Trial Outcomes & Findings for Changes of Depression After First-year of Tofacitinib in RA Patients (NCT NCT03992781)
NCT ID: NCT03992781
Last Updated: 2025-04-06
Results Overview
The CUDOS questionnaire assessed the level of depression in the past week. It consisted of 18 questions. For each question the participant indicated how well it described his/her feelings during past week on the following scale: 0 = not at all true, 1 = rarely true, 2 = sometimes true, 3 = often true and 4 = almost always true. The result of this questionnaire was the sum of responses to all questions and therefore the overall possible CUDOS score ranged from 0 to 72, higher score indicated more severe depression. Absolute values of CUDOS score at baseline (Visit 1) and 12 Months (Visit 3) are reported in descriptive data below. Mean relative change was calculated by averaging the relative changes of each of the participants (sum of all relative changes divided by the number of participants) and was reported in the statistical section.
COMPLETED
73 participants
Baseline (Visit 1), 12 Months (Visit 3)
2025-04-06
Participant Flow
Participants who were diagnosed with moderate to severe rheumatoid arthritis (RA), initiated tofacitinib treatment for the first time and scored at least 11 points on clinically useful depression outcome scale (CUDOS) were enrolled. Participants were followed up for 12 months.
Participant milestones
| Measure |
All Participants
All eligible participants who initiated tofacitinib treatment at Visit 1 (Day 1) in real world setting per routine care and in accordance with local marketing authorization, were included in this observational study.
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|---|---|
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Overall Study
STARTED
|
73
|
|
Overall Study
Safety Analysis Set
|
70
|
|
Overall Study
Full Analysis Set
|
62
|
|
Overall Study
COMPLETED
|
62
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
All Participants
All eligible participants who initiated tofacitinib treatment at Visit 1 (Day 1) in real world setting per routine care and in accordance with local marketing authorization, were included in this observational study.
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|---|---|
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Overall Study
Lost to Follow-up
|
5
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Overall Study
Adverse Event
|
1
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|
Overall Study
Lack of Efficacy
|
5
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants
n=70 Participants
All eligible participants who initiated tofacitinib treatment at Visit 1 (Day 1) in real world setting per routine care and in accordance with local marketing authorization, were included in this observational study.
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|---|---|
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Age, Continuous
|
57.3 Years
STANDARD_DEVIATION 13.4 • n=70 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=70 Participants
|
PRIMARY outcome
Timeframe: Baseline (Visit 1), 12 Months (Visit 3)Population: Full analysis set (FAS) included all participants who received at least one dose of tofacitinib and had the data for evaluation of primary hypothesis, which means CUDOS reported both at baseline and visit 3.
The CUDOS questionnaire assessed the level of depression in the past week. It consisted of 18 questions. For each question the participant indicated how well it described his/her feelings during past week on the following scale: 0 = not at all true, 1 = rarely true, 2 = sometimes true, 3 = often true and 4 = almost always true. The result of this questionnaire was the sum of responses to all questions and therefore the overall possible CUDOS score ranged from 0 to 72, higher score indicated more severe depression. Absolute values of CUDOS score at baseline (Visit 1) and 12 Months (Visit 3) are reported in descriptive data below. Mean relative change was calculated by averaging the relative changes of each of the participants (sum of all relative changes divided by the number of participants) and was reported in the statistical section.
Outcome measures
| Measure |
All Participants
n=62 Participants
All eligible participants who initiated tofacitinib treatment at Visit 1 (Day 1) in real world setting per routine care and in accordance with local marketing authorization, were included in this observational study.
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|---|---|
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CUDOS Score: Baseline (Visit 1) and 12 Months (Visit 3)
Baseline (Visit 1)
|
21.97 Units on a scale
Standard Deviation 9.45
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CUDOS Score: Baseline (Visit 1) and 12 Months (Visit 3)
12 Months (Visit 3)
|
9.29 Units on a scale
Standard Deviation 6.71
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SECONDARY outcome
Timeframe: Baseline (Visit 1), 6 Months (Visit 2)Population: FAS included all participants who received at least one dose of tofacitinib and had the data for evaluation of primary hypothesis, which means CUDOS reported both at baseline and visit 3.
The CUDOS questionnaire assessed the level of depression in the past week. It consisted of 18 questions. For each question the participant indicated how well it described his/her feelings during past week on the following scale: 0 = not at all true, 1 = rarely true, 2 = sometimes true, 3 = often true and 4 = almost always true. The result of this questionnaire was the sum of responses to all questions and therefore the overall possible CUDOS score ranged from 0 to 72, higher score indicated more severe depression. Absolute values of CUDOS score at baseline (Visit 1) and 6 Months (Visit 2) are reported in descriptive data below. Mean relative change was calculated by averaging the relative changes of each of the participants (sum of all relative changes divided by the number of participants) and was reported in the statistical section.
Outcome measures
| Measure |
All Participants
n=62 Participants
All eligible participants who initiated tofacitinib treatment at Visit 1 (Day 1) in real world setting per routine care and in accordance with local marketing authorization, were included in this observational study.
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|---|---|
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CUDOS Score: Baseline (Visit 1) and 6 Months (Visit 2)
Baseline (Visit 1)
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21.97 Units on a scale
Standard Deviation 9.45
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CUDOS Score: Baseline (Visit 1) and 6 Months (Visit 2)
6 Months (Visit 2)
|
12.79 Units on a scale
Standard Deviation 8.71
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SECONDARY outcome
Timeframe: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)Population: FAS included all participants who received at least one dose of tofacitinib and had the data for evaluation of primary hypothesis, which means CUDOS reported both at baseline and visit 3.
The clinically useful anxiety outcome scale (CUXOS) questionnaire assessed the level of anxiety in the past week. It consisted of 20 questions. For each question the participant indicated how well it described his/her feelings during past week on the following scale: 0 = not at all true, 1 = rarely true, 2 = sometimes true, 3 = often true and 4 = almost always true. The result of this questionnaire was the sum of responses to all questions and therefore the overall possible CUXOS score ranged from 0 to 80, higher score indicated higher anxiety level. Absolute values of CUXOS score at baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3) are reported in descriptive data below. Mean relative change was calculated by averaging the relative changes of each of the participants (sum of all relative changes divided by the number of participants) and was reported in the statistical section.
Outcome measures
| Measure |
All Participants
n=62 Participants
All eligible participants who initiated tofacitinib treatment at Visit 1 (Day 1) in real world setting per routine care and in accordance with local marketing authorization, were included in this observational study.
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|---|---|
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CUXOS Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
Baseline (Visit 1)
|
20.45 Units on a scale
Standard Deviation 14.21
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CUXOS Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
6 Months (Visit 2)
|
12.24 Units on a scale
Standard Deviation 11.31
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CUXOS Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
12 Months (Visit 3)
|
8.21 Units on a scale
Standard Deviation 8.66
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SECONDARY outcome
Timeframe: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)Population: FAS included all participants who received at least one dose of tofacitinib and had the data for evaluation of primary hypothesis, which means CUDOS reported both at baseline and visit 3.
The Jenkins sleep evaluation questionnaire (JSEQ) questionnaire assessed the level of insomnia, sleep disturbance in the past month. It consisted of 4 questions related to 1) trouble falling asleep, 2) trouble staying asleep, 3) waking up several times per night, and 4) waking up feeling tired and worn out after a usual amount of sleep. The response alternatives were: 0 = not at all, 1 = 1-3 days, 2 = 4-7 days, 3 = 8-14 days, 4 = 15-21 days, and 5 = 22-30 days. The result of this questionnaire was the sum of responses to all questions and therefore the overall possible JSEQ score ranged from 0 to 20, higher score indicated lower sleep quality. Absolute values of JSEQ score at baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3) are reported in descriptive data below. Mean relative change was calculated by averaging the relative changes of each of the participants (sum of all relative changes divided by the number of participants) and was reported in the statistical section.
Outcome measures
| Measure |
All Participants
n=62 Participants
All eligible participants who initiated tofacitinib treatment at Visit 1 (Day 1) in real world setting per routine care and in accordance with local marketing authorization, were included in this observational study.
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|---|---|
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JSEQ Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
Baseline (Visit 1)
|
9.40 Units on a scale
Standard Deviation 4.78
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JSEQ Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
6 Months (Visit 2)
|
6.63 Units on a scale
Standard Deviation 4.61
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JSEQ Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
12 Months (Visit 3)
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5.48 Units on a scale
Standard Deviation 3.52
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SECONDARY outcome
Timeframe: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)Population: FAS included all participants who received at least one dose of tofacitinib and had the data for evaluation of primary hypothesis, which means CUDOS reported both at baseline and visit 3. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Participants assessed how much arthritis impacted their life using a 100 millimeter (mm) visual analogue score (VAS) by placing a mark on the scale between 0 (not affecting) and 100 (maximal impact), which corresponded to the level arthritis affected their life. The score ranged from 0 mm to 100 mm, higher score indicated higher impact of arthritis on participants life. Absolute values of VAS score at baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3) are reported in descriptive data below. Mean relative change was calculated by averaging the relative changes of each of the participants (sum of all relative changes divided by the number of participants) and was reported in the statistical section.
