COXIBUS: A Study of the Patterns of Use of Etoricoxib in France (MK-0663-148)
Study Details
Study Description
Brief Summary
This postmarketing study will examine the use of etoricoxib (Arcoxia®) in routine clinical practice in France as well as the use of celecoxib (Celebrex®).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Group Arcoxia® Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Drug: etorocoxib
Administered as 30 mg or 60 mg oral film-coated tablets
Other Names:
|
Group Celebrex® Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Drug: celecoxib
Administered as 100 mg or 200 mg oral hard capsules
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Demonstrating Proper Use of Arcoxia® and Celebrex® [Up to 12 months]
Proper use of study medication is defined as administration of medication in terms of indication and dosage according to Market Authorization (MA). Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.
- Reasons for Misuse of Arcoxia® and Celebrex® [Up to 12 months]
Proper use of study medication is defined as administration of medication in terms of indication and dosage according to MA. Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.
- Indications for Which Arcoxia® and Celebrex® Were Prescribed [At study entry]
The reasons (indications) for prescribing of Arcoxia® or Celebrex® were collected in open-field forms by the Investigator; category assignment (i.e, re-codification) of verbatim entries was conducted by a group of medical experts under the guidance approved by the MA. This endpoint gives the number of participants treated per indication.
- Dosage of Arcoxia® and Celebrex® at Initiation [At study entry]
Dosage at initiation of treatment with Arcoxia® or Celebrex® was identified. MA compliant dosage at initiation corresponds to a (starting) dose of 30 mg daily for Arcoxia® or a (starting) dose of 200 mg daily for Celebrex®. The dose for initiation was calculated by multiplying the number of doses per day with the dose level (total daily dose) as noted in the prescription record.
- Mean Dosage of Arcoxia® and Celebrex® During Treatment [Up to 12 months]
The mean dosage of Arcoxia® and Celebrex® during treatment was determined. For participants who stopped treatment after their initial study visit, the maximum dose recorded at their final study visit was considered when calculating their mean dosage during treatment.
- Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex® [Up to 12 months]
Participants requiring modifications to their Arcoxia® or Celebrex® dose regimens during their on study treatment course were identified. Dose modifications were defined as an increase, decrease followed by increase, decrease, or increase followed by decrease in the participant's daily dose; all categorizations were exclusive. If the maximum dose at discontinuation of treatment was greater than that at initiation, the participant was considered as having had an increase in dose during treatment. Alternatively, if data obtained from a participant's prescription records showed a successive lowering of dosage, the participant was considered as having had a decrease in dose during treatment. Dosages at baseline were included in the dose modification determination for treatment renewal participants.
- Duration of Prescription for Arcoxia® and Celebrex® at Enrollment [Up to 3 months prior to study entry]
The mean duration of prescription at enrollment for participants treated with Arcoxia® and Celebrex® was determined using the participant's record.
- Total Duration of Treatment With Arcoxia® and Celebrex® [Up to 12 months]
The total duration of treatment (DoT) with Arcoxia® or Celebrex® was determined for populations that achieved end-of study and end-of-protocol or that were categorized as lost to follow-up. Participants enumerated as end-of-study had their treatment discontinued during the protocol-specified one year of follow-up. Participants enumerated as end-of-protocol were ongoing treatment at end of the protocol-specified one year of follow-up. Participants categorized as lost to follow-up had no follow-up visit where a determination of discontinuation from treatment could be made.
- Maximum Dosage Prescribed During Treatment With Arcoxia® and Celebrex® [Up to 12 months]
Mean maximum dosage prescribed during follow-up in participants treated with Arcoxia® or Celebrex®. Dosage is expressed as total daily dose.
- Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex® [Up to 12 months]
The individual reasons for discontinuation of treatment with Arcoxia® or Celebrex® were identified over the course of study through either physician selection from a pre-determined list or verbatim entry by the physician with subsequent re-codification by Sponsor.
- Type of Arcoxia® and Celebrex® Use [Up to 12 months]
The type of Arcoxia® or Celebrex® use during the study was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days) by the Investigating Physician at time of treatment discontinuation.
- Type of Arcoxia® and Celebrex® Use According to Duration of Treatment [Up to 12 months]
Use of selective cyclooxygenase-2 (COX-2) inhibitors (Arcoxia® and Celebrex®) as assessed by the Investigating Physician at time of treatment discontinuation was correlated to the overall duration of treatment experienced by the participant (i.e., intermittent or continuous selective COX-2 inhibitor use vs. total participant time on treatment). Type of use was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days). Four successive treatment intervals were assessed in this endpoint: 1) Up to thirty days of treatment 2) From one to three months of treatment 3) From three months to one year of treatment and 4) More than one year of treatment.
Secondary Outcome Measures
- Mean Body Mass Index (BMI) at Study Entry in Participants Treated With Arcoxia® and Celebrex® [At study entry (baseline)]
Participants' BMI was assessed at study entry by the Investigating Physician. BMI is calculated as the participant's weight in kilograms (kg) divided by height in meters squared. BMI under 18.5 is commonly considered underweight; within the range (18.5 to 25) as normal weight; within the range (25 to 30) as overweight; and over 30 as obese.
- Mean Systolic and Diastolic Blood Pressure (BP) at Study Entry in Participants Treated With Arcoxia® and Celebrex® [At study entry (baseline)]
Mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) were assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.
- Blood Pressure at Study Entry in Participants Treated With Arcoxia® and Celebrex® [At study entry (baseline)]
Participants' BP (SBP/DBP) was assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.
- Medical History of Participants Treated With Arcoxia® and Celebrex® [At study entry]
Relevant medical history of participants treated with Arcoxia® or Celebrex® was recorded by the Investigating Physician.
