Study: NCT00654953

Adverse event: Sexual dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Notes: erectile dysfunction/impotence/inability or delayed orgasm
Frequency: 1 affected / 36 at risk

Adverse event: Chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Chest pain in which cardiac involvement was ruled out.
Frequency: 1 affected / 36 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Notes: self-reported dizziness
Frequency: 2 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Nausea and/or Emesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: High Blood Pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 36 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Notes: erectile dysfunction/impotence/inability or delayed orgasm
Frequency: 4 affected / 36 at risk

Adverse event: Chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Chest pain in which cardiac involvement was ruled out.
Frequency: 2 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Nausea and/or Emesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: High Blood Pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 36 at risk

Adverse event: toothache and/or tooth abscess
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 36 at risk

Adverse event: Yawning
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Allergic reaction to study medication
Frequency: 1 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Notes: self-reported dizziness
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Nausea and/or Emesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 30 at risk

Adverse event: High Blood Pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: toothache and/or tooth abscess
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 30 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk