Trial Outcomes & Findings for Patient-Reported Effectiveness and Safety of Etoricoxib in Osteoarthritis (OA)(0663-113) (NCT NCT00757627)
NCT ID: NCT00757627
Last Updated: 2022-02-09
Results Overview
WOMAC for pain assessment by patient (0-100 mm Visual Analog Scale (VAS) with 0 represent "no pain" and 100 represent "extreme pain")
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
500 participants
Primary outcome timeframe
Baseline and end of week 4
Results posted on
2022-02-09
Participant Flow
Participant milestones
| Measure |
Etoricoxib
Etoricoxib 60 mg once a day (q.d.)
|
|---|---|
|
Overall Study
STARTED
|
500
|
|
Overall Study
COMPLETED
|
419
|
|
Overall Study
NOT COMPLETED
|
81
|
Reasons for withdrawal
| Measure |
Etoricoxib
Etoricoxib 60 mg once a day (q.d.)
|
|---|---|
|
Overall Study
Adverse Event
|
15
|
|
Overall Study
Lack of Efficacy
|
10
|
|
Overall Study
Lost to Follow-up
|
28
|
|
Overall Study
Withdrawal by Subject
|
27
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
Patient-Reported Effectiveness and Safety of Etoricoxib in Osteoarthritis (OA)(0663-113)
Baseline characteristics by cohort
| Measure |
Etoricoxib
n=500 Participants
Etoricoxib 60 mg once a day (q.d.)
|
|---|---|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
365 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=5 Participants
|
|
Patient-SF36 (Short form 36) domain scores
SF-36 Physical functional
|
45.1 Units on a scale
STANDARD_DEVIATION 51.3 • n=5 Participants
|
|
Patient-SF36 (Short form 36) domain scores
SF-36 Role limitation due to physical problem
|
24.0 Units on a scale
STANDARD_DEVIATION 42.5 • n=5 Participants
|
|
Patient-SF36 (Short form 36) domain scores
SF-36 Bodily pain
|
52.4 Units on a scale
STANDARD_DEVIATION 63.9 • n=5 Participants
|
|
Patient-SF36 (Short form 36) domain scores
SF-36 General health
|
52.7 Units on a scale
STANDARD_DEVIATION 54.5 • n=5 Participants
|
|
Patient-SF36 (Short form 36) domain scores
SF-36 Vitality
|
55.9 Units on a scale
STANDARD_DEVIATION 57.6 • n=5 Participants
|
|
Patient-SF36 (Short form 36) domain scores
SF-36 Social functioning
|
69.0 Units on a scale
STANDARD_DEVIATION 78.3 • n=5 Participants
|
|
Patient-SF36 (Short form 36) domain scores
SF-36 Role limitation due to emotional problem
|
41.3 Units on a scale
STANDARD_DEVIATION 56.6 • n=5 Participants
|
|
Patient-SF36 (Short form 36) domain scores
SF-36 Mental health
|
61.7 Units on a scale
STANDARD_DEVIATION 66.3 • n=5 Participants
|
|
TSQM (Treatment Satisfaction Questionnaire for Medication )domain scores
TSQM - Effectiveness
|
52.1 Units on a scale
STANDARD_DEVIATION 55.6 • n=5 Participants
|
|
TSQM (Treatment Satisfaction Questionnaire for Medication )domain scores
TSQM - Side effect
|
56.9 Units on a scale
STANDARD_DEVIATION 55.7 • n=5 Participants
|
|
TSQM (Treatment Satisfaction Questionnaire for Medication )domain scores
TSQM - Convenience
|
68.0 Units on a scale
STANDARD_DEVIATION 68.8 • n=5 Participants
|
|
TSQM (Treatment Satisfaction Questionnaire for Medication )domain scores
TSQM - Overall satisfaction
|
44.1 Units on a scale
STANDARD_DEVIATION 45.7 • n=5 Participants
|
|
The mean of patient BPI (Brief Pain Inventory) scores
BPI -Worst pain
|
6.4 Units on a scale
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
The mean of patient BPI (Brief Pain Inventory) scores
BPI -Least pain
|
3.2 Units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
The mean of patient BPI (Brief Pain Inventory) scores
BPI-Average pain
|
4.9 Units on a scale
STANDARD_DEVIATION 3.8 • n=5 Participants
|
|
The mean of patient BPI (Brief Pain Inventory) scores
BPI -Pain right now
|
4.4 Units on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
The mean of patient BPI (Brief Pain Inventory) scores
BPI -Interference on general activities