- Co-morbidities in Participants Treated With Arcoxia® and Celebrex® [At study entry]
Associated co-morbidities at study entry (baseline) in participants treated with Arcoxia® or Celebrex® were recorded by the Investigating Physician. CHF/IHD/PAD = Congestive heart failure/Ischemic heart disease/Peripheral artery disease
- Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex® [At study entry]
'Significant' treatments that preceded the use of selective COX-2 inhibitors (Arcoxia® or Celebrex®) were identified using a closed-ended (yes/ no/ do not know) questionnaire. Significant is defined as associated with a chronic disease or having a potential link with participant's current use of a selective COX-2 inhibitors (Arcoxia® or Celebrex®). ARBs = Angiotensin 2 receptor blockers. ACEIs = Angiotensin-converting enzyme inhibitors. SSRIs = Selective serotonin reuptake Inhibitors. PAIs = Platelet aggregation inhibitors.
- Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex® [At study entry]
Concomitant medications prescribed to participants treated with Arcoxia® and Celebrex® were collected via the physician prescription note at time of participant's study entry. NSAIDS = Non-steroidal anti-inflammatory agents.
- Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex® [Up to 12 months]
Concomitant medications prescribed during the course of follow-up to participants treated with Arcoxia® and Celebrex® were extracted from participants' medical records. NSAIDS = Non-steroidal anti-inflammatory agents.
- Number of Participants Treated With Other Agents Prior to Initiation of Arcoxia® and Celebrex® [Up to 3 months prior to study entry]
Other prescribed agents for the same study indication within 3 months preceding the decision to initiate treatment with selective COX-2 inhibitors (Arcoxia® or Celebrex®) were determined using the participant's medical record. NSAIDS = Non-steroidal inflammatory agents.
- Number of Participants Switching to Another Treatment With the Same Reason for Prescription [Up to 12 months]
Participants who switched to another NSAID or other therapy for the same reason for prescription upon discontinuation of treatment with Arcoxia® or Celebrex® were determined.
- Number of Participants With Contraindications for Use of Arcoxia® [At study entry]
Participants noted with contraindications for use of Arcoxia® according to the MA during initiation of treatment are described. CHF = congestive heart failure. HA = hepatic impairment. IBD = inflammatory bowel disease. IHD = ischemic heart disease. PAD = peripheral artery disease.
- Number of Participants Who Experienced at Least One Adverse Event [Up to 12 months]
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
- Number of Participants Who Discontinued Study Drug Due to an Adverse Event [Up to 12 months]
Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Treatment-naive, discontinued the previous treatment course of etoricoxib or celecoxib at least 3 months previously or currently receiving continuous treatment with oral etoricoxib or celecoxib
-
Consent to take part in the study
-
Included in his/her physician's client base for at least 1 year
Exclusion Criteria:
-
Unable to receive follow-up over a year
-
Included in an interventional trial
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Organon and Co
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0663-148
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | 621 total participants were screened; 71 participants were excluded for inclusion criteria violation and 3 were excluded for unavailability of informed consent. |
Arm/Group Title | Group Arcoxia® | Group Celebrex® |
---|---|---|
Arm/Group Description | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Period Title: Overall Study | ||
STARTED | 268 | 279 |
COMPLETED | 31 | 56 |
NOT COMPLETED | 237 | 223 |
Baseline Characteristics
Arm/Group Title | Group Arcoxia® | Group Celebrex® | Total |
---|---|---|---|
Arm/Group Description | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Total of all reporting groups |
Overall Participants | 268 | 279 | 547 |
Age (Years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Years] |
60.8
(13.8)
|
62.4
(14.2)
|
61.6
(14.0)
|
Sex: Female, Male (Count of Participants) | |||
Female |
166
61.9%
|
179
64.2%
|
345
63.1%
|
Male |
102
38.1%
|
100
35.8%
|
202
36.9%
|
Outcome Measures
Title | Number of Participants Demonstrating Proper Use of Arcoxia® and Celebrex® |
---|---|
Description | Proper use of study medication is defined as administration of medication in terms of indication and dosage according to Market Authorization (MA). Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse. |
Time Frame | Up to 12 months |
Outcome Measure Data
Analysis Population Description |
---|
All participants with complete data relative to correct use of the coxib and at least 1 data point relative to misuse of the coxib. |
Arm/Group Title | Group Arcoxia® | Group Celebrex® |
---|---|---|
Arm/Group Description | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 257 | 264 |
Number [Participants] |
65
24.3%
|
118
42.3%
|
Title | Reasons for Misuse of Arcoxia® and Celebrex® |
---|---|
Description | Proper use of study medication is defined as administration of medication in terms of indication and dosage according to MA. Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse. |
Time Frame | Up to 12 months |
Outcome Measure Data
Analysis Population Description |
---|
The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (misuse) |
Arm/Group Title | Group Arcoxia® | Group Celebrex® |
---|---|---|
