Trial Outcomes & Findings for Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery (NCT NCT01730339)
NCT ID: NCT01730339
Last Updated: 2016-02-17
Results Overview
Physician global assessment was performed using the overall opinion question of the POSAS scale. Physicians were asked to rate the severity of the participant's scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). Within participant treatment difference was assessed between the treatment regimens each participant received.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
103 participants
Primary outcome timeframe
Week 24
Results posted on
2016-02-17
Participant Flow
A total of 103 participants were randomized into the study. Of these, 100 participants received at least 1 dose of study drug and were included in the modified intent to treat (mITT) and safety population.
Participant milestones
| Measure |
PF-06473871/Placebo (4* 5 mg/cm)
Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
|
PF-06473871/Placebo (3* 5 mg/cm)
Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 milligrams per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
55
|
|
Overall Study
COMPLETED
|
40
|
52
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
PF-06473871/Placebo (4* 5 mg/cm)
Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
|
PF-06473871/Placebo (3* 5 mg/cm)
Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 milligrams per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Un-specified
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery
Baseline characteristics by cohort
| Measure |
PF-06473871/Placebo (4* 5 mg/cm)
n=45 Participants
Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
|
PF-06473871/Placebo (3* 5 mg/cm)
n=55 Participants
Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.2 years
STANDARD_DEVIATION 8.55 • n=99 Participants
|
37.6 years
STANDARD_DEVIATION 9.64 • n=107 Participants
|
37.9 years
STANDARD_DEVIATION 9.13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Pre-Surgery Physician Overall Opinion POSAS Score
|
6.62 units on scale
STANDARD_DEVIATION 1.545 • n=99 Participants
|
6.88 units on scale
STANDARD_DEVIATION 1.277 • n=107 Participants
|
6.76 units on scale
STANDARD_DEVIATION 1.404 • n=206 Participants
|
|
Pre-Surgery Subject Global Assessment Score
|
9.00 units on scale
STANDARD_DEVIATION 1.219 • n=99 Participants
|
8.49 units on scale
STANDARD_DEVIATION 1.617 • n=107 Participants
|
8.72 units on scale
STANDARD_DEVIATION 1.465 • n=206 Participants
|
|
Pre-Surgery Physician Photoguide Score
|
3.97 units on scale
STANDARD_DEVIATION 0.682 • n=99 Participants
|
3.98 units on scale
STANDARD_DEVIATION 0.725 • n=107 Participants
|
3.98 units on scale
STANDARD_DEVIATION 0.702 • n=206 Participants
|
|
Pre-Surgery Participant Photoguide Score
|
4.24 units on scale
STANDARD_DEVIATION 0.648 • n=99 Participants
|
4.28 units on scale
STANDARD_DEVIATION 0.637 • n=107 Participants
|
4.26 units on scale
STANDARD_DEVIATION 0.639 • n=206 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Modified Intent To Treat (mITT) population included all participants who were randomized and received at least 1 dose of investigational product. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Physician global assessment was performed using the overall opinion question of the POSAS scale. Physicians were asked to rate the severity of the participant's scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). Within participant treatment difference was assessed between the treatment regimens each participant received.
Outcome measures
| Measure |
Group 1: PF-06473871: 4* 5 mg/cm
n=43 Participants
Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
|
Group 1: Placebo 4* 5 mg/cm
n=43 Participants
Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
|
Group 2: PF¬06473871: 3* 5 mg/cm
n=53 Participants
Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
|
Group 2: Placebo 3* 5 mg/cm
n=53 Participants
Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
|
|---|---|---|---|---|
|
Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS)
|
4.00 units on scale
Standard Error 0.30
|
4.68 units on scale
Standard Error 0.27
|
4.61 units on scale
Standard Error 0.29
|
4.86 units on scale
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Week 8, 11, 18, 24Population: mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here,"n""= participants who were evaluable at given time point for each arm, respectively.
Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (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). Within participant treatment difference was assessed between the treatment regimens each participant received. Data for overall opinion scale score at Week 24 was not presented in this outcome measure because the data was reported separately under primary outcome measure 1.
Outcome measures
| Measure |
Group 1: PF-06473871: 4* 5 mg/cm
n=45 Participants
Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
|
Group 1: Placebo 4* 5 mg/cm
n=45 Participants
Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
|
Group 2: PF¬06473871: 3* 5 mg/cm
n=55 Participants
Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
|
Group 2: Placebo 3* 5 mg/cm
n=55 Participants
Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
|
|---|---|---|---|---|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Vascularity: Week 8 (n=43,43,51,51)
|
3.63 units on scale
Standard Error 0.24
|
3.51 units on scale
Standard Error 0.25
|
3.95 units on scale
Standard Error 0.24
|
3.79 units on scale
Standard Error 0.24
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Vascularity: Week 11 (n=43,43,52,52)
|
3.64 units on scale
Standard Error 0.25
|
3.83 units on scale
Standard Error 0.26
|
3.76 units on scale
Standard Error 0.26
|
3.83 units on scale
Standard Error 0.25
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Vascularity: Week 18 (n=40,40,52,52)
|
3.31 units on scale
Standard Error 0.27
|
3.73 units on scale
Standard Error 0.28
|
3.49 units on scale
Standard Error 0.27
|
3.84 units on scale
Standard Error 0.26
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Vascularity: Week 24 (n=43,43,53,53)
|
3.08 units on scale
Standard Error 0.27
|
3.40 units on scale
Standard Error 0.28
|
3.34 units on scale
Standard Error 0.27
|
3.55 units on scale
Standard Error 0.27
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Pigmentation: Week 8 (n=43,43,51,51)
|
3.42 units on scale
Standard Error 0.23
|
3.53 units on scale
Standard Error 0.23
|
3.49 units on scale
Standard Error 0.20
|
3.43 units on scale
Standard Error 0.19
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Pigmentation: Week 11 (n=43,43,52,52)
|
3.84 units on scale
Standard Error 0.27
|
3.73 units on scale
Standard Error 0.27
|
3.80 units on scale
Standard Error 0.23
|
3.53 units on scale
Standard Error 0.22
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Pigmentation: Week 18 (n=40,40,52,52)
|
3.85 units on scale
Standard Error 0.29
|
3.88 units on scale
Standard Error 0.29
|
3.73 units on scale
Standard Error 0.24
|
3.75 units on scale
Standard Error 0.23
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Pigmentation: Week 24 (n=43,43,53,53)
|
3.84 units on scale
Standard Error 0.29
|
3.99 units on scale
Standard Error 0.29
|
4.16 units on scale
Standard Error 0.25
|
4.12 units on scale
Standard Error 0.24
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Thickness: Week 8 (n=43,43,51,51)
|
3.38 units on scale
Standard Error 0.23
|
3.56 units on scale
Standard Error 0.24
|
3.59 units on scale
Standard Error 0.22
|
3.56 units on scale
Standard Error 0.22
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Thickness: Week 11(n=43,43,52,52)
|
3.58 units on scale
Standard Error 0.26
|
3.98 units on scale
Standard Error 0.26
|
4.01 units on scale
Standard Error 0.25
|
3.82 units on scale
Standard Error 0.24
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Thickness: Week 18 (n=40,40,52,52)
|
3.67 units on scale
Standard Error 0.32
|
4.61 units on scale
Standard Error 0.32
|
4.18 units on scale
Standard Error 0.30
|
4.39 units on scale
Standard Error 0.29
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Thickness: Week 24 (n=43,43,53,53)
|
3.90 units on scale
Standard Error 0.32
|
4.58 units on scale
Standard Error 0.33
|
4.63 units on scale
Standard Error 0.31
|
4.77 units on scale
Standard Error 0.30
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Relief: Week 8 (n=43,43,51,51)
|
3.19 units on scale
Standard Error 0.23
|
3.58 units on scale
Standard Error 0.24
|
3.48 units on scale
Standard Error 0.24
|
3.37 units on scale
Standard Error 0.22
