Trial Outcomes & Findings for Formation of Antibodies and Subsequent Prediction of Clinical Response in Patients With Rheumatoid Arthritis Treated With Four TNF Blocking Agents (NCT NCT01691014)
NCT ID: NCT01691014
Last Updated: 2016-12-29
Results Overview
Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.
Recruitment status
TERMINATED
Target enrollment
79 participants
Primary outcome timeframe
Month 6
Results posted on
2016-12-29
Participant Flow
Participant milestones
| Measure |
Adalimumab
Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
|
Etanercept
Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
Certolizumab
Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
Infliximab
Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
26
|
36
|
9
|
|
Overall Study
COMPLETED
|
5
|
11
|
25
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
15
|
11
|
5
|
Reasons for withdrawal
| Measure |
Adalimumab
Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
|
Etanercept
Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
Certolizumab
Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
Infliximab
Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
|---|---|---|---|---|
|
Overall Study
Premature Termination
|
1
|
6
|
0
|
3
|
|
Overall Study
Other
|
0
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
5
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
3
|
7
|
0
|
Baseline Characteristics
Formation of Antibodies and Subsequent Prediction of Clinical Response in Patients With Rheumatoid Arthritis Treated With Four TNF Blocking Agents
Baseline characteristics by cohort
| Measure |
Adalimumab
n=8 Participants
Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
|
Etanercept
n=26 Participants
Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
Certolizumab
n=36 Participants
Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
Infliximab
n=9 Participants
Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 6 • n=5 Participants
|
57 years
STANDARD_DEVIATION 13 • n=7 Participants
|
56 years
STANDARD_DEVIATION 14 • n=5 Participants
|
51 years
STANDARD_DEVIATION 11 • n=4 Participants
|
55 years
STANDARD_DEVIATION 13 • n=21 Participants
|
|
Gender
Female
|
4 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Gender
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: Data was not collected since this outcome measure was not analyzed due to premature termination of the study.
Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Month 6Population: Data was not collected since this outcome measure was not analyzed due to premature termination of the study.
Presence of active drugs in serum 6 months after treatment with Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 6, 12Population: Data was not collected since this outcome measure was not analyzed due to premature termination of the study.
Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and DAS28 was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 \[good condition\] to 10 \[worst condition\]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 6, 12Population: Data was not collected since this outcome measure was not analyzed due to premature termination of the study.
Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and HAQ scores was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 6, 12Population: Data was not collected since this outcome measure was not analyzed due to premature termination of the study.
Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and cessation of therapy was to be analyzed. Cessation of therapy between month 6 and month 12 was the time to withdrawal from study due to either adverse events or lack of effect between the 6 month visit and the 12 month visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 3, 12Population: Data was not collected since this outcome measure was not analyzed due to premature termination of the study.
Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 12Population: Data was not collected since this outcome measure was not analyzed due to premature termination of the study.
Association between formation of anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and concomitant Methotrexate treatment (weekly dose of 7.5 milligram) was to be analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 3, 6, 12Population: EAS included all participants that provided at least 1 post-baseline assessment. Here,"n" signifies number of participants evaluable at the specified time points for this outcome measure.
DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 \[good condition\] to 10 \[worst condition\]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS28-4 (CRP) less than or equal to (\<=) 3.2 implied low disease activity and greater than (\>) 3.2 to 5.1 implied moderate to high disease activity.
Outcome measures
| Measure |
Adalimumab
n=8 Participants
Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
|
Etanercept
n=26 Participants
Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
Certolizumab
n=36 Participants
Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
Infliximab
n=9 Participants
Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
|---|---|---|---|---|
|
Disease Activity Score Based on 28-Joints Count (DAS28) After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Month 3, 6 and 12
Month 3 (n= 7, 23, 34, 8)
|
3.2 units on a scale
Standard Deviation 1.0
|
3.0 units on a scale
Standard Deviation 1.1
|
3.0 units on a scale
Standard Deviation 1.4
|
3.0 units on a scale
Standard Deviation 2.0
|
|
Disease Activity Score Based on 28-Joints Count (DAS28) After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Month 3, 6 and 12
Month 6 (n= 6, 18, 26, 6)
|
2.7 units on a scale
Standard Deviation 1.6
|
2.2 units on a scale
Standard Deviation 1.1
|
2.4 units on a scale
Standard Deviation 1.3
|
1.8 units on a scale
Standard Deviation 1.0
|
|
Disease Activity Score Based on 28-Joints Count (DAS28) After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Month 3, 6 and 12
Month 12 (n= 5, 11, 25, 4)
|
2.6 units on a scale
Standard Deviation 0.8
|
2.4 units on a scale
Standard Deviation 0.8
|
2.5 units on a scale
Standard Deviation 1.1
|
2.7 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 12Population: EAS included all participants that provided at least 1 post-baseline assessment. Here, "n" signifies number of participants evaluable for this outcome measure at the specified time points.
HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.
Outcome measures
| Measure |
Adalimumab
n=8 Participants
Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
|
Etanercept
n=26 Participants
Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
Certolizumab
n=36 Participants
Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
Infliximab
n=9 Participants
Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
|---|---|---|---|---|
|
Health Assessment Questionnaire (HAQ) Score After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Baseline, Month 3, 6 and 12
Baseline (n= 8, 26, 36, 9)
|
1.1 units on a scale
Standard Deviation 0.6
|
1.2 units on a scale
Standard Deviation 0.6
|
1.2 units on a scale
Standard Deviation 0.7
|
1.1 units on a scale
Standard Deviation 0.5
|
|
Health Assessment Questionnaire (HAQ) Score After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Baseline, Month 3, 6 and 12
Month 3 (n= 7, 23, 34, 8)
|
0.8 units on a scale
Standard Deviation 0.6
|
0.9 units on a scale
Standard Deviation 0.7
|
0.8 units on a scale
Standard Deviation 0.7
|
1.2 units on a scale
Standard Deviation 0.8
|
|
Health Assessment Questionnaire (HAQ) Score After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Baseline, Month 3, 6 and 12
Month 6 (n= 6, 18, 26, 6)
|
0.8 units on a scale
Standard Deviation 0.2
|
0.6 units on a scale
Standard Deviation 0.6
|
0.7 units on a scale
Standard Deviation 0.6
|
0.8 units on a scale
Standard Deviation 0.7
|
|
Health Assessment Questionnaire (HAQ) Score After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Baseline, Month 3, 6 and 12
Month 12 (n= 5, 11, 25, 4)
|
0.7 units on a scale
Standard Deviation 0.4
|
1.0 units on a scale
Standard Deviation 0.8
|
0.6 units on a scale
Standard Deviation 0.6
|
0.8 units on a scale
Standard Deviation 0.7
|
Adverse Events
Adalimumab
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Etanercept
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Certolizumab
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Infliximab
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab
n=8 participants at risk
Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
|
Etanercept
n=26 participants at risk
Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
Certolizumab
n=36 participants at risk
Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
Infliximab
n=9 participants at risk
Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
2.8%
1/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Infection
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
2.8%
1/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
3.8%
1/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
2.8%
1/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of esophagus
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
3.8%
1/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Vasculitis
|
12.5%
1/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Adalimumab
n=8 participants at risk
Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
|
Etanercept
n=26 participants at risk
Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
Certolizumab
n=36 participants at risk
Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
Infliximab
n=9 participants at risk
Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
|
|---|---|---|---|---|
|
Vascular disorders
Deep vein thrombosis leg
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombopenia
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
3.8%
1/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
2.8%
1/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
2.8%
1/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Periumbilical pain
|
12.5%
1/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Feeling unwell
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fever
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
3.8%
1/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Injection site erythema
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
3.8%
1/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Therapeutic product ineffective
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
3.8%
1/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Polyp
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Foreign body reaction
|
12.5%
1/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
3.8%
1/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Immune system disorders
Allergy NOS
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Cold
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
2.8%
1/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Infection localised
|
12.5%
1/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Nose infection NOS
|
12.5%
1/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
7.7%
2/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
3.8%
1/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
2.8%
1/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
3.8%
1/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
22.2%
2/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Cold sores lip
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
3.8%
1/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Flu symptoms
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
2.8%
1/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Lung infection
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
2.8%
1/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
2.8%
1/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Elevated liver enzymes
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
2.8%
1/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
3.8%
1/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
3.8%
1/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema aggravated
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
3.8%
1/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
3.8%
1/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
3.8%
1/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
3.8%
1/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Palmoplantar pustulosis
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
3.8%
1/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Drug rash
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
3.8%
1/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
3.8%
1/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypertension arterial
|
12.5%
1/8 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/26 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/36 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline upto 12 months
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 participants may have experienced both a serious and non-serious event during the study.
|
Additional Information
Pfizer Inc.
Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc.
Phone: 001 800-718-1021
Email: [email protected]
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