Study: NCT00667459

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 280 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 280 at risk

Adverse event: Dysphagia/Dysphonia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 280 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 280 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 280 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 35 affected / 280 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 280 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 280 at risk

Adverse event: Urogenital
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 15 affected / 280 at risk

Adverse event: Vascular
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 280 at risk

Adverse event: Wound (Non-Infectious)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 280 at risk

Adverse event: Dysphagia/Dysphonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 280 at risk

Adverse event: Extraskeletal ossification
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 280 at risk

Adverse event: Implant Events
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 280 at risk

Adverse event: Neck and/or Arm Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 37 affected / 280 at risk

Adverse event: Spinal Events
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 280 at risk

Adverse event: Spinal Events
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 280 at risk

Adverse event: Spinal Events
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 280 at risk

Adverse event: Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 280 at risk

Adverse event: Other
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 280 at risk

Adverse event: Other
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 280 at risk

Adverse event: Other
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 280 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 280 at risk

Adverse event: Other
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 280 at risk

Adverse event: Other
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 280 at risk

Adverse event: Other
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 280 at risk

Adverse event: Other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 280 at risk

Adverse event: Other
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 280 at risk

Adverse event: Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 280 at risk

Adverse event: Other
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 280 at risk

Adverse event: Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 280 at risk

Adverse event: Other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 280 at risk

Adverse event: Other Pain
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 280 at risk

Adverse event: Other Pain
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 280 at risk

Adverse event: Other Pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 280 at risk

Adverse event: Other Pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 280 at risk

Adverse event: Other Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 280 at risk

Adverse event: Other Pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 280 at risk

Adverse event: Other Pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 280 at risk

Adverse event: Anatomical/technical difficulty
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 280 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 280 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 280 at risk

Adverse event: Dysphagia/Dysphonia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 280 at risk

Adverse event: Dysphagia/Dysphonia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 280 at risk

Adverse event: Dysphagia/Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 280 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 280 at risk

Adverse event: Extraskeletal ossification
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 280 at risk

Adverse event: Implant Events
Serious: no
Organ System: General disorders
Frequency: 12 affected / 280 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 280 at risk

Adverse event: Neck and/or Arm Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 125 affected / 280 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 116 affected / 280 at risk

Adverse event: Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 280 at risk

Adverse event: Other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 280 at risk

Adverse event: Other
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 280 at risk

Adverse event: Other
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 280 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 11 affected / 280 at risk

Adverse event: Other
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 280 at risk

Adverse event: Other
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 280 at risk

Adverse event: Other
Serious: no
Organ System: Investigations
Frequency: 15 affected / 280 at risk

Adverse event: Other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 280 at risk

Adverse event: Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 280 at risk

Adverse event: Other
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 280 at risk

Adverse event: Other
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 280 at risk

Adverse event: Other
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 280 at risk

Adverse event: Other
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 280 at risk

Adverse event: Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 280 at risk

Adverse event: Other
Serious: no
Organ System: Social circumstances
Frequency: 2 affected / 280 at risk

Adverse event: Other
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 280 at risk

Adverse event: Other
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 280 at risk

Adverse event: Other Pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 280 at risk

Adverse event: Other Pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 280 at risk

Adverse event: Other Pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 280 at risk

Adverse event: Other Pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 280 at risk

Adverse event: Other Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 280 at risk

Adverse event: Other Pain
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 280 at risk

Adverse event: Other Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 88 affected / 280 at risk

Adverse event: Other Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 43 affected / 280 at risk

Adverse event: Other Pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 280 at risk

Adverse event: Other Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 280 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 280 at risk

Adverse event: Spinal Events
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 50 affected / 280 at risk

Adverse event: Spinal Events
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 280 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 44 affected / 280 at risk

Adverse event: Urogenital
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 280 at risk

Adverse event: Vascular
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 280 at risk

Adverse event: Wound(Non-Infectious)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 280 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 265 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 265 at risk

Adverse event: Dysphagia/Dysphonia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 265 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 265 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 265 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 27 affected / 265 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 265 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 265 at risk

Adverse event: Urogenital
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 265 at risk

Adverse event: Wound (Non-Infectious)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 265 at risk

Adverse event: Extraskeletal ossification
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 265 at risk

Adverse event: Neck and/or Arm Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 265 at risk

Adverse event: Non-Union
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 265 at risk

Adverse event: Spinal Events
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 265 at risk

Adverse event: Spinal Events
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 31 affected / 265 at risk

Adverse event: Spinal Events
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 265 at risk

Adverse event: Other
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 265 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 265 at risk

Adverse event: Other
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 265 at risk

Adverse event: Other
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 265 at risk

Adverse event: Other
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 265 at risk

Adverse event: Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 265 at risk

Adverse event: Other
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 265 at risk

Adverse event: Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 265 at risk

Adverse event: Other
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 265 at risk

Adverse event: Other
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 265 at risk

Adverse event: Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 265 at risk

Adverse event: Other Pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 265 at risk

Adverse event: Other Pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 265 at risk

Adverse event: Other Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 265 at risk

Adverse event: Other Pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 265 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 265 at risk

Adverse event: Dysphagia/Dysphonia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 265 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 265 at risk

Adverse event: Extraskeletal ossification
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 265 at risk

Adverse event: Implant Events
Serious: no
Organ System: General disorders
Frequency: 5 affected / 265 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 265 at risk

Adverse event: Neck and/or Arm Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 113 affected / 265 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 92 affected / 265 at risk

Adverse event: Non-Union
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 265 at risk

Adverse event: Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 265 at risk

Adverse event: Other
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 265 at risk

Adverse event: Other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 265 at risk

Adverse event: Other
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 265 at risk

Adverse event: Other
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 265 at risk

Adverse event: Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 265 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 11 affected / 265 at risk

Adverse event: Other
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 265 at risk

Adverse event: Other
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 265 at risk

Adverse event: Other
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 265 at risk

Adverse event: Other
Serious: no
Organ System: Investigations
Frequency: 6 affected / 265 at risk

Adverse event: Other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 265 at risk

Adverse event: Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 265 at risk

Adverse event: Other
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 265 at risk

Adverse event: Other
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 265 at risk

Adverse event: Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 265 at risk

Adverse event: Other
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 265 at risk

Adverse event: Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 265 at risk

Adverse event: Other
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 265 at risk

Adverse event: Other Pain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 265 at risk

Adverse event: Other Pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 265 at risk

Adverse event: Other Pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 265 at risk

Adverse event: Other Pain
Serious: no
Organ System: General disorders
Frequency: 13 affected / 265 at risk

Adverse event: Other Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 265 at risk

Adverse event: Other Pain
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 265 at risk

Adverse event: Other Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 80 affected / 265 at risk

Adverse event: Other Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 265 at risk

Adverse event: Other Pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 265 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 265 at risk

Adverse event: Spinal Events
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 265 at risk

Adverse event: Spinal Events
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 265 at risk

Adverse event: Spinal Events
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 265 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 30 affected / 265 at risk

Adverse event: Urogenital
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 265 at risk

Adverse event: Vascular
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 265 at risk

Adverse event: Wound(Non-Infectious)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 265 at risk