Outcome measures
| Measure |
All Participants
n=38 Participants
All eligible participants who initiated tofacitinib treatment at Visit 1 (Day 1) in real world setting per routine care and in accordance with local marketing authorization, were included in this observational study.
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|---|---|
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VAS Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
Baseline (Visit 1)
|
61.42 Units on a scale
Standard Deviation 18.62
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|
VAS Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
6 Months (Visit 2)
|
33.58 Units on a scale
Standard Deviation 20.34
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|
VAS Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
12 Months (Visit 3)
|
33.75 Units on a scale
Standard Deviation 26.57
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SECONDARY outcome
Timeframe: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)Population: FAS included all participants who received at least one dose of tofacitinib and had the data for evaluation of primary hypothesis, which means CUDOS reported both at baseline and visit 3.
Number of participants who took at least 1 concomitant treatment like antidepressants, anxiolytics and hypnotics were reported in this outcome measure. Participants could have been counted in more than one category.
Outcome measures
| Measure |
All Participants
n=62 Participants
All eligible participants who initiated tofacitinib treatment at Visit 1 (Day 1) in real world setting per routine care and in accordance with local marketing authorization, were included in this observational study.
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|---|---|
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Number of Participants Who Took at Least 1 Concomitant Treatment of Mental Illness Per Study Visit
Visit 2: Antidepressants
|
2 Participants
|
|
Number of Participants Who Took at Least 1 Concomitant Treatment of Mental Illness Per Study Visit
Visit 1: Antidepressants
|
4 Participants
|
|
Number of Participants Who Took at Least 1 Concomitant Treatment of Mental Illness Per Study Visit
Visit 1: Anxiolytics
|
1 Participants
|
|
Number of Participants Who Took at Least 1 Concomitant Treatment of Mental Illness Per Study Visit
Visit 1: Hypnotics
|
5 Participants
|
|
Number of Participants Who Took at Least 1 Concomitant Treatment of Mental Illness Per Study Visit
Visit 2: Anxiolytics
|
0 Participants
|
|
Number of Participants Who Took at Least 1 Concomitant Treatment of Mental Illness Per Study Visit
Visit 2: Hypnotics
|
3 Participants
|
|
Number of Participants Who Took at Least 1 Concomitant Treatment of Mental Illness Per Study Visit
Visit 3: Antidepressants
|
5 Participants
|
|
Number of Participants Who Took at Least 1 Concomitant Treatment of Mental Illness Per Study Visit
Visit 3: Anxiolytics
|
0 Participants
|
|
Number of Participants Who Took at Least 1 Concomitant Treatment of Mental Illness Per Study Visit
Visit 3: Hypnotics
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), 12 Months (Visit 3)Population: FAS included all participants who received at least one dose of tofacitinib and had the data for evaluation of primary hypothesis, which means CUDOS reported both at baseline and visit 3.
Number of participants with change in number of used medications and in their dosage between 12 Months (Visit 3) and Baseline (Visit 1) were reported in this outcome measure.
Outcome measures
| Measure |
All Participants
n=62 Participants
All eligible participants who initiated tofacitinib treatment at Visit 1 (Day 1) in real world setting per routine care and in accordance with local marketing authorization, were included in this observational study.
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|---|---|
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Number of Participants With Change in Dosage of Concomitant Medication Between 12 Months (Visit 3) and Baseline (Visit 1)
Antidepressants
|
1 Participants
|
|
Number of Participants With Change in Dosage of Concomitant Medication Between 12 Months (Visit 3) and Baseline (Visit 1)
Anxiolytics
|
1 Participants
|
|
Number of Participants With Change in Dosage of Concomitant Medication Between 12 Months (Visit 3) and Baseline (Visit 1)
Hypnotics
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)Population: FAS included all participants who received at least one dose of tofacitinib and had the data for evaluation of primary hypothesis, which means CUDOS reported both at baseline and visit 3.
Disease activity score 28-4 (DAS28-4) C-reactive protein (CRP) was calculated from 28-tender joint counts and 28-swollen joint counts, CRP (milligram per liter \[mg/L\]) and patient global assessment (PGA); participant assessed overall disease activity on VAS, score: 0 \[no arthritis\] to 100 \[extreme arthritis\]. DAS 28 -4 CRP = 0.56\*sqrt (TJC28) + 0.28\*sqrt (SJC28) + 0.36\*In (CRP in mg/1 + 1) + 0.014\*PtGA + 0.96; ln = natural logarithm, sqrt = square root of, mg = milligram, PtGA = patient's global assessment of health. DAS28-4 (CRP) lower than (\<) 2.6 = RA in remission, 2.6 to 3.2 = low level of disease activity, 3.2 to 5.1 = active disease, may require change of treatment and greater than (\>) 5.1 = very active disease, required careful monitoring and change of treatment. Total score range: 0 to 9.4, higher score indicated more disease activity.
Outcome measures
| Measure |
All Participants
n=62 Participants
All eligible participants who initiated tofacitinib treatment at Visit 1 (Day 1) in real world setting per routine care and in accordance with local marketing authorization, were included in this observational study.
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|---|---|
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Absolute Change From Baseline in DAS28-4 (CRP) at 6 Months (Visit 2) and 12 Months (Visit 3)
Absolute change at Visit 2
|
-3.01 Units on a scale
Standard Deviation 1.19
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|
Absolute Change From Baseline in DAS28-4 (CRP) at 6 Months (Visit 2) and 12 Months (Visit 3)
Absolute change at Visit 3
|
-3.06 Units on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)Population: FAS included all participants who received at least one dose of tofacitinib and had the data for evaluation of primary hypothesis, which means CUDOS reported both at baseline and visit 3.
Remission was defined as DAS28-4 (CRP) \< 2.6. DAS28-4 CRP was calculated from 28-tender joint counts and 28-swollen joint counts, CRP (mg/L) and PGA; participant assessed overall disease activity on VAS, score: 0 \[no arthritis\] to 100 \[extreme arthritis\]. DAS 28 -4 CRP = 0.56\*sqrt (TJC28) + 0.28\*sqrt (SJC28) + 0.36\*In (CRP in mg/1 + 1) + 0.014\*PtGA + 0.96; ln = natural logarithm, sqrt = square root of, mg = milligram, PtGA = patient's global assessment of health. DAS28-4 (CRP) \< 2.6 = RA in remission, 2.6 to 3.2 = low level of disease activity, 3.2 to 5.1 = active disease, may require change of treatment and \> 5.1 = very active disease, required careful monitoring and change of treatment. Total score range: 0 to 9.4, higher score indicated more disease activity.
Outcome measures
| Measure |
All Participants
n=62 Participants
All eligible participants who initiated tofacitinib treatment at Visit 1 (Day 1) in real world setting per routine care and in accordance with local marketing authorization, were included in this observational study.
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|---|---|
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Number of Participants Achieving Remission as Assessed by DAS28-4 (CRP) < 2.6
Visit 1
|
0 Participants
|
|
Number of Participants Achieving Remission as Assessed by DAS28-4 (CRP) < 2.6
Visit 2
|
27 Participants
|
|
Number of Participants Achieving Remission as Assessed by DAS28-4 (CRP) < 2.6
Visit 3
|
26 Participants
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)Population: FAS included all participants who received at least one dose of tofacitinib and had the data for evaluation of primary hypothesis, which means CUDOS reported both at baseline and visit 3.
Low disease activity (LDA) was defined as DAS28-4 (CRP) \< 3.2. DAS28-4 CRP was calculated from 28-tender joint counts and 28-swollen joint counts, CRP (mg/L) and PGA; participant assessed overall disease activity on VAS, score: 0 \[no arthritis\] to 100 \[extreme arthritis\]. DAS 28 -4 CRP = 0.56\*sqrt (TJC28) + 0.28\*sqrt (SJC28) + 0.36\*In (CRP in mg/1 + 1) + 0.014\*PtGA + 0.96; ln = natural logarithm, sqrt = square root of, mg = milligram, PtGA = patient's global assessment of health. DAS28-4 (CRP) \< 2.6 = RA in remission, 2.6 to 3.2 = low level of disease activity, 3.2 to 5.1 = active disease, may require change of treatment and \> 5.1 = very active disease, required careful monitoring and change of treatment. Total score range: 0 to 9.4, higher score indicated more disease activity.
Outcome measures
| Measure |
All Participants
n=62 Participants
All eligible participants who initiated tofacitinib treatment at Visit 1 (Day 1) in real world setting per routine care and in accordance with local marketing authorization, were included in this observational study.
|
|---|---|
|
Number of Participants Achieving LDA as Assessed by DAS28-4 (CRP) < 3.2
Visit 1
|
0 Participants
|
|
Number of Participants Achieving LDA as Assessed by DAS28-4 (CRP) < 3.2
Visit 2
|
40 Participants
|
|
Number of Participants Achieving LDA as Assessed by DAS28-4 (CRP) < 3.2
Visit 3
|
44 Participants
|
SECONDARY outcome
Timeframe: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)Population: FAS included all participants who received at least one dose of tofacitinib and had the data for evaluation of primary hypothesis, which means CUDOS reported both at baseline and visit 3.
EQ-5D-3L designed to assess impact on health-related quality of life in 5 domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each domain had 3 responses and scored from 1-3 (1=no problems; 2=some problems; 3=extreme problems). The mean of the summed score ranged from 1 to 3 with "1" corresponding to no problems and "3" corresponding to severe problems, where higher score indicated more severe problems. The EQ-5D-3L index score summarized each possible health state on a numerical scale ranging from -0.594 to 1. A score of 1 indicated full health, score of 0 indicated a state equivalent to being dead, and score lower than 0 indicated a state equivalent to the worst possible health status. Higher score indicated a better quality of life.
Outcome measures
| Measure |
All Participants
n=62 Participants
All eligible participants who initiated tofacitinib treatment at Visit 1 (Day 1) in real world setting per routine care and in accordance with local marketing authorization, were included in this observational study.
|
|---|---|
|
Change From Baseline in EuroQol Five Dimension - 3 Level (EQ-5D-3L) Health State Profile at 6 Months (Visit 2) and 12 Months (Visit 3)
Change at Visit 2
|
0.157 Units on a scale
Standard Deviation 0.231
|
|
Change From Baseline in EuroQol Five Dimension - 3 Level (EQ-5D-3L) Health State Profile at 6 Months (Visit 2) and 12 Months (Visit 3)
Change at Visit 3
|
0.179 Units on a scale
Standard Deviation 0.271
|
SECONDARY outcome
Timeframe: From start of study treatment to 12 months post treatment initiationPopulation: The safety analysis set included all participants who received at least one dose of tofacitinib.
An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. 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. AEs included both SAEs and all non-SAEs. TEAEs were defined as newly occurring (not present at baseline) or worsening after first dose of study treatment.
Outcome measures
| Measure |
All Participants
n=70 Participants
All eligible participants who initiated tofacitinib treatment at Visit 1 (Day 1) in real world setting per routine care and in accordance with local marketing authorization, were included in this observational study.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
15 Participants
|
Adverse Events
All Participants
Serious adverse events
| Measure |
All Participants
n=70 participants at risk
All eligible participants who initiated tofacitinib treatment at Visit 1 (Day 1) in real world setting per routine care and in accordance with local marketing authorization, were included in this observational study.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombopenia
|
1.4%
1/70 • From start of study treatment to 12 months post treatment initiation
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of tofacitinib.
|
Other adverse events
| Measure |
All Participants
n=70 participants at risk
All eligible participants who initiated tofacitinib treatment at Visit 1 (Day 1) in real world setting per routine care and in accordance with local marketing authorization, were included in this observational study.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombopenia
|
1.4%
1/70 • From start of study treatment to 12 months post treatment initiation
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of tofacitinib.
|
|
Ear and labyrinth disorders
Vertigo
|
1.4%
1/70 • From start of study treatment to 12 months post treatment initiation
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of tofacitinib.
|
|
Eye disorders
Dryness of eyes
|
1.4%
1/70 • From start of study treatment to 12 months post treatment initiation
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of tofacitinib.
|
|
Gastrointestinal disorders
Dryness oral
|
1.4%
1/70 • From start of study treatment to 12 months post treatment initiation
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of tofacitinib.
|
|
General disorders
Drug effect lack of
|
7.1%
5/70 • From start of study treatment to 12 months post treatment initiation
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of tofacitinib.
|
|
Infections and infestations
Acute bronchitis
|
1.4%
1/70 • From start of study treatment to 12 months post treatment initiation
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of tofacitinib.
|
|
Infections and infestations
Cold
|
1.4%
1/70 • From start of study treatment to 12 months post treatment initiation
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of tofacitinib.
|
|
Infections and infestations
COVID-19
|
4.3%
3/70 • From start of study treatment to 12 months post treatment initiation
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of tofacitinib.
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
1/70 • From start of study treatment to 12 months post treatment initiation
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of tofacitinib.
|
|
Infections and infestations
Post herpetic neuralgia
|
1.4%
1/70 • From start of study treatment to 12 months post treatment initiation
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of tofacitinib.
|
|
Infections and infestations
Shingles
|
1.4%
1/70 • From start of study treatment to 12 months post treatment initiation
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of tofacitinib.
|
|
Infections and infestations
Virosis
|
2.9%
2/70 • From start of study treatment to 12 months post treatment initiation
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of tofacitinib.
|
|
Renal and urinary disorders
Hematuria
|
1.4%
1/70 • From start of study treatment to 12 months post treatment initiation
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of tofacitinib.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/70 • From start of study treatment to 12 months post treatment initiation
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of tofacitinib.
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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