Trial Outcomes & Findings for A Study of the Safety and Efficacy of MK-0773 in Women With Sarcopenia (Loss of Muscle Mass)(MK-0773-005) (NCT NCT00529659)
NCT ID: NCT00529659
Last Updated: 2015-02-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
170 participants
Primary outcome timeframe
Baseline, Month 6
Results posted on
2015-02-16
Participant Flow
Participants were randomized from 28 sites (2 sites in Mexico, 10 sites in South America, 8 sites in Europe, 5 sites in Asia Pacific, and 3 sites in South Africa).
After a 2-week placebo run-in period, patients were randomized in a 1:1 ratio to receive treatment with either oral MK-0773 50 mg twice daily or matching placebo.
Participant milestones
| Measure |
MK-0773
MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
|
Placebo
Placebo administered orally twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
89
|
|
Overall Study
COMPLETED
|
70
|
66
|
|
Overall Study
NOT COMPLETED
|
11
|
23
|
Reasons for withdrawal
| Measure |
MK-0773
MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
|
Placebo
Placebo administered orally twice daily.
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
7
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Protocol Violation
|
2
|
6
|
|
Overall Study
Withdrawal by Subject
|
1
|
6
|
Baseline Characteristics
A Study of the Safety and Efficacy of MK-0773 in Women With Sarcopenia (Loss of Muscle Mass)(MK-0773-005)
Baseline characteristics by cohort
| Measure |
MK-0773
n=81 Participants
MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
|
Placebo
n=89 Participants
Placebo administered orally twice daily.
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.0 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
76.8 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
75.9 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: The full analysis set (FAS) included all participants that received at least one dose of the study therapy and had a post-randomization measurement of lean body mass.
Outcome measures
| Measure |
MK-0773
n=65 Participants
MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
|
Placebo
n=60 Participants
Placebo administered orally twice daily.
|
|---|---|---|
|
Change From Baseline in Participant Lean Body Mass
|
1.26 kg
Standard Deviation 1.09
|
0.29 kg
Standard Deviation 1.29
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: N = Number of participants with at least one non-missing measurement at the time point.
BLP measurements were obtained with the participant sitting on the BLP exercise machine with flexed hips and knees. The participant held the handgrips with hips flexion and knees bent at a 90 degree angle and feet placed evenly on the footpad with heels placed approximately shoulder width apart. Participants were asked to slowly push the footpad forward, while keeping the knees slightly flexed, and bend back again slowly for one repetition. The BLP procedure measures the maximum amount of weight that the patient can push through his or her full range of motion one time.
Outcome measures
| Measure |
MK-0773
n=66 Participants
MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
|
Placebo
n=63 Participants
Placebo administered orally twice daily.
|
|---|---|---|
|
Change From Baseline in Bilateral Leg Press (BLP) Measurement
|
17.42 lbs
Standard Deviation 26.04
|
15.95 lbs
Standard Deviation 27.84
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: N = Number of participants with at least one non-missing measurement at the time point.
The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons. The SPPB consists of 3 types of physical maneuvers: balance test, speed gait test, and chair stand test. Results from each maneuvers test are scored on a scale of 0 to 4, with an increasing composite score indicating an improved function level. The total maximum score of SPPB is 12.
Outcome measures
| Measure |
MK-0773
n=66 Participants
MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
|
Placebo
n=63 Participants
Placebo administered orally twice daily.
|
|---|---|---|
|
Change From Baseline in Participant Short Physical Performance Battery (SPPB)
|
0.92 Score on a Scale
Standard Deviation 1.63
|
0.88 Score on a Scale
Standard Deviation 1.60
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: N = Number of participants with at least one non-missing measurement at the time point.
Outcome measures
| Measure |
MK-0773
n=66 Participants
MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
|
Placebo
n=63 Participants
Placebo administered orally twice daily.
|
|---|---|---|
|
Change From Baseline in Participant Gait Speed
|
6.24 cm/sec
Standard Deviation 17.65
|
8.91 cm/sec
Standard Deviation 15.05
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: The FAS included all participants that received at least one dose of the study therapy and had a post-randomization stair climbing power measurement.
