Study: NCT01354314

Adverse event: Surgery, knee replacement
Serious: yes
Organ System: Surgical and medical procedures
Notes: Inpatient elective surgery followed by complications
Frequency: 1 affected / 12 at risk

Adverse event: Surgery, neck
Serious: yes
Organ System: Surgical and medical procedures
Notes: Elective surgery to treat cervical stenosis
Frequency: 1 affected / 12 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 12 at risk

Adverse event: Back pain, generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Blood urea nitrogen (BUN), high
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Blood test, range: 23-41 mg/dL
Frequency: 3 affected / 12 at risk

Adverse event: Blood urea nitrogen (BUN), low
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Blood test, range: 5-6 mg/dL
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 (DAIDS 2.0)
Frequency: 5 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Self-reported, intermittent
Frequency: 2 affected / 12 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: Self-reported
Frequency: 3 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 2 (DAIDS 2.0)
Frequency: 1 affected / 12 at risk

Adverse event: Headache, non-specific
Serious: no
Organ System: General disorders
Notes: Intermittent, grade 2 (DAIDS 2.0)
Frequency: 1 affected / 12 at risk

Adverse event: Headache, post-lumbar puncture
Serious: no
Organ System: Nervous system disorders
Notes: Post-LP postural headache requiring follow-up care
Frequency: 1 affected / 12 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: General disorders
Notes: Grade 2 (DAIDS 2.0)
Frequency: 1 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 or 3 (DAIDS 2.0)
Frequency: 4 affected / 12 at risk

Adverse event: Nephrolithiasis (kidney stone)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Polyuria
Serious: no
Organ System: General disorders
Notes: Self-limited
Frequency: 1 affected / 12 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Syphilis, new infection/exposure
Serious: no
Organ System: Infections and infestations
Notes: Treated for infection
Frequency: 1 affected / 12 at risk

Adverse event: Urinary hesitation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 (DAIDS 2.0)
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal cramping or pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Generalized abdominal cramping or pain (non-focalized)
Frequency: 1 affected / 11 at risk

Adverse event: Agitation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Alanine aminotransferase (ALT), high
Serious: no
Organ System: Hepatobiliary disorders
Notes: Blood test, grade 2 (DAIDS 2.0)
Frequency: 1 affected / 11 at risk

Adverse event: Altered taste
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Passenger, visit to ED, back injury, discharged home
Frequency: 1 affected / 11 at risk

Adverse event: Back pain, generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Bilirubin, total, high
Serious: no
Organ System: Hepatobiliary disorders
Notes: Blood test, grade 2 or 3 (DAIDS 2.0)
Frequency: 2 affected / 11 at risk

Adverse event: Darkening of urine
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 (DAIDS 2.0)
Frequency: 1 affected / 11 at risk

Adverse event: Headache, non-specific
Serious: no
Organ System: General disorders
Notes: Intermittent, grade 2 (DAIDS 2.0)
Frequency: 2 affected / 11 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Joint pain, generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Joint pain, hip, unilateral
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Joint pain, shoulder, unilateral
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 or 3 (DAIDS 2.0)
Frequency: 1 affected / 11 at risk

Adverse event: Nephrolithiasis (kidney stone)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Psychotropic effects, non-specific
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 11 at risk

Adverse event: Sprain, ankle
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Tinnitus, bilateral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vivid or disturbing dreams
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 (DAIDS 2.0)
Frequency: 1 affected / 11 at risk

Adverse event: Heroin abuse, relapse
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Glucose, non-fasting, high
Serious: yes
Organ System: Endocrine disorders
Notes: Grade 4 (DAIDS); hyperglycemia in the context of acute uncontrolled diabetes
Frequency: 1 affected / 11 at risk

Adverse event: Depression, acute
Serious: yes
Organ System: Psychiatric disorders
Notes: Grade 3 (DAIDS); Acute episode, resolved
Frequency: 1 affected / 11 at risk

Adverse event: Abdominal cramping or pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Generalized abdominal cramping or pain (non-focalized)
Frequency: 1 affected / 11 at risk

Adverse event: Agitation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Aspartate aminotransferase (AST), high
Serious: no
Organ System: Hepatobiliary disorders
Notes: Blood test, grade 2 (DAIDS 2.0)
Frequency: 1 affected / 11 at risk

Adverse event: Alkaline phosphatase, high
Serious: no
Organ System: Hepatobiliary disorders
Notes: Blood test, grade 2 (DAIDS 2.0)
Frequency: 1 affected / 11 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Altered taste
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Bilirubin, total, high
Serious: no
Organ System: Hepatobiliary disorders
Notes: Blood test, grade 2 or 3 (DAIDS 2.0)
Frequency: 3 affected / 11 at risk

Adverse event: Blood urea nitrogen (BUN), high
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Blood test, range: 23-41 mg/dL
Frequency: 1 affected / 11 at risk

Adverse event: Blood urea nitrogen (BUN), low
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Blood test, range: 5-6 mg/dL
Frequency: 1 affected / 11 at risk

