Trial Outcomes & Findings for Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery (NCT NCT01346969)
NCT ID: NCT01346969
Last Updated: 2021-09-09
Results Overview
Physician assessment of scar was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. Composite score was the sum of all the scores, except the overall opinion score, and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Week 24
Results posted on
2021-09-09
Participant Flow
Participants who previously had breast surgery resulting in unacceptable bilateral scars and had chosen to have the breast scars revised were recruited in this study.
Participant milestones
| Measure |
EXC 001 (PF-06473871) 5 mg/cm
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (cm) section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 2 mg/cm and Placebo
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 0.8 mg/cm and Placebo
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 5 mg/cm and Placebo
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
14
|
13
|
13
|
|
Overall Study
Safety Population
|
27
|
14
|
13
|
13
|
|
Overall Study
COMPLETED
|
26
|
14
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
3
|
1
|
Reasons for withdrawal
| Measure |
EXC 001 (PF-06473871) 5 mg/cm
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (cm) section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 2 mg/cm and Placebo
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 0.8 mg/cm and Placebo
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 5 mg/cm and Placebo
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
|
Overall Study
Randomized but not treated
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
Baseline characteristics by cohort
| Measure |
EXC 001 (PF-06473871) 5 mg/cm
n=26 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 2 mg/cm and Placebo
n=14 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 0.8 mg/cm and Placebo
n=11 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 5 mg/cm and Placebo
n=12 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.7 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 7.16 • n=7 Participants
|
40.1 years
STANDARD_DEVIATION 13.29 • n=5 Participants
|
38.4 years
STANDARD_DEVIATION 8.22 • n=4 Participants
|
39.9 years
STANDARD_DEVIATION 10.13 • n=21 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'N' (Overall Number of Participants Analyzed) signifies participants who were evaluable for this outcome measure.
Physician assessment of scar was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. Composite score was the sum of all the scores, except the overall opinion score, and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received.
Outcome measures
| Measure |
EXC 001 (PF-06473871) 2 mg/cm and Placebo
n=14 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 0.8 mg/cm and Placebo
n=10 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 5 mg/cm and Placebo
n=12 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 5 mg/cm
n=26 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (cm) section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.
|
|---|---|---|---|---|
|
Physician Observer Scar Assessment Score at Week 24
Overall Opinion
|
-0.5 units on a scale
Standard Deviation 2.31
|
0.8 units on a scale
Standard Deviation 1.87
|
-0.3 units on a scale
Standard Deviation 1.97
|
0.0 units on a scale
Standard Deviation 1.92
|
|
Physician Observer Scar Assessment Score at Week 24
Vascularity
|
-0.6 units on a scale
Standard Deviation 1.91
|
0.9 units on a scale
Standard Deviation 1.52
|
-0.2 units on a scale
Standard Deviation 1.64
|
0.0 units on a scale
Standard Deviation 1.70
|
|
Physician Observer Scar Assessment Score at Week 24
Pigmentation
|
-0.4 units on a scale
Standard Deviation 2.10
|
0.7 units on a scale
Standard Deviation 1.42
|
-0.3 units on a scale
Standard Deviation 1.36
|
-0.3 units on a scale
Standard Deviation 1.41
|
|
Physician Observer Scar Assessment Score at Week 24
Thickness
|
-0.6 units on a scale
Standard Deviation 2.38
|
0.8 units on a scale
Standard Deviation 2.04
|
-0.2 units on a scale
Standard Deviation 1.90
|
0.2 units on a scale
Standard Deviation 2.41
|
|
Physician Observer Scar Assessment Score at Week 24
Relief
|
-0.4 units on a scale
Standard Deviation 1.95
|
0.7 units on a scale
Standard Deviation 2.36
|
-0.2 units on a scale
Standard Deviation 1.90
|
0.0 units on a scale
Standard Deviation 2.24
|
|
Physician Observer Scar Assessment Score at Week 24
Pliability
|
-0.6 units on a scale
Standard Deviation 2.27
|
0.6 units on a scale
Standard Deviation 1.71
|
-0.4 units on a scale
Standard Deviation 1.62
|
0.2 units on a scale
Standard Deviation 1.99
|
|
Physician Observer Scar Assessment Score at Week 24
Surface Area
|
-0.4 units on a scale
Standard Deviation 2.85
|
0.6 units on a scale
Standard Deviation 1.90
|
-0.1 units on a scale
Standard Deviation 2.15
|
0.1 units on a scale
Standard Deviation 1.75
|
|
Physician Observer Scar Assessment Score at Week 24
Composite Score
|
-3.1 units on a scale
Standard Deviation 12.60
|
4.3 units on a scale
Standard Deviation 9.76
|
-1.3 units on a scale
Standard Deviation 8.67
|
0.2 units on a scale
Standard Deviation 10.53
|
SECONDARY outcome
Timeframe: Week 11, 18Population: Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time point for each group, respectively.
Physician observer scar assessment score was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for a scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. Composite score was the sum of all the scores except the overall opinion score and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received.
Outcome measures
| Measure |
EXC 001 (PF-06473871) 2 mg/cm and Placebo
n=14 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 0.8 mg/cm and Placebo
n=11 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 5 mg/cm and Placebo
n=12 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 5 mg/cm
n=26 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (cm) section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.
|
|---|---|---|---|---|
|
Physician Observer Scar Assessment Score
Week 11, Overall Opinion
|
-0.6 units on a scale
Standard Deviation 2.07
|
0.2 units on a scale
Standard Deviation 2.04
|
0.3 units on a scale
Standard Deviation 1.54
|
-0.3 units on a scale
Standard Deviation 2.27
|
|
Physician Observer Scar Assessment Score
Week 11, Vascularity
|
-0.2 units on a scale
Standard Deviation 1.70
|
0.1 units on a scale
Standard Deviation 1.38
|
0.0 units on a scale
Standard Deviation 1.21
|
0.0 units on a scale
Standard Deviation 2.12
|
|
Physician Observer Scar Assessment Score
Week 11, Pigmentation
|
-0.1 units on a scale
Standard Deviation 1.78
|
0.4 units on a scale
Standard Deviation 1.50
|
0.0 units on a scale
Standard Deviation 1.54
|
-0.5 units on a scale
Standard Deviation 1.88
|
|
Physician Observer Scar Assessment Score
Week 11, Thickness
|
-0.1 units on a scale
Standard Deviation 2.15
|
0.2 units on a scale
Standard Deviation 1.99
|
-0.2 units on a scale
Standard Deviation 1.85
|
-0.4 units on a scale
Standard Deviation 2.18
|
|
Physician Observer Scar Assessment Score
Week 11, Relief
|
-0.3 units on a scale
Standard Deviation 2.05
|
0.0 units on a scale
Standard Deviation 2.28
|
0.0 units on a scale
Standard Deviation 2.26
|
-0.4 units on a scale
Standard Deviation 2.00
|
|
Physician Observer Scar Assessment Score
Week 11, Pliability
|
-0.2 units on a scale
Standard Deviation 2.29
|
-0.2 units on a scale
Standard Deviation 2.27
|
-0.3 units on a scale
Standard Deviation 1.76
|
-0.4 units on a scale
Standard Deviation 2.40
|
|
Physician Observer Scar Assessment Score
Week 11, Surface Area
|
-0.3 units on a scale
Standard Deviation 2.27
|
0.1 units on a scale
Standard Deviation 1.04
|
0.3 units on a scale
Standard Deviation 1.82
|
-0.4 units on a scale
Standard Deviation 2.14
|
|
Physician Observer Scar Assessment Score
Week 11, Composite Score
|
-1.1 units on a scale
Standard Deviation 11.19
|
0.5 units on a scale
Standard Deviation 9.75
|
-0.2 units on a scale
Standard Deviation 8.57
|
-2.1 units on a scale
Standard Deviation 11.46
|
|
Physician Observer Scar Assessment Score
Week 18, Overall Opinion
|
-0.7 units on a scale
Standard Deviation 2.43
|
0.3 units on a scale
Standard Deviation 2.05
|
0.4 units on a scale
Standard Deviation 2.25
|
0.1 units on a scale
Standard Deviation 2.07
|
|
Physician Observer Scar Assessment Score
Week 18, Vascularity
|
-0.6 units on a scale
Standard Deviation 2.24
|
-0.1 units on a scale
Standard Deviation 1.97
|
0.5 units on a scale
Standard Deviation 1.57
|
0.3 units on a scale
Standard Deviation 1.51
|
|
Physician Observer Scar Assessment Score
Week 18, Pigmentation
|
-0.6 units on a scale
Standard Deviation 2.34
|
0.3 units on a scale
Standard Deviation 1.56
|
0.0 units on a scale
Standard Deviation 1.79
|
-0.2 units on a scale
Standard Deviation 1.49
|
|
Physician Observer Scar Assessment Score
Week 18, Thickness
|
-0.4 units on a scale
Standard Deviation 2.28
|
0.5 units on a scale
Standard Deviation 1.97
|
0.6 units on a scale
Standard Deviation 2.29
|
-0.1 units on a scale
Standard Deviation 2.24
|
|
Physician Observer Scar Assessment Score
Week 18, Relief
|
-0.3 units on a scale
Standard Deviation 2.49
|
0.5 units on a scale
Standard Deviation 1.86
|
0.5 units on a scale
Standard Deviation 2.21
|
0.2 units on a scale
Standard Deviation 2.41
|
|
Physician Observer Scar Assessment Score
Week 18, Pliability
|
-0.7 units on a scale
Standard Deviation 2.52
|
0.5 units on a scale
Standard Deviation 1.21
|
0.7 units on a scale
Standard Deviation 2.24
|
0.2 units on a scale
Standard Deviation 2.19
|
|
Physician Observer Scar Assessment Score
Week 18, Surface Area
|
-0.4 units on a scale
Standard Deviation 2.50
|
0.4 units on a scale
Standard Deviation 1.75
|
0.2 units on a scale
Standard Deviation 2.40
|
-0.1 units on a scale
Standard Deviation 2.28
|
|
Physician Observer Scar Assessment Score
Week 18, Composite Score
|
-3.1 units on a scale
Standard Deviation 13.44
|
2.1 units on a scale
Standard Deviation 9.45
|
2.5 units on a scale
Standard Deviation 11.21
|
0.4 units on a scale
Standard Deviation 10.45
|
SECONDARY outcome
Timeframe: Week 11, 18, 24Population: Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time point for each group, respectively.
Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 = best possible scar and a score of 100 = worst possible scar, where lower scores indicated better outcome. The rater first marked a rating for the "worse" scar and then rated the other scar. The difference between these two ratings was the "improvement of scar severity." If there was no difference, the expert could check a box to indicate that determination. This method provided information on the absolute severity of the scars as well as the differences between the two scars in the pair.
Outcome measures
| Measure |
EXC 001 (PF-06473871) 2 mg/cm and Placebo
n=14 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 0.8 mg/cm and Placebo
n=11 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 5 mg/cm and Placebo
n=12 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 5 mg/cm
n=26 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (cm) section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.
|
|---|---|---|---|---|
|
Expert Panel Scar Assessment Score
Week 11
|
0.4 units on a scale
Standard Deviation 15.89
|
3.7 units on a scale
Standard Deviation 13.18
|
-4.1 units on a scale
Standard Deviation 13.71
|
2.0 units on a scale
Standard Deviation 14.67
|
|
Expert Panel Scar Assessment Score
Week 18
|
-2.7 units on a scale
Standard Deviation 13.54
|
9.5 units on a scale
Standard Deviation 14.28
|
-2.1 units on a scale
Standard Deviation 15.94
|
2.2 units on a scale
Standard Deviation 14.70
|
|
Expert Panel Scar Assessment Score
Week 24
|
-2.5 units on a scale
Standard Deviation 17.78
|
6.5 units on a scale
Standard Deviation 15.38
|
-1.5 units on a scale
Standard Deviation 15.43
|
4.1 units on a scale
Standard Deviation 15.94
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'N' (Overall Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
Participants rated pain, itching, color, stiffness, thickness, irregularity, and overall opinion of scar on 10-point scale. For pain and itching associated with scar: range = 1 (no, not at all) to 10 (yes, worst imaginable) and for other parameters associated with scar compared to normal skin: range = 1 (no, same as normal skin) to 10 (yes, very different). Composite score = sum of all scores except overall opinion and range 6 (best) to 60 (worst). Scar appearance composite score = sum of all scores except overall opinion, pain and itching, range 4 (best) to 40 (worst). Within participant treatment difference was assessed between the treatment regimens each participant received. A lower score indicated a better outcome.
Outcome measures
| Measure |
EXC 001 (PF-06473871) 2 mg/cm and Placebo
n=14 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 0.8 mg/cm and Placebo
n=10 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 5 mg/cm and Placebo
n=12 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 5 mg/cm
n=26 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (cm) section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.
|
|---|---|---|---|---|
|
Subject Observer Scar Assessment Score
Composite Score
|
0.2 units on a scale
Standard Deviation 6.80
|
3.0 units on a scale
Standard Deviation 8.52
|
-0.1 units on a scale
Standard Deviation 11.34
|
-1.7 units on a scale
Standard Deviation 9.03
|
|
Subject Observer Scar Assessment Score
Scar Appearance Composite Score
|
-0.1 units on a scale
Standard Deviation 6.44
|
2.4 units on a scale
Standard Deviation 7.68
|
0.3 units on a scale
Standard Deviation 10.71
|
-1.5 units on a scale
Standard Deviation 6.77
|
|
Subject Observer Scar Assessment Score
Overall Opinion
|
0.0 units on a scale
Standard Deviation 2.22
|
1.2 units on a scale
Standard Deviation 2.35
|
-0.2 units on a scale
Standard Deviation 2.55
|
-0.1 units on a scale
Standard Deviation 2.47
|
|
Subject Observer Scar Assessment Score
Pain
|
0.2 units on a scale
Standard Deviation 0.89
|
0.3 units on a scale
Standard Deviation 0.95
|
-0.1 units on a scale
Standard Deviation 0.51
|
-0.2 units on a scale
Standard Deviation 2.25
|
|
Subject Observer Scar Assessment Score
Itching
|
0.1 units on a scale
Standard Deviation 0.86
|
0.3 units on a scale
Standard Deviation 0.95
|
-0.3 units on a scale
Standard Deviation 0.65
|
0.0 units on a scale
Standard Deviation 1.11
|
|
Subject Observer Scar Assessment Score
Color
|
-0.1 units on a scale
Standard Deviation 1.82
|
0.6 units on a scale
Standard Deviation 1.17
|
0.3 units on a scale
Standard Deviation 2.05
|
-0.5 units on a scale
Standard Deviation 1.58
|
|
Subject Observer Scar Assessment Score
Stiffness
|
0.1 units on a scale
Standard Deviation 2.06
|
0.4 units on a scale
Standard Deviation 2.22
|
-0.1 units on a scale
Standard Deviation 3.00
|
-0.4 units on a scale
Standard Deviation 1.68
|
|
Subject Observer Scar Assessment Score
Thickness
|
0.0 units on a scale
Standard Deviation 1.36
|
0.7 units on a scale
Standard Deviation 2.41
|
0.2 units on a scale
Standard Deviation 3.19
|
-0.2 units on a scale
Standard Deviation 2.22
|
|
Subject Observer Scar Assessment Score
Irregular
|
-0.1 units on a scale
Standard Deviation 1.96
|
0.7 units on a scale
Standard Deviation 2.58
|
0.0 units on a scale
Standard Deviation 3.05
|
-0.3 units on a scale
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Physician rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times).
Outcome measures
| Measure |
EXC 001 (PF-06473871) 2 mg/cm and Placebo
n=14 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 0.8 mg/cm and Placebo
n=10 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 5 mg/cm and Placebo
n=12 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 5 mg/cm
n=26 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (cm) section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.
|
|---|---|---|---|---|
|
Number of Participants With Physician Photonumeric Guide Scar Assessment Score
4 times EXC 001, minimal
|
4 Participants
|
1 Participants
|
0 Participants
|
10 Participants
|
|
Number of Participants With Physician Photonumeric Guide Scar Assessment Score
4 times EXC 001, mild
|
3 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants With Physician Photonumeric Guide Scar Assessment Score
4 times EXC 001, moderate
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Physician Photonumeric Guide Scar Assessment Score
4 times EXC 001, severe
|
3 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With Physician Photonumeric Guide Scar Assessment Score
4 times EXC 001, very severe
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Physician Photonumeric Guide Scar Assessment Score
3 times EXC 001/Placebo, minimal
|
2 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Physician Photonumeric Guide Scar Assessment Score
3 times EXC 001/Placebo, mild
|
5 Participants
|
1 Participants
|
0 Participants
|
13 Participants
|
|
Number of Participants With Physician Photonumeric Guide Scar Assessment Score
3 times EXC 001/Placebo, moderate
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Physician Photonumeric Guide Scar Assessment Score
3 times EXC 001/Placebo, severe
|
4 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Physician Photonumeric Guide Scar Assessment Score
3 times EXC 001/Placebo, very severe
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Participants rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times).
Outcome measures
| Measure |
EXC 001 (PF-06473871) 2 mg/cm and Placebo
n=13 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 0.8 mg/cm and Placebo
n=10 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 5 mg/cm and Placebo
n=12 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 5 mg/cm
n=26 Participants
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (cm) section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.
|
|---|---|---|---|---|
|
Number of Participants With Participant Photonumeric Guide Scar Assessment Score
4 times EXC 001, minimal
|
1 Participants
|
1 Participants
|
1 Participants
|
8 Participants
|
|
Number of Participants With Participant Photonumeric Guide Scar Assessment Score
4 times EXC 001, mild
|
1 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants With Participant Photonumeric Guide Scar Assessment Score
4 times EXC 001, moderate
|
4 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Participant Photonumeric Guide Scar Assessment Score
4 times EXC 001, severe
|
5 Participants
|
1 Participants
|
2 Participants
|
7 Participants
|
|
Number of Participants With Participant Photonumeric Guide Scar Assessment Score
4 times EXC 001, very severe
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Participant Photonumeric Guide Scar Assessment Score
3 times EXC 001/Placebo, minimal
|
1 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Participant Photonumeric Guide Scar Assessment Score
3 times EXC 001/Placebo, mild
|
3 Participants
|
2 Participants
|
3 Participants
|
13 Participants
|
|
Number of Participants With Participant Photonumeric Guide Scar Assessment Score
3 times EXC 001/Placebo, moderate
|
4 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Participant Photonumeric Guide Scar Assessment Score
3 times EXC 001/Placebo, severe
|
3 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Participant Photonumeric Guide Scar Assessment Score
3 times EXC 001/Placebo, very severe
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
EXC 001 (PF-06473871) 5 mg/cm
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
EXC 001 (PF-06473871) 2 mg/cm and Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
EXC 001 (PF-06473871) 0.8 mg/cm and Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
EXC 001 (PF-06473871) 5 mg/cm and Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EXC 001 (PF-06473871) 5 mg/cm
n=27 participants at risk
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 2 mg/cm and Placebo
n=14 participants at risk
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 0.8 mg/cm and Placebo
n=13 participants at risk
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
EXC 001 (PF-06473871) 5 mg/cm and Placebo
n=13 participants at risk
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast.
|
|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Infections and infestations
Eye infection
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Infections and infestations
Fungal infection
|
0.00%
0/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
7.7%
1/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/27 • Day 1 up to Week 24
|
7.1%
1/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Infections and infestations
Lyme disease
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/27 • Day 1 up to Week 24
|
7.1%
1/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Infections and infestations
Sinusitis
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Infections and infestations
Urinary tract infection
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
General disorders
Application site rash
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
General disorders
Impaired healing
|
0.00%
0/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
7.7%
1/13 • Day 1 up to Week 24
|
|
General disorders
Influenza like illness
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
General disorders
Injection site erythema
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
General disorders
Oedema peripheral
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Gastrointestinal disorders
Nausea
|
7.4%
2/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Gastrointestinal disorders
Toothache
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
7.7%
1/13 • Day 1 up to Week 24
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
7.7%
1/13 • Day 1 up to Week 24
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.00%
0/27 • Day 1 up to Week 24
|
7.1%
1/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Nervous system disorders
Headache
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
7.7%
1/13 • Day 1 up to Week 24
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
7.7%
1/13 • Day 1 up to Week 24
|
|
Reproductive system and breast disorders
Breast induration
|
0.00%
0/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
7.7%
1/13 • Day 1 up to Week 24
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.7%
1/27 • Day 1 up to Week 24
|
7.1%
1/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/27 • Day 1 up to Week 24
|
7.1%
1/14 • Day 1 up to Week 24
|
7.7%
1/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
7.7%
1/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
7.7%
1/13 • Day 1 up to Week 24
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/27 • Day 1 up to Week 24
|
7.1%
1/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/27 • Day 1 up to Week 24
|
7.1%
1/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
|
Vascular disorders
Hypertension
|
3.7%
1/27 • Day 1 up to Week 24
|
0.00%
0/14 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
0.00%
0/13 • Day 1 up to Week 24
|
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