|
2.9 Units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
The mean of patient BPI (Brief Pain Inventory) scores
BPI - Mood
|
3.2 Units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
The mean of patient BPI (Brief Pain Inventory) scores
BPI -Walking
|
4.3 Units on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
The mean of patient BPI (Brief Pain Inventory) scores
BPI - Normal work
|
4.2 Units on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
The mean of patient BPI (Brief Pain Inventory) scores
BPI- Relations with other people
|
2.5 Units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
The mean of patient BPI (Brief Pain Inventory) scores
BPI - Sleep
|
3.3 Units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
The mean of patient BPI (Brief Pain Inventory) scores
BPI - Enjoyment of life
|
3.0 Units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
The mean of patient WOMAC ( Western Ontario and McMaster Universities Osteoarthritis Index) subscale
WOMAC Pain subscale
|
38.5 Units on a Scale
STANDARD_DEVIATION 22.9 • n=5 Participants
|
|
The mean of patient WOMAC ( Western Ontario and McMaster Universities Osteoarthritis Index) subscale
WOMAC Stiffness subscale
|
36.3 Units on a Scale
STANDARD_DEVIATION 26.9 • n=5 Participants
|
|
The mean of patient WOMAC ( Western Ontario and McMaster Universities Osteoarthritis Index) subscale
WOMAC Physical Function subscale
|
38.0 Units on a Scale
STANDARD_DEVIATION 24.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and end of week 4Population: Per protocol (all patients who completed the WOMAC"pain walking on a flat surface " question at baseline and follow up visit at week 4 will be included for analysis of this endpoint. Among the 419 patients with follow up visit data, 27 patients rated 0 in their VAS pain score at baseline and were excluded from this analysis.
WOMAC for pain assessment by patient (0-100 mm Visual Analog Scale (VAS) with 0 represent "no pain" and 100 represent "extreme pain")
Outcome measures
| Measure |
Etoricoxib
n=392 Participants
Etoricoxib 60 mg q.d.
|
|---|---|
|
The Percentage of Participants Achieving ≥30% Decrease From Baseline in Pain Intensity as Measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Question 1 "Pain Walking on a Flat Surface" at Week 4
|
52.04 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Only patients with baseline and week 4 data were included in this analysis of change
The change from baseline in 3 domain scores (pain, stiffness, and difficult in doing daily activity) of WOMAC at week 4 were measured. Each domain comprises of questions and VAS scales for scoring. For pain domain, 0 represents no pain and 100 represents extreme pain; for stiffness domain, 0 represents no stiffness and 100 represents extreme stiffness; for difficult in doing daily activity domain, 0 represents no difficulty and 100 represents most difficulty.
Outcome measures
| Measure |
Etoricoxib
n=418 Participants
Etoricoxib 60 mg q.d.
|
|---|---|
|
Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4
WOMAC Physical Function subscale (n=416)
|
-8.0 Units on a Scale
Standard Deviation 19.6
|
|
Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4
WOMAC Pain subscale (n=418)
|
-10.0 Units on a Scale
Standard Deviation 20.5
|
|
Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4
WOMAC Stiffness subscale (n=418)
|
-7.9 Units on a Scale
Standard Deviation 25.7
|
SECONDARY outcome
Timeframe: BaselinePopulation: Only patients with baseline and week 4 data were included.
The IGART comprised of five categories: No response, poor response, fair response, good response, and excellent response. The percentage of participants who met the criteria of any of the 5 categories at baseline were collected.
Outcome measures
| Measure |
Etoricoxib
n=500 Participants
Etoricoxib 60 mg q.d.
|
|---|---|
|
Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy)
No Response
|
4.40 Percentage of Participants
|
|
Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy)
Poor Response
|
57.60 Percentage of Participants
|
|
Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy)
Fair Response
|
36.40 Percentage of Participants
|
|
Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy)
Good Response
|
1.60 Percentage of Participants
|
|
Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy)
Excellent Response
|
0.00 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 4Population: Per Protocol
The IGART comprised of five categories: No response, poor response, fair response, good response, and excellent response. The percentage of participants met the criteria of any of the 5 categories at week 4 were collected.
Outcome measures
| Measure |
Etoricoxib
n=430 Participants
Etoricoxib 60 mg q.d.
|
|---|---|
|
Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART
Good response
|
36.74 Percentage of Participants
|
|
Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART
No response
|
5.81 Percentage of Participants
|
|
Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART
Poor response
|
16.05 Percentage of Participants
|
|
Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART
Fair response
|
35.35 Percentage of Participants
|
|
Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART
Excellent response
|
6.05 Percentage of Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Only patients with baseline and week 4 data were included in the analysis. Week 4 N Values; Motility 423 , Self care 422 , Daily Activity 421 , Pain/Discomfort 421 , Anxiety/Depressed 422
The percentage of participants who met the criteria of any of the 3 categories of EQ-5D at baseline and at week 4 were collected.The EQ-5D comprises of 5 dimensions (mobility, self-care, usual activities, pain / discomfort, and anxiety / depression) to be answered using a 3-categorical Likert's scales of: \[No problem, Some problem, and Not able to carry out\] for mobility, self-care and usual activities and \[Not present, moderate and extreme\] for discomfort and anxiety/depression.
Outcome measures
| Measure |
Etoricoxib
n=500 Participants
Etoricoxib 60 mg q.d.
|
|---|---|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline
Pain/Discomfort (n=500) Not present
|
10.00 Percentage of Participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline
Daily activity (n=499) No problem
|
54.91 Percentage of Participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline
Anxiety/Depressed (n=500) Not present
|
51.60 Percentage of Participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline
Motility (n=499) No problem
|
54.91 Percentage of Participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline
Motility (n=499) Some problem
|
45.09 Percentage of Participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline
Motility (n=499) Not able to carry out
|
0.00 Percentage of Participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline
Self care (n=499) No problem
|
86.97 Percentage of Participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline
Self care (n=499) Some problem
|
12.63 Percentage of Participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline
Self care (n=499) Not able to carry out
|
0.40 Percentage of Participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline
Daily activity (n=499) Some problem
|
43.69 Percentage of Participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline
Daily activity (n=499) Not able to carry out
|
1.40 Percentage of Participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline
Pain/Discomfort (n=500) Moderate
|
79.60 Percentage of Participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline
Pain/Discomfort (n=500) Extreme
|
10.40 Percentage of Participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline
Anxiety/Depressed (n=500) Moderate
|
44.00 Percentage of Participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline
Anxiety/Depressed (n=500) Extreme
|
4.40 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 4Population: per protocol
The percentage of participants who met the criteria of any of the 3 categories of EQ-5D at baseline and at week 4 were collected.The EQ-5D comprises of 5 dimensions (mobility, self-care, usual activities, pain / discomfort, and anxiety / depression) to be answered using a 3-categorical Likert's scales of: \[No problem, Some problem, and Not able to carry out\] for mobility, self-care and usual activities and \[ Not present, moderate and extreme\]for discomfort and anxiety/depression
Outcome measures
| Measure |
Etoricoxib
n=423 Participants
Etoricoxib 60 mg q.d.
