Trial Outcomes & Findings for A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108) (NCT NCT01208207)
NCT ID: NCT01208207
Last Updated: 2024-06-18
Results Overview
Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1015 participants
Primary outcome timeframe
Baseline and up to Week 6
Results posted on
2024-06-18
Participant Flow
All Patients Randomized
Participant milestones
| Measure |
Etoricoxib 60 mg (Part I)
Etoricoxib 60 mg oral tablet once daily for 6 weeks
|
Etoricoxib 90 mg (Part I)
Etoricoxib 90 mg oral tablet once daily for 6 weeks
|
Naproxen 1000 mg (Part I)
Naproxen 500 mg oral tablet twice daily for 6 weeks
|
Etoricoxib 60 mg / 60 mg (Part II)
A continuation of the etoricoxib 60 mg oral tablet once daily for 20 weeks (Part II)
|
Etoricoxib 60 mg / 90 mg (Part II)
An increase of etoricoxib to 90 mg for 20 weeks (Part II)
|
Etoricoxib 90 mg / 90 mg (Part II)
A continuation of the etoricoxib 90 mg oral tablet once daily for 20 weeks (Part II)
|
Naproxen 1000 mg (Part II)
A continuation of the naproxen 500 mg oral tablet twice daily for 20 weeks (Part II)
|
|---|---|---|---|---|---|---|---|
|
Part I
STARTED
|
702
|
156
|
157
|
0
|
0
|
0
|
0
|
|
Part I
COMPLETED
|
632
|
145
|
142
|
0
|
0
|
0
|
0
|
|
Part I
NOT COMPLETED
|
70
|
11
|
15
|
0
|
0
|
0
|
0
|
|
Part II
STARTED
|
0
|
0
|
0
|
314
|
318
|
145
|
142
|
|
Part II
COMPLETED
|
0
|
0
|
0
|
282
|
295
|
129
|
131
|
|
Part II
NOT COMPLETED
|
0
|
0
|
0
|
32
|
23
|
16
|
11
|
Reasons for withdrawal
| Measure |
Etoricoxib 60 mg (Part I)
Etoricoxib 60 mg oral tablet once daily for 6 weeks
|
Etoricoxib 90 mg (Part I)
Etoricoxib 90 mg oral tablet once daily for 6 weeks
|
Naproxen 1000 mg (Part I)
Naproxen 500 mg oral tablet twice daily for 6 weeks
|
Etoricoxib 60 mg / 60 mg (Part II)
A continuation of the etoricoxib 60 mg oral tablet once daily for 20 weeks (Part II)
|
Etoricoxib 60 mg / 90 mg (Part II)
An increase of etoricoxib to 90 mg for 20 weeks (Part II)
|
Etoricoxib 90 mg / 90 mg (Part II)
A continuation of the etoricoxib 90 mg oral tablet once daily for 20 weeks (Part II)
|
Naproxen 1000 mg (Part II)
A continuation of the naproxen 500 mg oral tablet twice daily for 20 weeks (Part II)
|
|---|---|---|---|---|---|---|---|
|
Part I
Adverse Event
|
19
|
2
|
6
|
0
|
0
|
0
|
0
|
|
Part I
Lack of Efficacy
|
21
|
3
|
2
|
0
|
0
|
0
|
0
|
|
Part I
Lost to Follow-up
|
6
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part I
Non-Compliance With Study Drug
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part I
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part I
Progressive Disease
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part I
Protocol Violation
|
8
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Part I
Withdrawal by Subject
|
14
|
4
|
4
|
0
|
0
|
0
|
0
|
|
Part II
Withdrawal by Subject
|
0
|
0
|
0
|
10
|
9
|
3
|
5
|
|
Part II
Adverse Event
|
0
|
0
|
0
|
5
|
9
|
4
|
2
|
|
Part II
Lack of Efficacy
|
0
|
0
|
0
|
6
|
4
|
3
|
3
|
|
Part II
Lost to Follow-up
|
0
|
0
|
0
|
4
|
0
|
2
|
1
|
|
Part II
Non-Compliance With Study Drug
|
0
|
0
|
0
|
4
|
1
|
1
|
0
|
|
Part II
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
|
Part II
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part II
Technical Problems
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)
Baseline characteristics by cohort
| Measure |
Etoricoxib 60 mg
n=702 Participants
Etoricoxib 60 mg oral tablet once daily
|
Etoricoxib 90 mg
n=156 Participants
Etoricoxib 90 mg once daily
|
Naproxen 1000 mg
n=157 Participants
Naproxen 500 mg oral tablet twice daily
|
Total
n=1015 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.4 Years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
45.2 Years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
44.5 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
45.2 Years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
209 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
295 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
493 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
720 Participants
n=4 Participants
|
|
Spinal Pain Intensity
|
76.7 mm VAS
STANDARD_DEVIATION 14.2 • n=5 Participants
|
76.7 mm VAS
STANDARD_DEVIATION 15.2 • n=7 Participants
|
77.0 mm VAS
STANDARD_DEVIATION 14.0 • n=5 Participants
|
76.8 mm VAS
STANDARD_DEVIATION 14.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to Week 6Population: Per-Protocol Population - excluded participants due to important protocol deviations that may have had a substantial effect on the result of the primary efficacy endpoint.
Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Outcome measures
| Measure |
Etoricoxib 90 mg
n=144 Participants
Etoricoxib 90 mg oral tablet once daily for 6 weeks
|
Naproxen 1000 mg
n=143 Participants
Naproxen 500 mg oral tablet twice daily for 6 weeks
|
Naproxen 1000 mg (Part I)
Naproxen 500 mg oral tablet twice daily for 6 weeks
|
Etoricoxib 60 mg / 60 mg (Part II)
A continuation of the etoricoxib 60 mg oral tablet once daily for 20 weeks (Part II)
|
Etoricoxib 60 mg / 90 mg (Part II)
An increase of etoricoxib to 90 mg for 20 weeks (Part II)
|
Etoricoxib 90 mg / 90 mg (Part II)
A continuation of the etoricoxib 90 mg oral tablet once daily for 20 weeks (Part II)
|
Naproxen 1000 mg (Part II)
A continuation of the naproxen 500 mg oral tablet twice daily for 20 weeks (Part II)
|
|---|---|---|---|---|---|---|---|
|
Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Naproxen
|
-31.23 mm VAS
Interval -34.7 to -27.76
|
-30.59 mm VAS
Interval -34.07 to -27.1
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to Week 6Population: Per-Protocol Population - excluded participants due to important protocol deviations that may have had a substantial effect on the result of the primary efficacy endpoint.
Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Outcome measures
| Measure |
Etoricoxib 90 mg
n=660 Participants
Etoricoxib 90 mg oral tablet once daily for 6 weeks
|
Naproxen 1000 mg
n=143 Participants
Naproxen 500 mg oral tablet twice daily for 6 weeks
|
Naproxen 1000 mg (Part I)
Naproxen 500 mg oral tablet twice daily for 6 weeks
|
Etoricoxib 60 mg / 60 mg (Part II)
A continuation of the etoricoxib 60 mg oral tablet once daily for 20 weeks (Part II)
|
Etoricoxib 60 mg / 90 mg (Part II)
An increase of etoricoxib to 90 mg for 20 weeks (Part II)
|
Etoricoxib 90 mg / 90 mg (Part II)
A continuation of the etoricoxib 90 mg oral tablet once daily for 20 weeks (Part II)
|
Naproxen 1000 mg (Part II)
A continuation of the naproxen 500 mg oral tablet twice daily for 20 weeks (Part II)
|
|---|---|---|---|---|---|---|---|
|
Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 60 mg vs. Naproxen
|
-29.00 mm VAS
Interval -30.69 to -27.31
|
-30.59 mm VAS
Interval -34.07 to -27.1
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 26 weeksPopulation: All Patients as Treated Population (APaT) - Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to 60 mg in Part II received 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
Outcome measures
| Measure |
Etoricoxib 90 mg
n=702 Participants
Etoricoxib 90 mg oral tablet once daily for 6 weeks
|
Naproxen 1000 mg
n=155 Participants
Naproxen 500 mg oral tablet twice daily for 6 weeks
|
Naproxen 1000 mg (Part I)
n=156 Participants
Naproxen 500 mg oral tablet twice daily for 6 weeks
|
Etoricoxib 60 mg / 60 mg (Part II)
n=313 Participants
A continuation of the etoricoxib 60 mg oral tablet once daily for 20 weeks (Part II)
|
Etoricoxib 60 mg / 90 mg (Part II)
n=319 Participants
An increase of etoricoxib to 90 mg for 20 weeks (Part II)
|
Etoricoxib 90 mg / 90 mg (Part II)
n=145 Participants
A continuation of the etoricoxib 90 mg oral tablet once daily for 20 weeks (Part II)
|
Naproxen 1000 mg (Part II)
n=142 Participants
A continuation of the naproxen 500 mg oral tablet twice daily for 20 weeks (Part II)
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Discontinuing Study Treatment Due to an Adverse Event
|
22 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
9 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to Week 6Population: Modified Intent-to-Treat (mITT) Population - the mITT population in Part I consisted of all randomized participants who received at least 1 dose of study treatment, had at least 1 measurement of interest post-randomization that was collected within 3 days of the last dose of study medication taken in Part I, and had baseline data.
Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Outcome measures
| Measure |
Etoricoxib 90 mg
n=153 Participants
Etoricoxib 90 mg oral tablet once daily for 6 weeks
|
Naproxen 1000 mg
n=694 Participants
Naproxen 500 mg oral tablet twice daily for 6 weeks
|
Naproxen 1000 mg (Part I)
Naproxen 500 mg oral tablet twice daily for 6 weeks
|
Etoricoxib 60 mg / 60 mg (Part II)
A continuation of the etoricoxib 60 mg oral tablet once daily for 20 weeks (Part II)
|
Etoricoxib 60 mg / 90 mg (Part II)
An increase of etoricoxib to 90 mg for 20 weeks (Part II)
|
Etoricoxib 90 mg / 90 mg (Part II)
A continuation of the etoricoxib 90 mg oral tablet once daily for 20 weeks (Part II)
|
Naproxen 1000 mg (Part II)
A continuation of the naproxen 500 mg oral tablet twice daily for 20 weeks (Part II)
|
|---|---|---|---|---|---|---|---|
|
Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Etoricoxib 60 mg
|
-30.51 mm VAS
Interval -33.87 to -27.15
|
-28.94 mm VAS
Interval -30.58 to -27.29
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 6 to Week 10 and Week 12Population: Modified Intent-to-Treat (mITT) Population - the mITT population in Part I consisted of all randomized participants who received at least 1 dose of study treatment, had at least 1 measurement of interest post-randomization that was collected within 3 days of the last dose of study medication taken in Part I, and had baseline data.
Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. Average change from Week 6 in Spinal Pain Intensity (VAS) over Weeks 10 and 12 is calculated as the average Spinal pain Intensity (VAS) value over Weeks 10 and 12 minus the Spinal Pain Intensity (VAS) at Week 6.
Outcome measures
| Measure |
Etoricoxib 90 mg
n=178 Participants
Etoricoxib 90 mg oral tablet once daily for 6 weeks
|
Naproxen 1000 mg
n=175 Participants
Naproxen 500 mg oral tablet twice daily for 6 weeks
|
Naproxen 1000 mg (Part I)
Naproxen 500 mg oral tablet twice daily for 6 weeks
|
Etoricoxib 60 mg / 60 mg (Part II)
A continuation of the etoricoxib 60 mg oral tablet once daily for 20 weeks (Part II)
|
Etoricoxib 60 mg / 90 mg (Part II)
An increase of etoricoxib to 90 mg for 20 weeks (Part II)
|
Etoricoxib 90 mg / 90 mg (Part II)
A continuation of the etoricoxib 90 mg oral tablet once daily for 20 weeks (Part II)
|
Naproxen 1000 mg (Part II)
A continuation of the naproxen 500 mg oral tablet twice daily for 20 weeks (Part II)
|
|---|---|---|---|---|---|---|---|
|
Average Change From Week 6 in the Spinal Pain Intensity Over Weeks 10 and 12 in Study Part 2: Etoricoxib 60/90 mg vs. Etoricoxib 60mg (Non-responders From Part I)
|
-9.97 mm VAS
Interval -12.42 to -7.51
|
-7.26 mm VAS
Interval -9.73 to -4.8
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Etoricoxib 60 mg / Etoricoxib 60 mg
Serious events: 1 serious events
Other events: 55 other events
Deaths: 0 deaths
Etoricoxib 60 mg / Etoricoxib 90 mg
Serious events: 7 serious events
Other events: 50 other events
Deaths: 0 deaths
Etoricoxib 90 mg / Etoricoxib 90 mg
Serious events: 6 serious events
Other events: 24 other events
Deaths: 0 deaths
Naproxen 1000 mg / Naproxen 1000 mg
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Etoricoxib 60 mg
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
Etoricoxib 90 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Naproxen 1000 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etoricoxib 60 mg / Etoricoxib 60 mg
n=313 participants at risk
Participants who received Etoricoxib 60 mg in Part I and at least one dose of Etoricoxib 60 mg in Part II.
