Trial Outcomes & Findings for Patient-Reported Outcomes In Rheumatoid Arthritis Patients Treated With Tofacitinib Or Biological Disease-Modifying Antirheumatic Drugs (DMARDs) In Real Life Conditions (NCT NCT03073109)
NCT ID: NCT03073109
Last Updated: 2020-10-22
Results Overview
Disease activity was assessed using RAPID3, which was based on participant-reported multi-dimensional health assessment questionnaire (MDHAQ). RAPID3 included 3 core data set measures of physical function, pain, and patient global estimate. Physical function=mean of scores from 10 individual questions on activities of daily living (each question scored from '0'=no difficulty to '3'=much difficulty), scores were transformed to give a total score=0 to 10, higher scores=greater difficulty. Pain and global estimate of health measured on Likert scale from '0'=no pain/feeling very well to '10'=pain as bad as it could be/ feeling very poorly, higher scores=greater difficulty/ worsening of condition. RAPID3 composite score: mean of physical function, pain, and global assessment scores, ranging from 0 to 10, higher values=greater disease activity. Data has been provided in terms of adjusted (consider impact of co-variables) and unadjusted mean (does not consider co-variables impact).
Recruitment status
COMPLETED
Target enrollment
170 participants
Primary outcome timeframe
Baseline, Month 6
Results posted on
2020-10-22
Participant Flow
The study included participants from two Latin American countries (Colombia and Peru) from 15 March 2017 to 16 September 2019.
This was a non-interventional, hybrid study (prospective and retrospective data collection).
Participant milestones
| Measure |
Tofacitinib
Participants with rheumatoid arthritis (RA) treated with tofacitinib after failure of conventional disease-modifying anti-rheumatic drugs (DMARDs) were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
|
Biologics
Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
70
|
|
Overall Study
COMPLETED
|
90
|
68
|
|
Overall Study
NOT COMPLETED
|
10
|
2
|
Reasons for withdrawal
| Measure |
Tofacitinib
Participants with rheumatoid arthritis (RA) treated with tofacitinib after failure of conventional disease-modifying anti-rheumatic drugs (DMARDs) were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
|
Biologics
Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Other
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
8
|
1
|
Baseline Characteristics
Patient-Reported Outcomes In Rheumatoid Arthritis Patients Treated With Tofacitinib Or Biological Disease-Modifying Antirheumatic Drugs (DMARDs) In Real Life Conditions
Baseline characteristics by cohort
| Measure |
Tofacitinib
n=100 Participants
Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
|
Biologics
n=70 Participants
Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
51.3 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
15 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
85 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
100 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latin American
|
100 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: Analysis was performed on all participants included in the study. Here, 'Number analyzed' = participants evaluable for this outcome measure (OM) at specified time points.
Disease activity was assessed using RAPID3, which was based on participant-reported multi-dimensional health assessment questionnaire (MDHAQ). RAPID3 included 3 core data set measures of physical function, pain, and patient global estimate. Physical function=mean of scores from 10 individual questions on activities of daily living (each question scored from '0'=no difficulty to '3'=much difficulty), scores were transformed to give a total score=0 to 10, higher scores=greater difficulty. Pain and global estimate of health measured on Likert scale from '0'=no pain/feeling very well to '10'=pain as bad as it could be/ feeling very poorly, higher scores=greater difficulty/ worsening of condition. RAPID3 composite score: mean of physical function, pain, and global assessment scores, ranging from 0 to 10, higher values=greater disease activity. Data has been provided in terms of adjusted (consider impact of co-variables) and unadjusted mean (does not consider co-variables impact).
Outcome measures
| Measure |
Tofacitinib
n=100 Participants
Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
Biologics
n=70 Participants
Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
|---|---|---|
|
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Month 6
Baseline - adjusted mean
|
7.12 units on a scale
Standard Error 0.39
|
5.95 units on a scale
Standard Error 0.31
|
|
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Month 6
Baseline - unadjusted mean
|
5.88 units on a scale
Standard Error 0.22
|
5.94 units on a scale
Standard Error 0.22
|
|
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Month 6
Change at Month 6 - adjusted mean
|
-0.20 units on a scale
Standard Error 0.70
|
-0.32 units on a scale
Standard Error 0.72
|
|
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Month 6
Change at Month 6 - unadjusted mean
|
-2.71 units on a scale
Standard Error 0.26
|
-3.28 units on a scale
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Month 6Population: Analysis was performed on participants included in the study who were evaluable for adapted HAQ-DI at month 6. Hence, 'Overall number of participants analyzed' = Participants who had data available for this OM.