Stair-climbing power is an alternate measure of lower extremity muscle strength. Participants were asked to climb a standardized 4-step flight of stairs. The study coordinator timed how long it took the participant to walk up the stairs as quickly as possible. The test starts when the tester says "go" and ends when both of the patient's feet are flat on the platform area at the top of the staircase. Participants were permitted to use the railing, and/or an assistive device, if needed. Stair climbing power was calculated as = participant weight × gravity constant × height of stairs / time.
Outcome measures
| Measure |
MK-0773
n=65 Participants
MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
|
Placebo
n=63 Participants
Placebo administered orally twice daily.
|
|---|---|---|
|
Change From Baseline in Stair Climbing Power
|
19.68 watts
Standard Deviation 23.85
|
14.98 watts
Standard Deviation 20.71
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: N = Number of patient with at least one non-missing measurement at the time point.
The Activity Measure for Post Acute Care (AM-PAC) measures function in three domains: basic mobility, daily activities, and applied cognitive function. AM-PAC scores in each functional domain have a mean of 50 with a standard deviation of 10 and scores are distributed along a continuum of function. The AM-PAC tracks outcomes as a participant progresses across an episode of care with higher scores indicating an improved level of functioning.
Outcome measures
| Measure |
MK-0773
n=65 Participants
MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
|
Placebo
n=63 Participants
Placebo administered orally twice daily.
|
|---|---|---|
|
Change From Baseline in Activity Measure for Post Acute Care (AM-PAC) Physical Movement Score
Baseline
|
59.79 Score on a Scale
Standard Deviation 6.29
|
59.13 Score on a Scale
Standard Deviation 5.28
|
|
Change From Baseline in Activity Measure for Post Acute Care (AM-PAC) Physical Movement Score
Change from Baseline
|
2.52 Score on a Scale
Standard Deviation 4.98
|
2.38 Score on a Scale
Standard Deviation 4.55
|
Adverse Events
MK-0773
Serious events: 12 serious events
Other events: 50 other events
Deaths: 0 deaths
Placebo
Serious events: 9 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-0773
n=81 participants at risk
MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
|
Placebo
n=89 participants at risk
Placebo administered orally twice daily.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Gastrointestinal disorders
Abdominal distention
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Gastrointestinal disorders
Pancreatic mass
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
General disorders
Death
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Injury, poisoning and procedural complications
Medical device complication
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Investigations
Alanine aminotransferase increased
|
2.5%
2/81 • Number of events 2
|
0.00%
0/89
|
|
Investigations
Aspartate aminotransferase increased
|
2.5%
2/81 • Number of events 2
|
0.00%
0/89
|
|
Investigations
Transaminases increased
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Nervous system disorders
Ischaemic stroke
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Vascular disorders
Hypertension
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
Other adverse events
| Measure |
MK-0773
n=81 participants at risk
MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
|
Placebo
n=89 participants at risk
Placebo administered orally twice daily.
|
|---|---|---|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Cardiac disorders
Subendocardial ischaemia
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Cardiac disorders
Supraventricular extrasystoles
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Endocrine disorders
Addison's disease
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Endocrine disorders
Hypopituitarism
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Endocrine disorders
Hypothyroidism
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Eye disorders
Cataract
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
1.2%
1/81 • Number of events 1
|
1.1%
1/89 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
1.2%
1/81 • Number of events 1
|
1.1%
1/89 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/81 • Number of events 1
|
1.1%
1/89 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.7%
3/81 • Number of events 3
|
0.00%
0/89
|
|
Gastrointestinal disorders
Anorectal discomfort
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Gastrointestinal disorders
Colitis
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Gastrointestinal disorders
Constipation
|
3.7%
3/81 • Number of events 3
|
3.4%
3/89 • Number of events 3
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
5/81 • Number of events 5
|
3.4%
3/89 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
2/81 • Number of events 2
|
0.00%
0/89
|
|
Gastrointestinal disorders
Flatulence
|
1.2%
1/81 • Number of events 1
|
1.1%
1/89 • Number of events 1
|
|
Gastrointestinal disorders
Food poisoning
|
1.2%
1/81 • Number of events 1
|
1.1%
1/89 • Number of events 1
|
|
General disorders
Gastritis
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Gastrointestinal disorders
Pancreatic mass
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
General disorders
Asthenia
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
General disorders
Death
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
General disorders
Discomfort
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
General disorders
Face oedema
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
General disorders
Fatigue
|
2.5%
2/81 • Number of events 2
|
0.00%
0/89
|
|
General disorders
Gait disturbance
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
General disorders
Influenza like illness
|
7.4%
6/81 • Number of events 6
|
2.2%
2/89 • Number of events 2
|
|
General disorders
Malaise
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
General disorders
Oedema peripheral
|
2.5%
2/81 • Number of events 2
|
2.2%
2/89 • Number of events 2
|
|
General disorders
Pyrexia
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Immune system disorders
Hypersensitivity
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Infections and infestations
Bronchitis
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Infections and infestations
Bronchopneumonia
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Infections and infestations
Cellulitis
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Infections and infestations
Folliculitis
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Infections and infestations
Gastroenteritis viral
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Infections and infestations
Herpes zoster
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Infections and infestations
Influenza
|
1.2%
1/81 • Number of events 1
|
2.2%
2/89 • Number of events 2
|
|
Infections and infestations
Localised infection
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
1/81 • Number of events 1
|
1.1%
1/89 • Number of events 1
|
|
Infections and infestations
Oral herpes
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Infections and infestations
Pneumonia
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Infections and infestations
Tooth abscess
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/81
|
3.4%
3/89 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
3.7%
3/81 • Number of events 3
|
2.2%
2/89 • Number of events 2
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
1/81 • Number of events 1
|
3.4%
3/89 • Number of events 3
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Injury, poisoning and procedural complications
Head injury
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.2%
1/81 • Number of events 1
|
1.1%
1/89 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint sprain
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Injury, poisoning and procedural complications
Medical device complication
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Investigations
Alanine aminotransferase increased
|
9.9%
8/81 • Number of events 8
|
1.1%
1/89 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
8.6%
7/81 • Number of events 7
|
1.1%
1/89 • Number of events 1
|
|
Investigations
Blood cortisol decreased
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Investigations
Blood sodium decreased
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Investigations
Electrocardiogram T wave inversion
|
1.2%
1/81 • Number of events 1
|
1.1%
1/89 • Number of events 1
|
|
Investigations
Haematocrit decreased
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Investigations
Haematocrit increased
|
9.9%
8/81 • Number of events 8
|
2.2%
2/89 • Number of events 2
|
|
Investigations
Haemoglobin decreased
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Investigations
Haemoglobin increased
|
3.7%
3/81 • Number of events 3
|
1.1%
1/89 • Number of events 1
|
|
Investigations
High density lipoprotein decreased
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Investigations
Neutrophil count increased
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Investigations
Platelet count increased
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Investigations
Transaminases increased
|
2.5%
2/81 • Number of events 2
|
1.1%
1/89 • Number of events 1
|
|
Investigations
Weight increased
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Investigations
White blood cell count increased
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.5%
2/81 • Number of events 2
|
0.00%
0/89
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
3/81 • Number of events 3
|
2.2%
2/89 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
3/81 • Number of events 3
|
1.1%
1/89 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/81
|
2.2%
2/89 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
2/81 • Number of events 2
|
0.00%
0/89
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/81
|
2.2%
2/89 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Nervous system disorders
Oesophageal carcinoma
|
2.5%
2/81 • Number of events 2
|
1.1%
1/89 • Number of events 1
|
|
Nervous system disorders
Dysstasia
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Nervous system disorders
Essential tremor
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Nervous system disorders
Headache
|
2.5%
2/81 • Number of events 2
|
3.4%
3/89 • Number of events 3
|
|
Nervous system disorders
Ischaemic stroke
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Nervous system disorders
Lethargy
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Nervous system disorders
Paraesthesia
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Nervous system disorders
Sciatica
|
0.00%
0/81
|
2.2%
2/89 • Number of events 2
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Psychiatric disorders
Depression
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Psychiatric disorders
Insomnia
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.7%
3/81 • Number of events 3
|
2.2%
2/89 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Vascular disorders
Haematoma
|
2.5%
2/81 • Number of events 2
|
0.00%
0/89
|
|
Vascular disorders
Hypertension
|
2.5%
2/81 • Number of events 2
|
4.5%
4/89 • Number of events 4
|
|
Vascular disorders
Hypotension
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Vascular disorders
Varicose ulceration
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60