Study: NCT00471705

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 145 at risk

Adverse event: Fever (Middle of treatment)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 130 at risk

Adverse event: Myalgia (Middle of treatment)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 130 at risk

Adverse event: Arthralgia (Middle of treatment)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 130 at risk

Adverse event: Cephalea (Middle of treatment)
Serious: no
Organ System: General disorders
Frequency: 23 affected / 130 at risk

Adverse event: Vomiting (Middle of treatment)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 130 at risk

Adverse event: Nausea (Middle of treatment)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 130 at risk

Adverse event: Anorexia (Middle of treatment)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 130 at risk

Adverse event: ALT (Middle of treatment)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 132 at risk

Adverse event: Amylase (Middle of treatment)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 29 affected / 112 at risk

Adverse event: Fever (End of treatment)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 129 at risk

Adverse event: Myalgia (End of treatment)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 129 at risk

Adverse event: Arthralgia (End of treatment)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 129 at risk

Adverse event: Cephalea (End of treatment)
Serious: no
Organ System: General disorders
Frequency: 30 affected / 129 at risk

Adverse event: Vomiting (End of treatment)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 129 at risk

Adverse event: Nausea (End of treatment )
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 129 at risk

Adverse event: Anorexia (End of treatment )
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 129 at risk

Adverse event: Diarrhea (End of treatment)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 129 at risk

Adverse event: Abdominal Pain (End of treatment)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 129 at risk

Adverse event: BUN (End of treatment)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 102 at risk

Adverse event: AST (End of treatment)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 103 at risk

Adverse event: ALT (End of treatment)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 15 affected / 92 at risk

Adverse event: Amylase (End of treatment )
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 11 affected / 108 at risk

Adverse event: Haemoglobin (End of treatment)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Creatinine (middle of treatment)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 120 at risk

Adverse event: Creatinine (end of treatment)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 99 at risk

Adverse event: Lesion pain (middle of treatment)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 130 at risk

Adverse event: Lesion infection (middle of treatment)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 130 at risk

Adverse event: AST (Middle of treatment)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 105 at risk

Adverse event: Haemoglobin (middle of treatment
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 113 at risk

Adverse event: Lesion pain (end of treatment)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 129 at risk

Adverse event: Death in combat
Serious: yes
Organ System: Social circumstances
Frequency: 2 affected / 143 at risk

Adverse event: Stab wound
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 143 at risk

Adverse event: Fever (Middle of treatment)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 119 at risk

Adverse event: Myalgia (Middle of treatment)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 119 at risk

Adverse event: Arthralgia (Middle of treatment)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 119 at risk

Adverse event: Cephalea (Middle of treatment)
Serious: no
Organ System: General disorders
Frequency: 17 affected / 119 at risk

Adverse event: Vomiting (Middle of treatment)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 119 at risk

Adverse event: Nausea (Middle of treatment)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 119 at risk

Adverse event: Anorexia (Middle of treatment)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 119 at risk

Adverse event: BUN (Middle of treatment)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 99 at risk

Adverse event: ALT (Middle of treatment)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 19 affected / 137 at risk

Adverse event: Amylase (Middle of treatment)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 15 affected / 111 at risk

Adverse event: Fever (End of treatment)
Serious: no
Organ System: General disorders
Frequency: 29 affected / 131 at risk

Adverse event: Myalgia (End of treatment)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 67 affected / 131 at risk

Adverse event: Arthralgia (End of treatment)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 65 affected / 131 at risk

Adverse event: Cephalea (End of treatment)
Serious: no
Organ System: General disorders
Frequency: 52 affected / 131 at risk

Adverse event: Vomiting (End of treatment)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 131 at risk

Adverse event: Nausea (End of treatment )
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 131 at risk

Adverse event: Anorexia (End of treatment )
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 131 at risk

Adverse event: Diarrhea (End of treatment)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 131 at risk

Adverse event: Abdominal Pain (End of treatment)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 131 at risk

Adverse event: BUN (End of treatment)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 114 at risk

Adverse event: AST (End of treatment)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 11 affected / 111 at risk

Adverse event: ALT (End of treatment)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 11 affected / 90 at risk

Adverse event: Amylase (End of treatment )
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 24 affected / 109 at risk

Adverse event: Haemoglobin (End of treatment)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 108 at risk

Adverse event: Creatinine (middle of treatment)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 112 at risk

Adverse event: Creatinine (end of treatment)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 115 at risk

Adverse event: Lesion pain (middle of treatment)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 119 at risk

Adverse event: Lesion infection (middle of treatment)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 119 at risk

Adverse event: AST (Middle of treatment)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 99 at risk

Adverse event: Haemoglobin (middle of treatment
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 107 at risk

Adverse event: Lesion pain (end of treatment)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 131 at risk

Adverse event: Fever (Middle of treatment)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 124 at risk

Adverse event: Myalgia (Middle of treatment)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 124 at risk

Adverse event: Arthralgia (Middle of treatment)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 124 at risk

Adverse event: Cephalea (Middle of treatment)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 124 at risk

Adverse event: Vomiting (Middle of treatment)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 124 at risk

Adverse event: Nausea (Middle of treatment)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 124 at risk

Adverse event: Anorexia (Middle of treatment)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 124 at risk

Adverse event: BUN (Middle of treatment)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 96 at risk

Adverse event: ALT (Middle of treatment)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 106 at risk

Adverse event: Amylase (Middle of treatment)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 87 at risk

Adverse event: Fever (End of treatment)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 132 at risk

Adverse event: Myalgia (End of treatment)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 132 at risk

Adverse event: Arthralgia (End of treatment)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 132 at risk

Adverse event: Cephalea (End of treatment)
Serious: no
Organ System: General disorders
Frequency: 13 affected / 132 at risk

Adverse event: Vomiting (End of treatment)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 132 at risk

Adverse event: Nausea (End of treatment )
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 132 at risk

Adverse event: Anorexia (End of treatment )
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 132 at risk

Adverse event: Diarrhea (End of treatment)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 132 at risk

Adverse event: BUN (End of treatment)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 78 at risk

Adverse event: AST (End of treatment)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 75 at risk

Adverse event: ALT (End of treatment)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 12 affected / 105 at risk

Adverse event: Amylase (End of treatment )
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 70 at risk

Adverse event: Haemoglobin (End of treatment)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 70 at risk

Adverse event: Creatinine (middle of treatment)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 87 at risk

Adverse event: Creatinine (end of treatment)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 81 at risk

Adverse event: Lesion pain (middle of treatment)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 124 at risk

Adverse event: Lesion infection (middle of treatment)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 124 at risk

Adverse event: AST (Middle of treatment)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 11 affected / 93 at risk

Adverse event: Haemoglobin (middle of treatment
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 96 at risk

Adverse event: Lesion pain (end of treatment)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 122 at risk