Functional status of participants was assessed using adapted HAQ-DI. Adapted HAQ-DI is a participant-reported questionnaire for the assessment of ability to perform tasks in 8 categories of daily living activities due to rheumatoid arthritis: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point Likert scale from 0 to 3, where 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by total number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Data has been provided in terms of adjusted (consider impact of co-variables) and unadjusted mean (does not consider co-variables impact).
Outcome measures
| Measure |
Tofacitinib
n=90 Participants
Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
Biologics
n=68 Participants
Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
|---|---|---|
|
Adapted Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6
Adjusted mean
|
0.93 units on a scale
Standard Error 0.13
|
0.77 units on a scale
Standard Error 0.10
|
|
Adapted Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6
Unadjusted mean
|
0.96 units on a scale
Standard Error 0.08
|
0.78 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Analysis was performed on all participants included in the study. Here, 'Number analyzed' = participants evaluable for this OM at specified time points.
Functional status of participants was assessed using adapted HAQ-DI. Adapted HAQ-DI is a participant-reported questionnaire for the assessment of ability to perform tasks in 8 categories of daily living activities due to rheumatoid arthritis: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point Likert scale from 0 to 3, where 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by total number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Data has been provided in terms of adjusted (consider impact of co-variable) and unadjusted mean (does not consider co-variable impact).
Outcome measures
| Measure |
Tofacitinib
n=100 Participants
Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
Biologics
n=70 Participants
Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
|---|---|---|
|
Change From Baseline in Adapted Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6
Baseline - adjusted mean
|
1.63 units on a scale
Standard Error 0.13
|
1.50 units on a scale
Standard Error 0.10
|
|
Change From Baseline in Adapted Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6
Baseline - unadjusted mean
|
1.62 units on a scale
Standard Error 0.08
|
1.46 units on a scale
Standard Error 0.08
|
|
Change From Baseline in Adapted Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6
Change at Month 6 - adjusted mean
|
-0.56 units on a scale
Standard Error 0.07
|
-0.50 units on a scale
Standard Error 0.08
|
|
Change From Baseline in Adapted Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6
Change at Month 6 - unadjusted mean
|
-0.66 units on a scale
Standard Error 0.07
|
-0.68 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Month 6Population: Analysis was performed on participants included in the study. Hence, 'Overall number of participants analyzed' = only those participants who had data available for this OM.
EQ-5D-3L is a standardized, participant-administered measure of self-reported health outcomes. It consists of two parts: EQ-5D index score (Part I) and the EQ-VAS (Part II). For Part I, i.e. EQ-5D-3L index score, participants rated their current health state on 5 single-item dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with each dimension having three levels of measure: 1= no problems, 2= some problems and 3= extreme problems. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total index score range of 0 to 1.00; higher scores indicating a better health state. Data has been provided in terms of adjusted (consider impact of co-variables) and unadjusted mean (does not consider co-variables impact).
Outcome measures
| Measure |
Tofacitinib
n=90 Participants
Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
Biologics
n=68 Participants
Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
|---|---|---|
|
European Quality of Life- 5 Dimension-3 Levels (EQ-5D-3L) Index Score at Month 6
Adjusted mean
|
0.54 units on a scale
Standard Error 0.05
|
0.67 units on a scale
Standard Error 0.04
|
|
European Quality of Life- 5 Dimension-3 Levels (EQ-5D-3L) Index Score at Month 6
Unadjusted mean
|
0.63 units on a scale
Standard Error 0.03
|
0.65 units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Analysis was performed on all participants included in the study. Here, 'Number analyzed' = participants evaluable for this OM at specified time points.
EQ-5D-3L is a standardized, participant-administered measure of self-reported health outcomes. It consists of two parts: EQ-5D index score (Part I) and the EQ-VAS (Part II). For Part I, i.e. EQ-5D-3L index score, participants rated their current health state on 5 single-item dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with each dimension having three levels of function:. 1=no problems, 2=some problems and 3=extreme problems. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total index score range of 0 to 1.00; higher scores indicating a better health state. Data has been provided in terms of adjusted (consider impact of co-variables) and unadjusted mean (does not consider co-variables impact).
Outcome measures
| Measure |
Tofacitinib
n=100 Participants
Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
Biologics
n=70 Participants
Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
|---|---|---|
|
Change From Baseline in European Quality of Life- 5 Dimension-3 Levels (EQ-5D-3L) Index Score at Month 6
Baseline - adjusted mean
|
0.19 units on a scale
Standard Error 0.05
|
0.23 units on a scale
Standard Error 0.04
|
|
Change From Baseline in European Quality of Life- 5 Dimension-3 Levels (EQ-5D-3L) Index Score at Month 6
Baseline - unadjusted mean
|
0.30 units on a scale
Standard Error 0.03
|
0.22 units on a scale
Standard Error 0.04
|
|
Change From Baseline in European Quality of Life- 5 Dimension-3 Levels (EQ-5D-3L) Index Score at Month 6
Change at Month 6 - adjusted mean
|
0.23 units on a scale
Standard Error 0.06
|
0.29 units on a scale
Standard Error 0.06
|
|
Change From Baseline in European Quality of Life- 5 Dimension-3 Levels (EQ-5D-3L) Index Score at Month 6
Change at Month 6 - unadjusted mean
|
0.35 units on a scale
Standard Error 0.04
|
0.43 units on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Month 6Population: Analysis was performed on participants included in the study. Here, 'Overall number of participants analyzed' = only those participants who had data available for this OM. 'Number analyzed' = participants evaluable for this OM at specified categories.
WPAI-RA: 6-questions participant rated questionnaire that measures effect of participant's RA on general health and symptom severity on work productivity and regular activities. Consisted of 6 questions, a binary question on current employment, 3 questions on hours of work and work-loss, and 2 questions based on 0-10 point scale to judge how RA affected productivity at work and outside of work (0 = no effect on work and 10 = completely prevented from working). It yielded four sub-scores: percent work time missed due to health (absenteeism), percent impairment while working (presenteeism), percent overall work impairment due to health (work productivity loss) and percent activity impairment due to health (daily activity impairment/loss). Sub-scores were expressed as an impairment percentage range from 0 to 100, where 0 = no impairment, 100 = completely impaired, higher scores=greater impairment and less productivity. Data has been provided in terms of adjusted and unadjusted mean.
Outcome measures
| Measure |
Tofacitinib
n=90 Participants
Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
Biologics
n=68 Participants
Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
|---|---|---|
|
Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Absenteeism: adjusted mean
|
12.3 units on a scale
Standard Error 8.83
|
10.8 units on a scale
Standard Error 6.74
|
|
Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Absenteeism: unadjusted mean
|
8.78 units on a scale
Standard Error 6.95
|
10.8 units on a scale
Standard Error 6.74
|
|
Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Presenteeism: adjusted mean
|
32.10 units on a scale
Standard Error 8.82
|
27.7 units on a scale
Standard Error 6.33
|
|
Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Presenteeism: unadjusted mean
|
23.30 units on a scale
Standard Error 5.76
|
27.7 units on a scale
Standard Error 6.33
|
|
Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Productivity loss: adjusted mean
|
37.8 units on a scale
Standard Error 10.25
|
26.9 units on a scale
Standard Error 6.67
|
|
Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Productivity loss: unadjusted mean
|
29.3 units on a scale
Standard Error 6.67
|
26.9 units on a scale
Standard Error 6.67
|
|
Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Activity loss: adjusted mean
|
42.7 units on a scale
Standard Error 4.34
|
31.0 units on a scale
Standard Error 4.79
|
|
Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Activity loss: unadjusted mean
|
35.7 units on a scale
Standard Error 2.75
|
27.1 units on a scale
Standard Error 3.01
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Analysis was performed on participants included in the study. Here, 'Overall number of participants analyzed' = only those participants who had data available for this OM. 'Number analyzed' = participants evaluable for this OM at specified categories.
WPAI-RA: 6-questions participant rated questionnaire that measures effect of participant's RA on general health and symptom severity on work productivity and regular activities. Consisted of 6 questions, a binary question on current employment, 3 questions on hours of work and work-loss, and 2 questions based on 0-10 point scale to judge how RA affected productivity at work and outside of work (0 = no effect on work and 10 = completely prevented from working). It yielded four sub-scores: percent work time missed due to health (absenteeism), percent impairment while working (presenteeism), percent overall work impairment due to health (work productivity loss) and percent activity impairment due to health (daily activity impairment/loss). Sub-scores were expressed as an impairment percentage range from 0 to 100, where 0 = no impairment, 100 = completely impaired, higher numbers=greater impairment and less productivity. Data has been provided in terms of adjusted and unadjusted mean.
Outcome measures
| Measure |
Tofacitinib
n=99 Participants
Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
Biologics
n=70 Participants
Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Absenteeism: Baseline - adjusted
|
35.20 units on a scale
Standard Error 8.59
|
36.10 units on a scale
Standard Error 5.98
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Absenteeism: Baseline - unadjusted
|
31.49 units on a scale
Standard Error 6.41
|
36.10 units on a scale
Standard Error 5.98
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Absenteeism: Change at Month 6- adjusted
|
-18.4 units on a scale
Standard Error 7.74
|
-19.4 units on a scale
Standard Error 7.99
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Absenteeism: Change at Month 6- unadjusted
|
-22.4 units on a scale
Standard Error 7.02
|
-24.2 units on a scale
Standard Error 7.02
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Presenteeism: Baseline - adjusted
|
66.7 units on a scale
Standard Error 8.35
|
59.2 units on a scale
Standard Error 5.82
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Presenteeism: Baseline - unadjusted
|
56.4 units on a scale
Standard Error 5.33
|
59.2 units on a scale
Standard Error 5.82
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Presenteeism: Change at Month 6- adjusted
|
-34.8 units on a scale
Standard Error 5.89
|
-34.8 units on a scale
Standard Error 6.16
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Presenteeism: Change at Month 6- unadjusted
|
-34.8 units on a scale
Standard Error 5.89
|
-34.8 units on a scale
Standard Error 6.16
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Productivity loss: Baseline - adjusted
|
71.1 units on a scale
Standard Error 9.69
|
65.1 units on a scale
Standard Error 5.98
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Productivity loss: Baseline - unadjusted
|
62.8 units on a scale
Standard Error 6.15
|
65.1 units on a scale
Standard Error 5.98
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Productivity loss: Change at Month 6- adjusted
|
-11.0 units on a scale
Standard Error 16.5
|
-15.9 units on a scale
Standard Error 15.2
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Productivity loss: Change at Month 6- unadjusted
|
-36.9 units on a scale
Standard Error 6.47
|
-39.2 units on a scale
Standard Error 6.79
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Activity loss: Baseline - adjusted
|
78.0 units on a scale
Standard Error 4.43
|
70.1 units on a scale
Standard Error 4.79
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Activity loss: Baseline - unadjusted
|
67.1 units on a scale
Standard Error 2.64
|
66.2 units on a scale
Standard Error 3.01
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Activity loss: Change at Month 6- adjusted
|
-43.80 units on a scale
Standard Error 11.00
|
-49.90 units on a scale
Standard Error 13.30
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Activity loss: Change at Month 6- unadjusted
|
-32.80 units on a scale
Standard Error 3.18
|
-38.40 units on a scale
Standard Error 3.66
|
SECONDARY outcome
Timeframe: Month 6Population: Analysis was performed on participants included in the study. Here, 'Overall number of participants analyzed' = only those participants who had data available for this OM.
DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, erythrocyte sedimentation rate (ESR) (measured in millimeters per hour \[mm/hour\]) and patient's global assessment of disease activity according to 100-millimeter (mm) Visual Analog Scale (VAS) (scores ranging 0 \[very well\] to 100 mm \[extremely bad\], higher scores=worsening of condition). DAS28-ESR scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. DAS28 scores ranged from 0 to 10; higher scores indicated greater affectation due to disease activity. Data has been provided in terms of adjusted and unadjusted mean.
Outcome measures
| Measure |
Tofacitinib
n=86 Participants
Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
Biologics
n=61 Participants
Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
|---|---|---|
|
Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
Adjusted Mean
|
3.02 units on a scale
Standard Error 0.24
|
2.61 units on a scale
Standard Error 0.12
|
|
Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
Unadjusted Mean
|
3.10 units on a scale
Standard Error 0.13
|
2.88 units on a scale
Standard Error 0.43
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Analysis was performed on all participants included in the study. Here, 'Number analyzed' = participants evaluable for this OM at specified time points.
DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, erythrocyte sedimentation rate (ESR) (measured in millimeters per hour \[mm/hour\]) and patient's global assessment of disease activity according to 100-millimeter (mm) Visual Analog Scale (VAS) (scores ranging 0 \[very well\] to 100 mm \[extremely bad\], higher scores=worsening of condition). DAS28-ESR scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. DAS28 scores ranged from 0 to 10; higher scores indicated greater affectation due to disease activity. Data has been provided in terms of adjusted and unadjusted mean.
Outcome measures
| Measure |
Tofacitinib
n=100 Participants
Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
Biologics
n=70 Participants
Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
|---|---|---|
|
Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
Baseline - adjusted mean
|
5.59 units on a scale
Standard Error 0.22
|
5.21 units on a scale
Standard Error 0.11
|
|
Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
Baseline - unadjusted mean
|
5.21 units on a scale
Standard Error 0.12
|
5.88 units on a scale
Standard Error 0.40
|
|
Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
Change at Month 6 - adjusted mean
|
-3.86 units on a scale
Standard Error 0.59
|
-4.23 units on a scale
Standard Error 0.61
|
|
Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
Change at Month 6 - unadjusted mean
|
-2.13 units on a scale
Standard Error 0.35
|
-3.03 units on a scale
Standard Error 0.42
|
SECONDARY outcome
Timeframe: Baseline up to Month 6Population: Analysis was performed on all participants included in the study.
Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs included both serious and non-serious adverse event. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Tofacitinib
n=100 Participants
Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
Biologics
n=70 Participants
Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
|---|---|---|
|
Number of Participants With Serious Adverse Event (SAE) and Non-serious Adverse Events (AEs)
Participants with SAE
|
1 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Event (SAE) and Non-serious Adverse Events (AEs)
Participants with Non-Serious AE
|
20 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 6Population: Analysis was performed on all participants included in the study.
Serious infection defined as any infection that requires hospitalization.
Outcome measures
| Measure |
Tofacitinib
n=100 Participants
Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
Biologics
n=70 Participants
Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
|---|---|---|
|
Number of Participants With Serious Infections
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 6Population: Analysis was performed on all participants included in the study.
Here, number of participants who withdrew from study due to AEs and due to all causes (withdrawals due to AEs, lost to follow up and unspecified reasons) have been described.
Outcome measures
| Measure |
Tofacitinib
n=100 Participants
Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
Biologics
n=70 Participants
Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
|
|---|---|---|
|
Number of Participants Who Withdrew From Study Due to Adverse Events And Due to All Causes
Due to AEs
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Withdrew From Study Due to Adverse Events And Due to All Causes
Due to All causes
|
10 Participants
|
2 Participants
|
Adverse Events
Biologics
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Tofacitinib
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Biologics
n=70 participants at risk
Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
|
Tofacitinib
n=100 participants at risk
Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
|
|---|---|---|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Peritonitis
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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 |
Biologics
n=70 participants at risk
Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
|
Tofacitinib
n=100 participants at risk
Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Bicytopenia
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
|
1.4%
1/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
0.00%
0/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Purpura
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Oligomenorrhea
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Photophobia
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Vision blurred
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Abdominal pain
|
1.4%
1/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
0.00%
0/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Diarrhea
|
4.3%
3/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Malaise
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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 simplex
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Fall
|
2.9%
2/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
0.00%
0/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Arthralgia
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Coccydynia
|
1.4%
1/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
0.00%
0/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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 vertebral fracture
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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 pain
|
1.4%
1/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
0.00%
0/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Myalgia
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
|
2.9%
2/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
3.0%
3/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Spinal pain
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Cystitis
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Pollakiuria
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Urinary tract infection
|
2.9%
2/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Vulvovaginitis
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Cough
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Influenza
|
1.4%
1/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
3.0%
3/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Nasopharyngitis
|
2.9%
2/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
0.00%
0/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Pharyngitis
|
4.3%
3/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Pharyngitis bacterial
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Pharyngotonsillitis
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
2.0%
2/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Rhinorrhea
|
1.4%
1/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
0.00%
0/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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
Ecchymosis
|
0.00%
0/70 • Baseline up to Month 6
The same event may appear as both an AE and a 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.
|
1.0%
1/100 • Baseline up to Month 6
The same event may appear as both an AE and a 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