Arm/Group Description | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 192 | 146 |
Non-MA-Compliant Indication |
83
31%
|
114
40.9%
|
Non-MA-Compliant Starting Dose |
62
23.1%
|
19
6.8%
|
Non-MA-Compliant Starting Dose and Indication |
46
17.2%
|
13
4.7%
|
Non-MA-Compliant Indication & Dose (Starting &Max) |
1
0.4%
|
0
0%
|
Title | Indications for Which Arcoxia® and Celebrex® Were Prescribed |
---|---|
Description | The reasons (indications) for prescribing of Arcoxia® or Celebrex® were collected in open-field forms by the Investigator; category assignment (i.e, re-codification) of verbatim entries was conducted by a group of medical experts under the guidance approved by the MA. This endpoint gives the number of participants treated per indication. |
Time Frame | At study entry |
Outcome Measure Data
Analysis Population Description |
---|
The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (indication) |
Arm/Group Title | Group Arcoxia® | Group Celebrex® |
---|---|---|
Arm/Group Description | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 264 | 275 |
Other pain (e.g., spinal pain, joint pain) |
113
42.2%
|
117
41.9%
|
Osteoarthritis |
105
39.2%
|
104
37.3%
|
Inflammatory rheumatism |
13
4.9%
|
18
6.5%
|
Neuralgia |
17
6.3%
|
24
8.6%
|
Non-joint rheumatism |
12
4.5%
|
12
4.3%
|
Unclassified arthropathy |
4
1.5%
|
0
0%
|
Missing data |
4
1.5%
|
4
1.4%
|
Title | Dosage of Arcoxia® and Celebrex® at Initiation |
---|---|
Description | Dosage at initiation of treatment with Arcoxia® or Celebrex® was identified. MA compliant dosage at initiation corresponds to a (starting) dose of 30 mg daily for Arcoxia® or a (starting) dose of 200 mg daily for Celebrex®. The dose for initiation was calculated by multiplying the number of doses per day with the dose level (total daily dose) as noted in the prescription record. |
Time Frame | At study entry |
Outcome Measure Data
Analysis Population Description |
---|
The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (dosage at initiation) |
Arm/Group Title | Group Arcoxia® | Group Celebrex® |
---|---|---|
Arm/Group Description | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 268 | 279 |
30 mg |
151
56.3%
|
0
0%
|
60 mg |
107
39.9%
|
0
0%
|
> 60 mg; <100 mg |
1
0.4%
|
0
0%
|
100 mg |
0
0%
|
23
8.2%
|
>100 mg; < 200 mg |
1
0.4%
|
0
0%
|
200 mg |
0
0%
|
219
78.5%
|
400 mg |
0
0%
|
32
11.5%
|
> 400 mg |
0
0%
|
0
0%
|
Title | Mean Dosage of Arcoxia® and Celebrex® During Treatment |
---|---|
Description | The mean dosage of Arcoxia® and Celebrex® during treatment was determined. For participants who stopped treatment after their initial study visit, the maximum dose recorded at their final study visit was considered when calculating their mean dosage during treatment. |
Time Frame | Up to 12 months |
Outcome Measure Data
Analysis Population Description |
---|
All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis. |
Arm/Group Title | Group Arcoxia® | Group Celebrex® |
---|---|---|
Arm/Group Description | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 246 | 252 |
Mean (Standard Deviation) [mg/day] |
44.1
(14.8)
|
221.9
(73.1)
|
Title | Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex® |
---|---|
Description | Participants requiring modifications to their Arcoxia® or Celebrex® dose regimens during their on study treatment course were identified. Dose modifications were defined as an increase, decrease followed by increase, decrease, or increase followed by decrease in the participant's daily dose; all categorizations were exclusive. If the maximum dose at discontinuation of treatment was greater than that at initiation, the participant was considered as having had an increase in dose during treatment. Alternatively, if data obtained from a participant's prescription records showed a successive lowering of dosage, the participant was considered as having had a decrease in dose during treatment. Dosages at baseline were included in the dose modification determination for treatment renewal participants. |
Time Frame | Up to 12 months |
Outcome Measure Data
Analysis Population Description |
---|
All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis. |
Arm/Group Title | Group Arcoxia® | Group Celebrex® |
---|---|---|
Arm/Group Description | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 246 | 252 |
Missing data |
1
0.4%
|
5
1.8%
|
Dose increase |
42
15.7%
|
33
11.8%
|
Dose decrease followed by increase |
1
0.4%
|
0
0%
|
Dose decrease |
2
0.7%
|
5
1.8%
|
Dose increase followed by decrease |
0
0%
|
3
1.1%
|
Title | Duration of Prescription for Arcoxia® and Celebrex® at Enrollment |
---|---|
Description | The mean duration of prescription at enrollment for participants treated with Arcoxia® and Celebrex® was determined using the participant's record. |
Time Frame | Up to 3 months prior to study entry |
Outcome Measure Data
Analysis Population Description |
---|
The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (duration of prescription) |
Arm/Group Title | Group Arcoxia® - Initiation | Group Arcoxia® - Renewal | Group Celebrex® - Initiation | Group Celebrex® - Renewal | Group Arcoxia® | Group Celebrex® |
---|---|---|---|---|---|---|
Arm/Group Description | Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 149 | 119 | 119 | 157 | 268 | 276 |
Mean (Standard Deviation) [Days] |
25.5
(18.4)
|
38.1
(24.1)
|
23.9
(17.6)
|
41.7
(26.9)
|
31.1
(22.0)
|
34.0
(24.9)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Group Arcoxia®, Group Celebrex® |
---|---|---|
