper respiratory
Frequency: 11 affected / 121 at risk

Adverse event: Syndromes - Not related to study
Serious: no
Organ System: Infections and infestations
Notes: Influenza-like illness
Frequency: 1 affected / 121 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: TOOTH DISORDER VOMITING No relation to study
Frequency: 3 affected / 118 at risk

Adverse event: Cardiac
Serious: yes
Organ System: Cardiac disorders
Notes: Arrhythmia, palpitations General cardiac Chest pain No relation to study
Frequency: 2 affected / 118 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Notes: Prostatic obstruction - No relation to study
Frequency: 1 affected / 118 at risk

Adverse event: Dermatology/Skin
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: No relation to study
Frequency: 1 affected / 118 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: UPPER RESPIRATORY-Possibly related to study
Frequency: 1 affected / 118 at risk

Adverse event: Hemorrhage/Bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Upper GI Epistaxis - possibly related to study
Frequency: 1 affected / 118 at risk

Adverse event: Blood/Bone Marrow
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Low hemoglobin - No relation to study
Frequency: 1 affected / 118 at risk

Adverse event: Infection
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Clostridial infection - No relation to study
Frequency: 2 affected / 118 at risk

Adverse event: Rhinitis Allergic nos/ Allergy Other-Possibly related to study
Serious: no
Organ System: Immune system disorders
Notes: MedDRA codes provided in the CTC AE (Publish date: December 12, 2003) correspond with MedDRA 6.0
Frequency: 35 affected / 118 at risk

Adverse event: Dermatology/Skin - Possibly related to study
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mask irritation of the skin Dermatitis exfoliative nos Dermatology/skin - other Ecchymosis
Frequency: 22 affected / 118 at risk

Adverse event: Constitutional Symptoms
Serious: no
Organ System: General disorders
Notes: Fatigue - Possibly related to study Insomnia
Frequency: 9 affected / 118 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal distention- Possibly related to study Constipation Diarrhea nos Dry mouth- Possibly related to study Dyspepsia Gastrointestinal - other Nausea - Possibly related to study Vomiting nos
Frequency: 21 affected / 118 at risk

Adverse event: Infection - Not related to study
Serious: no
Organ System: Infections and infestations
Notes: Sinus infection Upper aerodigestive Upper airway Not study related
Frequency: 25 affected / 118 at risk

Adverse event: Musculoskeletal/Soft Tissue- Not related to study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Upper extremity/function Soft tissue
Frequency: 10 affected / 118 at risk

Adverse event: Neurology - Not related to study
Serious: no
Organ System: Nervous system disorders
Notes: Anxiety Dizziness Neurology-other
Frequency: 10 affected / 118 at risk

Adverse event: Pain- possibly related to study
Serious: no
Organ System: General disorders
Notes: Arthralgia, back pain, chest wall pain, facial pain,headache, neck pain, oral pain, pain - other, pain in extremity, pharyngolary pain, sinus pain, stomach discomfort, toothache
Frequency: 51 affected / 118 at risk

Adverse event: Pulmonary/Upper Respiratory - Possibly related to study
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Bronchospasm Cough, Nasal cavity/paranasal sinus pulmonary/upper respiratory
Frequency: 15 affected / 118 at risk

Adverse event: Syndromes - Not related to study
Serious: no
Organ System: Infections and infestations
Notes: Influenza-like illness
Frequency: 8 affected / 118 at risk