Trial Outcomes & Findings for Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects (NCT NCT02378506)
NCT ID: NCT02378506
Last Updated: 2017-05-15
Results Overview
Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
188 participants
Primary outcome timeframe
Week 12
Results posted on
2017-05-15
Participant Flow
Participant milestones
| Measure |
Etanercept
Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
|
|---|---|
|
Overall Study
STARTED
|
188
|
|
Overall Study
Treated
|
187
|
|
Overall Study
COMPLETED
|
163
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Etanercept
Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Death
|
1
|
|
Overall Study
Adverse Event
|
14
|
|
Overall Study
Randomized But Not Treated
|
1
|
Baseline Characteristics
Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects
Baseline characteristics by cohort
| Measure |
Etanercept
n=187 Participants
Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
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|---|---|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 12.89 • n=39 Participants
|
|
Sex: Female, Male
Female
|
159 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation. Here, "Number of Participants Analyzed" (N) signifies number of participants evaluable for this outcome measure.
Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
Outcome measures
| Measure |
Etanercept
n=158 Participants
Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
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|---|---|
|
Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12
|
1.9 percentage of participants
Interval 0.5 to 5.0
|
PRIMARY outcome
Timeframe: Week 24Population: Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation. Here, "N" signifies number of participants evaluable for this outcome measure.
Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
Outcome measures
| Measure |
Etanercept
n=175 Participants
Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
|
|---|---|
|
Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status at Week 24
|
2.9 percentage of participants
Interval 1.1 to 6.1
|
PRIMARY outcome
Timeframe: Baseline up to Week 24Population: Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation.
Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
Outcome measures
| Measure |
Etanercept
n=176 Participants
Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
|
|---|---|
|
Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status: Throughout Study Treatment
|
4.5 percentage of participants
Interval 2.2 to 8.4
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 24Population: Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation.
Percentage of participants with positive Etanercept neutralizing anti-drug antibodies were summarized.
Outcome measures
| Measure |
Etanercept
n=176 Participants
Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
|
|---|---|
|
Percentage of Participants With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment
|
0.00 percentage of participants
Interval 0.0 to 1.4
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 28 (Follow-up)Population: Safety population included all participants who had taken at least 1 dose of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Outcome measures
| Measure |
Etanercept
n=187 Participants
Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
|
|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
90 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
9 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 28 (Follow-up)Population: Safety population included all participants who had taken at least 1 dose of study medication.
Infection was considered as serious by investigator for any of the following outcomes: death; life-threatening; required initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity or congenital anomaly/birth defect.
Outcome measures
| Measure |
Etanercept
n=187 Participants
Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
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|---|---|
|
Number of Participants With Investigator-Identified Serious Infections
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 28 (Follow-up)Population: Safety population included all participants who had taken at least 1 dose of study medication.
Injection site reactions included injection site erythema, swelling, pain and warmth.
Outcome measures
| Measure |
Etanercept
n=187 Participants
Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
|
|---|---|
|
Number of Participants With Injection Site Reactions
|
27 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 28 (Follow-up)Population: Safety population included all participants who had taken at least 1 dose of study medication.
Laboratory abnormalities(national cancer institute toxicity criteria version 4.0),Grade 3:neutrophil (greater than or equal to\[\>=\]0.5,less than\[\<\]1.0 10\^9/L),lymphocyte (\<0.5 10\^9/L),hemoglobin (Hb) (\<80,\>=65 gram per liter \[g/L\]),platelet(\<50.0,\>=25.0 10\^9/L),white blood count(WBC) (\<2.0, \>=1.0 10\^9/L);alkaline phosphatase (AP),aspartate aminotransferase(AST),alanine aminotransferase(ALT) (greater than\[\>\]5.0\*upper range \[UR\], \<=20.0\*UR unit per liter\[U/L\]);bilirubin(\>1.5\*UR, less than or equal to\[\<=\]3.0\*UR micromole per liter\[mcmol/L\]);creatinine(\>3.0\*UR, \<=6.0\*UR mcmol/L);albumin (\<20.0 g/L),urea(\>3.0\*UR, \<=4.0\*UR g/L);potassium (K)-high,low (\>6.0,\<=7.0or\<3.0,\>=2.5 mcmol/L); sodium(Na)-high,low(\>155, \<=160 or \<130, \>=120 mcmol/L)and Grade 4: neutrophil(\<0.5 10\^9/L),Hb (\<65 g/L);platelet (\<25.0 10\^9/L); WBC(\<1.0 10\^9/L);AP,AST,ALT(\>20.0\*UR U/L);bilirubin(\>3.0\*UR mcmol/L);creatinine (\>6.0\*UR mcmol/L);urea (\>4.0\*UR g/L);K-high,low (\>7.0or\<2.5 mcmol/L);Na-high, low (\>160or\<120 mcmol/L).
Outcome measures
| Measure |
Etanercept
n=187 Participants
Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
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|---|---|
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Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities
|
5 participants
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SECONDARY outcome
Timeframe: Week 4, 12, 24Population: Modified intent-to-treat (mITT) population included all participants who had taken at least 1 dose of study medication. Here, "n" signifies number of participants who were evaluable for specified time points.
ACR20 responder: participants with 20 percent (%) improvement in tender and swollen 28-joint counts and 20% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR20 response were reported.
Outcome measures
| Measure |
Etanercept
n=187 Participants
Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
|
|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Week 12 (n =179)
|
76.5 percentage of participants
Interval 69.9 to 82.3
|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Week 24 (n =161)
|
82.0 percentage of participants
Interval 75.5 to 87.3
|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Week 4 (n =186)
|
55.9 percentage of participants
Interval 48.7 to 62.9
|
SECONDARY outcome
Timeframe: Week 4, 12, 24Population: mITT population included all participants who had taken at least 1 dose of study medication. Here, "n" signifies number of participants who were evaluable for specified time points.
ACR50 responder: participants with 50% improvement in tender and swollen 28-joint counts and 50% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR50 response were reported.
Outcome measures
| Measure |
Etanercept
n=187 Participants
Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
|
|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Week 12 (n =179)
|
36.3 percentage of participants
Interval 29.5 to 43.5
|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Week 24 (n =161)
|
57.8 percentage of participants
Interval 50.1 to 65.2
|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Week 4 (n =186)
|
16.1 percentage of participants
Interval 11.4 to 21.9
|
SECONDARY outcome
Timeframe: Week 4, 12, 24Population: mITT population included all participants who had taken at least 1 dose of study medication. Here, "n" signifies number of participants who were evaluable for specified time points.
ACR70 responder: participants with 70% improvement in tender and swollen 28-joint counts and 70% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR70 response were reported.
Outcome measures
| Measure |
Etanercept
n=187 Participants
Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
|
|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Week 12 (n =179)
|
13.4 percentage of participants
Interval 9.0 to 19.0
|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Week 24 (n =161)
|
26.7 percentage of participants
Interval 20.3 to 33.9
|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Week 4 (n =186)
|
3.2 percentage of participants
Interval 1.4 to 6.5
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 12, 24Population: mITT population included all participants who had taken at least 1 dose of study medication. Here, "n" signifies number of participants who were evaluable for specified time points.
DAS28: measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, erythrocyte sedimentation rate (millimeter per hour \[mm/hour\]) and participant's general health visual analog scale assessment (scores: 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicate worse health condition). Total DAS28-4 (ESR) score: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (ESR) less than (\<) 2.6= remission, \<3.2= low disease activity, greater than or equal to (\>=) 3.2 to 5.1= moderate disease activity and \>5.1= high disease activity.
Outcome measures
| Measure |
Etanercept
n=187 Participants
Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
|
|---|---|
|
Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24
Baseline (n =187)
|
6.2 units on a scale
Standard Deviation 0.93
|
|
Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24
Change at Week 4 (n =186)
|
-1.5 units on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24
Change at Week 12 (n =180)
|
-2.3 units on a scale
Standard Deviation 1.19
|
|
Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24
Change at Week 24 (n =162)
|
-2.8 units on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 12, 24Population: mITT population included all participants who had taken at least 1 dose of study medication. Here, "n" signifies number of participants who were evaluable for specified time points.
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from the number of swollen joints and tender joints using the 28 joints count, C-Reactive protein (milligram per liter \[mg/L\]) and participant's general health visual analog scale assessment (scores ranging 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (CRP) less than (\<) 2.6= remission, \<3.2= low disease activity, greater than or equal to (\>=) 3.2 to 5.1= moderate disease activity and \>5.1= high disease activity.
Outcome measures
| Measure |
Etanercept
n=187 Participants
Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
|
|---|---|
|
Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24
Baseline (n =187)
|
5.4 units on a scale
Standard Deviation 0.91
|
|
Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24
Change at Week 4 (n =187)
|
-1.5 units on a scale
Standard Deviation 1.02
|
|
Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24
Change at Week 12 (n =179)
|
-2.2 units on a scale
Standard Deviation 1.09
|
|
Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24
Change at Week 24 (n =162)
|
-2.5 units on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 12, 24Population: mITT population included all participants who had taken at least 1 dose of study medication. Here, "n" signifies number of participants who were evaluable for specified time points.
HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each item scored on 4-point scale from 0 to 3: 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 the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.
Outcome measures
| Measure |
Etanercept
n=187 Participants
Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
|
|---|---|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24
Change at Week 4 (n =186)
|
-0.3 units on a scale
Standard Deviation 0.39
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24
Change at Week 12 (n =179)
|
-0.4 units on a scale
Standard Deviation 0.48
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24
Change at Week 24 (n =161)
|
-0.5 units on a scale
Standard Deviation 0.56
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24
Baseline (n =186)
|
1.3 units on a scale
Standard Deviation 0.58
|
Adverse Events
Etanercept
Serious events: 9 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etanercept
n=187 participants at risk
Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Cardiac disorders
Cardiac failure acute
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Diverticulitis
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Pneumonia
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Wound infection
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Metatarsalgia
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Osteoarthritis
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Psychiatric disorders
Major depression
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Calculus ureteric
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Urticaria
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Vascular disorders
Deep vein thrombosis
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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 |
Etanercept
n=187 participants at risk
Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Thrombocytopenia
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Cardiac disorders
Sinus bradycardia
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Cardiac disorders
Tachycardia
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Retinal detachment
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Diarrhoea
|
1.6%
3/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Stomatitis
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Fatigue
|
2.7%
5/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Influenza like illness
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Injection site erythema
|
10.7%
20/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Injection site nodule
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Injection site pruritus
|
3.7%
7/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Injection site rash
|
1.1%
2/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Injection site reaction
|
2.7%
5/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Injection site swelling
|
1.6%
3/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Injection site urticaria
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Injection site vesicles
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Peripheral swelling
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Immune system disorders
Seasonal allergy
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Asymptomatic bacteriuria
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Bronchitis
|
1.6%
3/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Fungal skin infection
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Gastroenteritis
|
1.1%
2/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Genitourinary tract infection
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Gingivitis
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Influenza
|
1.1%
2/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Nasopharyngitis
|
7.0%
13/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Otitis media acute
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Pneumonia
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Rhinitis
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Tonsillitis
|
1.1%
2/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Upper respiratory tract infection
|
7.0%
13/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Urinary tract infection
|
2.1%
4/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Arthropod bite
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Contusion
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Foot fracture
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Ligament sprain
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Lumbar vertebral fracture
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Investigations
Alanine aminotransferase increased
|
1.1%
2/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Investigations
Aspartate aminotransferase increased
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Investigations
Blood pressure diastolic abnormal
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Investigations
Hepatic enzyme increased
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Investigations
Lymphocyte count decreased
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Investigations
Neutrophil count decreased
|
1.1%
2/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Investigations
Platelet count decreased
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Investigations
Vitamin D decreased
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Investigations
White blood cell count decreased
|
1.6%
3/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
|
1.6%
3/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Back pain
|
1.1%
2/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Joint instability
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Muscle spasms
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Rheumatoid arthritis
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Cerebrovascular disorder
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
|
2.7%
5/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Migraine
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Neuralgia
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Paraesthesia
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Psychiatric disorders
Anxiety
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Psychiatric disorders
Depression
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Psychiatric disorders
Impulsive behaviour
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Amenorrhoea
|
0.63%
1/159 • Baseline (Day 1) up to Week 28 (follow-up)
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
Asthma
|
1.1%
2/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
|
1.1%
2/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Upper-airway cough syndrome
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Dermatitis allergic
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Erythema
|
2.1%
4/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Pruritus
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Pruritus generalised
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Psoriasis
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Rash
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Rash macular
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Rash pruritic
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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
Skin fissures
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Surgical and medical procedures
Tooth extraction
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Vascular disorders
Haematoma
|
0.53%
1/187 • Baseline (Day 1) up to Week 28 (follow-up)
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.
|
|
Vascular disorders
Hypertension
|
2.1%
4/187 • Baseline (Day 1) up to Week 28 (follow-up)
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