Comments | Group comparison (Arcoxia® [Initiation] vs Arcoxia® [Renewal]) for duration of prescription at enrollment | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | p-student | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Group Celebrex® - Initiation, Group Celebrex® - Renewal |
---|---|---|
Comments | Group comparison (Celebrex® [Initiation] vs Celebrex® [Renewal]) for duration of prescription at enrollment | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | p-student | |
Comments |
Title | Total Duration of Treatment With Arcoxia® and Celebrex® |
---|---|
Description | The total duration of treatment (DoT) with Arcoxia® or Celebrex® was determined for populations that achieved end-of study and end-of-protocol or that were categorized as lost to follow-up. Participants enumerated as end-of-study had their treatment discontinued during the protocol-specified one year of follow-up. Participants enumerated as end-of-protocol were ongoing treatment at end of the protocol-specified one year of follow-up. Participants categorized as lost to follow-up had no follow-up visit where a determination of discontinuation from treatment could be made. |
Time Frame | Up to 12 months |
Outcome Measure Data
Analysis Population Description |
---|
The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (duration of prescription) |
Arm/Group Title | Group Arcoxia® | Group Celebrex® |
---|---|---|
Arm/Group Description | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 251 | 256 |
DoT - End-of-study participants (n=215,196) |
85.2
(127.1)
|
117.8
(307.6)
|
DoT - End-of-protocol participants (n=31,56) |
472.9
(90.7)
|
595.2
(456.7)
|
DoT - Lost to follow-up participants (n=5,4) |
122.4
(131.6)
|
142.0
(128.8)
|
Title | Maximum Dosage Prescribed During Treatment With Arcoxia® and Celebrex® |
---|---|
Description | Mean maximum dosage prescribed during follow-up in participants treated with Arcoxia® or Celebrex®. Dosage is expressed as total daily dose. |
Time Frame | Up to 12 months |
Outcome Measure Data
Analysis Population Description |
---|
All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis. |
Arm/Group Title | Group Arcoxia® - Initiation | Group Arcoxia® - Renewal | Group Celebrex® - Initiation | Group Celebrex® - Renewal | Group Arcoxia® | Group Celebrex® |
---|---|---|---|---|---|---|
Arm/Group Description | Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 137 | 109 | 109 | 143 | 246 | 252 |
Mean (Standard Deviation) [mg/day] |
47.1
(16.2)
|
48.4
(14.7)
|
228.4
(79.5)
|
242.7
(86.0)
|
47.7
(15.5)
|
236.5
(83.4)
|
Title | Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex® |
---|---|
Description | The individual reasons for discontinuation of treatment with Arcoxia® or Celebrex® were identified over the course of study through either physician selection from a pre-determined list or verbatim entry by the physician with subsequent re-codification by Sponsor. |
Time Frame | Up to 12 months |
Outcome Measure Data
Analysis Population Description |
---|
All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis. |
Arm/Group Title | Group Arcoxia® | Group Celebrex® |
---|---|---|
Arm/Group Description | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 215 | 196 |
End of prescribed treatment |
140
52.2%
|
118
42.3%
|
Recovery |
16
6%
|
23
8.2%
|
Lack of efficacy |
31
11.6%
|
31
11.1%
|
Intolerance |
6
2.2%
|
5
1.8%
|
Improved symptoms |
8
3%
|
2
0.7%
|
Surgical intervention |
3
1.1%
|
6
2.2%
|
Participant decision |
5
1.9%
|
1
0.4%
|
Physician decision |
2
0.7%
|
2
0.7%
|
Death unrelated to coxibs |
1
0.4%
|
1
0.4%
|
Other disease detected |
1
0.4%
|
1
0.4%
|
Other - unknown reason |
1
0.4%
|
1
0.4%
|
Rheumatologist new evaluation |
0
0%
|
1
0.4%
|
Missing data |
1
0.4%
|
4
1.4%
|
Title | Type of Arcoxia® and Celebrex® Use |
---|---|
Description | The type of Arcoxia® or Celebrex® use during the study was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days) by the Investigating Physician at time of treatment discontinuation. |
Time Frame | Up to 12 months |
Outcome Measure Data
Analysis Population Description |
---|
All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis. |
Arm/Group Title | Group Arcoxia® | Group Celebrex® |
---|---|---|
Arm/Group Description | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 215 | 194 |
Missing data |
0
0%
|
2
0.7%
|
Intermittent |
44
16.4%
|
47
16.8%
|
Continuous |
171
63.8%
|
147
52.7%
|
Title | Type of Arcoxia® and Celebrex® Use According to Duration of Treatment |
---|---|
Description | Use of selective cyclooxygenase-2 (COX-2) inhibitors (Arcoxia® and Celebrex®) as assessed by the Investigating Physician at time of treatment discontinuation was correlated to the overall duration of treatment experienced by the participant (i.e., intermittent or continuous selective COX-2 inhibitor use vs. total participant time on treatment). Type of use was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days). Four successive treatment intervals were assessed in this endpoint: 1) Up to thirty days of treatment 2) From one to three months of treatment 3) From three months to one year of treatment and 4) More than one year of treatment. |
Time Frame | Up to 12 months |
Outcome Measure Data
Analysis Population Description |
---|
All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis. |
Arm/Group Title | Up to Thirty Days | From One to Three Months | From Three Months to One Year | More Than One Year |
---|---|---|---|---|
Arm/Group Description | Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated for ≤ 30 days | Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated from one to three months total | Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated from three months to one year | Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated for more than one year |
Measure Participants | 206 | 112 | 75 | 18 |
Missing data |
0
(127.1)
0%
|
1
(307.6)
0.4%
|
1
0.2%
|
0
NaN
|
Intermittent |
24
(90.7)
9%
|
38
(456.7)
13.6%
|
22
4%
|
7
NaN
|
Continuous |
182
(131.6)
67.9%
|
73
(128.8)
26.2%
|
52
9.5%
|
11
NaN
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Group Arcoxia®, Group Celebrex® - Renewal |
---|---|---|
Comments | Duration of treatment comparison (More than one year vs Up to thirty days) for intermittent selective COX-2 inhibitor use. The analysis assessed whether long-term treatment was more correlated with intermittent selective COX-2 inhibitor use compared to short-term treatment. | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | Chi-squared | |
Comments |
Title | Mean Body Mass Index (BMI) at Study Entry in Participants Treated With Arcoxia® and Celebrex® |
---|---|
Description | Participants' BMI was assessed at study entry by the Investigating Physician. BMI is calculated as the participant's weight in kilograms (kg) divided by height in meters squared. BMI under 18.5 is commonly considered underweight; within the range (18.5 to 25) as normal weight; within the range (25 to 30) as overweight; and over 30 as obese. |
Time Frame | At study entry (baseline) |
Outcome Measure Data
Analysis Population Description |
---|
The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (BMI) |
Arm/Group Title | Group Arcoxia® - Initiation | Group Arcoxia® - Renewal | Group Celebrex® - Initiation | Group Celebrex® - Renewal | Group Arcoxia® | Group Celebrex® |
---|---|---|---|---|---|---|
Arm/Group Description | Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 147 | 119 | 120 | 158 | 266 | 278 |
Mean (Standard Deviation) [kg/m^2] |
26.6
(5.2)
|
27.1
(4.5)
|
27.3
(4.5)
|
27.0
(5.6)
|
26.8
(4.9)
|
27.1
(5.1)
|
Title | Mean Systolic and Diastolic Blood Pressure (BP) at Study Entry in Participants Treated With Arcoxia® and Celebrex® |
---|---|
Description | Mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) were assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg. |
Time Frame | At study entry (baseline) |
Outcome Measure Data
Analysis Population Description |
---|
The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (SBP and DBP) |
Arm/Group Title | Group Arcoxia® - Initiation | Group Arcoxia® - Renewal | Group Celebrex® - Initiation | Group Celebrex® - Renewal | Group Arcoxia® | Group Celebrex® |
---|---|---|---|---|---|---|
Arm/Group Description | Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 146 | 118 | 116 | 158 | 264 | 274 |
SBP |
127.4
(10.7)
|
130.9
(9.9)
|
127.9
(9.5)
|
128.4
(8.2)
|
129.0
(10.4)
|
128.2
(8.8)
|
DBP |
76.0
(7.0)
|
76.8
(7.3)
|
76.0
(7.6)
|
75.1
(7.1)
|
76.4
(7.1)
|
75.4
(7.3)
|
Title | Blood Pressure at Study Entry in Participants Treated With Arcoxia® and Celebrex® |
---|---|
Description | Participants' BP (SBP/DBP) was assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg. |
Time Frame | At study entry (baseline) |
Outcome Measure Data
Analysis Population Description |
---|
The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (BP) |
Arm/Group Title | Group Arcoxia® - Initiation | Group Arcoxia® - Renewal | Group Celebrex® - Initiation | Group Celebrex® - Renewal | Group Arcoxia® | Group Celebrex® |
---|---|---|---|---|---|---|
Arm/Group Description | Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 149 | 119 | 121 | 158 | 268 | 279 |
MIssing data |
3
(10.7)
1.1%
|
1
(9.9)
0.4%
|
5
(9.5)
0.9%
|
0
(8.2)
NaN
|
4
(10.4)
NaN
|
5
(8.8)
NaN
|
<120/80 mmHg |
15
(7.0)
5.6%
|
5
(7.3)
1.8%
|
8
(7.6)
1.5%
|
6
(7.1)
NaN
|
20
(7.1)
NaN
|
14
(7.3)
NaN
|
120 mmHg ≤SBP<140 mmHg and/or 80 mmHg ≤DBP<90 mmHg |
105
39.2%
|
80
28.7%
|
87
15.9%
|
127
NaN
|
185
NaN
|
214
NaN
|
140 mmHg ≤SBP<180 mmHg and/or 90 mmHg≤DBP<100 mmHg |
26
9.7%
|
33
11.8%
|
21
3.8%
|
25
NaN
|
59
NaN
|
46
NaN
|
SBP≥180 mmHg and/or DBP≥110 mmHg |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Group Arcoxia®, Group Celebrex® |
---|---|---|
Comments | Group comparison (Arcoxia® vs Celebrex®) for controlled BP (SBP <140 mmHg and DBP <90 mmHg) at study entry | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.104 |
Comments | ||
Method | Chi-squared | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Group Arcoxia®, Group Celebrex® |
---|---|---|
Comments | Group comparison (Arcoxia® [Initiation] vs Arcoxia® [Renewal]) for controlled BP (SBP <140 mmHg and DBP <90 mmHg) at study entry | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0049 |
Comments | ||
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Group Celebrex® - Initiation, Group Celebrex® - Renewal |
---|---|---|
Comments | Group comparison (Celebrex® [Initiation] vs Celebrex® [Renewal]) for controlled BP (SBP <140 mmHg and DBP <90 mmHg) at study entry | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.618 |
Comments | ||
Method | Chi-squared | |
Comments |
Title | Medical History of Participants Treated With Arcoxia® and Celebrex® |
---|---|
Description | Relevant medical history of participants treated with Arcoxia® or Celebrex® was recorded by the Investigating Physician. |
Time Frame | At study entry |
Outcome Measure Data
Analysis Population Description |
---|
The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (medical history) |
Arm/Group Title | Group Arcoxia® - Initiation | Group Arcoxia® - Renewal | Group Celebrex® - Initiation | Group Celebrex® - Renewal | Group Arcoxia® | Group Celebrex® |
---|---|---|---|---|---|---|
Arm/Group Description | Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 149 | 119 | 121 | 158 | 268 | 279 |
Arterial hypertension (n=146,118,116,156,264,272) |
37
13.8%
|
47
16.8%
|
34
6.2%
|
58
NaN
|
84
NaN
|
92
NaN
|
Acute rhinitis (n=145,115,115,157,260,272) |
20
7.5%
|
15
5.4%
|
10
1.8%
|
12
NaN
|
35
NaN
|
22
NaN
|
Bronchospam (n=145,117,115,158,262,273) |
9
3.4%
|
6
2.2%
|
2
0.4%
|
6
NaN
|
15
NaN
|
8
NaN
|
Urticaria (n=146,116,115,156,262,271) |
5
1.9%
|
5
1.8%
|
0
0%
|
4
NaN
|
10
NaN
|
4
NaN
|
Peptic ulcer/bleeding (n=146,118,117,158,264,275) |
5
1.9%
|
0
0%
|
3
0.5%
|
4
NaN
|
5
NaN
|
7
NaN
|
Angioedema (n=145,117,114,157,262,271) |
2
0.7%
|
0
0%
|
1
0.2%
|
2
NaN
|
2
NaN
|
3
NaN
|
Nasal polyps (n=146,116,114,158,262,272) |
0
0%
|
1
0.4%
|
0
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Group Arcoxia®, Group Celebrex® |
---|---|---|
Comments | Group comparison (Arcoxia® [Initiation] vs Arcoxia® [Renewal]) for medical history of arterial hypertension | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.012 |
Comments | ||
Method | Chi-squared | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Group Celebrex® - Initiation, Group Celebrex® - Renewal |
---|---|---|
Comments | Group comparison (Celebrex® [Initiation] vs Celebrex® [Renewal]) for medical history of arterial hypertension | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.175 |
Comments | ||
Method | Chi-squared | |
Comments |
Title | Co-morbidities in Participants Treated With Arcoxia® and Celebrex® |
---|---|
Description | Associated co-morbidities at study entry (baseline) in participants treated with Arcoxia® or Celebrex® were recorded by the Investigating Physician. CHF/IHD/PAD = Congestive heart failure/Ischemic heart disease/Peripheral artery disease |
Time Frame | At study entry |
Outcome Measure Data
Analysis Population Description |
---|
The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (co-morbidities) |
Arm/Group Title | Group Arcoxia® - Initiation | Group Arcoxia® - Renewal | Group Celebrex® - Initiation | Group Celebrex® - Renewal | Group Arcoxia® | Group Celebrex® |
---|---|---|---|---|---|---|
Arm/Group Description | Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 149 | 119 | 121 | 158 | 268 | 279 |
At least one co-morbidity |
55
20.5%
|
44
15.8%
|
32
5.9%
|
62
NaN
|
99
NaN
|
94
NaN
|
Hyperlipidemia |
43
16%
|
34
12.2%
|
26
4.8%
|
46
NaN
|
77
NaN
|
72
NaN
|
Diabetes |
14
5.2%
|
11
3.9%
|
6
1.1%
|
22
NaN
|
25
NaN
|
28
NaN
|
Hepatic insufficiency |
4
1.5%
|
3
1.1%
|
0
0%
|
2
NaN
|
7
NaN
|
2
NaN
|
Inflammatory bowel disease |
2
0.7%
|
4
1.4%
|
3
0.5%
|
1
NaN
|
6
NaN
|
4
NaN
|
CHF/IHD/PAD |
1
0.4%
|
2
0.7%
|
3
0.5%
|
6
NaN
|
3
NaN
|
9
NaN
|
Active peptic ulceration/ GI bleeding |
1
0.4%
|
0
0%
|
0
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
Missing data |
5
1.9%
|
2
0.7%
|
4
0.7%
|
0
NaN
|
7
NaN
|
4
NaN
|
Title | Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex® |
---|---|
Description | 'Significant' treatments that preceded the use of selective COX-2 inhibitors (Arcoxia® or Celebrex®) were identified using a closed-ended (yes/ no/ do not know) questionnaire. Significant is defined as associated with a chronic disease or having a potential link with participant's current use of a selective COX-2 inhibitors (Arcoxia® or Celebrex®). ARBs = Angiotensin 2 receptor blockers. ACEIs = Angiotensin-converting enzyme inhibitors. SSRIs = Selective serotonin reuptake Inhibitors. PAIs = Platelet aggregation inhibitors. |
Time Frame | At study entry |
Outcome Measure Data
Analysis Population Description |
---|
The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (past treatments) |
Arm/Group Title | Group Arcoxia® - Initiation | Group Arcoxia® - Renewal | Group Celebrex® - Initiation | Group Celebrex® - Renewal | Group Arcoxia® | Group Celebrex® |
---|---|---|---|---|---|---|
Arm/Group Description | Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 149 | 119 | 121 | 158 | 268 | 279 |
At least one treatment (n=146,118,117,158,264,275) |
102
38.1%
|
75
26.9%
|
67
12.2%
|
118
NaN
|
177
NaN
|
185
NaN
|
Proton-pump inhibitors (n=146,115,116,156,261,272) |
58
21.6%
|
43
15.4%
|
30
5.5%
|
65
NaN
|
101
NaN
|
95
NaN
|
Hypolipidemic agents (n=146,116,117,156,262,273) |
39
14.6%
|
32
11.5%
|
24
4.4%
|
45
NaN
|
71
NaN
|
69
NaN
|
ARBs (n=144,115,116,155,259,271) |
22
8.2%
|
29
10.4%
|
23
4.2%
|
37
NaN
|
51
NaN
|
60
NaN
|
Diuretics (N=146,117,117,156,263,273) |
16
6%
|
24
8.6%
|
10
1.8%
|
29
NaN
|
40
NaN
|
39
NaN
|
ACEIs (n=145,116,117,157,261,274) |
11
4.1%
|
22
7.9%
|
13
2.4%
|
20
NaN
|
33
NaN
|
33
NaN
|
SSRIs (n=146,116,117,158,262,275) |
15
5.6%
|
15
5.4%
|
8
1.5%
|
25
NaN
|
30
NaN
|
33
NaN
|
Anti-diabetic agents (n=146,115,117,158,261,275) |
14
5.2%
|
8
2.9%
|
6
1.1%
|
19
NaN
|
22
NaN
|
25
NaN
|
Histamine H2 blockers (n=146,117,117,156,263,273) |
14
5.2%
|
14
5%
|
7
1.3%
|
20
NaN
|
28
NaN
|
27
NaN
|
PAIs (n=146,118,117,158,264,275) |
5
1.9%
|
8
2.9%
|
6
1.1%
|
8
NaN
|
13
NaN
|
14
NaN
|
Oral anticoagulants (n=146,118,117,158,264,275) |
1
0.4%
|
4
1.4%
|
3
0.5%
|
6
NaN
|
5
NaN
|
9
NaN
|
Alpha-blockers (n=146,116,117,157,262,274) |
1
0.4%
|
1
0.4%
|
4
0.7%
|
5
NaN
|
2
NaN
|
9
NaN
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Group Arcoxia®, Group Celebrex® |
---|---|---|
Comments | Group comparison (Arcoxia® [Initiation] vs Arcoxia® [Renewal]) for significant past treatments | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.701 |
Comments | ||
Method | Chi-squared | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Group Celebrex® - Initiation, Group Celebrex® - Renewal |
---|---|---|
Comments | Group comparison (Celebrex® [Initiation] vs Celebrex® [Renewal]) for significant past treatments | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.007 |
Comments | ||
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Group Arcoxia®, Group Celebrex® |
---|---|---|
Comments | Group comparison (Arcoxia® vs Celebrex®) for significant past treatments | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.955 |
Comments | ||
Method | Chi-squared | |
Comments |
Title | Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex® |
---|---|
Description | Concomitant medications prescribed to participants treated with Arcoxia® and Celebrex® were collected via the physician prescription note at time of participant's study entry. NSAIDS = Non-steroidal anti-inflammatory agents. |
Time Frame | At study entry |
Outcome Measure Data
Analysis Population Description |
---|
The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (co-prescriptions at entry) |
Arm/Group Title | Group Arcoxia® - Initiation | Group Arcoxia® - Renewal | Group Celebrex® - Initiation | Group Celebrex® - Renewal | Group Arcoxia® | Group Celebrex® |
---|---|---|---|---|---|---|
Arm/Group Description | Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 149 | 119 | 121 | 158 | 268 | 279 |
Missing data |
15
5.6%
|
22
7.9%
|
3
0.5%
|
23
NaN
|
37
NaN
|
26
NaN
|
At least one treatment |
95
35.4%
|
89
31.9%
|
73
13.3%
|
120
NaN
|
184
NaN
|
193
NaN
|
Analgesics |
52
19.4%
|
66
23.7%
|
38
6.9%
|
75
NaN
|
118
NaN
|
113
NaN
|
Cardiovascular agents |
30
11.2%
|
40
14.3%
|
31
5.7%
|
59
NaN
|
70
NaN
|
90
NaN
|
Digestive system agents |
37
13.8%
|
33
11.8%
|
22
4%
|
61
NaN
|
70
NaN
|
83
NaN
|
Nervous system agents |
17
6.3%
|
24
8.6%
|
14
2.6%
|
45
NaN
|
41
NaN
|
59
NaN
|
NSAIDS |
25
9.3%
|
21
7.5%
|
15
2.7%
|
28
NaN
|
46
NaN
|
43
NaN
|
Rheumatologic agents |
17
6.3%
|
21
7.5%
|
23
4.2%
|
29
NaN
|
38
NaN
|
52
NaN
|
Metabolic system agents |
14
5.2%
|
23
8.2%
|
11
2%
|
38
NaN
|
37
NaN
|
49
NaN
|
Respiratory system agents |
9
3.4%
|
16
5.7%
|
7
1.3%
|
21
NaN
|
25
NaN
|
28
NaN
|
Hormonal agents |
8
3%
|
13
4.7%
|
6
1.1%
|
15
NaN
|
21
NaN
|
21
NaN
|
Hematologic agents |
1
0.4%
|
10
3.6%
|
6
1.1%
|
16
NaN
|
11
NaN
|
22
NaN
|
Urinary-genital system agents |
4
1.5%
|
4
1.4%
|
6
1.1%
|
12
NaN
|
8
NaN
|
18
NaN
|
Dermatological agents |
7
2.6%
|
1
0.4%
|
4
0.7%
|
14
NaN
|
8
NaN
|
18
NaN
|
Anti-infectious agents |
4
1.5%
|
4
1.4%
|
2
0.4%
|
12
NaN
|
8
NaN
|
14
NaN
|
Other not-classified |
6
2.2%
|
5
1.8%
|
5
0.9%
|
23
NaN
|
11
NaN
|
28
NaN
|
Title | Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex® |
---|---|
Description | Concomitant medications prescribed during the course of follow-up to participants treated with Arcoxia® and Celebrex® were extracted from participants' medical records. NSAIDS = Non-steroidal anti-inflammatory agents. |
Time Frame | Up to 12 months |
Outcome Measure Data
Analysis Population Description |
---|
All participants in compliance with study inclusion criteria with at least one follow-up visit (with an available prescription file) other than the end-of-study visit were used for analysis of the endpoint |
Arm/Group Title | Group Arcoxia® | Group Celebrex® |
---|---|---|
Arm/Group Description | Participants who either previously received Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who either previously received Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 104 | 116 |
Missing data |
26
9.7%
|
38
13.6%
|
At least one treatment |
75
28%
|
65
23.3%
|
Analgesics |
58
21.6%
|
55
19.7%
|
Cardiovascular agents |
41
15.3%
|
39
14%
|
Digestive system agents |
39
14.6%
|
36
12.9%
|
Nervous system agents |
25
9.3%
|
32
11.5%
|
Respiratory system agents |
32
11.9%
|
23
8.2%
|
Metabolic system agents |
28
10.4%
|
22
7.9%
|
Rheumatologic agents |
19
7.1%
|
20
7.2%
|
NSAIDS |
17
6.3%
|
21
7.5%
|
Anti-infectious agents |
16
6%
|
16
5.7%
|
Hormonal agents |
12
4.5%
|
13
4.7%
|
Dermatological agents |
13
4.9%
|
12
4.3%
|
Hematologic agents |
14
5.2%
|
8
2.9%
|
Urinary-genital system agents |
8
3%
|
8
2.9%
|
Other |
17
6.3%
|
17
6.1%
|
Title | Number of Participants Treated With Other Agents Prior to Initiation of Arcoxia® and Celebrex® |
---|---|
Description | Other prescribed agents for the same study indication within 3 months preceding the decision to initiate treatment with selective COX-2 inhibitors (Arcoxia® or Celebrex®) were determined using the participant's medical record. NSAIDS = Non-steroidal inflammatory agents. |
Time Frame | Up to 3 months prior to study entry |
Outcome Measure Data
Analysis Population Description |
---|
The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (other prior agents) |
Arm/Group Title | Group Arcoxia® - Initiation | Group Arcoxia® - Renewal | Group Celebrex® - Initiation | Group Celebrex® - Renewal | Group Arcoxia® | Group Celebrex® |
---|---|---|---|---|---|---|
Arm/Group Description | Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 149 | 119 | 121 | 158 | 268 | 279 |
At least one treatment (n=146,118,117,158,264,275) |
93
34.7%
|
86
30.8%
|
62
11.3%
|
102
NaN
|
179
NaN
|
164
NaN
|
Paracetamol (n=146,118,117,158,264,275) |
83
31%
|
82
29.4%
|
54
9.9%
|
90
NaN
|
165
NaN
|
144
NaN
|
NSAIDS (n=146,118,117,158,264,275) |
33
12.3%
|
19
6.8%
|
19
3.5%
|
23
NaN
|
52
NaN
|
42
NaN
|
Analgesics (n=146,118,117,158,264,275) |
4
1.5%
|
4
1.4%
|
1
0.2%
|
7
NaN
|
8
NaN
|
8
NaN
|
Corticosteroids (n=140,107,111,152,247,263) |
7
2.6%
|
3
1.1%
|
6
1.1%
|
13
NaN
|
10
NaN
|
19
NaN
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Group Arcoxia®, Group Celebrex® |
---|---|---|
Comments | Group comparsion (Arcoxia® vs Celebrex®) for previous treatment with other agents prior to initiation of Arcoxia® and Celebrex® for the main study indications | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.049 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | Number of Participants Switching to Another Treatment With the Same Reason for Prescription |
---|---|
Description | Participants who switched to another NSAID or other therapy for the same reason for prescription upon discontinuation of treatment with Arcoxia® or Celebrex® were determined. |
Time Frame | Up to 12 months |
Outcome Measure Data
Analysis Population Description |
---|
All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis. |
Arm/Group Title | Group Arcoxia® | Group Celebrex® |
---|---|---|
Arm/Group Description | Participants who either previously received Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who either previously received Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 215 | 196 |
Prescription of a new treatment |
33
12.3%
|
29
10.4%
|
NSAIDS |
22
8.2%
|
22
7.9%
|
Analgesics |
9
3.4%
|
6
2.2%
|
Other (TNF-alpha inhibitors, corticosteroids) |
1
0.4%
|
1
0.4%
|
Title | Number of Participants With Contraindications for Use of Arcoxia® |
---|---|
Description | Participants noted with contraindications for use of Arcoxia® according to the MA during initiation of treatment are described. CHF = congestive heart failure. HA = hepatic impairment. IBD = inflammatory bowel disease. IHD = ischemic heart disease. PAD = peripheral artery disease. |
Time Frame | At study entry |
Outcome Measure Data
Analysis Population Description |
---|
The safety population consisting of all participants who enrolled in the study with data of sufficient quality for analysis of the endpoint (contraindications) |
Arm/Group Title | Group Arcoxia® - Initiation | Group Arcoxia® - Renewal | Group Arcoxia® |
---|---|---|---|
Arm/Group Description | Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 149 | 119 | 268 |
At least one contraindication (n=122,100,122) |
36
13.4%
|
34
12.2%
|
70
12.8%
|
One total contraindication (n=36,34,70) |
29
10.8%
|
32
11.5%
|
61
11.2%
|
Two total contraindications (n=36,34,70) |
7
2.6%
|
2
0.7%
|
9
1.6%
|
History of acute rhinitis (n=145,115,260) |
20
7.5%
|
15
5.4%
|
35
6.4%
|
Creatinine clearance <30 ml/min (n=125,108,233) |
1
0.4%
|
0
0%
|
1
0.2%
|
History of bronchospasm (n=145,117,262) |
9
3.4%
|
6
2.2%
|
15
2.7%
|
History of urticaria (n=146,116,262) |
5
1.9%
|
5
1.8%
|
10
1.8%
|
Presence of IBD (n=146,118,264) |
2
0.7%
|
4
1.4%
|
6
1.1%
|
Presence of CHF (n=146,118,264) |
0
0%
|
2
0.7%
|
2
0.4%
|
Presence of IHD and/or PAD (n=142,118,260) |
1
0.4%
|
2
0.7%
|
3
0.5%
|
History of allergic reaction (n=145,118,263) |
1
0.4%
|
0
0%
|
1
0.2%
|
History of nasal polyps (n=146,116,262) |
0
0%
|
1
0.4%
|
1
0.2%
|
Blood pressure not controlled (n=146,118,264) |
1
0.4%
|
0
0%
|
1
0.2%
|
History of angioedema (n=145,117,262) |
2
0.7%
|
0
0%
|
2
0.4%
|
Patients with severe HA (n=146,118,264) |
1
0.4%
|
0
0%
|
1
0.2%
|
<16 years of age (n=149,119,268) |
0
0%
|
0
0%
|
0
0%
|
Pregnancy or lactation (n=92,73,165) |
0
0%
|
1
0.4%
|
1
0.2%
|
Title | Number of Participants Who Experienced at Least One Adverse Event |
---|---|
Description | An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. |
Time Frame | Up to 12 months |
Outcome Measure Data
Analysis Population Description |
---|
The safety population consisting of all participants who enrolled in the study |
Arm/Group Title | Group Arcoxia® | Group Celebrex® |
---|---|---|
Arm/Group Description | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 268 | 279 |
Number [Participants] |
10
3.7%
|
5
1.8%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Group Arcoxia®, Group Celebrex® |
---|---|---|
Comments | Group comparsion (Arcoxia® vs Celebrex®) of adverse events experienced during treatment | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.165 |
Comments | ||
Method | Chi-squared | |
Comments |
Title | Number of Participants Who Discontinued Study Drug Due to an Adverse Event |
---|---|
Description | Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. |
Time Frame | Up to 12 months |
Outcome Measure Data
Analysis Population Description |
---|
The safety population consisting of all participants who enrolled in the study |
Arm/Group Title | Group Arcoxia® | Group Celebrex® |
---|---|---|
Arm/Group Description | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Measure Participants | 268 | 279 |
Number [Participants] |
6
2.2%
|
5
1.8%
|
Adverse Events
Time Frame | Up to 12 months | |||
---|---|---|---|---|
Adverse Event Reporting Description | An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All participants who enrolled in the study were included in the safety reporting. | |||
Arm/Group Title | Group Arcoxia® | Group Celebrex® | ||
Arm/Group Description | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. | ||
All Cause Mortality |
||||
Group Arcoxia® | Group Celebrex® | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Group Arcoxia® | Group Celebrex® | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/268 (0%) | 0/279 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Group Arcoxia® | Group Celebrex® | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/268 (0%) | 0/279 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Senior Vice President, Global Clinical Development |
---|---|
Organization | Merck Sharp & Dohme Corp. |
Phone | 1-800-672-6372 |
ClinicalTrialsDisclosure@merck.com |
- 0663-148