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Relief: Week 11(n=43,43,52,52)
|
3.63 units on scale
Standard Error 0.26
|
3.85 units on scale
Standard Error 0.27
|
3.89 units on scale
Standard Error 0.27
|
3.70 units on scale
Standard Error 0.25
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Relief: Week 18 (n=40,40,52,52)
|
3.75 units on scale
Standard Error 0.31
|
4.48 units on scale
Standard Error 0.32
|
3.99 units on scale
Standard Error 0.31
|
4.08 units on scale
Standard Error 0.28
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Relief: Week 24 (n=43,43,53,53)
|
3.87 units on scale
Standard Error 0.30
|
4.39 units on scale
Standard Error 0.31
|
4.38 units on scale
Standard Error 0.29
|
4.53 units on scale
Standard Error 0.27
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Pliability: Week 8 (n=43,43,51,51)
|
3.55 units on scale
Standard Error 0.25
|
3.84 units on scale
Standard Error 0.24
|
3.57 units on scale
Standard Error 0.22
|
3.55 units on scale
Standard Error 0.21
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Pliability: Week 11(n=43,43,52,52)
|
3.71 units on scale
Standard Error 0.28
|
4.02 units on scale
Standard Error 0.27
|
4.01 units on scale
Standard Error 0.25
|
3.65 units on scale
Standard Error 0.24
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Pliability: Week 18 (n=40,40,52,52)
|
3.46 units on scale
Standard Error 0.31
|
4.19 units on scale
Standard Error 0.30
|
3.86 units on scale
Standard Error 0.27
|
3.84 units on scale
Standard Error 0.26
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Pliability: Week 24 (n=43,43,53,53)
|
3.73 units on scale
Standard Error 0.34
|
4.27 units on scale
Standard Error 0.32
|
4.05 units on scale
Standard Error 0.30
|
4.54 units on scale
Standard Error 0.29
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Surface Area: Week 8 (n=43,43,51,51)
|
3.42 units on scale
Standard Error 0.25
|
3.59 units on scale
Standard Error 0.23
|
3.48 units on scale
Standard Error 0.22
|
3.55 units on scale
Standard Error 0.21
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Surface Area: Week 11 (n=43,43,52,52)
|
3.55 units on scale
Standard Error 0.27
|
4.06 units on scale
Standard Error 0.25
|
3.91 units on scale
Standard Error 0.23
|
3.76 units on scale
Standard Error 0.22
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Surface Area: Week 18 (n=40,40,52,52)
|
3.97 units on scale
Standard Error 0.31
|
4.61 units on scale
Standard Error 0.29
|
4.33 units on scale
Standard Error 0.26
|
4.32 units on scale
Standard Error 0.25
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Surface Area: Week 24 (n=43,43,53,53)
|
4.05 units on scale
Standard Error 0.33
|
4.73 units on scale
Standard Error 0.30
|
4.55 units on scale
Standard Error 0.28
|
4.78 units on scale
Standard Error 0.27
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Overall Opinion: Week 8 (n=43,43,51,51)
|
3.50 units on scale
Standard Error 0.22
|
3.74 units on scale
Standard Error 0.20
|
3.66 units on scale
Standard Error 0.22
|
3.75 units on scale
Standard Error 0.21
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Overall Opinion: Week 11 (n=43,43,52,52)
|
3.82 units on scale
Standard Error 0.25
|
4.05 units on scale
Standard Error 0.24
|
4.13 units on scale
Standard Error 0.25
|
3.91 units on scale
Standard Error 0.24
|
|
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
Overall Opinion: Week 18 (n=40,40,52,52)
|
3.86 units on scale
Standard Error 0.29
|
4.68 units on scale
Standard Error 0.27
|
4.35 units on scale
Standard Error 0.28
|
4.47 units on scale
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Week 8, 11, 18, 24Population: mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here, "n""= participants who were evaluable at given time point for each arm, respectively.
Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin). Within participant treatment difference was assessed between the treatment regimens each participant received
Outcome measures
| Measure |
Group 1: PF-06473871: 4* 5 mg/cm
n=45 Participants
Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
|
Group 1: Placebo 4* 5 mg/cm
n=45 Participants
Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
|
Group 2: PF¬06473871: 3* 5 mg/cm
n=55 Participants
Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
|
Group 2: Placebo 3* 5 mg/cm
n=55 Participants
Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
|
|---|---|---|---|---|
|
Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS)
Week 8: (n=43,43,51,51)
|
5.38 units on scale
Standard Error 0.33
|
5.48 units on scale
Standard Error 0.31
|
5.09 units on scale
Standard Error 0.32
|
5.20 units on scale
Standard Error 0.29
|
|
Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS)
Week 11: (n=43,43,52,52)
|
5.58 units on scale
Standard Error 0.33
|
5.59 units on scale
Standard Error 0.32
|
4.52 units on scale
Standard Error 0.32
|
4.73 units on scale
Standard Error 0.30
|
|
Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS)
Week 18: (n=40,40,52,52)
|
5.34 units on scale
Standard Error 0.38
|
5.78 units on scale
Standard Error 0.36
|
5.18 units on scale
Standard Error 0.36
|
5.18 units on scale
Standard Error 0.33
|
|
Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS)
Week 24: (n=43,43,53,53)
|
5.65 units on scale
Standard Error 0.39
|
5.94 units on scale
Standard Error 0.37
|
5.33 units on scale
Standard Error 0.38
|
5.15 units on scale
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Week 8, 24Population: mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here,"n""= participants who were evaluable at given time point for each arm, respectively.
PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing \[14 attributes\]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Participants completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0-100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity. Within participant treatment difference was assessed between the treatment regimens each participant received.
Outcome measures
| Measure |
Group 1: PF-06473871: 4* 5 mg/cm
n=45 Participants
Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
|
Group 1: Placebo 4* 5 mg/cm
n=45 Participants
Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
|
Group 2: PF¬06473871: 3* 5 mg/cm
n=55 Participants
Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
|
Group 2: Placebo 3* 5 mg/cm
n=55 Participants
Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
|
|---|---|---|---|---|
|
Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score
Appearance: Week 8: (n=43,43,53,53)
|
34.95 units on scale
Standard Error 2.38
|
36.27 units on scale
Standard Error 2.27
|
34.50 units on scale
Standard Error 2.20
|
34.14 units on scale
Standard Error 2.20
|
|
Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score
Appearance: Week 24: (n=43,43,54,54)
|
43.55 units on scale
Standard Error 3.32
|
47.37 units on scale
Standard Error 3.16
|
42.41 units on scale
Standard Error 3.04
|
42.56 units on scale
Standard Error 3.04
|
|
Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score
Symptoms: Week 8: (n=43,43,53,53)
|
17.89 units on scale
Standard Error 2.62
|
17.19 units on scale
Standard Error 2.34
|
18.46 units on scale
Standard Error 2.71
|
16.92 units on scale
Standard Error 2.47
|
|
Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score
Symptoms: Week 24: (n=43,43,54,54)
|
13.74 units on scale
Standard Error 2.75
|
15.49 units on scale
Standard Error 2.45
|
18.22 units on scale
Standard Error 2.81
|
17.09 units on scale
Standard Error 2.57
|
SECONDARY outcome
Timeframe: Week 8, 11, 18, 24Population: mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here, "n"= participants who were evaluable at given time point for each arm, respectively.
Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Within participant treatment difference was assessed between the treatment regimens each participant received.
Outcome measures
| Measure |
Group 1: PF-06473871: 4* 5 mg/cm
n=45 Participants
Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
|
Group 1: Placebo 4* 5 mg/cm
n=45 Participants
Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
|
Group 2: PF¬06473871: 3* 5 mg/cm
n=55 Participants
Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
|
Group 2: Placebo 3* 5 mg/cm
n=55 Participants
Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
|
|---|---|---|---|---|
|
Physician and Participant Photoguide Scar Assessment Scale Score
Physician: Week 8 (n=43,43,52,52)
|
2.35 units on scale
Standard Error 0.15
|
2.45 units on scale
Standard Error 0.14
|
2.24 units on scale
Standard Error 0.16
|
2.28 units on scale
Standard Error 0.14
|
|
Physician and Participant Photoguide Scar Assessment Scale Score
Physician: Week 11 (n=43,43,53,53)
|
2.42 units on scale
Standard Error 0.15
|
2.71 units on scale
Standard Error 0.14
|
2.58 units on scale
Standard Error 0.16
|
2.48 units on scale
Standard Error 0.14
|
|
Physician and Participant Photoguide Scar Assessment Scale Score
Physician: Week 18 (n=40,40,53,53)
|
2.48 units on scale
Standard Error 0.15
|
3.05 units on scale
Standard Error 0.14
|
2.70 units on scale
Standard Error 0.16
|
2.74 units on scale
Standard Error 0.14
|
|
Physician and Participant Photoguide Scar Assessment Scale Score
Physician: Week 24 (n=43,43,54,54)
|
2.60 units on scale
Standard Error 0.15
|
3.03 units on scale
Standard Error 0.14
|
3.00 units on scale
Standard Error 0.16
|
3.07 units on scale
Standard Error 0.14
|
|
Physician and Participant Photoguide Scar Assessment Scale Score
Participant: Week 8 (n=43,43,52,52)
|
2.41 units on scale
Standard Error 0.16
|
2.51 units on scale
Standard Error 0.16
|
2.28 units on scale
Standard Error 0.15
|
2.25 units on scale
Standard Error 0.14
|
|
Physician and Participant Photoguide Scar Assessment Scale Score
Participant: Week 11 (n=43,43,53,53)
|
2.65 units on scale
Standard Error 0.16
|
2.66 units on scale
Standard Error 0.16
|
2.48 units on scale
Standard Error 0.15
|
2.56 units on scale
Standard Error 0.14
|
|
Physician and Participant Photoguide Scar Assessment Scale Score
Participant: Week 18 (n=39,39,53,53)
|
2.38 units on scale
Standard Error 0.16
|
2.80 units on scale
Standard Error 0.17
|
2.80 units on scale
Standard Error 0.15
|
2.79 units on scale
Standard Error 0.14
|
|
Physician and Participant Photoguide Scar Assessment Scale Score
Participant: Week 24 (n=43,43,54,54)
|
2.75 units on scale
Standard Error 0.16
|
2.95 units on scale
Standard Error 0.16
|
2.75 units on scale
Standard Error 0.15
|
2.89 units on scale
Standard Error 0.14
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 24Population: Safety population included all participants who received at least 1 dose of investigational product.
Vital Sign included pulse rate, systolic blood pressure, diastolic blood pressure, and weight.
Outcome measures
| Measure |
Group 1: PF-06473871: 4* 5 mg/cm
n=45 Participants
Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
|
Group 1: Placebo 4* 5 mg/cm
n=55 Participants
Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
|
Group 2: PF¬06473871: 3* 5 mg/cm
Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
|
Group 2: Placebo 3* 5 mg/cm
Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Sign Abnormalities
|
0 participants
0.39
|
0 participants
0.37
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 24Population: Safety population included all participants who received at least 1 dose of investigational product.
Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), respiratory, cardiovascular, abdomen - liver and kidney, musculoskeletal, gastrointestinal, genitourinary, and neurological systems.
Outcome measures
| Measure |
Group 1: PF-06473871: 4* 5 mg/cm
n=45 Participants
Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
|
Group 1: Placebo 4* 5 mg/cm
n=55 Participants
Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
|
Group 2: PF¬06473871: 3* 5 mg/cm
Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
|
Group 2: Placebo 3* 5 mg/cm
Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Physical Examinations
|
0 participants
0.39
|
0 participants
0.37
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 11Population: Safety population included all participants who received at least 1 dose of investigational product. Here, "n""= participants who were evaluable at given time point for each arm, respectively.
Following parameters were assessed: heart rate, PR Interval, QRS Interval, QT Interval, and Fridericia's Correction Formula (QTcF) interval. Electrocardiogram Results were reported as normal, abnormal, not clinically significant (NCS) and abnormal and clinically significant (CS) as determined by investigator.
Outcome measures
| Measure |
Group 1: PF-06473871: 4* 5 mg/cm
n=45 Participants
Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
|
Group 1: Placebo 4* 5 mg/cm
n=55 Participants
Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
|
Group 2: PF¬06473871: 3* 5 mg/cm
Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
|
Group 2: Placebo 3* 5 mg/cm
Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
|
|---|---|---|---|---|
|
Number of Participants With Electrocardiogram Findings
Week 11: Normal (n=42,53)
|
33 participants
|
43 participants
|
—
|
—
|
|
Number of Participants With Electrocardiogram Findings
Baseline: Normal (n=45,55)
|
38 participants
0.39
|
43 participants
0.37
|
—
|
—
|
|
Number of Participants With Electrocardiogram Findings
Baseline: Abnormal, NCS (n=45,55)
|
7 participants
|
12 participants
|
—
|
—
|
|
Number of Participants With Electrocardiogram Findings
Baseline: Abnormal , CS (n=45,55)
|
0 participants
|
0 participants
|
—
|
—
|
|
Number of Participants With Electrocardiogram Findings
Week 11: Abnormal, NCS (n=42,53)
|
9 participants
|
10 participants
|
—
|
—
|
|
Number of Participants With Electrocardiogram Findings
Week 11: Abnormal, CS (n=42,53)
|
0 participants
|
0 participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 24Population: Safety population included all participants who received at least 1 dose of investigational product. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Treatment Emergent Adverse Events (AEs) of special interest included injection site erythema, maculopapular rash, pruritus, bronchospasm, dyspnea, cough, fever and diarrhea.
Outcome measures
| Measure |
Group 1: PF-06473871: 4* 5 mg/cm
n=45 Participants
Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
|
Group 1: Placebo 4* 5 mg/cm
n=55 Participants
Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
|
Group 2: PF¬06473871: 3* 5 mg/cm
Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
|
Group 2: Placebo 3* 5 mg/cm
Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) of Special Interest
|
3 participants
0.39
|
9 participants
0.37
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 24Population: Safety population included all participants who received at least 1 dose of investigational product.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse event are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs related to laboratory abnormalities are reported.
Outcome measures
| Measure |
Group 1: PF-06473871: 4* 5 mg/cm
n=45 Participants
Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
|
Group 1: Placebo 4* 5 mg/cm
n=55 Participants
Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
|
Group 2: PF¬06473871: 3* 5 mg/cm
Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
|
Group 2: Placebo 3* 5 mg/cm
Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities
Amylase increased
|
1 participants
|
1 participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities
Blood glucose increased
|
0 participants
|
1 participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities
Blood lactate dehydrogenase (LDH) increased
|
0 participants
|
1 participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities
Leukopenia
|
0 participants
0.39
|
1 participants
0.37
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities
Hyperbilrubinemia
|
0 participants
|
1 participants
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities
Blood creatine phosphokinase (CPK) increased
|
2 participants
|
6 participants
|
—
|
—
|
Adverse Events
PF-06473871/Placebo (4* 5 mg/cm)
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
PF-06473871/Placebo (3* 5 mg/cm)
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-06473871/Placebo (4* 5 mg/cm)
n=45 participants at risk
Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
|
PF-06473871/Placebo (3* 5 mg/cm)
n=55 participants at risk
Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
|
|---|---|---|
|
General disorders
Injection site erythema
|
6.7%
3/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
9.1%
5/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
7.3%
4/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
11.1%
5/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
7.3%
4/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
8.9%
4/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Injury, poisoning and procedural complications
Incision site pruritus
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
3.6%
2/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Injury, poisoning and procedural complications
Incision site complication
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Injury, poisoning and procedural complications
Suture rupture
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Injury, poisoning and procedural complications
Incision site blister
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
General disorders
Injection site pain
|
22.2%
10/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
16.4%
9/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
General disorders
Injection site pruritus
|
6.7%
3/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
7.3%
4/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
General disorders
Application site rash
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
General disorders
Injection site rash
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
General disorders
Injection site reaction
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
General disorders
Injection site urticaria
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
General disorders
Oedema peripheral
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
General disorders
Pyrexia
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
3.6%
2/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
3.6%
2/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Infections and infestations
Sinusitis
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Infections and infestations
Acute sinusitis
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Infections and infestations
Bronchitis
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Infections and infestations
Cellulitis
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Infections and infestations
Vaginal infection
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Infections and infestations
Viral rhinitis
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
4.4%
2/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
10.9%
6/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Investigations
Amylase increased
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Investigations
Blood glucose increased
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Investigations
Weight increased
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Nervous system disorders
Headache
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
3.6%
2/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Nervous system disorders
Paraesthesia
|
4.4%
2/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Nervous system disorders
Piriformis syndrome
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
3.6%
2/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Skin and subcutaneous tissue disorders
Itching scar
|
4.4%
2/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Gastrointestinal disorders
Constipation
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.4%
2/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Psychiatric disorders
Anxiety
|
4.4%
2/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
3.6%
2/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.2%
1/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
0.00%
0/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
|
Social circumstances
Treatment noncompliance
|
0.00%
0/45 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
1.8%
1/55 • Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
|
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