Trial Outcomes & Findings for POC Study in Partially Responsive Generalized Anxiety Disorder (NCT NCT02310568)
NCT ID: NCT02310568
Last Updated: 2017-01-09
Results Overview
The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)
Results posted on
2017-01-09
Participant Flow
This was a sequential parallel study consisting of 2 stages: 4 week randomized treatment period (Stage 1) followed by a 4 week treatment period (Stage 2). Participants randomized to placebo for Stage 1, received either PF-06372865 or placebo in Stage 2 and participants randomized to PF-06372865 in Stage 1 were assigned to Placebo in Stage 2.
Participant milestones
| Measure |
Placebo + Placebo
Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
|
Placebo + PF-06372865 2.5 mg
Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by a single oral dose of PF-06372865 2.5 milligram (mg) tablet twice daily for 4 weeks during Stage 2.
|
Placebo + PF-06372865 7.5 mg
Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then single oral dose of PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 2.
|
PF-06372865 2.5 mg + Placebo
Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
|
PF-06372865 7.5 mg + Placebo
Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
|
|---|---|---|---|---|---|
|
Stage 1 ( 4 Weeks)
STARTED
|
15
|
15
|
15
|
24
|
21
|
|
Stage 1 ( 4 Weeks)
COMPLETED
|
12
|
13
|
14
|
22
|
20
|
|
Stage 1 ( 4 Weeks)
NOT COMPLETED
|
3
|
2
|
1
|
2
|
1
|
|
Stage 2 (4 Weeks)
STARTED
|
12
|
13
|
14
|
22
|
20
|
|
Stage 2 (4 Weeks)
COMPLETED
|
11
|
12
|
13
|
17
|
19
|
|
Stage 2 (4 Weeks)
NOT COMPLETED
|
1
|
1
|
1
|
5
|
1
|
Reasons for withdrawal
| Measure |
Placebo + Placebo
Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
|
Placebo + PF-06372865 2.5 mg
Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by a single oral dose of PF-06372865 2.5 milligram (mg) tablet twice daily for 4 weeks during Stage 2.
|
Placebo + PF-06372865 7.5 mg
Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then single oral dose of PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 2.
|
PF-06372865 2.5 mg + Placebo
Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
|
PF-06372865 7.5 mg + Placebo
Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
|
|---|---|---|---|---|---|
|
Stage 1 ( 4 Weeks)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
|
Stage 1 ( 4 Weeks)
Withdrawal by Participants
|
1
|
0
|
0
|
0
|
0
|
|
Stage 1 ( 4 Weeks)
Other
|
1
|
1
|
0
|
0
|
0
|
|
Stage 1 ( 4 Weeks)
Adverse Event
|
1
|
1
|
1
|
0
|
0
|
|
Stage 1 ( 4 Weeks)
No Longer Meets Eligibility Criteria
|
0
|
0
|
0
|
1
|
0
|
|
Stage 1 ( 4 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
|
Stage 2 (4 Weeks)
Withdrawal by Participants
|
1
|
0
|
0
|
1
|
0
|
|
Stage 2 (4 Weeks)
Other
|
0
|
1
|
1
|
0
|
0
|
|
Stage 2 (4 Weeks)
Adverse Event
|
0
|
0
|
0
|
1
|
1
|
|
Stage 2 (4 Weeks)
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
|
Stage 2 (4 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
POC Study in Partially Responsive Generalized Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Placebo + Placebo
n=15 Participants
Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
|
Placebo + PF-06372865 2.5 mg
n=15 Participants
Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by a single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 2.
|
Placebo + PF-06372865 7.5 mg
n=15 Participants
Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then single oral dose of PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 2.
|
PF-06372865 2.5 mg + Placebo
n=24 Participants
Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
|
PF-06372865 7.5 mg + Placebo
n=21 Participants
Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.5 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 15.6 • n=7 Participants
|
42.7 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 14 • n=4 Participants
|
42 years
STANDARD_DEVIATION 12 • n=21 Participants
|
41.2 years
STANDARD_DEVIATION 13.7 • n=8 Participants
|
|
Gender
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
67 Participants
n=8 Participants
|
|
Gender
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)Population: Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Stage 2 placebo non-responder set: Subset of Stage 2 placebo set (participants who received placebo in Stage 1) with less than (\<) 50% reduction in HAM-A during Stage 1 baseline,Week 4 and HAM-A value of greater than or equal to (\>=)16 at Week 4.
The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.
Outcome measures
| Measure |
Placebo (Stage 1)
n=45 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 2.5 mg (Stage 1)
n=24 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 7.5 mg (Stage 1)
n=21 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
Placebo (Stage 2)
n=6 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
|
PF-06372865 2.5 mg (Stage 2)
n=8 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
PF-06372865 7.5 mg (Stage 2)
n=8 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
|---|---|---|---|---|---|---|
|
Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2
|
28 units on a scale
Standard Deviation 4.48
|
26.7 units on a scale
Standard Deviation 4.27
|
26.1 units on a scale
Standard Deviation 4.0
|
26.2 units on a scale
Standard Deviation 6.91
|
22.5 units on a scale
Standard Deviation 4.24
|
22.5 units on a scale
Standard Deviation 4.63
|
PRIMARY outcome
Timeframe: Week 4Population: Full analysis set for Stage 1 included all randomized participants who had received at least 1 dose of randomized treatment. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.
The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.
Outcome measures
| Measure |
Placebo (Stage 1)
n=40 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 2.5 mg (Stage 1)
n=22 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 7.5 mg (Stage 1)
n=20 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
Placebo (Stage 2)
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
|
PF-06372865 2.5 mg (Stage 2)
All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
PF-06372865 7.5 mg (Stage 2)
All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4: Stage 1
|
-10.5 units on a scale
Standard Error 1.16
|
-7.9 units on a scale
Standard Error 1.54
|
-9.9 units on a scale
Standard Error 1.62
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Stage 1: Week 4, Stage 2: Week 8Population: Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.
The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.
Outcome measures
| Measure |
Placebo (Stage 1)
n=40 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 2.5 mg (Stage 1)
n=22 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 7.5 mg (Stage 1)
n=20 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
Placebo (Stage 2)
n=6 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
|
PF-06372865 2.5 mg (Stage 2)
n=8 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
PF-06372865 7.5 mg (Stage 2)
n=7 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
|---|---|---|---|---|---|---|
|
Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2
|
17.5 units on a scale
Standard Deviation 8.03
|
18.7 units on a scale
Standard Deviation 9.49
|
16.5 units on a scale
Standard Deviation 6.87
|
21.7 units on a scale
Standard Deviation 9.44
|
15.5 units on a scale
Standard Deviation 7.01
|
19.4 units on a scale
Standard Deviation 8.44
|
SECONDARY outcome
Timeframe: Week 5, 6, 7, 8Population: Stage 2 placebo non-responder set: Subset of Stage 2 placebo set (participants who received placebo in Stage 1) \< 50 % reduction in HAM-A during Stage 1 baseline, Week 4 and HAM-A value of \>=16 at Week 4. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.
Outcome measures
| Measure |
Placebo (Stage 1)
n=6 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 2.5 mg (Stage 1)
n=8 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 7.5 mg (Stage 1)
n=8 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
Placebo (Stage 2)
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
|
PF-06372865 2.5 mg (Stage 2)
All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
PF-06372865 7.5 mg (Stage 2)
All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2
Week 5 (n = 6, 8, 8)
|
-0.4 units on a scale
Standard Error 1.77
|
-1.5 units on a scale
Standard Error 1.49
|
0.5 units on a scale
Standard Error 1.49
|
—
|
—
|
—
|
|
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2
Week 6 (n = 6, 8, 8)
|
-3.3 units on a scale
Standard Error 2.25
|
-0.8 units on a scale
Standard Error 1.89
|
-1.2 units on a scale
Standard Error 1.89
|
—
|
—
|
—
|
|
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2
Week 7 (n = 6, 8, 7)
|
-4.6 units on a scale
Standard Error 2.02
|
-4.4 units on a scale
Standard Error 1.70
|
-1.9 units on a scale
Standard Error 1.74
|
—
|
—
|
—
|
|
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2
Week 8 (n = 6, 8, 7)
|
-4.1 units on a scale
Standard Error 2.92
|
-7.2 units on a scale
Standard Error 2.46
|
-3.4 units on a scale
Standard Error 2.54
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)Population: Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment.
Outcome measures
| Measure |
Placebo (Stage 1)
n=45 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 2.5 mg (Stage 1)
n=24 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 7.5 mg (Stage 1)
n=21 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
Placebo (Stage 2)
n=6 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
|
PF-06372865 2.5 mg (Stage 2)
n=8 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
PF-06372865 7.5 mg (Stage 2)
n=8 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
|---|---|---|---|---|---|---|
|
Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2
Total Score (n=45,24,21,6,8,8)
|
18.6 units on a scale
Standard Deviation 5.80
|
19.6 units on a scale
Standard Deviation 5.73
|
17.0 units on a scale
Standard Deviation 5.55
|
23.0 units on a scale
Standard Deviation 2.76
|
15.3 units on a scale
Standard Deviation 6.86
|
17.4 units on a scale
Standard Deviation 4.89
|
|
Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2
Social Subscale Score (n=45,24,21,6,8,8)
|
6.6 units on a scale
Standard Deviation 1.96
|
7.2 units on a scale
Standard Deviation 1.88
|
5.9 units on a scale
Standard Deviation 1.80
|
7.8 units on a scale
Standard Deviation 1.17
|
5.0 units on a scale
Standard Deviation 2.56
|
5.5 units on a scale
Standard Deviation 1.20
|
|
Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2
Work Subscale Score (n =37,19,16,6,6,7)
|
5.9 units on a scale
Standard Deviation 2.59
|
5.8 units on a scale
Standard Deviation 3.06
|
5.9 units on a scale
Standard Deviation 2.28
|
7.5 units on a scale
Standard Deviation 1.38
|
5.3 units on a scale
Standard Deviation 2.58
|
5.6 units on a scale
Standard Deviation 2.44
|
|
Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2
Family Subscale Score (n= 45,24,21,6,8,8)
|
6.2 units on a scale
Standard Deviation 2.10
|
6.2 units on a scale
Standard Deviation 2.17
|
5.5 units on a scale
Standard Deviation 2.23
|
7.7 units on a scale
Standard Deviation 1.03
|
5.3 units on a scale
Standard Deviation 2.49
|
6.3 units on a scale
Standard Deviation 2.60
|
SECONDARY outcome
Timeframe: Stage 1: Week 4, Stage 2: Week 8Population: Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment.
Outcome measures
| Measure |
Placebo (Stage 1)
n=45 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 2.5 mg (Stage 1)
n=24 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 7.5 mg (Stage 1)
n=21 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
Placebo (Stage 2)
n=6 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
|
PF-06372865 2.5 mg (Stage 2)
n=8 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
PF-06372865 7.5 mg (Stage 2)
n=8 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2
Total Score (n= 40,22,20,6,8,7)
|
-3.5 units on a scale
Standard Error 0.98
|
-5.3 units on a scale
Standard Error 1.33
|
-4.7 units on a scale
Standard Error 1.40
|
-3.5 units on a scale
Standard Error 2.90
|
-5.9 units on a scale
Standard Error 2.36
|
-2.4 units on a scale
Standard Error 2.40
|
|
Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2
Social Sub-scale Score (n= 40,22,20,6,8,7)
|
-1.8 units on a scale
Standard Error 0.53
|
-1.7 units on a scale
Standard Error 0.50
|
-1.8 units on a scale
Standard Error 0.53
|
-0.3 units on a scale
Standard Error 1.32
|
-2.3 units on a scale
Standard Error 1.03
|
-0.6 units on a scale
Standard Error 1.07
|
|
Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2
Work Sub-scale Score (n= 30,16,14,6,5,6)
|
-0.7 units on a scale
Standard Error 0.41
|
-2.4 units on a scale
Standard Error 0.56
|
-1.5 units on a scale
Standard Error 0.60
|
-0.7 units on a scale
Standard Error 0.96
|
-2.6 units on a scale
Standard Error 1.01
|
-1.4 units on a scale
Standard Error 0.93
|
|
Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2
Family Sub-scale Score 9 (n= 40, 22, 20,6,8,7)
|
-0.9 units on a scale
Standard Error 0.36
|
-1.6 units on a scale
Standard Error 0.48
|
-1.4 units on a scale
Standard Error 0.51
|
-1.4 units on a scale
Standard Error 0.92
|
-1.9 units on a scale
Standard Error 0.78
|
-1.0 units on a scale
Standard Error 0.80
|
SECONDARY outcome
Timeframe: Week 1, 2, 3Population: Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.
Outcome measures
| Measure |
Placebo (Stage 1)
n=45 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 2.5 mg (Stage 1)
n=24 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 7.5 mg (Stage 1)
n=21 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
Placebo (Stage 2)
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
|
PF-06372865 2.5 mg (Stage 2)
All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
PF-06372865 7.5 mg (Stage 2)
All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1
Week 1 (n= 41,24,21)
|
-6.0 units on a scale
Standard Error 0.84
|
-5.3 units on a scale
Standard Error 1.09
|
-5.7 units on a scale
Standard Error 1.18
|
—
|
—
|
—
|
|
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1
Week 2 (n= 39,23,21)
|
-6.9 units on a scale
Standard Error 1.05
|
-6.3 units on a scale
Standard Error 1.37
|
-7.7 units on a scale
Standard Error 1.45
|
—
|
—
|
—
|
|
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1
Week 3 (n= 39,22,21)
|
-10.2 units on a scale
Standard Error 1.00
|
-8.6 units on a scale
Standard Error 1.32
|
-9.2 units on a scale
Standard Error 1.38
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1: Week 4, Stage 2: Week 8Population: Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.
A responder was defined as a participant with \>= to 50 percent decrease in their total HAM-A score from baseline to the last week in the stage (Week 4 in Stage 1, Week 8 in Stage 2). The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety. Percentage of responders of total HMA scale were reported.
Outcome measures
| Measure |
Placebo (Stage 1)
n=45 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 2.5 mg (Stage 1)
n=24 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 7.5 mg (Stage 1)
n=21 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
Placebo (Stage 2)
n=6 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
|
PF-06372865 2.5 mg (Stage 2)
n=8 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
PF-06372865 7.5 mg (Stage 2)
n=8 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
|---|---|---|---|---|---|---|
|
Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2
|
33.33 percentage of participants
|
25.00 percentage of participants
|
28.57 percentage of participants
|
16.67 percentage of participants
|
25.00 percentage of participants
|
12.50 percentage of participants
|
SECONDARY outcome
Timeframe: Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)Population: Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.
CGI-I was a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score indicated more affected. Change is equal to score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo (Stage 1)
n=45 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 2.5 mg (Stage 1)
n=24 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 7.5 mg (Stage 1)
n=21 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
Placebo (Stage 2)
n=6 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
|
PF-06372865 2.5 mg (Stage 2)
n=8 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
PF-06372865 7.5 mg (Stage 2)
n=8 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2
Baseline : S1, S2 (n=45,23,21,6,8,8)
|
3.8 units on a scale
Standard Deviation 0.53
|
3.8 units on a scale
Standard Deviation 0.74
|
3.9 units on a scale
Standard Deviation 0.36
|
3.5 units on a scale
Standard Deviation 0.55
|
3.3 units on a scale
Standard Deviation 0.71
|
3.0 units on a scale
Standard Deviation 0.76
|
|
Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2
Change at S1: W1, S2: W5 (n=41,23,21,6,8,8)
|
-0.4 units on a scale
Standard Deviation 0.89
|
-0.6 units on a scale
Standard Deviation 1.04
|
-0.5 units on a scale
Standard Deviation 0.87
|
-0.2 units on a scale
Standard Deviation 0.98
|
-0.5 units on a scale
Standard Deviation 1.20
|
0.3 units on a scale
Standard Deviation 0.46
|
|
Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2
Change at S1: W2, S2: W6 (n=39,22,21,6,8,8)
|
-0.6 units on a scale
Standard Deviation 0.91
|
-0.7 units on a scale
Standard Deviation 1.17
|
-0.9 units on a scale
Standard Deviation 1.11
|
-0.5 units on a scale
Standard Deviation 1.22
|
-0.3 units on a scale
Standard Deviation 1.16
|
0.1 units on a scale
Standard Deviation 0.64
|
|
Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2
Change at S1: W3, S2: W7 (n=39,21,21,6,8,7)
|
-1.0 units on a scale
Standard Deviation 0.99
|
-0.9 units on a scale
Standard Deviation 1.20
|
-1.1 units on a scale
Standard Deviation 1.01
|
-0.7 units on a scale
Standard Deviation 1.03
|
-0.8 units on a scale
Standard Deviation 1.16
|
0.0 units on a scale
Standard Deviation 0.58
|
|
Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2
Change at S1: W4, S2: W8 (n=40,21,20,6,8,7)
|
-1.1 units on a scale
Standard Deviation 1.06
|
-1.0 units on a scale
Standard Deviation 1.24
|
-1.1 units on a scale
Standard Deviation 1.05
|
-0.5 units on a scale
Standard Deviation 1.38
|
-1.0 units on a scale
Standard Deviation 1.20
|
-0.3 units on a scale
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)Population: Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.
The CGI-S consisted of a single 7-point rating score of illness severity, was completed by a clinician. Raters selected one response based on the following question, "Considering your total clinical experience with that particular population, how mentally ill was your participant at that time?" Scores were: 1 (normal, not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill) 6 (severely ill) or 7 (among the most severely ill participants). Higher scores indicate more severity.
Outcome measures
| Measure |
Placebo (Stage 1)
n=45 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 2.5 mg (Stage 1)
n=24 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 7.5 mg (Stage 1)
n=21 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
Placebo (Stage 2)
n=6 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
|
PF-06372865 2.5 mg (Stage 2)
n=8 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
PF-06372865 7.5 mg (Stage 2)
n=8 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2
Change at S1: W1, S2: W5 (n=41,24,21,6,8,8)
|
-0.5 units on a scale
Standard Deviation 0.78
|
-0.5 units on a scale
Standard Deviation 0.93
|
-0.7 units on a scale
Standard Deviation 0.72
|
0.0 units on a scale
Standard Deviation 1.10
|
-0.1 units on a scale
Standard Deviation 0.99
|
0.0 units on a scale
Standard Deviation 0.53
|
|
Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2
Baseline: S1 and S2 (n=45,24,21,6,8,8)
|
4.8 units on a scale
Standard Deviation 0.63
|
4.6 units on a scale
Standard Deviation 0.58
|
4.8 units on a scale
Standard Deviation 0.54
|
4.5 units on a scale
Standard Deviation 1.05
|
4.3 units on a scale
Standard Deviation 0.89
|
4.0 units on a scale
Standard Deviation 0.76
|
|
Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2
Change at S1: W2, S2: W6 (n=39,23,21,6,8,8)
|
-0.8 units on a scale
Standard Deviation 0.90
|
-0.7 units on a scale
Standard Deviation 1.01
|
-1.0 units on a scale
Standard Deviation 1.07
|
-0.5 units on a scale
Standard Deviation 1.64
|
0.0 units on a scale
Standard Deviation 0.93
|
-0.1 units on a scale
Standard Deviation 0.64
|
|
Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2
Change at S1: W3, S2: W7 (n=39,22,21,6,8,7)
|
-1.2 units on a scale
Standard Deviation 1.12
|
-1.0 units on a scale
Standard Deviation 1.21
|
-1.4 units on a scale
Standard Deviation 0.98
|
-0.8 units on a scale
Standard Deviation 1.33
|
-1.0 units on a scale
Standard Deviation 0.93
|
-0.3 units on a scale
Standard Deviation 0.49
|
|
Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2
Change at S1: W4, S2: W8 (n=40,22,20,6,8,7)
|
-1.3 units on a scale
Standard Deviation 1.16
|
-1.0 units on a scale
Standard Deviation 1.21
|
-1.3 units on a scale
Standard Deviation 1.08
|
-0.5 units on a scale
Standard Deviation 1.87
|
-1.1 units on a scale
Standard Deviation 0.83
|
-0.6 units on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 2, 3, 4Population: Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Participants who received PF-06372865 2.5 mg or PF-06372865 7.5 mg were evaluable for this measure. Here,'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 nanogram per milliliter (ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.
Outcome measures
| Measure |
Placebo (Stage 1)
n=24 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 2.5 mg (Stage 1)
n=21 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 7.5 mg (Stage 1)
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
Placebo (Stage 2)
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
|
PF-06372865 2.5 mg (Stage 2)
All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
PF-06372865 7.5 mg (Stage 2)
All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
|---|---|---|---|---|---|---|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 1
Week 2 : 0 Hour (n= 12, 10)
|
10.89 ng/mL
Standard Deviation 7.1367
|
64.73 ng/mL
Standard Deviation 58.463
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 1
Week 2 : 2 Hour (n= 13, 10)
|
20.76 ng/mL
Standard Deviation 10.060
|
113.8 ng/mL
Standard Deviation 55.517
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 1
Week 2 : 4 Hour (n= 5, 8)
|
16.07 ng/mL
Standard Deviation 18.541
|
77.75 ng/mL
Standard Deviation 65.594
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 1
Week 2 : 10 Hour (n= 5, 9)
|
17.41 ng/mL
Standard Deviation 14.951
|
66.60 ng/mL
Standard Deviation 53.888
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 1
Week 3 : 0 Hour (n= 6, 5)
|
11.62 ng/mL
Standard Deviation 10.440
|
33.44 ng/mL
Standard Deviation 34.409
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 1
Week 3 : 2 Hour (n= 6, 4)
|
16.42 ng/mL
Standard Deviation 13.626
|
54.02 ng/mL
Standard Deviation 54.091
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 1
Week 3 : 4 Hour (n= 10, 9)
|
22.20 ng/mL
Standard Deviation 19.110
|
81.58 ng/mL
Standard Deviation 54.133
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 1
Week 3 : 10 Hour (n= 10, 9)
|
19.40 ng/mL
Standard Deviation 13.880
|
73.31 ng/mL
Standard Deviation 57.082
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 1
Week 4 : 0 Hour (n= 7, 9)
|
14.36 ng/mL
Standard Deviation 18.770
|
27.15 ng/mL
Standard Deviation 20.840
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 1
Week 4 : 2 Hour (n= 8, 10)
|
26.32 ng/mL
Standard Deviation 20.328
|
61.98 ng/mL
Standard Deviation 21.457
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 1
Week 4 : 4 Hour (n= 11, 5)
|
29.58 ng/mL
Standard Deviation 12.398
|
79.00 ng/mL
Standard Deviation 69.914
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 1
Week 4 : 10 Hour (n= 10, 5)
|
28.48 ng/mL
Standard Deviation 11.550
|
78.60 ng/mL
Standard Deviation 81.529
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 6, 7, 8Population: Placebo Non-Responder set for Stage 2. Participants who received PF-06372865 2.5 mg or PF-06372865 7.5 mg were evaluable for this measure. Here,'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.
Outcome measures
| Measure |
Placebo (Stage 1)
n=8 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 2.5 mg (Stage 1)
n=8 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 7.5 mg (Stage 1)
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
Placebo (Stage 2)
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
|
PF-06372865 2.5 mg (Stage 2)
All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
PF-06372865 7.5 mg (Stage 2)
All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
|---|---|---|---|---|---|---|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 2
Week 6 : 0 Hour (n= 3, 2)
|
23.12 ng/mL
Standard Deviation 22.644
|
35.67 ng/mL
Standard Deviation 31.015
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 2
Week 6 : 2 Hour (n= 5, 3)
|
24.62 ng/mL
Standard Deviation 16.959
|
59.40 ng/mL
Standard Deviation 46.218
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 2
Week 6 : 4 Hour (n= 2, 3)
|
16.83 ng/mL
Standard Deviation 19.459
|
75.98 ng/mL
Standard Deviation 60.380
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 2
Week 6 : 10 Hour (n= 2, 3)
|
14.00 ng/mL
Standard Deviation 16.191
|
66.43 ng/mL
Standard Deviation 52.402
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 2
Week 7 : 0 Hour (n= 3, 3)
|
25.88 ng/mL
Standard Deviation 20.591
|
17.54 ng/mL
Standard Deviation 9.7180
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 2
Week 7 : 2 Hour (n= 4, 2)
|
24.54 ng/mL
Standard Deviation 17.913
|
16.40 ng/mL
Standard Deviation 14.262
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 2
Week 7 : 4 Hour (n= 3, 4)
|
34.80 ng/mL
Standard Deviation 44.089
|
57.28 ng/mL
Standard Deviation 38.837
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 2
Week 7 : 10 Hour (n= 3, 4)
|
33.54 ng/mL
Standard Deviation 38.779
|
64.45 ng/mL
Standard Deviation 22.420
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 2
Week 8 : 0 Hour (n= 3, 5)
|
25.18 ng/mL
Standard Deviation 17.783
|
32.73 ng/mL
Standard Deviation 25.175
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 2
Week 8 : 2 Hour (n= 4, 6)
|
34.55 ng/mL
Standard Deviation 14.856
|
48.83 ng/mL
Standard Deviation 39.032
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 2
Week 8 : 4 Hour (n= 4, 3)
|
13.54 ng/mL
Standard Deviation 15.435
|
13.54 ng/mL
Standard Deviation 15.435
|
—
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Summary of PF-06372865: Stage 2
Week 8 : 10 Hour (n= 3, 2)
|
14.00 ng/mL
Standard Deviation 15.880
|
14.00 ng/mL
Standard Deviation 15.880
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)Population: Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.
The HAM-A scale was a clinician interview-administered scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Psychic subscale of the HAM-A was the sum of 7 items. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 28 (very severe), where lower scores indicates less anxiety.
Outcome measures
| Measure |
Placebo (Stage 1)
n=45 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 2.5 mg (Stage 1)
n=24 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 7.5 mg (Stage 1)
n=21 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
Placebo (Stage 2)
n=6 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
|
PF-06372865 2.5 mg (Stage 2)
n=8 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
PF-06372865 7.5 mg (Stage 2)
n=8 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8
Change at S1: W4, S2: W8 (n=40,22,20,6,8,7)
|
-5.9 units on a scale
Standard Deviation 4.63
|
-4.0 units on a scale
Standard Deviation 5.19
|
-5.8 units on a scale
Standard Deviation 3.89
|
-2.5 units on a scale
Standard Deviation 3.56
|
-3.9 units on a scale
Standard Deviation 3.27
|
-1.6 units on a scale
Standard Deviation 3.05
|
|
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8
Baseline: S1 and S2 (n=45,24,21,6,8,8)
|
16.5 units on a scale
Standard Deviation 2.23
|
15.2 units on a scale
Standard Deviation 2.36
|
16.1 units on a scale
Standard Deviation 1.77
|
15.5 units on a scale
Standard Deviation 2.88
|
13.0 units on a scale
Standard Deviation 4.54
|
12.9 units on a scale
Standard Deviation 3.87
|
|
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8
Change at S1: W1, S2: W5 (n=41,24, 21,6,8,8)
|
-2.8 units on a scale
Standard Deviation 3.87
|
-2.7 units on a scale
Standard Deviation 3.42
|
-3.2 units on a scale
Standard Deviation 2.87
|
-0.3 units on a scale
Standard Deviation 2.88
|
-0.6 units on a scale
Standard Deviation 2.83
|
0.3 units on a scale
Standard Deviation 1.28
|
|
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8
Change at S1: W2, S2: W6 (n=39,23,21,6,8,8)
|
-3.8 units on a scale
Standard Deviation 3.92
|
-3.4 units on a scale
Standard Deviation 4.97
|
-4.6 units on a scale
Standard Deviation 4.35
|
-0.8 units on a scale
Standard Deviation 2.86
|
0.4 units on a scale
Standard Deviation 2.97
|
-0.6 units on a scale
Standard Deviation 2.20
|
|
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8
Change at S1: W3, S2: W7 (n=39,22,21,6,8,7)
|
-5.3 units on a scale
Standard Deviation 4.21
|
-4.4 units on a scale
Standard Deviation 4.53
|
-5.4 units on a scale
Standard Deviation 3.63
|
-1.7 units on a scale
Standard Deviation 2.42
|
-2.3 units on a scale
Standard Deviation 3.28
|
-0.7 units on a scale
Standard Deviation 1.80
|
SECONDARY outcome
Timeframe: Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)Population: Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.
The HAM-A scale was a clinician interview-administered scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Somatic subscale of the HAM-A was the sum of 7 items. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 28 (very severe), where lower scores indicates less anxiety.
Outcome measures
| Measure |
Placebo (Stage 1)
n=45 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 2.5 mg (Stage 1)
n=24 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 7.5 mg (Stage 1)
n=21 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
Placebo (Stage 2)
n=6 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
|
PF-06372865 2.5 mg (Stage 2)
n=8 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
PF-06372865 7.5 mg (Stage 2)
n=8 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8
Baseline: S1 and S2 (n=45,24,21,6,8,8)
|
11.5 units on a scale
Standard Deviation 3.76
|
11.5 units on a scale
Standard Deviation 3.15
|
10.0 units on a scale
Standard Deviation 4.01
|
10.7 units on a scale
Standard Deviation 5.20
|
9.5 units on a scale
Standard Deviation 2.98
|
9.6 units on a scale
Standard Deviation 3.34
|
|
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8
Change at S1: W1, S2: W5 (n=41,24, 21,6,8,8)
|
-3.2 units on a scale
Standard Deviation 3.37
|
-2.6 units on a scale
Standard Deviation 2.90
|
-2.4 units on a scale
Standard Deviation 2.77
|
-0.3 units on a scale
Standard Deviation 3.78
|
-0.8 units on a scale
Standard Deviation 2.60
|
0.4 units on a scale
Standard Deviation 2.07
|
|
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8
Change at S1: W2, S2: W6 (n=39,23,21,6,8,8)
|
-3.2 units on a scale
Standard Deviation 3.09
|
-2.8 units on a scale
Standard Deviation 2.24
|
-2.9 units on a scale
Standard Deviation 4.27
|
-2.7 units on a scale
Standard Deviation 4.68
|
-1.1 units on a scale
Standard Deviation 2.03
|
-0.5 units on a scale
Standard Deviation 3.51
|
|
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8
Change at S1: W3, S2: W7 (n=39,22,21,6,8,7)
|
-4.9 units on a scale
Standard Deviation 3.63
|
-4.1 units on a scale
Standard Deviation 3.19
|
-3.6 units on a scale
Standard Deviation 3.47
|
-2.8 units on a scale
Standard Deviation 3.66
|
-2.3 units on a scale
Standard Deviation 2.82
|
-1.3 units on a scale
Standard Deviation 3.50
|
|
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8
Change at S1: W4, S2: W8 (n=40,22,20,6,8,7)
|
-4.8 units on a scale
Standard Deviation 4.62
|
-3.7 units on a scale
Standard Deviation 3.27
|
-3.8 units on a scale
Standard Deviation 3.49
|
-2.0 units on a scale
Standard Deviation 5.62
|
-3.1 units on a scale
Standard Deviation 3.14
|
-2.0 units on a scale
Standard Deviation 4.08
|
SECONDARY outcome
Timeframe: Stage 1: Week 1 up to Week 4 and Stage 2: Week 5 up to Week 8Population: Full analysis set for Stage 1 was defined as all participants randomized and who had received at least 1 dose of randomized treatment. The Stage 2 placebo non-responder set was defined as the subset of subjects in the Stage 2 placebo set who had both a \<50% reduction in HAM-A between Stage 1 baseline and Week 4, and HAM-A value of \>= 16 at Week 4.
Percentage of participants with HAM-A total score less than or equal to 7 in the last week of the Stage (Week 4 in Stage 1, Week 8 in Stage 2). The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.
Outcome measures
| Measure |
Placebo (Stage 1)
n=45 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 2.5 mg (Stage 1)
n=24 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
PF-06372865 7.5 mg (Stage 1)
n=21 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
|
Placebo (Stage 2)
n=6 Participants
All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
|
PF-06372865 2.5 mg (Stage 2)
n=8 Participants
All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
PF-06372865 7.5 mg (Stage 2)
n=8 Participants
All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores
|
6.67 percentage of participants
|
12.50 percentage of participants
|
4.76 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.50 percentage of participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
PF-06372865 2.5 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
PF-06372865 7.5 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=87 participants at risk
All participants received placebo matched to PF-06372865 twice daily for 4 weeks in Stage 1 and Stage 2.
|
PF-06372865 2.5 mg
n=37 participants at risk
All participants received PF-06372865 2.5 mg twice daily for 4 weeks in Stage 1 and Stage 2.
|
PF-06372865 7.5 mg
n=35 participants at risk
All participants received PF-06372865 7.5 mg twice daily for 4 weeks in Stage 1 and Stage 2.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo positional
|
1.1%
1/87
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/37
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/35
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
Other adverse events
| Measure |
Placebo
n=87 participants at risk
All participants received placebo matched to PF-06372865 twice daily for 4 weeks in Stage 1 and Stage 2.
|
PF-06372865 2.5 mg
n=37 participants at risk
All participants received PF-06372865 2.5 mg twice daily for 4 weeks in Stage 1 and Stage 2.
|
PF-06372865 7.5 mg
n=35 participants at risk
All participants received PF-06372865 7.5 mg twice daily for 4 weeks in Stage 1 and Stage 2.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
3/87
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
8.1%
3/37
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
5.7%
2/35
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/87
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.7%
1/37
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
5.7%
2/35
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
6.9%
6/87
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.7%
1/37
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.9%
1/35
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Fatigue
|
4.6%
4/87
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
5.4%
2/37
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
8.6%
3/35
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
1/87
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
8.1%
3/37
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
5.7%
2/35
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
2.3%
2/87
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
5.4%
2/37
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/35
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Dizziness
|
5.7%
5/87
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
2.7%
1/37
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
20.0%
7/35
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Headache
|
6.9%
6/87
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
8.1%
3/37
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
11.4%
4/35
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Somnolence
|
5.7%
5/87
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
8.1%
3/37
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
14.3%
5/35
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/87
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/37
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
5.7%
2/35
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER