Trial Outcomes & Findings for Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate (NCT NCT00628095)
NCT ID: NCT00628095
Last Updated: 2022-04-04
Results Overview
ACR20 response: compared to baseline, greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Week 12
Results posted on
2022-04-04
Participant Flow
Participant milestones
| Measure |
CE-224,535
CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
Placebo
Placebo tablet matched to CE-224,535 500 mg tablet orally twice daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
47
|
|
Overall Study
COMPLETED
|
46
|
40
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
CE-224,535
CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
Placebo
Placebo tablet matched to CE-224,535 500 mg tablet orally twice daily for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate
Baseline characteristics by cohort
| Measure |
CE-224,535
n=53 Participants
CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
53.1 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
53.3 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of the randomized study medication. Last observation carried forward (LOCF) was used to impute missing ACR components before computing ACR20 response.
ACR20 response: compared to baseline, greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Outcome measures
| Measure |
CE-224,535
n=53 Participants
CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 12
|
33.96 Percentage of participants
|
36.17 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8Population: FAS included all randomized participants who received at least 1 dose of the randomized study medication. LOCF was used to impute missing ACR components before computing ACR20 response.
ACR20 response: compared to baseline, \>=20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Outcome measures
| Measure |
CE-224,535
n=53 Participants
CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 2, 4 and 8
Week 2
|
13.21 Percentage of participants
|
25.53 Percentage of participants
|
|
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 2, 4 and 8
Week 4
|
32.08 Percentage of participants
|
38.30 Percentage of participants
|
|
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 2, 4 and 8
Week 8
|
30.19 Percentage of participants
|
29.79 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12Population: FAS included all randomized participants who received at least 1 dose of the randomized study medication. LOCF was used to impute missing ACR components before computing ACR50 response.
ACR50 response: compared to baseline, \>=50% improvement in tender joint count; \>= 50% improvement in swollen joint count; and \>= 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Outcome measures
| Measure |
CE-224,535
n=53 Participants
CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
Week 2
|
5.66 Percentage of participants
|
6.38 Percentage of participants
|
|
Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
Week 4
|
7.55 Percentage of participants
|
8.51 Percentage of participants
|
|
Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
Week 8
|
13.21 Percentage of participants
|
12.77 Percentage of participants
|
|
Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
Week 12
|
11.32 Percentage of participants
|
17.02 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12Population: FAS included all randomized participants who received at least 1 dose of the randomized study medication. LOCF was used to impute missing ACR components before computing ACR70 response.
ACR70 response: compared to baseline, \>=70% improvement in tender joint count; \>= 70% improvement in swollen joint count; and \>= 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Outcome measures
| Measure |
CE-224,535
n=53 Participants
CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
Week 2
|
3.77 Percentage of participants
|
0.00 Percentage of participants
|
|
Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
Week 4
|
5.66 Percentage of participants
|
4.26 Percentage of participants
|
|
Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
Week 8
|
5.66 Percentage of participants
|
0.00 Percentage of participants
|
|
Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
Week 12
|
3.77 Percentage of participants
|
0.00 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12Population: FAS included all randomized participants who received at least 1 dose of the randomized study medication. Here, 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Number of tender/painful joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.
Outcome measures
| Measure |
CE-224,535
n=53 Participants
CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
|---|---|---|
|
Number of Tender/Painful and Swollen Joints
Baseline: Tender joints
|
13.13 Joints
Standard Deviation 7.13
|
14.45 Joints
Standard Deviation 7.03
|
|
Number of Tender/Painful and Swollen Joints
Baseline: Swollen joints
|
11.68 Joints
Standard Deviation 6.30
|
12.45 Joints
Standard Deviation 6.80
|
|
Number of Tender/Painful and Swollen Joints
Week 2: Tender joints
|
10.33 Joints
Standard Deviation 7.19
|
12.26 Joints
Standard Deviation 7.11
|
|
Number of Tender/Painful and Swollen Joints
Week 2: Swollen joints
|
8.39 Joints
Standard Deviation 6.52
|
9.43 Joints
Standard Deviation 6.45
|
|
Number of Tender/Painful and Swollen Joints
Week 4: Tender joints
|
8.64 Joints
Standard Deviation 6.54
|
10.54 Joints
Standard Deviation 7.70
|
|
Number of Tender/Painful and Swollen Joints
Week 4: Swollen joints
|
7.47 Joints
Standard Deviation 6.57
|
7.80 Joints
Standard Deviation 6.47
|
|
Number of Tender/Painful and Swollen Joints
Week 8: Tender joints
|
8.33 Joints
Standard Deviation 7.35
|
9.81 Joints
Standard Deviation 6.83
|
|
Number of Tender/Painful and Swollen Joints
Week 8: Swollen joints
|
7.00 Joints
Standard Deviation 6.16
|
7.57 Joints
Standard Deviation 6.15
|
|
Number of Tender/Painful and Swollen Joints
Week 12: Tender joints
|
7.80 Joints
Standard Deviation 6.72
|
8.48 Joints
Standard Deviation 6.89
|
|
Number of Tender/Painful and Swollen Joints
Week 12: Swollen joints
|
6.91 Joints
Standard Deviation 6.33
|
6.63 Joints
Standard Deviation 6.23
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12Population: FAS included all randomized participants who received at least 1 dose of the randomized study medication. Here, 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Physician global assessment of arthritis was measured on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), with 0 mm= very good and 100 mm= very poor. This was an evaluation based on the participant's disease signs, functional capacity and physical examination.
Outcome measures
| Measure |
CE-224,535
n=53 Participants
CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
|---|---|---|
|
Physician Global Assessment (PGA) of Arthritis
Baseline
|
53.74 mm
Standard Deviation 23.82
|
54.83 mm
Standard Deviation 23.56
|
|
Physician Global Assessment (PGA) of Arthritis
Week 2
|
48.04 mm
Standard Deviation 25.78
|
50.65 mm
Standard Deviation 22.06
|
|
Physician Global Assessment (PGA) of Arthritis
Week 4
|
42.15 mm
Standard Deviation 22.77
|
48.28 mm
Standard Deviation 26.22
|
|
Physician Global Assessment (PGA) of Arthritis
Week 8
|
41.59 mm
Standard Deviation 24.87
|
47.72 mm
Standard Deviation 25.09
|
|
Physician Global Assessment (PGA) of Arthritis
Week 12
|
40.02 mm
Standard Deviation 25.87
|
41.25 mm
Standard Deviation 21.14
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12Population: FAS included all randomized participants who received at least 1 dose of the randomized study medication. Here, 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 to 100 mm VAS, with 0 mm= very well and 100 mm= very poorly.
Outcome measures
| Measure |
CE-224,535
n=53 Participants
CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
|---|---|---|
|
Patient's Global Assessment of Arthritis
Week 4
|
42.94 mm
Standard Deviation 20.70
|
42.24 mm
Standard Deviation 23.87
|
|
Patient's Global Assessment of Arthritis
Baseline
|
56.91 mm
Standard Deviation 18.80
|
59.34 mm
Standard Deviation 15.19
|
|
Patient's Global Assessment of Arthritis
Week 2
|
50.43 mm
Standard Deviation 22.24
|
49.66 mm
Standard Deviation 21.57
|
|
Patient's Global Assessment of Arthritis
Week 8
|
43.00 mm
Standard Deviation 23.27
|
42.81 mm
Standard Deviation 23.68
|
|
Patient's Global Assessment of Arthritis
Week 12
|
40.57 mm
Standard Deviation 23.26
|
40.00 mm
Standard Deviation 21.16
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12Population: FAS included all randomized participants who received at least 1 dose of the randomized study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Participants measured their pain at the time of assessment on a 0 to 100 mm VAS, with 0 mm= no pain and 100 mm= most severe pain.
Outcome measures
| Measure |
CE-224,535
n=51 Participants
CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
|---|---|---|
|
Patient's Global Assessment of Arthritic Pain
Baseline
|
51.33 mm
Standard Deviation 25.08
|
60.13 mm
Standard Deviation 20.96
|
|
Patient's Global Assessment of Arthritic Pain
Week 2
|
49.20 mm
Standard Deviation 23.85
|
51.51 mm
Standard Deviation 24.38
|
|
Patient's Global Assessment of Arthritic Pain
Week 4
|
43.70 mm
Standard Deviation 22.75
|
48.43 mm
Standard Deviation 27.20
|
|
Patient's Global Assessment of Arthritic Pain
Week 8
|
40.90 mm
Standard Deviation 24.94
|
48.79 mm
Standard Deviation 24.19
|
|
Patient's Global Assessment of Arthritic Pain
Week 12
|
42.07 mm
Standard Deviation 27.02
|
43.13 mm
Standard Deviation 23.47
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12Population: FAS included all randomized participants who received at least 1 dose of the randomized study medication. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. 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 0-3 where 0= least difficulty and 3= extreme difficulty.
Outcome measures
| Measure |
CE-224,535
n=53 Participants
CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
|---|---|---|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Baseline
|
1.26 units on a scale
Standard Deviation 0.68
|
1.38 units on a scale
Standard Deviation 0.62
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Week 2
|
1.15 units on a scale
Standard Deviation 0.69
|
1.22 units on a scale
Standard Deviation 0.65
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Week 4
|
1.06 units on a scale
Standard Deviation 0.75
|
1.19 units on a scale
Standard Deviation 0.74
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Week 8
|
1.00 units on a scale
Standard Deviation 0.75
|
1.23 units on a scale
Standard Deviation 0.74
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Week 12
|
0.97 units on a scale
Standard Deviation 0.78
|
1.04 units on a scale
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12Population: FAS included all randomized participants who received at least 1 dose of the randomized study medication. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (milligram per liter \[mg/L\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (\<=) 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
Outcome measures
| Measure |
CE-224,535
n=53 Participants
CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
|---|---|---|
|
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Baseline: (n= 53, 47)
|
5.11 units on a scale
Standard Deviation 0.94
|
5.22 units on a scale
Standard Deviation 0.95
|
|
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Week 2
|
4.55 units on a scale
Standard Deviation 1.16
|
4.84 units on a scale
Standard Deviation 1.12
|
|
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Week 4
|
4.22 units on a scale
Standard Deviation 1.32
|
4.48 units on a scale
Standard Deviation 1.37
|
|
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Week 8
|
4.21 units on a scale
Standard Deviation 1.31
|
4.47 units on a scale
Standard Deviation 1.23
|
|
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Week 12
|
4.10 units on a scale
Standard Deviation 1.38
|
4.28 units on a scale
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12Population: FAS included all randomized participants who received at least 1 dose of the randomized study medication. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Outcome measures
| Measure |
CE-224,535
n=53 Participants
CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
|---|---|---|
|
C-Reactive Protein (CRP)
Week 8
|
12.88 milligram per liter (mg/L)
Standard Deviation 17.96
|
10.38 milligram per liter (mg/L)
Standard Deviation 12.53
|
|
C-Reactive Protein (CRP)
Baseline
|
11.53 milligram per liter (mg/L)
Standard Deviation 13.78
|
9.22 milligram per liter (mg/L)
Standard Deviation 9.91
|
|
C-Reactive Protein (CRP)
Week 2
|
11.04 milligram per liter (mg/L)
Standard Deviation 14.32
|
9.23 milligram per liter (mg/L)
Standard Deviation 11.19
|
|
C-Reactive Protein (CRP)
Week 4
|
11.22 milligram per liter (mg/L)
Standard Deviation 15.60
|
8.97 milligram per liter (mg/L)
Standard Deviation 9.29
|
|
C-Reactive Protein (CRP)
Week 12
|
11.85 milligram per liter (mg/L)
Standard Deviation 17.10
|
9.26 milligram per liter (mg/L)
Standard Deviation 10.78
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 14Population: FAS included all randomized participants who received at least 1 dose of the randomized study medication.
Number of participants who withrew due to lack of efficacy were reported.
Outcome measures
| Measure |
CE-224,535
n=53 Participants
CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
Placebo
n=47 Participants
Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
|---|---|---|
|
Incidence of Withdrawal Due to Lack of Efficacy
Week 2
|
0 participants
|
0 participants
|
|
Incidence of Withdrawal Due to Lack of Efficacy
Week 4
|
0 participants
|
0 participants
|
|
Incidence of Withdrawal Due to Lack of Efficacy
Week 8
|
0 participants
|
0 participants
|
|
Incidence of Withdrawal Due to Lack of Efficacy
Week 12
|
0 participants
|
3 participants
|
|
Incidence of Withdrawal Due to Lack of Efficacy
Week 14
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 14Population: Results are not reported because median time could not be estimated as very few participants discontinued study due to lack of efficacy.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 hour (pre-dose), 2 hours post-dose at Day 1; 1, 3 hours post-dose at Week 2; 0 hour (pre-dose), 3 hours post-dose at Week 4Population: FAS included all randomized participants who received at least 1 dose of the randomized study medication.
Nominal times were used for summarizing the pharmacokinetic results (0 hours at randomization \[Day 1\] and Week 4 \[pre-dose\]; 1 hour at Week 2 \[post-dose\]; 2 hours at randomization \[post-dose on Day 1\]; and 3 hours at Week 2 \[post-dose\] and Week 4 \[post-dose\]).
Outcome measures
| Measure |
CE-224,535
n=53 Participants
CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
Placebo
Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
|---|---|---|
|
CE-224,535 Plasma Concentrations
0 hour
|
256 nanogram per milliliter (ng/mL)
Interval 13.0 to 4060.0
|
—
|
|
CE-224,535 Plasma Concentrations
1 hour
|
3110 nanogram per milliliter (ng/mL)
Interval 56.0 to 8690.0
|
—
|
|
CE-224,535 Plasma Concentrations
2 hours
|
4280 nanogram per milliliter (ng/mL)
Interval 1170.0 to 10200.0
|
—
|
|
CE-224,535 Plasma Concentrations
3 hours
|
2935 nanogram per milliliter (ng/mL)
Interval 90.0 to 11500.0
|
—
|
Adverse Events
CE-224,535
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CE-224,535
n=53 participants at risk
CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
Placebo
n=47 participants at risk
Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Capsular contracture associated with breast implant
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Breast prosthesis implantation
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
CE-224,535
n=53 participants at risk
CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
Placebo
n=47 participants at risk
Placebo tablet matched to CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Tachycardia
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Ear canal erythema
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctivitis
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Diplopia
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Dry eye
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.4%
3/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
3.8%
2/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
4/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Eructation
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
11.3%
6/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
3/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Feeling hot
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
5.7%
3/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Folliculitis
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Fungal skin infection
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Hordeolum
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
3/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral herpes
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
2/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.4%
3/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.4%
3/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
2/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
5.7%
3/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
5.7%
3/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.5%
4/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Lethargy
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Nerve compression
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.4%
3/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.8%
2/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
1/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
5.7%
3/53
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious 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