Study: NCT00120874

Adverse event: Left Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: abnormal blood results
Serious: no
Organ System: Investigations
Notes: slightly low copper, low zinc, mild elevation of serotonin
Frequency: 1 affected / 10 at risk

Adverse event: red blotch on face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: lasted 2-3 hours
Frequency: 1 affected / 10 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Treated with antibiotics
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Infections and infestations
Notes: C. dificil
Frequency: 1 affected / 10 at risk

Adverse event: Fungal skin rash in groin
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: toenail fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Calcified bone mass on hip due to muscle tear
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: abnormal urine analysis
Serious: no
Organ System: Investigations
Notes: possible urinary tract infection
Frequency: 1 affected / 10 at risk

Adverse event: Vitamin D insufficiency
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Infections and infestations
Notes: C. dificil infection
Frequency: 1 affected / 10 at risk

Adverse event: Left heel Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Left heel Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Left Pelvic Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Stage II Pressure Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Located above Anus to tail bone
Frequency: 1 affected / 10 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalized, determined by CT scan
Frequency: 1 affected / 10 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: No growth on Culture and sensitivity
Frequency: 1 affected / 10 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: General disorders
Notes: Unexpected event
Frequency: 1 affected / 10 at risk

Adverse event: Atherosclerotic Heart Disease
Serious: yes
Organ System: General disorders
Notes: Vascular disorders Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Notes: 1 Subject had 2 episodes \& was placed in hospice. 2nd subject had 2 syncopal episodes, 1 at a restaurant \& 2nd episode in Dr. office
Frequency: 2 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Infections and infestations
Notes: C. dificil
Frequency: 1 affected / 10 at risk

Adverse event: Muscle rigidity
Serious: no
Organ System: Nervous system disorders
Notes: 1 subject had Parkinsonian symptoms of rigidity and instability, a second subject had rigidity possibly due to supplement usage
Frequency: 2 affected / 10 at risk

Adverse event: Abnormal sensation in hands
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Increasing hypothyroidism
Serious: no
Organ System: Endocrine disorders
Notes: Subject was euthyroid at baseline on medication \& later diagnosed with hypothyroidism
Frequency: 1 affected / 10 at risk

Adverse event: Increased alkaline phosphatase
Serious: no
Organ System: Investigations
Notes: 1 subject had an increased alkaline phosphatase at 2 study visits, a second subject had an elevated alkaline phosphatase at 1 visit
Frequency: 2 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: 3 subjects each had 1 episode of constipation reported by caregiver, a 4th subject had 1 episode determined by hosp dr, a 5th subject had chronic constipation reported once,
Frequency: 1 affected / 10 at risk

Adverse event: Elevated Platelet Count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Black blister on Left heel
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Notes: 4 subjects were reported to have difficulty swallowing pills.
Frequency: 4 affected / 10 at risk

Adverse event: Brown liquid coming from nose
Serious: no
Organ System: General disorders
Notes: Occurred simultaneously with diarrhea
Frequency: 1 affected / 10 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: 1 subject had dec appetite in general once starting carbidopa/levodopa, a 2nd subject stopped eating for 2 days then had a decreased appetite afterwards
Frequency: 1 affected / 10 at risk

Adverse event: Electrolyte imbalance
Serious: no
Organ System: General disorders
Notes: elevated calcium
Frequency: 1 affected / 10 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: 1 subject developed hearing loss when started taking Namenda
Frequency: 1 affected / 10 at risk

Adverse event: Increased leg edema
Serious: no
Organ System: General disorders
Notes: 1 subject had mild leg edema at baseline and it was reported to have worsened at Wk 4 study visit
Frequency: 1 affected / 10 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 subject had 1 episode,a 2nd subject had 2 episodes,
Frequency: 2 affected / 10 at risk

Adverse event: Stage I Pressure Sore
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Notes: 1 subject had 2 episodes which occurred concurrently with syncope and hypotension
Frequency: 1 affected / 10 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Notes: 1 subject fell out of bed
Frequency: 1 affected / 10 at risk

Adverse event: Bruised ribs
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 subject from falling out of bed. Dx on PE by Dr.
Frequency: 1 affected / 10 at risk

Adverse event: Buttocks abscess
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Buttocks ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Elevated creatinine and decreased GFR
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: General disorders
Notes: 1 subject had 1 asymptomatic episode on Wk 4 bloodwork, 1 subject had mild hypoglycemia
Frequency: 2 affected / 10 at risk

Adverse event: Elevated C Reactive Protein
Serious: no
Organ System: General disorders
Notes: Cause not found
Frequency: 1 affected / 10 at risk

Adverse event: mild hypercholesterolemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: CT scan
Frequency: 1 affected / 10 at risk

Adverse event: Oligodipsia
Serious: no
Organ System: General disorders
Notes: Lasted 2 days
Frequency: 1 affected / 10 at risk

Adverse event: Lost ability to walk
Serious: no
Organ System: General disorders
Notes: Occurred simultaneously with syncopal event
Frequency: 1 affected / 10 at risk

Adverse event: Lip smacking and chomping
Serious: no
Organ System: General disorders
Notes: Occurred continuously, reported at 2 study visits wk4 \& wk12
Frequency: 1 affected / 10 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: RLE
Frequency: 1 affected / 10 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Right hip
Frequency: 1 affected / 10 at risk