Trial Outcomes & Findings for A Study of Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P04223) (NCT NCT01502371)
NCT ID: NCT01502371
Last Updated: 2024-06-17
Results Overview
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the primary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI and Placebo treatment groups. The comparison between the MF MDI 50 mcg BID vs. MF DPI 100 mcg QD treatment groups is presented in a subsequent outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
583 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2024-06-17
Participant Flow
A total of 583 participants were randomized; 5 participants were randomized in error and did not receive any doses of randomized study drug.
Participant milestones
| Measure |
MF MDI 50 mcg BID
Participants receive mometasone furoate (MF) metered dose inhaler (MDI) 25 mcg x 2 inhalations (50 mcg total dose) twice daily (BID) PLUS Placebo dry powder inhaler (DPI) x 1 inhalation once daily (QD) in the evening for 12 weeks.
|
MF MDI 100 mcg BID
Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF MDI 200 mcg BID
Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF DPI 100 mcg QD
Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
|
Placebo
Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
120
|
113
|
108
|
125
|
112
|
|
Overall Study
COMPLETED
|
79
|
81
|
83
|
88
|
60
|
|
Overall Study
NOT COMPLETED
|
41
|
32
|
25
|
37
|
52
|
Reasons for withdrawal
| Measure |
MF MDI 50 mcg BID
Participants receive mometasone furoate (MF) metered dose inhaler (MDI) 25 mcg x 2 inhalations (50 mcg total dose) twice daily (BID) PLUS Placebo dry powder inhaler (DPI) x 1 inhalation once daily (QD) in the evening for 12 weeks.
|
MF MDI 100 mcg BID
Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF MDI 200 mcg BID
Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF DPI 100 mcg QD
Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
|
Placebo
Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
1
|
1
|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
4
|
3
|
|
Overall Study
Treatment Failure
|
22
|
20
|
12
|
19
|
30
|
|
Overall Study
Lack of Efficacy
|
3
|
3
|
2
|
2
|
4
|
|
Overall Study
Physician Decision
|
3
|
0
|
0
|
0
|
1
|
|
Overall Study
Noncompliance with Study Drug
|
0
|
0
|
1
|
2
|
1
|
|
Overall Study
Technical Problems
|
1
|
0
|
2
|
4
|
1
|
|
Overall Study
Protocol Violation
|
9
|
5
|
6
|
5
|
10
|
|
Overall Study
Excluded Medication
|
0
|
1
|
1
|
0
|
1
|
Baseline Characteristics
A Study of Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P04223)
Baseline characteristics by cohort
| Measure |
MF MDI 50 mcg BID
n=120 Participants
Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF MDI 100 mcg BID
n=113 Participants
Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF MDI 200 mcg BID
n=108 Participants
Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF DPI 100 mcg QD
n=125 Participants
Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
|
Placebo
n=112 Participants
Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
Total
n=578 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
8.7 Years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
8.6 Years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
8.7 Years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
8.7 Years
STANDARD_DEVIATION 1.7 • n=4 Participants
|
9.0 Years
STANDARD_DEVIATION 1.7 • n=21 Participants
|
8.8 Years
STANDARD_DEVIATION 1.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
232 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
346 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The Full Analysis Set (FAS) population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure. Only participants who received MF MDI or Placebo were included in this primary analysis.
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the primary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI and Placebo treatment groups. The comparison between the MF MDI 50 mcg BID vs. MF DPI 100 mcg QD treatment groups is presented in a subsequent outcome measure.
Outcome measures
| Measure |
MF MDI 50 mcg BID
n=114 Participants
Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF MDI 100 mcg BID
n=109 Participants
Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF MDI 200 mcg BID
n=105 Participants
Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
Placebo
n=111 Participants
Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF DPI 100 mcg QD
Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo
|
4.52 Percentage of Predicted FEV1
Interval 2.32 to 6.72
|
6.95 Percentage of Predicted FEV1
Interval 4.73 to 9.16
|
6.00 Percentage of Predicted FEV1
Interval 3.74 to 8.25
|
0.66 Percentage of Predicted FEV1
Interval -1.72 to 3.03
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The FAS population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure.
PEF, measured in liters per minute, is the highest flow during exhalation. Participants recorded diary entries for PEF twice daily (in the morning upon rising and in the evening at bedtime). The goal of the secondary outcome measure was to compare the change from Baseline in AM PEF between the MF MDI and Placebo treatment groups.
Outcome measures
| Measure |
MF MDI 50 mcg BID
n=118 Participants
Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF MDI 100 mcg BID
n=112 Participants
Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF MDI 200 mcg BID
n=108 Participants
Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
Placebo
n=111 Participants
Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF DPI 100 mcg QD
n=123 Participants
Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in AM Peak Expiratory Flow (PEF) - MF MDI vs. Placebo
|
17.83 Liters/minute
Interval 5.35 to 30.3
|
26.03 Liters/minute
Interval 13.55 to 38.51
|
16.68 Liters/minute
Interval 4.5 to 28.86
|
-1.32 Liters/minute
Interval -15.49 to 12.85
|
-0.92 Liters/minute
Interval -12.82 to 10.99
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The FAS population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure.
The PAQLQ(S) consists of 23 questions in 3 categories: Symptoms (10 items), Activity Limitations (5 items), and Emotional Function (8 items). Responses are based on a 7-point scale (7=not bothered at all to 1=extremely bothered). PAQLQ(S) Total Scores could range from 23 to 161, with a lower score indicating a lower quality of life. The PAQLQ(S) included only participants in participating countries in which a validated translated questionnaire was available. The goal of the secondary outcome measure was to compare the change from Baseline in PAQLQ(S) between the MF MDI and Placebo treatment groups.
Outcome measures
| Measure |
MF MDI 50 mcg BID
n=111 Participants
Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF MDI 100 mcg BID
n=105 Participants
Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF MDI 200 mcg BID
n=101 Participants
Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
Placebo
n=102 Participants
Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF DPI 100 mcg QD
n=115 Participants
Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Paediatric Asthma Quality of Life Questionnaire With Standardised Activities (PAQLQ(S)) Total Score - MF MDI vs. Placebo
|
0.35 Score on a Scale
Interval 0.23 to 0.48
|
0.38 Score on a Scale
Interval 0.25 to 0.5
|
0.44 Score on a Scale
Interval 0.31 to 0.56
|
0.26 Score on a Scale
Interval 0.12 to 0.39
|
0.47 Score on a Scale
Interval 0.35 to 0.59
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The FAS population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure. Only participants who received MF MDI 50 mcg or MF DPI were included in this secondary analysis.
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the secondary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI 50 mcg BID and MF DPI 100 mcg QD treatment groups. The comparisons between the other MF MDI BID and Placebo treatment groups are presented in a previous outcome measure.
Outcome measures
| Measure |
MF MDI 50 mcg BID
n=114 Participants
Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF MDI 100 mcg BID
n=122 Participants
Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF MDI 200 mcg BID
Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
Placebo
Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF DPI 100 mcg QD
Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Percent Predicted AM FEV1 - MF MDI 50 mcg BID vs. MF DPI 100 mcg QD
|
4.52 Percentage of Predicted FEV1
Interval 2.32 to 6.72
|
3.13 Percentage of Predicted FEV1
Interval 1.01 to 5.25
|
—
|
—
|
—
|
Adverse Events
MF MDI 50 mcg BID
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
MF MDI 100 mcg BID
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
MF MDI 200 mcg BID
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
MF DPI 100 mcg QD
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MF MDI 50 mcg BID
n=120 participants at risk
Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF MDI 100 mcg BID
n=113 participants at risk
Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF MDI 200 mcg BID
n=108 participants at risk
Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF DPI 100 mcg QD
n=125 participants at risk
Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
|
Placebo
n=112 participants at risk
Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/120 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.88%
1/113 • Number of events 1 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/108 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/125 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/112 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/120 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/113 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/108 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.80%
1/125 • Number of events 1 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/112 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/120 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/113 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/108 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.80%
1/125 • Number of events 1 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/112 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/120 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/113 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/108 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.80%
1/125 • Number of events 1 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/112 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
|
Infections and infestations
Otitis media
|
0.00%
0/120 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/113 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.93%
1/108 • Number of events 1 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/125 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/112 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/120 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/113 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/108 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.80%
1/125 • Number of events 1 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/112 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/120 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/113 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.93%
1/108 • Number of events 1 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/125 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/112 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.7%
2/120 • Number of events 2 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/113 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/108 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
0.00%
0/125 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
1.8%
2/112 • Number of events 2 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
Other adverse events
| Measure |
MF MDI 50 mcg BID
n=120 participants at risk
Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF MDI 100 mcg BID
n=113 participants at risk
Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF MDI 200 mcg BID
n=108 participants at risk
Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
MF DPI 100 mcg QD
n=125 participants at risk
Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
|
Placebo
n=112 participants at risk
Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.7%
8/120 • Number of events 9 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
4.4%
5/113 • Number of events 6 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
6.5%
7/108 • Number of events 9 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
6.4%
8/125 • Number of events 8 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
7.1%
8/112 • Number of events 9 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
10.8%
13/120 • Number of events 18 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
11.5%
13/113 • Number of events 19 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
11.1%
12/108 • Number of events 19 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
8.0%
10/125 • Number of events 14 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
11.6%
13/112 • Number of events 19 • Up to 12 weeks
The Safety population consisted of all participants who received at least one dose of randomized study drug.
|
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 The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
- Publication restrictions are in place
Restriction type: OTHER