Study: NCT01168596

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: Thought by PI to be unlikely related to study drug.
Frequency: 1 affected / 16 at risk

Adverse event: exostosis foot
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: bone spur on left foot. Moderate in severity. Thought by the PI to be unrelated to the study.
Frequency: 1 affected / 16 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Intermittent dizzy spells reported by patient. PI thought it unlikely to be related to study medication.
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Patient reported having headaches occasionally in the past but now having worsened headache meaning the pain was slightly worse when he had headaches. The PI thought it unlikely to be related to the study medication.
Frequency: 1 affected / 16 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Patient on active drug had depression already and reported a worsening of depression symptoms. PI thought to be unrelated to the study medication.

Sub-I felt patient on placebo was unlikely related to study medication.
Frequency: 1 affected / 16 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: PI thought it unlikely to be related to the study medication.
Frequency: 1 affected / 16 at risk

Adverse event: thrombolembolic event
Serious: no
Organ System: Vascular disorders
Notes: blood clot in left calf reported by patient. Thought by sub-I to be unrelated.
Frequency: 1 affected / 16 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: infection on left arm. Thought by sub-I to be unrelated to study medication.
Frequency: 1 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: The sub-I thought the 2 instances in one of the patients affected was possibly related to the study medication and the other patient's nausea was probably related to the study medication.
Frequency: 1 affected / 16 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Thought by PI to be unrelated to study medication.
Frequency: 1 affected / 16 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Sub-I thought it unlikely hese were related to the study medication.
Frequency: 2 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Two patients reported worsened/increased fatigue which was thought by sub-I and PI unlikely to be related to study medication.
Frequency: 1 affected / 16 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Patient reported fever only in the evening. PI thought it unlikely to be related to study medication.
Frequency: 1 affected / 16 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Body aches considered unlikely to be related to study medication by sub-I.
Frequency: 1 affected / 16 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Notes: Patient reported increased freezing. Thought to be unrelated to study medication by the PI.
Frequency: 1 affected / 16 at risk

Adverse event: Gastrointestinal disorders - other, diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diverticulitis thought by sub-I to be unlikely related to study medication.
Frequency: 1 affected / 16 at risk

Adverse event: Neoplasms benign, malignant and unspecified, other - squamous cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: patient had a squamous cell carcinoma removed from right hand. Though by PI to be unrelated to study medication.
Frequency: 1 affected / 16 at risk

Adverse event: injury, poisoning and procedureal complications, other - skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: patient reported a skin tear (from tape) on left arm. Sub-I thought to be unrelated to study medication.
Frequency: 1 affected / 16 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Notes: patient reported dyskinesias. Thought by PI to be possibly related to study medication.
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Patient reported having headaches occasionally in the past but now having worsened headache meaning the pain was slightly worse when he had headaches. The PI thought it unlikely to be related to the study medication.
Frequency: 2 affected / 14 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Patient on active drug had depression already and reported a worsening of depression symptoms. PI thought to be unrelated to the study medication.

Sub-I felt patient on placebo was unlikely related to study medication.
Frequency: 1 affected / 14 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 14 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Notes: Patient reported worsened urinary urgency. Thought by PI to be unrelated to study medication.
Frequency: 1 affected / 14 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Thought to be possibly related to study drug by sub-I.
Frequency: 1 affected / 14 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: PI and sub-I each thought their patient's UTI was unlikely related to the study medication.
Frequency: 2 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: The sub-I thought the 2 instances in one of the patients affected was possibly related to the study medication and the other patient's nausea was probably related to the study medication.
Frequency: 1 affected / 14 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Two patients reported worsened/increased fatigue which was thought by sub-I and PI unlikely to be related to study medication.
Frequency: 1 affected / 14 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: patient reported mild numbness in fingers - bilateral. Sub-I thought to be possibly related to study medication.
Frequency: 1 affected / 14 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient reported right hip pain. Thought by PI to be unlikely related to study medication.
Frequency: 1 affected / 14 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient reported muscle cramp in right leg. Sub-I thought to be possibly related to study medication.
Frequency: 1 affected / 14 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Notes: Patient reported burning upon urination. PI thought it to be unrelated to study medication.
Frequency: 1 affected / 14 at risk