|
|---|---|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
Motility (n=423) No problem
|
67.61 Percentage of participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
Motility (n=423) Some problem
|
32.39 Percentage of participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
Motility (n=423) Not able to carry out
|
0.00 Percentage of participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
Self care (n=422) No problem
|
90.05 Percentage of participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
Self care (n=422) Some problem
|
9.48 Percentage of participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
Self care (n=422) Not able to carry out
|
0.47 Percentage of participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
Daily activity (n=421) No problem
|
61.76 Percentage of participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
Daily activity (n=421) Some problem
|
37.29 Percentage of participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
Daily activity (n=421) Not able to carry out
|
0.95 Percentage of participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
Pain/Discomfort (n=421) Not present
|
23.04 Percentage of participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
Pain/Discomfort (n=421) Moderate
|
73.63 Percentage of participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
Pain/Discomfort (n=421) Extreme
|
3.33 Percentage of participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
Anxiety/Depressed (n=422) Not present
|
61.37 Percentage of participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
Anxiety/Depressed (n=422) Moderate
|
36.97 Percentage of participants
|
|
Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4
Anxiety/Depressed (n=422) Extreme
|
1.66 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Only patients with both baseline and week 4 follow up data were included in this analysis.
BPI consists of pain and pain interference domains. For pain (0=no pain to 10=extreme pain); for pain interference ( 0=no interference to 10= greatest interference).
Outcome measures
| Measure |
Etoricoxib
n=419 Participants
Etoricoxib 60 mg q.d.
|
|---|---|
|
Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4
BPI Worst pain (n=418)
|
-1.5 Units on a Scale
Standard Deviation 2.4
|
|
Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4
BPI Least pain (n=417)
|
-0.6 Units on a Scale
Standard Deviation 2.2
|
|
Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4
BPI Average pain (n=419)
|
-1.0 Units on a Scale
Standard Deviation 2.0
|
|
Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4
BPI Pain right now (n=416)
|
-1.3 Units on a Scale
Standard Deviation 2.6
|
|
Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4
BPI Interference on general activities (n=419)
|
-0.8 Units on a Scale
Standard Deviation 2.5
|
|
Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4
BPI Interference on Mood (n=419)
|
-1.0 Units on a Scale
Standard Deviation 2.7
|
|
Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4
BPI Interference on Walking (n=419)
|
-1.2 Units on a Scale
Standard Deviation 2.5
|
|
Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4
BPI Interference on Normal work (n=419)
|
-1.1 Units on a Scale
Standard Deviation 2.8
|
|
Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4
BPI Interference on Relations (n=418)
|
-0.6 Units on a Scale
Standard Deviation 2.6
|
|
Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4
BPI Interference on Sleep (n=419)
|
-1.0 Units on a Scale
Standard Deviation 2.8
|
|
Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4
BPI Interference on Enjoyment of life(n=419)
|
-0.8 Units on a Scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: 22 patients who reported side effects at baseline and week 4 were included in "side effect" evaluation.
TSQM consists of four domains (effectiveness; side effect; convenience and overall satisfaction), domain scores ranged from 0 (0=worst) to 100 (100=best) were derived from converting the original Likert's scales to VAS scale.
Outcome measures
| Measure |
Etoricoxib
n=419 Participants
Etoricoxib 60 mg q.d.
|
|---|---|
|
Changes From Baseline in Patient TSQM (Treatment Satisfaction Questionnaire for Medication) Domain Scores at Week 4
Side Effect (n=22)
|
-3.8 Units on a Scale
Standard Deviation 16.4
|
|
Changes From Baseline in Patient TSQM (Treatment Satisfaction Questionnaire for Medication) Domain Scores at Week 4
Convenience (n=418)
|
0.9 Units on a Scale
Standard Deviation 10.8
|
|
Changes From Baseline in Patient TSQM (Treatment Satisfaction Questionnaire for Medication) Domain Scores at Week 4
Overall (n=419)
|
1.1 Units on a Scale
Standard Deviation 20.9
|
|
Changes From Baseline in Patient TSQM (Treatment Satisfaction Questionnaire for Medication) Domain Scores at Week 4
Effectiveness ((n=418)
|
2.8 Units on a Scale
Standard Deviation 17.0
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Only patients with both baseline and week 4 data were included in this analysis.
Outcome measures
| Measure |
Etoricoxib
n=411 Participants
Etoricoxib 60 mg q.d.
|
|---|---|
|
Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4
Days Missed From Work (n=138)
|
-0.4 Days
Standard Deviation 1.6
|
|
Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4
Days Missed From Housekeeping Work (n=411)
|
-2.3 Days
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Intention to treat (ITT)
Weighted scores of the 8 domains of SF36 (i.e., physical functioning; role limiting due to physical problem; bodily pain; general health; vitality; social functioning; role limiting due to emotional problem; mental health) were scored on a scale from 0 \~100, with 100 representing the best possible functioning)
Outcome measures
| Measure |
Etoricoxib
n=419 Participants
Etoricoxib 60 mg q.d.
|
|---|---|
|
Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4
SF36 Physical Functioning (n=418)
|
5.2 Units on a Scale
Standard Deviation 19.9
|
|
Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4
SF36 Role Limiting Due to Physical Problem (n=418)
|
17.6 Units on a Scale
Standard Deviation 49.3
|
|
Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4
SF36 Bodily Pain (n=418)
|
10.6 Units on a Scale
Standard Deviation 17.7
|
|
Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4
SF36 General Health (n=419)
|
2.0 Units on a Scale
Standard Deviation 16.2
|
|
Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4
SF36 Vitality (n=417)
|
1.4 Units on a Scale
Standard Deviation 15.1
|
|
Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4
SF36 Social Functioning (n=419)
|
8.7 Units on a Scale
Standard Deviation 20.3
|
|
Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4
SF36 Role Limiting Due to Emotional Problem(n=418)
|
14.0 Units on a Scale
Standard Deviation 50.4
|
|
Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4
SF36 Mental Health (n=417)
|
4.4 Units on a Scale
Standard Deviation 14.0
|
Adverse Events
Etoricoxib
Serious events: 6 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etoricoxib
n=500 participants at risk
Etoricoxib 60 mg once a day (q.d.)
|
|---|---|
|
Gastrointestinal disorders
Peritoneal adhesion
|
0.20%
1/500 • Number of events 1 • From baseline to end of week 4
|
|
Infections and infestations
Bacterial infection
|
0.20%
1/500 • Number of events 1 • From baseline to end of week 4
|
|
General disorders
Lung abscess, chest pain/tightness and tremor
|
0.20%
1/500 • Number of events 1 • From baseline to end of week 4
|
|
Injury, poisoning and procedural complications
Traffic accident
|
0.20%
1/500 • Number of events 1 • From baseline to end of week 4
|
|
Renal and urinary disorders
Urethritis
|
0.20%
1/500 • Number of events 1 • From baseline to end of week 4
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.20%
1/500 • Number of events 1 • From baseline to end of week 4
|
Other adverse events
| Measure |
Etoricoxib
n=500 participants at risk
Etoricoxib 60 mg once a day (q.d.)
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension / flatulence
|
1.2%
6/500 • Number of events 6 • From baseline to end of week 4
|
|
Gastrointestinal disorders
Abdominal pain, upper
|
1.2%
6/500 • Number of events 6 • From baseline to end of week 4
|
|
Nervous system disorders
Dizziness
|
2.2%
11/500 • Number of events 12 • From baseline to end of week 4
|
|
Vascular disorders
Edema , face/eye /hand/leg
|
4.8%
24/500 • Number of events 24 • From baseline to end of week 4
|
|
Nervous system disorders
Headache
|
1.0%
5/500 • Number of events 5 • From baseline to end of week 4
|
|
Vascular disorders
Hypertension / elevated blood pressure
|
1.8%
9/500 • Number of events 9 • From baseline to end of week 4
|
|
Gastrointestinal disorders
Nausea
|
1.2%
6/500 • Number of events 6 • From baseline to end of week 4
|
|
Cardiac disorders
Palpitation
|
1.6%
8/500 • Number of events 8 • From baseline to end of week 4
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
1.4%
7/500 • Number of events 7 • From baseline to end of week 4
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER