Trial Outcomes & Findings for A Long-Term Safety Study of Org 50081 (Esmirtazapine) in Elderly Outpatients With Chronic Primary Insomnia (176005/P05697/MK-8265-001) (NCT NCT00561574)
NCT ID: NCT00561574
Last Updated: 2021-01-27
Results Overview
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
259 participants
Primary outcome timeframe
Up to 53 weeks
Results posted on
2021-01-27
Participant Flow
Participant milestones
| Measure |
Esmirtazapine 1.5 mg
Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
Esmirtazapine 3.0 mg
Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
131
|
|
Overall Study
COMPLETED
|
80
|
73
|
|
Overall Study
NOT COMPLETED
|
48
|
58
|
Reasons for withdrawal
| Measure |
Esmirtazapine 1.5 mg
Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
Esmirtazapine 3.0 mg
Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
21
|
24
|
|
Overall Study
Lack of Efficacy
|
11
|
21
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Reason Unrelated to Trial
|
6
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Other
|
5
|
7
|
Baseline Characteristics
A Long-Term Safety Study of Org 50081 (Esmirtazapine) in Elderly Outpatients With Chronic Primary Insomnia (176005/P05697/MK-8265-001)
Baseline characteristics by cohort
| Measure |
Esmirtazapine 1.5 mg
n=128 Participants
Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
Esmirtazapine 3.0 mg
n=131 Participants
Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
Total
n=259 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.7 Years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
71.1 Years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
70.9 Years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 53 weeksPopulation: The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of study drug.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.
Outcome measures
| Measure |
Esmirtazapine 1.5 mg
n=128 Participants
Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
Esmirtazapine 3.0 mg
n=131 Participants
Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
|---|---|---|
|
Number of Participants Who Experience at Least One Adverse Event (AE)
|
115 Participants
|
116 Participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: The AST population consisted of all participants who received at least one dose of study drug.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.
Outcome measures
| Measure |
Esmirtazapine 1.5 mg
n=128 Participants
Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
Esmirtazapine 3.0 mg
n=131 Participants
Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
|---|---|---|
|
Number of Participants Who Discontinue Study Drug Due to an AE
|
21 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: The AST population consisted of all participants who received at least one dose of study drug.
Alertness at awakening was assessed by participants using a 0-100 mm visual analog scale (VAS) in response to Weekly Sleep Diary question 6 "How did you feel upon awakening over the past 7 days?". Scores could range from 0=Tired to 100=Alert. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an observed cases (OC) approach.
Outcome measures
| Measure |
Esmirtazapine 1.5 mg
n=128 Participants
Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
Esmirtazapine 3.0 mg
n=131 Participants
Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
|---|---|---|
|
Change From Baseline in Alertness at Awakening
Baseline (BL) (n=121, 123)
|
38.3 Score on a Scale
Standard Deviation 17.2
|
38.3 Score on a Scale
Standard Deviation 18.3
|
|
Change From Baseline in Alertness at Awakening
Change from BL at Week 52 (n=61, 53)
|
25.6 Score on a Scale
Standard Deviation 29.1
|
21.7 Score on a Scale
Standard Deviation 25.1
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: The AST population consisted of all participants who received at least one dose of study drug.
Feeling full of energy was assessed by participants using a 0-100 mm visual analog scale (VAS) in response to Weekly Sleep Diary question 7 "How full of energy have you felt over the past 7 days?". Scores could range from 0=Terribly tired to 100=Full of energy. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an OC approach.
Outcome measures
| Measure |
Esmirtazapine 1.5 mg
n=128 Participants
Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
Esmirtazapine 3.0 mg
n=131 Participants
Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
|---|---|---|
|
Change From Baseline in Feeling Full of Energy
Change from BL at Week 52 (n=61, 53)
|
20.1 Score on a Scale
Standard Deviation 29.3
|
20.8 Score on a Scale
Standard Deviation 22.6
|
|
Change From Baseline in Feeling Full of Energy
BL (n=121, 123)
|
42.6 Score on a Scale
Standard Deviation 16.8
|
43.3 Score on a Scale
Standard Deviation 18.2
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: The AST population consisted of all participants who received at least one dose of study drug.
Ability to work/function was assessed by participants using a 0-100 mm visual analog scale (VAS) in response to Weekly Sleep Diary question 8 "How were you able to work or function over the past 7 days?". Scores could range from 0=Not at all to 100=Very well. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an OC approach.
Outcome measures
| Measure |
Esmirtazapine 1.5 mg
n=128 Participants
Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
Esmirtazapine 3.0 mg
n=131 Participants
Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
|---|---|---|
|
Change From Baseline in Ability to Work/Function
BL (n=121, 123)
|
46.9 Score on a Scale
Standard Deviation 16.8
|
45.9 Score on a Scale
Standard Deviation 18.7
|
|
Change From Baseline in Ability to Work/Function
Change from BL at Week 52 (n=61, 53)
|
19.7 Score on a Scale
Standard Deviation 27.3
|
21.7 Score on a Scale
Standard Deviation 21.5
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: The AST population consisted of all participants who received at least one dose of study drug.
Total nap time was assessed by participants in response to Weekly Sleep Diary question 9a "How much time per day did you nap, on average?". Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an OC approach.
Outcome measures
| Measure |
Esmirtazapine 1.5 mg
n=128 Participants
Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
Esmirtazapine 3.0 mg
n=131 Participants
Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
|---|---|---|
|
Change From Baseline in Total Nap Time
BL (n=48, 45)
|
23.3 Minutes
Standard Deviation 16.0
|
30.5 Minutes
Standard Deviation 31.6
|
|
Change From Baseline in Total Nap Time
Change from BL at Week 52 (n=18, 14)
|
10.7 Minutes
Standard Deviation 65.2
|
2.9 Minutes
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: The Intent-To-Treat (ITT) population consisted of all participants who received at least one dose of study drug and had at least one postbaseline TST assessment.
TST was defined as the time recorded by participants in response to Weekly Sleep Diary question 4 "During the past 7 nights, how much time did you actually spend sleeping, on average?". Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a last observation carried forward (LOCF) approach.
Outcome measures
| Measure |
Esmirtazapine 1.5 mg
n=128 Participants
Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
Esmirtazapine 3.0 mg
n=129 Participants
Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
|---|---|---|
|
Change From Baseline in Total Sleep Time (TST)
BL (n=121,121)
|
294.3 Minutes
Standard Deviation 71.0
|
292.3 Minutes
Standard Deviation 67.4
|
|
Change From Baseline in Total Sleep Time (TST)
Change from BL at Week 52 (n=123,128)
|
88.3 Minutes
Standard Deviation 89.5
|
86.3 Minutes
Standard Deviation 96.3
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: The ITT population consisted of all participants who received at least one dose of study drug and had at least one postbaseline WASO assessment.
WASO was defined as the time recorded by participants in response to Weekly Sleep Diary question 4 "During the past 7 nights, how much time were you awake, on average, after falling asleep initially?" Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a LOCF approach.
Outcome measures
| Measure |
Esmirtazapine 1.5 mg
n=128 Participants
Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
Esmirtazapine 3.0 mg
n=129 Participants
Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
|---|---|---|
|
Change From Baseline in Wake Time After Sleep Onset (WASO)
BL (n=121,121)
|
110.2 Minutes
Standard Deviation 88.0
|
102.4 Minutes
Standard Deviation 72.2
|
|
Change From Baseline in Wake Time After Sleep Onset (WASO)
Change from BL at Week 52 (n=122,128)
|
-62.7 Minutes
Standard Deviation 81.2
|
-47.2 Minutes
Standard Deviation 84.9
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: The ITT population consisted of all participants who received at least one dose of study drug and had at least one postbaseline SL assessment.
SL was defined as the time recorded by participants in response to Weekly Sleep Diary question 4 "During the past 7 nights, how long did it take you to fall asleep, on average?" Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a LOCF approach.
Outcome measures
| Measure |
Esmirtazapine 1.5 mg
n=128 Participants
Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
Esmirtazapine 3.0 mg
n=129 Participants
Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
|---|---|---|
|
Change From Baseline in Sleep Latency (SL)
BL (n=121,121)
|
89.8 Minutes
Standard Deviation 73.6
|
92.5 Minutes
Standard Deviation 79.1
|
|
Change From Baseline in Sleep Latency (SL)
Change from BL at Week 52 (n=123,128)
|
-26.1 Minutes
Standard Deviation 99.2
|
-22.2 Minutes
Standard Deviation 101.3
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: The ITT population consisted of all participants who received at least one dose of study drug and had at least one postbaseline NAW assessment.
NAW was defined as the time recorded by participants in response to Weekly Sleep Diary question 2a "During the past 7 nights, how many times did you wake up, on average?" Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a LOCF approach.
Outcome measures
| Measure |
Esmirtazapine 1.5 mg
n=128 Participants
Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
Esmirtazapine 3.0 mg
n=129 Participants
Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
|---|---|---|
|
Change From Baseline in Number of Awakenings (NAW)
Change from BL at Week 52 (n=114, 109)
|
-0.3 Number of Awakenings
Standard Deviation 1.3
|
-0.4 Number of Awakenings
Standard Deviation 1.2
|
|
Change From Baseline in Number of Awakenings (NAW)
BL (n=118,114)
|
2.5 Number of Awakenings
Standard Deviation 1.4
|
2.6 Number of Awakenings
Standard Deviation 1.3
|
Adverse Events
Esmirtazapine 1.5 mg
Serious events: 9 serious events
Other events: 83 other events
Deaths: 0 deaths
Esmirtazapine 3.0 mg
Serious events: 6 serious events
Other events: 102 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Esmirtazapine 1.5 mg
n=128 participants at risk
Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
Esmirtazapine 3.0 mg
n=131 participants at risk
Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/128 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
0.76%
1/131 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Cardiac disorders
Cardiac failure
|
0.78%
1/128 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
0.00%
0/131 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Cardiac disorders
Coronary artery occlusion
|
0.78%
1/128 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
0.00%
0/131 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Cardiac disorders
Hypertensive heart disease
|
0.78%
1/128 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
0.00%
0/131 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/128 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
0.76%
1/131 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
1.6%
2/128 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
0.00%
0/131 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
General disorders
Chest pain
|
0.78%
1/128 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
0.00%
0/131 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
General disorders
Hernia
|
0.00%
0/128 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
0.76%
1/131 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/128 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
0.76%
1/131 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Infections and infestations
Pneumonia
|
0.78%
1/128 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
0.76%
1/131 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Injury, poisoning and procedural complications
Contusion
|
0.78%
1/128 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
0.00%
0/131 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Injury, poisoning and procedural complications
Fall
|
0.78%
1/128 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
0.00%
0/131 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Injury, poisoning and procedural complications
Narcotic intoxication
|
0.78%
1/128 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
0.00%
0/131 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.78%
1/128 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
0.00%
0/131 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.00%
0/128 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
0.76%
1/131 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Nervous system disorders
Dizziness
|
0.78%
1/128 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
0.00%
0/131 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Surgical and medical procedures
Angioplasty
|
0.00%
0/128 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
0.76%
1/131 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.78%
1/128 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
0.00%
0/131 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/128 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
0.76%
1/131 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
Other adverse events
| Measure |
Esmirtazapine 1.5 mg
n=128 participants at risk
Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
Esmirtazapine 3.0 mg
n=131 participants at risk
Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.5%
7/128 • Number of events 7 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
6.9%
9/131 • Number of events 9 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Gastrointestinal disorders
Dry mouth
|
7.8%
10/128 • Number of events 13 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
10.7%
14/131 • Number of events 15 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
General disorders
Fatigue
|
13.3%
17/128 • Number of events 18 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
11.5%
15/131 • Number of events 18 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Infections and infestations
Nasopharyngitis
|
16.4%
21/128 • Number of events 26 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
13.0%
17/131 • Number of events 21 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Infections and infestations
Urinary tract infection
|
1.6%
2/128 • Number of events 3 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
7.6%
10/131 • Number of events 10 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Investigations
Weight increased
|
8.6%
11/128 • Number of events 13 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
15.3%
20/131 • Number of events 20 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Metabolism and nutrition disorders
Increased appetite
|
3.9%
5/128 • Number of events 7 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
9.2%
12/131 • Number of events 15 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.7%
6/128 • Number of events 6 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
6.9%
9/131 • Number of events 11 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
8/128 • Number of events 9 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
6.1%
8/131 • Number of events 11 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Nervous system disorders
Dizziness
|
9.4%
12/128 • Number of events 13 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
14.5%
19/131 • Number of events 21 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Nervous system disorders
Headache
|
10.2%
13/128 • Number of events 14 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
9.2%
12/131 • Number of events 13 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Nervous system disorders
Restless legs syndrome
|
2.3%
3/128 • Number of events 3 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
6.1%
8/131 • Number of events 8 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
8/128 • Number of events 9 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
2.3%
3/131 • Number of events 3 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
|
Vascular disorders
Hypertension
|
2.3%
3/128 • Number of events 3 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
8.4%
11/131 • Number of events 12 • Up to 30 days after last dose of study drug for serious AEs. Up to 7 days after last dose of study drug for non-serious AEs
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60