Trial Outcomes & Findings for Correlation Between Beliefs About Medicine and Objective Measures of Efficacy and Safety in Rheumatoid Arthritis (RA) (NCT NCT01432366)
NCT ID: NCT01432366
Last Updated: 2016-01-20
Results Overview
Correlation between BMQ necessity and DAS28 was assessed by using Pearson correlation coefficient. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of swollen joint count (SJC); tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour \[mm/hour\]) and participant's assessment of disease activity (DA) on visual analog scale (VAS) (range 0 \[very well\] to 100 millimeter (mm) \[extremely bad\]). DAS28 less than or equal to (\<=) 3.2=low DA; greater than (\>) 3.2 to \<=5.1=moderate DA; \>5.1=high DA; \<2.6=remission.
Recruitment status
COMPLETED
Target enrollment
460 participants
Primary outcome timeframe
Month 12
Results posted on
2016-01-20
Participant Flow
Participant milestones
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Overall Study
STARTED
|
460
|
|
Overall Study
COMPLETED
|
392
|
|
Overall Study
NOT COMPLETED
|
68
|
Reasons for withdrawal
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Overall Study
Non-Responder
|
7
|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Withdrawal Due to Non-Compliance
|
3
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Lost to Follow-up
|
13
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Site Closed
|
20
|
|
Overall Study
Investigator Forget to Complete Visits
|
1
|
|
Overall Study
Other
|
14
|
Baseline Characteristics
Correlation Between Beliefs About Medicine and Objective Measures of Efficacy and Safety in Rheumatoid Arthritis (RA)
Baseline characteristics by cohort
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
n=460 Participants
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
336 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: Full Analysis Set (FAS) included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Correlation between BMQ necessity and DAS28 was assessed by using Pearson correlation coefficient. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of swollen joint count (SJC); tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour \[mm/hour\]) and participant's assessment of disease activity (DA) on visual analog scale (VAS) (range 0 \[very well\] to 100 millimeter (mm) \[extremely bad\]). DAS28 less than or equal to (\<=) 3.2=low DA; greater than (\>) 3.2 to \<=5.1=moderate DA; \>5.1=high DA; \<2.6=remission.
Outcome measures
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
n=317 Participants
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Correlation Between Beliefs About Medicines Questionnaire (BMQ) Necessity Score and Disease Activity Score Based on 28 Joints Count (DAS28) at Month 12
|
-0.06 correlation coefficient
Interval -0.16 to 0.06
|
SECONDARY outcome
Timeframe: Month 12Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Correlation between BMQ necessity score and safety was assessed by using Spearman correlation coefficient. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported adverse events (AEs) considered related to anti-TNF- alpha therapy.
Outcome measures
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
n=357 Participants
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Correlation Between Beliefs About Medicines Questionnaire Necessity Score and Safety at Month 12
|
-0.03 correlation coefficient
Interval -0.13 to 0.07
|
SECONDARY outcome
Timeframe: Month 12Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Correlation between BMQ concerns score and DAS28 score was assessed by using Pearson correlation coefficient. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 \[very well\] to 100 mm \[extremely bad\]). DAS28 \<=3.2= low DA; \>3.2 to \<=5.1= moderate DA; \>5.1=high DA; \<2.6=remission.
Outcome measures
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
n=315 Participants
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Disease Activity Score Based on 28 Joints Count at Month 12
|
0.10 correlation coefficient
Interval -0.01 to 0.21
|
SECONDARY outcome
Timeframe: Month 12Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Correlation between BMQ concerns score and safety was assessed by using Spearman correlation coefficient. BMQ Concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.
Outcome measures
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
n=356 Participants
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Safety at Month 12
|
0.03 correlation coefficient
Interval -0.07 to 0.13
|
SECONDARY outcome
Timeframe: Month 6, 12Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable at specified time point.
Correlation between evolution of BMQ necessity score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 \[very well\] to 100 mm \[extremely bad\]). DAS28 \<=3.2= low DA; \>3.2 to \<=5.1= moderate DA; \>5.1=high DA; \<2.6=remission.