|
Etoricoxib 60 mg / Etoricoxib 90 mg
n=319 participants at risk
Participants who received Etoricoxib 60 mg in Part I and at least one dose of Etoricoxib 90 mg in Part II.
|
Etoricoxib 90 mg / Etoricoxib 90 mg
n=145 participants at risk
Participants who received Etoricoxib 90 mg in Part I and at least one dose of Etoricoxib 90 mg in Part II.
|
Naproxen 1000 mg / Naproxen 1000 mg
n=142 participants at risk
Participants who received Naproxen 1000 mg in Part I and at least one dose of Naproxen 1000 mg in Part II.
|
Etoricoxib 60 mg
n=70 participants at risk
Participants who received at least one dose of Etoricoxib 60 mg in Part I, but no drug in Part II.
|
Etoricoxib 90 mg
n=10 participants at risk
Participants who received at least one dose of Etoricoxib 90 mg in Part I, but no drug in Part II.
|
Naproxen 1000 mg
n=14 participants at risk
Participants who received at least one dose of Naproxen 1000 mg in Part I, but no drug in Part II.
|
|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.31%
1/319 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
1.4%
1/70 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.69%
1/145 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.31%
1/319 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.31%
1/319 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Eye disorders
Glaucoma
|
0.32%
1/313 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.31%
1/319 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.31%
1/319 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
General disorders
Death
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.31%
1/319 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.70%
1/142 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Infections and infestations
Abscess
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.70%
1/142 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.69%
1/145 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.31%
1/319 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.70%
1/142 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.69%
1/145 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.69%
1/145 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.69%
1/145 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ear neoplasm
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.31%
1/319 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.31%
1/319 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.69%
1/145 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Psychiatric disorders
Depression
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.31%
1/319 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
1.4%
2/145 • Number of events 2 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.69%
1/145 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Vascular disorders
Hypertension
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.31%
1/319 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
1.4%
1/70 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
1.4%
1/70 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
1.4%
1/70 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Nervous system disorders
Headache
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
1.4%
1/70 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
1.4%
1/70 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
1.4%
1/70 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
Other adverse events
| Measure |
Etoricoxib 60 mg / Etoricoxib 60 mg
n=313 participants at risk
Participants who received Etoricoxib 60 mg in Part I and at least one dose of Etoricoxib 60 mg in Part II.
|
Etoricoxib 60 mg / Etoricoxib 90 mg
n=319 participants at risk
Participants who received Etoricoxib 60 mg in Part I and at least one dose of Etoricoxib 90 mg in Part II.
|
Etoricoxib 90 mg / Etoricoxib 90 mg
n=145 participants at risk
Participants who received Etoricoxib 90 mg in Part I and at least one dose of Etoricoxib 90 mg in Part II.
|
Naproxen 1000 mg / Naproxen 1000 mg
n=142 participants at risk
Participants who received Naproxen 1000 mg in Part I and at least one dose of Naproxen 1000 mg in Part II.
|
Etoricoxib 60 mg
n=70 participants at risk
Participants who received at least one dose of Etoricoxib 60 mg in Part I, but no drug in Part II.
|
Etoricoxib 90 mg
n=10 participants at risk
Participants who received at least one dose of Etoricoxib 90 mg in Part I, but no drug in Part II.
|
Naproxen 1000 mg
n=14 participants at risk
Participants who received at least one dose of Naproxen 1000 mg in Part I, but no drug in Part II.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.8%
15/313 • Number of events 28 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
2.5%
8/319 • Number of events 12 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
1.4%
2/145 • Number of events 2 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
7.0%
10/142 • Number of events 10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
4.3%
3/70 • Number of events 6 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
17/313 • Number of events 19 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
6.6%
21/319 • Number of events 21 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
4.8%
7/145 • Number of events 7 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
2.8%
4/142 • Number of events 4 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Nervous system disorders
Headache
|
3.2%
10/313 • Number of events 15 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
4.1%
13/319 • Number of events 18 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
6.2%
9/145 • Number of events 11 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
3.5%
5/142 • Number of events 5 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
5.7%
4/70 • Number of events 13 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
10.0%
1/10 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
7.1%
1/14 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Vascular disorders
Hypertension
|
5.8%
18/313 • Number of events 21 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
4.7%
15/319 • Number of events 16 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
5.5%
8/145 • Number of events 8 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
5.6%
8/142 • Number of events 8 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
5.7%
4/70 • Number of events 4 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
14.3%
2/14 • Number of events 2 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.64%
2/313 • Number of events 2 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
7.1%
1/14 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Cardiac disorders
Palpitations
|
0.64%
2/313 • Number of events 2 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
10.0%
1/10 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
7.1%
1/14 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.31%
1/319 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
7.1%
1/14 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.3%
4/313 • Number of events 4 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
2.2%
7/319 • Number of events 8 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.70%
1/142 • Number of events 2 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
7.1%
1/14 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.96%
3/313 • Number of events 3 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.94%
3/319 • Number of events 3 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.70%
1/142 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
1.4%
1/70 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
10.0%
1/10 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
7/313 • Number of events 7 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
2.5%
8/319 • Number of events 8 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
1.4%
2/145 • Number of events 2 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
2.8%
4/142 • Number of events 5 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
5.7%
4/70 • Number of events 6 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
10.0%
1/10 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
7.1%
1/14 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
5/313 • Number of events 5 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.94%
3/319 • Number of events 4 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
2.1%
3/145 • Number of events 3 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.70%
1/142 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
5.7%
4/70 • Number of events 4 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
14.3%
2/14 • Number of events 2 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
7.1%
1/14 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Gastrointestinal disorders
Vomiting
|
0.64%
2/313 • Number of events 2 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.63%
2/319 • Number of events 2 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
1.4%
1/70 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
7.1%
1/14 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
7.1%
1/14 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Investigations
Blood pressure increased
|
2.9%
9/313 • Number of events 10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
2.2%
7/319 • Number of events 7 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
1.4%
1/70 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
10.0%
1/10 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
7.1%
1/14 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Nervous system disorders
Dizziness
|
0.32%
1/313 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
1.3%
4/319 • Number of events 10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
2.9%
2/70 • Number of events 2 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
7.1%
1/14 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
2.1%
3/145 • Number of events 3 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
10.0%
1/10 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
7.1%
1/14 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.32%
1/313 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
1.9%
6/319 • Number of events 6 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.69%
1/145 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
10.0%
1/10 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
7.1%
1/14 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/313 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/319 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/10 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
7.1%
1/14 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.64%
2/313 • Number of events 2 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.31%
1/319 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.69%
1/145 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
1.4%
2/142 • Number of events 2 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
2.9%
2/70 • Number of events 2 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
10.0%
1/10 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
4/313 • Number of events 5 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.31%
1/319 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/145 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.70%
1/142 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
2.9%
2/70 • Number of events 2 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
10.0%
1/10 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.32%
1/313 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.31%
1/319 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.69%
1/145 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/142 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/70 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
10.0%
1/10 • Number of events 1 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
0.00%
0/14 • Up to Week 30 (including up to 28 days after last dose of study drug)
AE's were collected for the All Patients as Treated Population. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to Etoricoxib 60 mg in Part II received Etoricoxib 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.
|
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