Study: NCT00749580

Adverse event: Erthema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 1 affected / 21 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 2 affected / 21 at risk

Adverse event: Pruritus( local, not drug rash))
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 2 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 1 affected / 21 at risk

Adverse event: Swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2, Not related, not anticipated
Frequency: 2 affected / 21 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 1 affected / 21 at risk

Adverse event: Instability
Serious: no
Organ System: Nervous system disorders
Notes: Grade 2, Not related, not anticipated
Frequency: 1 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1, Not related, and anticipated Two event in the RAL arm is grade 2. Not related, and anticipated
Frequency: 6 affected / 21 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 1 affected / 21 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 2 affected / 21 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 1 affected / 21 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 2 affected / 21 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Infections and infestations
Notes: Grade 1, Not related, not anticipated
Frequency: 1 affected / 21 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 1 affected / 21 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2, Not related, not anticipated
Frequency: 1 affected / 21 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 1 affected / 21 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 1 affected / 21 at risk

Adverse event: Increase appetite
Serious: no
Organ System: General disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 1 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 1 affected / 21 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1 and 2, Not related, not anticipated
Frequency: 3 affected / 21 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1
Frequency: 1 affected / 21 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 2
Frequency: 1 affected / 21 at risk

Adverse event: Condyloma removal
Serious: no
Organ System: Surgical and medical procedures
Notes: Grade 2-not related
Frequency: 1 affected / 21 at risk

Adverse event: Squamous cell carcinoma insitu
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2-not related
Frequency: 1 affected / 21 at risk

Adverse event: Abnormal liver function
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3, recovered , no action taken
Frequency: 1 affected / 21 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1-no action taken
Frequency: 1 affected / 21 at risk

Adverse event: Faconi syndrome
Serious: yes
Organ System: Renal and urinary disorders
Notes: Faconi's syndrome in a patient who is on TDF/FTC base regimen. The patient recovered, the regimen switched TDF/FTC was switched to TDF sparing regimen and the patient was wihtdrawn form the study.
Frequency: 1 affected / 25 at risk

Adverse event: Erthema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 1 affected / 25 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 3 affected / 25 at risk

Adverse event: Pruritus( local, not drug rash))
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 1 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 2 affected / 25 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 1 affected / 25 at risk

Adverse event: loss appetitie
Serious: no
Organ System: General disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 2 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1, Not related, and anticipated Two event in the RAL arm is grade 2. Not related, and anticipated
Frequency: 1 affected / 25 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 1 affected / 25 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 1 affected / 25 at risk

Adverse event: Worsening seasonal allergy
Serious: no
Organ System: Immune system disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 1 affected / 25 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2, Not related, not anticipated
Frequency: 1 affected / 25 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1, Not related, not anticipated
Frequency: 1 affected / 25 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1 and 2, Not related, not anticipated
Frequency: 1 affected / 25 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2, Not related, not anticipated
Frequency: 1 affected / 25 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 25 at risk