Outcome measures
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
n=427 Participants
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Disease Activity Score Based on 28 Joints Count
Month 6 (n=309)
|
-0.05 correlation coefficient
Interval -0.16 to 0.06
|
|
Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Disease Activity Score Based on 28 Joints Count
Month 12 (n=285)
|
-0.09 correlation coefficient
Interval -0.2 to 0.03
|
SECONDARY outcome
Timeframe: Month 6, 12Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable at specified time point.
Correlation between evolution of BMQ necessity score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in safety score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.
Outcome measures
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
n=427 Participants
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Safety
Month 6 (n=354)
|
0.01 correlation coefficient
Interval -0.1 to 0.11
|
|
Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Safety
Month 12 (n=334)
|
-0.05 correlation coefficient
Interval -0.16 to 0.05
|
SECONDARY outcome
Timeframe: Month 6, 12Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable at specified time point.
Correlation between evolution of BMQ concerns score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ concerns score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 \[very well\] to 100 mm \[extremely bad\]). DAS28 \<=3.2= low DA; \>3.2 to \<=5.1= moderate DA; \>5.1=high DA; \<2.6=remission.
Outcome measures
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
n=427 Participants
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Disease Activity Score Based on 28 Joints Count
Month 6 (n=296)
|
0.07 correlation coefficient
Interval -0.04 to 0.18
|
|
Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Disease Activity Score Based on 28 Joints Count
Month 12 (n=277)
|
0.02 correlation coefficient
Interval -0.09 to 0.14
|
SECONDARY outcome
Timeframe: Month 6, 12Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable at each specified time point.
Correlation between evolution of BMQ concerns score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in BMQ concerns score and safety score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.
Outcome measures
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
n=427 Participants
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Safety
Month 6 (n=338)
|
0.03 correlation coefficient
Interval -0.08 to 0.13
|
|
Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Safety
Month 12 (n=326)
|
0.01 correlation coefficient
Interval -0.1 to 0.11
|
SECONDARY outcome
Timeframe: BaselinePopulation: BAS included all participants who were enrolled in the study and seen at baseline. Here 'n' signifies those participants who were evaluable for the given sub-scale items.
BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).
Outcome measures
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
n=460 Participants
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ1: Necessity (Agree) (n=426)
|
44.6 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ1: Necessity (Totally Agree) (n=426)
|
49.3 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ2: Concern (Agree) (n=422)
|
35.5 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ2: Concern (Totally Agree) (n=422)
|
10.4 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ3: Necessity (Agree) (n=424)
|
41.3 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ3: Necessity (Totally Agree) (n=424)
|
43.9 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ4: Concern (Agree) (n=424)
|
40.6 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ4: Concern (Totally Agree) (n=424)
|
21.2 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ5: Necessity (Agree) (n=427)
|
42.9 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ5: Necessity (Totally Agree) (n=427)
|
37.9 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ6: Concern (Agree) (n=419)
|
21.0 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ6: Concern (Totally Agree) (n=419)
|
10.0 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ7: Necessity (Agree) (n=426)
|
50.2 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ7: Necessity (Totally Agree) (n=426)
|
38.0 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ8: Concern (Agree) (n=426)
|
13.4 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ8: Concern (Totally Agree) (n=426)
|
2.3 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ9: Concern (Agree) (n=424)
|
29.5 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ9: Concern (Totally Agree) (n=424)
|
6.8 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ10: Necessity (Agree) (n=427)
|
43.6 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ10: Necessity (Totally Agree (n=427)
|
50.8 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ11: Concern (Agree) (n=428)
|
16.8 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline
BMQ11: Concern (Totally Agree) (n=428)
|
5.6 percentage of participants
|
SECONDARY outcome
Timeframe: Month 6, 12Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.
BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).
Outcome measures
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
n=427 Participants
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ5: Necessity (Totally Agree)- Month 12 (n=362)
|
39.5 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ6: Concern (Agree)- Month 6 (n=373)
|
22.8 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ6: Concern (Agree)- Month 12 (n=359)
|
25.9 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ6: Concern (Totally Agree)- Month 6 (n=373)
|
5.9 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ6: Concern (Totally Agree)- Month 12 (n=359)
|
9.2 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ7: Necessity (Agree)- Month 6 (n=376)
|
49.2 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ7: Necessity (Agree)- Month 12 (n=361)
|
49.3 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ7: Necessity (Totally Agree)- Month 6 (n=376)
|
33.8 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ7: Necessity (Totally Agree)- Month 12 (n=361)
|
38.0 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ8: Concern (Agree)- Month 6 (n=373)
|
13.9 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ1: Necessity (Agree)- Month 6 (n=379)
|
47.0 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ1: Necessity (Agree)- Month 12 (n=363)
|
46.6 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ1: Necessity (Totally Agree)- Month 6 (n=379)
|
45.9 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ1: Necessity (Totally Agree)- Month 12 (n=363)
|
47.1 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ2: Concern (Agree)- Month 6 (n=374)
|
33.7 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ2: Concern (Agree)- Month 12 (n=360)
|
31.4 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ2: Concern (Totally Agree)- Month 6 (n=374)
|
5.3 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ2: Concern (Totally Agree)- Month 12 (n=360)
|
7.2 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ3: Necessity (Agree)- Month 6 (n=376)
|
46.0 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ3: Necessity (Agree)- Month 12 (n=363)
|
43.0 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ3: Necessity (Totally Agree)- Month 6 (n=376)
|
37.5 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ3: Necessity (Totally Agree)- Month 12 (n=363)
|
41.0 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ4: Concern (Agree)- Month 6 (n=376)
|
39.4 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ4: Concern (Agree)- Month 12 (n=361)
|
34.1 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ4: Concern (Totally Agree)- Month 6 (n=376)
|
18.6 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ4: Concern (Totally Agree)- Month 12 (n=361)
|
18.0 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ5: Necessity (Agree)- Month 6 (n=375)
|
45.3 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ5: Necessity (Agree)- Month 12 (n=362)
|
44.2 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ5: Necessity (Totally Agree)- Month 6 (n=375)
|
35.5 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ8: Concern (Agree)- Month 12 (n=361)
|
8.9 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ8: Concern (Totally Agree)- Month 6 (n=373)
|
2.4 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ8: Concern (Totally Agree)- Month 12 (n=361)
|
3.6 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ9: Concern (Agree)- Month 6 (n=375)
|
25.3 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ9: Concern (Agree)- Month 12 (n=361)
|
30.2 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ9: Concern (Totally Agree)- Month 6 (n=375)
|
6.1 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ9: Concern (Totally Agree)- Month 12 (n=361)
|
6.4 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ10: Necessity (Agree)- Month 6 (n=380)
|
51.8 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ10: Necessity (Agree)- Month 12 (n=363)
|
44.9 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ10: Necessity (Totally Agree)- Month 6 (n=380)
|
40.8 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ10: Necessity (Totally Agree)- Month 12 (n=363)
|
46.0 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ11: Concern (Agree)- Month 6 (n=378)
|
15.3 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ11: Concern (Agree)- Month 12 (n=363)
|
10.2 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ11: Concern (Totally Agree)- Month 6 (n=378)
|
5.3 percentage of participants
|
|
Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12
BMQ11: Concern (Totally Agree)- Month 12 (n=363)
|
6.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.
BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).
Outcome measures
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
n=427 Participants
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ1: Necessity- Baseline (n=343)
|
93.3 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ1: Necessity- Change at Month 12 (n=343)
|
0.3 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ2: Concern- Baseline (n=336)
|
45.8 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ2: Concern-Change at Month 12 (n=336)
|
-7.1 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ3: Necessity- Baseline (n=341)
|
85.0 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ3: Necessity-Change at Month 12 (n=341)
|
0 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ4: Concern- Baseline (n=340)
|
63.5 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ4: Concern-Change at Month 12 (n=340)
|
-11.7 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ5: Necessity- Baseline (n=344)
|
81.1 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ5: Necessity-Change at Month 12 (n=344)
|
2.9 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ6: Concern- Baseline (n=339)
|
30.1 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ6: Concern-Change at Month 12 (n=339)
|
3.5 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ7: Necessity- Baseline (n=341)
|
89.7 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ7: Necessity-Change at Month 12 (n=341)
|
-2.6 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ8: Concern- Baseline (n=342)
|
14.0 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ8: Concern-Change at Month 12 (n=342)
|
-1.7 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ9: Concern- Baseline (n=339)
|
36.3 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ9: Concern-Change at Month 12 (n=339)
|
0.3 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ10: Necessity (n=344)- Baseline (n=344)
|
94.2 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ10: Necessity-Change at Month 12 (n=344)
|
-3.2 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ11: Concern- Baseline (n=344)
|
21.8 percentage of participants
|
|
Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12
BMQ11: Concern-Change at Month 12 (n=344)
|
-5.5 percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: BAS included all participants who were enrolled in the study and seen at baseline. Here, 'n' signifies those participants who were evaluable for each specified subscales.
BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity-concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost-benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence.
Outcome measures
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
n=460 Participants
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale (MARS) at Baseline
BMQ-Necessity (n=409)
|
0.13 correlation coefficient
Interval 0.04 to 0.22
|
|
Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale (MARS) at Baseline
BMQ -Concerns (n=400)
|
-0.18 correlation coefficient
Interval -0.27 to -0.08
|
|
Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale (MARS) at Baseline
BMQ differential (Necessity-Concerns) (n=399)
|
0.22 correlation coefficient
Interval 0.12 to 0.31
|
|
Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale (MARS) at Baseline
BMQ Overuse (n=405)
|
-0.17 correlation coefficient
Interval -0.26 to -0.1
|
|
Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale (MARS) at Baseline
BMQ Harm (n=408)
|
-0.10 correlation coefficient
Interval -0.2 to 0.0
|
SECONDARY outcome
Timeframe: Month 6, 12Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable for each specified subscales.
BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity-concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost-benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence.
Outcome measures
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
n=427 Participants
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12
BMQ-Necessity: Month 6 (n=366)
|
0.18 correlation coefficient
Interval 0.08 to 0.28
|
|
Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12
BMQ-Necessity: Month 12 (n=349)
|
0.16 correlation coefficient
Interval 0.05 to 0.26
|
|
Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12
BMQ -Concerns: Month 6 (n=359)
|
-0.15 correlation coefficient
Interval -0.25 to -0.05
|
|
Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12
BMQ -Concerns: Month 12 (n=348)
|
-0.24 correlation coefficient
Interval -0.34 to -0.14
|
|
Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12
BMQ (Necessity-Concerns): Month 6 (n=356)
|
0.22 correlation coefficient
Interval 0.12 to 0.31
|
|
Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12
BMQ (Necessity-Concerns): Month 12 (n=344)
|
0.27 correlation coefficient
Interval 0.17 to 0.37
|
|
Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12
BMQ Overuse: Month 6 (n=364)
|
-0.13 correlation coefficient
Interval -0.23 to -0.03
|
|
Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12
BMQ Overuse: Month 12 (n=349)
|
-0.15 correlation coefficient
Interval -0.26 to -0.05
|
|
Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12
BMQ Harm: Month 6 (n=366)
|
-0.11 correlation coefficient
Interval -0.21 to 0.0
|
|
Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12
BMQ Harm: Month 12 (n=350)
|
-0.19 correlation coefficient
Interval -0.29 to -0.09
|
SECONDARY outcome
Timeframe: BaselinePopulation: BAS included all participants who were enrolled in the study and seen at baseline. Here, 'n' signifies those participants who were evaluable for the specified characteristics.
Correlation between BMQ necessity score and participant's characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants' beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant's characteristics included age, height, weight, body mass index (BMI), time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery.
Outcome measures
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
n=460 Participants
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Necessity Score at Baseline
Age (n=422)
|
-0.030 correlation coefficient
Interval -0.13 to 0.07
|
|
Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Necessity Score at Baseline
Height (n=403)
|
-0.090 correlation coefficient
Interval -0.19 to 0.008
|
|
Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Necessity Score at Baseline
Weight (n=406)
|
-0.048 correlation coefficient
Interval -0.15 to 0.05
|
|
Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Necessity Score at Baseline
BMI (n=402)
|
-0.008 correlation coefficient
Interval -0.11 to 0.09
|
|
Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Necessity Score at Baseline
Time since first RA symptoms (n=409)
|
0.11 correlation coefficient
Interval 0.01 to 0.2
|
|
Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Necessity Score at Baseline
Time since first RA diagnosis (n= 422)
|
0.13 correlation coefficient
Interval 0.04 to 0.22
|
|
Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Necessity Score at Baseline
Number (No.) of comorbidities (n=422)
|
0.051 correlation coefficient
Interval -0.04 to 0.15
|
|
Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Necessity Score at Baseline
No. of joint replacement/surgery (n= 422)
|
0.053 correlation coefficient
Interval -0.04 to 0.15
|
SECONDARY outcome
Timeframe: BaselinePopulation: BAS included all participants who were enrolled in the study and seen at baseline. Here, 'n' signifies those participants who were evaluable for the specified characteristics.
Correlation between BMQ concerns score and participant's characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants' beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant's characteristics included age, height, weight, BMI, time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery.
Outcome measures
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
n=460 Participants
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Concerns Score at Baseline
Age (n=409)
|
-0.078 correlation coefficient
Interval -0.17 to 0.02
|
|
Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Concerns Score at Baseline
Height (n=390)
|
0.057 correlation coefficient
Interval -0.04 to 0.16
|
|
Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Concerns Score at Baseline
Weight (n=393)
|
-0.052 correlation coefficient
Interval -0.15 to 0.05
|
|
Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Concerns Score at Baseline
BMI (n=389)
|
-0.098 correlation coefficient
Interval -0.2 to 0.002
|
|
Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Concerns Score at Baseline
Time since first RA symptoms (n=396)
|
-0.06 correlation coefficient
Interval -0.16 to 0.04
|
|
Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Concerns Score at Baseline
Time since first RA diagnosis (n=409)
|
-0.08 correlation coefficient
Interval -0.17 to 0.02
|
|
Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Concerns Score at Baseline
No. of comorbidities (n=409)
|
-0.076 correlation coefficient
Interval -0.17 to 0.02
|
|
Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Concerns Score at Baseline
No. of joint replacement/surgery (n=409)
|
-0.051 correlation coefficient
Interval -0.15 to 0.05
|
Adverse Events
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
Serious events: 33 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
n=460 participants at risk
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Colitis
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Appendicitis
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Cellulitis
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Diverticulitis
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Erysipelas
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.43%
2/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.43%
2/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Tuberculosis
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adeocarcinoma
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Aphonia
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.43%
2/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Loss of consciousness
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Colon operation
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.43%
2/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Osteosynthesis
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Peripheral endarterectomy
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Prolapse repair
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Salivary gland operation
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Sinus antrostomy
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Stent placement
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Surgery
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Aortic stenosis
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Haematoma
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Peripheral ischaemia
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
n=460 participants at risk
Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.43%
2/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Endocrine disorders
Hyperthyroidism
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Conjunctivitis
|
0.43%
2/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Anal erosion
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Anal ulcer
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.43%
2/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
0.43%
2/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Hernia
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Oedema peripheral
|
0.43%
2/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Swelling
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Temperature intolerance
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Immune system disorders
Sarcoidosis
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Bronchitis
|
1.7%
8/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Erysipelas
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.43%
2/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Herpes virus infection
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Herpes zoster
|
1.1%
5/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Infection
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Influenza
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Localised infection
|
0.43%
2/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Oral herpes
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.43%
2/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Post procedural infection
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Rhinitis
|
0.43%
2/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.43%
2/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Sinusitis aspergillus
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Subcutaneous abscess
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.65%
3/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Viral infection
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.43%
2/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Suture rupture
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Wound
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Hepatic enzyme increased
|
0.43%
2/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Weight decreased
|
0.43%
2/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
5/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.65%
3/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myelomas
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Burning sensation
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
0.65%
3/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Morton's neuralgia
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Sciatica
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Syncope
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Sleep disorder
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Menopausal symptom
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.43%
2/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Bunion operation
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Cyst removal
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Ear operation
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Foot operation
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Injection
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Surgical and medical procedures
Renal artery stent placement
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypertension
|
0.87%
4/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Phlebitis
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.22%
1/460
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER