Study: NCT00699140

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: A male subject of 54-year-old, with morbid obesity, sedentary lifestyle, previous steroid treatment and difficulty with line insertion was diagnosed with deep venous thrombosis and hospitalized. The subject recovered from the event.
Frequency: 1 affected / 18 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Notes: A 75-year-old male with high blood glucose levels and hypertension presented a drop in hemoglobin from 11.7 g/dL to 9.8 g/dL. The reaction was transient with no complications or clinical symptoms of hemolysis. The subject was recovered from the event
Frequency: 1 affected / 18 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: A 75-year-old male with high blood glucose levels and hypertension presented a drop in leukocyte count from 5.3x10\^9/L to 2.7x10\^9/L. The reaction was transient, with no complications. The subject was discharged from hospital totally recovered
Frequency: 1 affected / 18 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All of these events were considered not related to the study drug
Frequency: 12 affected / 18 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Only 1 out of 11 events was considered related to the study drug
Frequency: 8 affected / 18 at risk

Adverse event: Palmar erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: It was considered related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Only 1 of the 2 events was considered related to the study drug
Frequency: 2 affected / 18 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Three out of 4 events were considered related to the study drug
Frequency: 4 affected / 18 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: All of 2 events were considered related to the study drug
Frequency: 2 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Two events were considered related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: One patient had 3 events that were considered not related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Notes: Two patients had 2 events that were considered not related to the study drug
Frequency: 2 affected / 18 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: A patient had 2 events that were considered not related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: It was considered related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: It was considered related to the stuy drug
Frequency: 1 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Twelve out of 15 events were considered related to the study drug
Frequency: 7 affected / 18 at risk

Adverse event: Radiculopathy
Serious: no
Organ System: Nervous system disorders
Notes: It was considered related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: It was considered not related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Two patients had 3 events that were considered related to the study drug
Frequency: 2 affected / 18 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A patient had 2 events that were considered not related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: It was considered not related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: A patient had 1 event that was considered not related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Limb discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: A patient had 2 events that were considered related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: A patient had 1 event that was considered not related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: It was considered not related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Notes: It was considered not related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Notes: It was considered not related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Lipids abnormal
Serious: no
Organ System: Investigations
Notes: It was considered not related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: It was considered related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: A patient had 2 events that were considered not related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Bicytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: It was considered related to the study drug
Frequency: 1 affected / 18 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: It was considered not related to the study drug
Frequency: 1 affected / 18 at risk