Adverse event: Chlamydia, new infection/exposure
Serious: no
Organ System: Infections and infestations
Notes: Treated for infection
Frequency: 1 affected / 11 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 or 3 (DAIDS 2.0)
Frequency: 1 affected / 11 at risk

Adverse event: Cyst, subcutaneous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: Self-reported
Frequency: 2 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 (DAIDS 2.0)
Frequency: 1 affected / 11 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: Self-reported
Frequency: 2 affected / 11 at risk

Adverse event: Flank pain, unilateral
Serious: no
Organ System: General disorders
Notes: Non-specific, self-limited
Frequency: 1 affected / 11 at risk

Adverse event: Glucose, blood, high
Serious: no
Organ System: Endocrine disorders
Notes: Blood test, non-fasting, grade 2 or 3 (DAIDS 2.0)
Frequency: 3 affected / 11 at risk

Adverse event: Glucose, blood, low
Serious: no
Organ System: General disorders
Notes: Blood test, non-fasting, grade 2 (DAIDS 2.0)
Frequency: 1 affected / 11 at risk

Adverse event: Headache, non-specific
Serious: no
Organ System: General disorders
Notes: Intermittent, grade 2 (DAIDS 2.0)
Frequency: 1 affected / 11 at risk

Adverse event: Incontinence, acute nocturnal
Serious: no
Organ System: General disorders
Notes: Self-limited
Frequency: 1 affected / 11 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Joint pain, generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Lymph node infection, neck
Serious: no
Organ System: Infections and infestations
Notes: Treated for infection
Frequency: 1 affected / 11 at risk

Adverse event: Lymphadenopathy, cervical
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 or 3 (DAIDS 2.0)
Frequency: 4 affected / 11 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Notes: Self-limited
Frequency: 1 affected / 11 at risk

Adverse event: Prostitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

Adverse event: Syphilis, new infection/exposure
Serious: no
Organ System: Infections and infestations
Notes: Treated for infection
Frequency: 1 affected / 11 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Notes: Treated for infection
Frequency: 1 affected / 11 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Visual changes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 (DAIDS 2.0)
Frequency: 1 affected / 11 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Notes: Grade 2 (DAIDS 2.0)
Frequency: 1 affected / 11 at risk

Adverse event: Surgery, knee replacement
Serious: yes
Organ System: Surgical and medical procedures
Notes: Inpatient elective surgery followed by complications
Frequency: 1 affected / 11 at risk

Adverse event: Heroin abuse, relapse
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Abdominal cramping or pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Generalized abdominal cramping or pain (non-focalized)
Frequency: 1 affected / 11 at risk

Adverse event: Absolute neutrophil count (ANC), low
Serious: no
Organ System: Immune system disorders
Notes: Blood test, grade 2 (DAIDS 2.0)
Frequency: 1 affected / 11 at risk

Adverse event: Acute bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 2 (DAIDS 2.0); context of chronic obstructive pulmonary disease requiring visit to emergency department
Frequency: 1 affected / 11 at risk

Adverse event: Alanine aminotransferase (ALT), high
Serious: no
Organ System: Hepatobiliary disorders
Notes: Blood test, grade 2 (DAIDS 2.0)
Frequency: 1 affected / 11 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Bilirubin, total, high
Serious: no
Organ System: Hepatobiliary disorders
Notes: Blood test, grade 2 or 3 (DAIDS 2.0)
Frequency: 1 affected / 11 at risk

Adverse event: Blood urea nitrogen (BUN), high
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Blood test, range: 23-41 mg/dL
Frequency: 3 affected / 11 at risk

Adverse event: Blood urea nitrogen (BUN), low
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Blood test, range: 5-6 mg/dL
Frequency: 1 affected / 11 at risk

Adverse event: Creatinine, blood, high
Serious: no
Organ System: Hepatobiliary disorders
Notes: Blood test, grade 2 (DAIDS 2.0)
Frequency: 1 affected / 11 at risk

Adverse event: Darkening of urine
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 (DAIDS 2.0)
Frequency: 2 affected / 11 at risk

Adverse event: Gastroenteritis, foodborne illness
Serious: no
Organ System: Gastrointestinal disorders
Notes: Self-reported
Frequency: 1 affected / 11 at risk

Adverse event: Glucose, blood, high
Serious: no
Organ System: Endocrine disorders
Notes: Blood test, non-fasting, grade 2 or 3 (DAIDS 2.0)
Frequency: 1 affected / 11 at risk

Adverse event: Glucose, blood, low
Serious: no
Organ System: General disorders
Notes: Blood test, non-fasting, grade 2 (DAIDS 2.0)
Frequency: 1 affected / 11 at risk

Adverse event: Headache, post-lumbar puncture
Serious: no
Organ System: Nervous system disorders
Notes: Post-LP postural headache requiring follow-up care
Frequency: 1 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 or 3 (DAIDS 2.0)
Frequency: 1 affected / 11 at risk

Adverse event: Nephrolithiasis (kidney stone)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3 (DAIDS); context of diagnosed/treated hypertension, participant had not taken morning medications
Frequency: 1 affected / 11 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk