Trial Outcomes & Findings for A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107) (NCT NCT01208181)
NCT ID: NCT01208181
Last Updated: 2024-06-18
Results Overview
Disease Activity Score Using C-Reactive Protein \[DAS28-CRP\] (0 - 10 Range). The DAS28-CRP index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56\*square root (sqrt) (tender joint count \[28\])+0.28\*sqrt(swollen joint count \[28\] )+0.36\* ln(crp+1) + 0.014\* Patient Global Assessment of Disease Activity + 0.96. The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1404 participants
Primary outcome timeframe
Baseline and Week 6
Results posted on
2024-06-18
Participant Flow
Participant milestones
| Measure |
Etoricoxib 60 mg
The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
|
Etoricoxib 90 mg
The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
|
Etoricoxib 60 mg/Etoricoxib 60 mg
The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence received etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
|
Etoricoxib 60/Etoricoxib 90mg
The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
|
Placebo
The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
|
|---|---|---|---|---|---|
|
Part 1
STARTED
|
818
|
468
|
0
|
0
|
118
|
|
Part 1
COMPLETED
|
719
|
413
|
0
|
0
|
96
|
|
Part 1
NOT COMPLETED
|
99
|
55
|
0
|
0
|
22
|
|
Part 2
STARTED
|
0
|
0
|
350
|
363
|
0
|
|
Part 2
COMPLETED
|
0
|
0
|
334
|
343
|
0
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
16
|
20
|
0
|
Reasons for withdrawal
| Measure |
Etoricoxib 60 mg
The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
|
Etoricoxib 90 mg
The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
|
Etoricoxib 60 mg/Etoricoxib 60 mg
The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence received etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
|
Etoricoxib 60/Etoricoxib 90mg
The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
|
Placebo
The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
|
|---|---|---|---|---|---|
|
Part 1
Withdrawal by Subject
|
11
|
10
|
0
|
0
|
0
|
|
Part 1
Technical problem
|
5
|
0
|
0
|
0
|
0
|
|
Part 1
Protocol Violation
|
10
|
5
|
0
|
0
|
0
|
|
Part 1
Physician Decision
|
4
|
0
|
0
|
0
|
0
|
|
Part 1
Non-compliance with study drug
|
1
|
1
|
0
|
0
|
0
|
|
Part 1
Lost to Follow-up
|
5
|
3
|
0
|
0
|
1
|
|
Part 1
Lack of Efficacy
|
37
|
12
|
0
|
0
|
17
|
|
Part 1
Adverse Event
|
26
|
24
|
0
|
0
|
4
|
|
Part 2
Adverse Event
|
0
|
0
|
6
|
7
|
0
|
|
Part 2
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
0
|
|
Part 2
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
|
Part 2
Physician Decision
|
0
|
0
|
1
|
2
|
0
|
|
Part 2
Non-compliance with study drug
|
0
|
0
|
1
|
1
|
0
|
|
Part 2
Lost to Follow-up
|
0
|
0
|
1
|
2
|
0
|
|
Part 2
Lack of Efficacy
|
0
|
0
|
5
|
7
|
0
|
Baseline Characteristics
A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)
Baseline characteristics by cohort
| Measure |
Etoricoxib 60 mg
n=818 Participants
The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
|
Etoricoxib 90 mg
n=468 Participants
The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
|
Placebo
n=118 Participants
The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
|
Total
n=1404 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.8 Years
STANDARD_DEVIATION 11.9 • n=93 Participants
|
54.0 Years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
53.6 Years
STANDARD_DEVIATION 11.0 • n=27 Participants
|
53.8 Years
STANDARD_DEVIATION 12.0 • n=483 Participants
|
|
Sex: Female, Male
Female
|
677 Participants
n=93 Participants
|
395 Participants
n=4 Participants
|
100 Participants
n=27 Participants
|
1172 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
141 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
232 Participants
n=483 Participants
|
|
Disease Activity Score using C reactive protein (DAS28-CRP)
|
5.64 Scores on a scale
STANDARD_DEVIATION 0.99 • n=93 Participants
|
5.62 Scores on a scale
STANDARD_DEVIATION 1.00 • n=4 Participants
|
5.65 Scores on a scale
STANDARD_DEVIATION 1.12 • n=27 Participants
|
5.63 Scores on a scale
STANDARD_DEVIATION 1.00 • n=483 Participants
|
|
Patient Global Assessment of Pain
|
70.84 Scores on a scale
STANDARD_DEVIATION 15.50 • n=93 Participants
|
70.58 Scores on a scale
STANDARD_DEVIATION 15.02 • n=4 Participants
|
74.08 Scores on a scale
STANDARD_DEVIATION 14.23 • n=27 Participants
|
71.02 Scores on a scale
STANDARD_DEVIATION 15.24 • n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: The modified intention-to-treat (mITT) population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.
Disease Activity Score Using C-Reactive Protein \[DAS28-CRP\] (0 - 10 Range). The DAS28-CRP index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56\*square root (sqrt) (tender joint count \[28\])+0.28\*sqrt(swollen joint count \[28\] )+0.36\* ln(crp+1) + 0.014\* Patient Global Assessment of Disease Activity + 0.96. The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed.
Outcome measures
| Measure |
Etoricoxib 60 mg
n=732 Participants
The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
|
Etoricoxib 90 mg
n=426 Participants
The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
|
Placebo
n=103 Participants
The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
|
Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2
The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
|
Placebo - Part 1
The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
|
|---|---|---|---|---|---|
|
Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib vs. Placebo)
|
-1.39 Scores on a scale
Interval -1.48 to -1.3
|
-1.37 Scores on a scale
Interval -1.48 to -1.26
|
-1.10 Scores on a scale
Interval -1.29 to -0.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: The mITT population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.
A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker "no pain" (0 mm) or right-hand marker "extreme pain" (100 mm). The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed.
Outcome measures
| Measure |
Etoricoxib 60 mg
n=751 Participants
The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
|
Etoricoxib 90 mg
n=430 Participants
The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
|
Placebo
n=108 Participants
The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
|
Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2
The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
|
Placebo - Part 1
The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
|
|---|---|---|---|---|---|
|
Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib vs. Placebo)
|
-28.25 Scores on a scale
Interval -30.05 to -26.44
|
-30.96 Scores on a scale
Interval -33.13 to -28.79
|
-20.26 Scores on a scale
Interval -24.04 to -16.48
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 112 daysPopulation: All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Outcome measures
| Measure |
Etoricoxib 60 mg
n=819 Participants
The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
|
Etoricoxib 90 mg
n=467 Participants
The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
|
Placebo
n=350 Participants
The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
|
Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2
n=363 Participants
The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
|
Placebo - Part 1
n=118 Participants
The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced at Least One Adverse Event (AE)
|
30.3 Percentage of participants
|
36.0 Percentage of participants
|
19.1 Percentage of participants
|
24.5 Percentage of participants
|
25.4 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 12Population: ASaT population defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Outcome measures
| Measure |
Etoricoxib 60 mg
n=819 Participants
The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
|
Etoricoxib 90 mg
n=467 Participants
The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
|
Placebo
n=350 Participants
The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
|
Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2
n=363 Participants
The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
|
Placebo - Part 1
n=118 Participants
The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Discontinued Study Drug Due to an AE
|
3.3 Percentage of participants
|
5.1 Percentage of participants
|
1.4 Percentage of participants
|
1.9 Percentage of participants
|
3.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: The mITT population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.
Disease Activity Score Using C-Reactive Protein \[DAS28-CRP\] (0 - 10 Range). The DAS28-CRP index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56\*square root (sqrt) (tender joint count \[28\])+0.28\*sqrt(swollen joint count \[28\] )+0.36\* ln(crp+1) + 0.014\* Patient Global Assessment of Disease Activity + 0.96. The key secondary objectives compared the relative efficacy between etoricoxib 90 mg and 60 mg in Part 1 of this study so data for only these 2 arms are displayed.
Outcome measures
| Measure |
Etoricoxib 60 mg
n=732 Participants
The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
|
Etoricoxib 90 mg
n=426 Participants
The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
|
Placebo
The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
|
Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2
The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
|
Placebo - Part 1
The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
|
|---|---|---|---|---|---|
|
Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg)
|
-1.39 Scores on a scale
Interval -1.48 to -1.3
|
-1.37 Scores on a scale
Interval -1.48 to -1.26
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: The mITT population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.
A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker "no pain" (0 mm) or right-hand marker "extreme pain" (100 mm). The key secondary objectives compared the relative efficacy between etoricoxib 90 mg and 60 mg in Part 1 of this study so data for only these 2 arms are displayed.
Outcome measures
| Measure |
Etoricoxib 60 mg
n=751 Participants
The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
|
Etoricoxib 90 mg
n=430 Participants
The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
|
Placebo
The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
|
Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2
The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
|
Placebo - Part 1
The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
|
|---|---|---|---|---|---|
|
Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg)
|
-28.25 Scores on a scale
Interval -30.05 to -26.44
|
-30.96 Scores on a scale
Interval -33.13 to -28.79
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 6 and Week 10 to Week 12Population: This population (a subpopulation of the mITT population) was composed of pain inadequate responder (PIRs) in Part 1. PIRs were defined as participants with \<50% improvement from baseline in Patient Global Assessment of Pain (VAS) at Week 6 and received at least one dose of study medication in Part 2.
A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker "no pain" (0 mm) or right-hand marker "extreme pain" (100 mm). In those participants who were considered inadequate responders to etoricoxib 60 mg in Part 1 (defined as a participant with \<50% improvement from baseline in PGAP \[VAS\] at Week 6), the incremental benefit of increasing the etoricoxib dose from 60 mg (in Part 1) to 90 mg (in Part 2) compared to remaining on 60 mg in Part 2 was evaluated via average change from Week 6 over Weeks 10 and 12 in Patient Global Assessment of Pain score. Therefore, data for only these 2 arms are displayed.
Outcome measures
| Measure |
Etoricoxib 60 mg
n=188 Participants
The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
|
Etoricoxib 90 mg
n=187 Participants
The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
|
Placebo
The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
|
Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2
The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
|
Placebo - Part 1
The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
|
|---|---|---|---|---|---|
|
Average Change From Week 6 in Patient Global Assessment of Pain Over Weeks 10 and 12 in Part 2 Among Pain Inadequate Responders From Part 1
|
-11.96 Scores on a scale
Interval -14.96 to -8.97
|
-10.35 Scores on a scale
Interval -13.32 to -7.39
|
—
|
—
|
—
|
Adverse Events
Etoricoxib 60 mg - Part 1
Serious events: 7 serious events
Other events: 25 other events
Deaths: 0 deaths
Etoricoxib 90 mg - Part 1
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo - Part 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etoricoxib 60 mg - Part 1
n=819 participants at risk
The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
|
Etoricoxib 90 mg - Part 1
n=467 participants at risk
The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
|
Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2
n=350 participants at risk
The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
|
Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2
n=363 participants at risk
The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
|
Placebo - Part 1
n=118 participants at risk
The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/819 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/467 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/350 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.28%
1/363 • Number of events 1 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/118 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/819 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/467 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.29%
1/350 • Number of events 1 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/363 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/118 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/819 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/467 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/350 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.28%
1/363 • Number of events 1 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/118 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.12%
1/819 • Number of events 1 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/467 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/350 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/363 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/118 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.12%
1/819 • Number of events 1 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/467 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/350 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/363 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/118 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/819 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/467 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.29%
1/350 • Number of events 1 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/363 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/118 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
General disorders
Chest discomfort
|
0.12%
1/819 • Number of events 1 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/467 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/350 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/363 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/118 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
General disorders
Non-cardiac chest pain
|
0.24%
2/819 • Number of events 2 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/467 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.29%
1/350 • Number of events 1 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/363 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/118 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Infections and infestations
Cellulitis
|
0.12%
1/819 • Number of events 1 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/467 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/350 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/363 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/118 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/819 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/467 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/350 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.28%
1/363 • Number of events 1 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/118 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Infections and infestations
Pyomyositis
|
0.00%
0/819 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/467 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/350 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.28%
1/363 • Number of events 1 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/118 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/819 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.21%
1/467 • Number of events 1 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/350 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/363 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/118 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/819 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.21%
1/467 • Number of events 1 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/350 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/363 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/118 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/819 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/467 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/350 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.28%
1/363 • Number of events 1 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/118 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/819 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/467 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.29%
1/350 • Number of events 1 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/363 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/118 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/819 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/467 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/350 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.28%
1/363 • Number of events 1 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/118 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.12%
1/819 • Number of events 1 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/467 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/350 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/363 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/118 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.12%
1/819 • Number of events 1 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/467 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/350 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/363 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/118 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
Other adverse events
| Measure |
Etoricoxib 60 mg - Part 1
n=819 participants at risk
The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
|
Etoricoxib 90 mg - Part 1
n=467 participants at risk
The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
|
Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2
n=350 participants at risk
The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
|
Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2
n=363 participants at risk
The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
|
Placebo - Part 1
n=118 participants at risk
The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
3.1%
25/819 • Number of events 27 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
3.6%
17/467 • Number of events 27 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
1.7%
6/350 • Number of events 6 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
1.7%
6/363 • Number of events 7 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
5.1%
6/118 • Number of events 8 • Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
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 sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER