Study: NCT00959894

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Participant had longstanding history of intermittent vomiting prior to study enrollment that fluctuated while on study. He was hospitalized and stopped study drugs since the possibility that drugs were contributing to vomiting could not be excluded.
Frequency: 1 affected / 79 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Notes: Participant on ACE inhibitor therapy for treatment of hypertension developed renal insufficiency and hyperkalemia, resolved when ACE inhibitor discontinued.
Frequency: 1 affected / 79 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Osteoplasty of the mandible
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 79 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 79 at risk

Adverse event: Prostatectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 79 at risk

Adverse event: Disseminated atypical mycobacterium infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 79 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Skin lesion present prior to study enrollment, subsequent biopsy revealed squamous cell carcinoma.
Frequency: 1 affected / 79 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 79 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 79 at risk

Adverse event: Elevated level of transaminase
Serious: no
Organ System: Hepatobiliary disorders
Notes: One participant was diagnosed with acute hepatitis C at the time of transaminase elevation and was consequently discontinued from the study.
Frequency: 9 affected / 79 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: For two participants hyperbilirubinemia occurred after stopping study drug and starting other antiretrovirals due to virologic failure. One participant had sickle cell disease and elevated indirect bilirubin at entry and subsequent visits.
Frequency: 6 affected / 79 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 79 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 79 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 79 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 79 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 79 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 79 at risk