Trial Outcomes & Findings for Long-term Study of Efficacy/Safety of Adapalene/Benzoyl Peroxide Topical Gel in Acne Vulgaris Subjects (NCT NCT00446043)
NCT ID: NCT00446043
Last Updated: 2023-07-11
Results Overview
Percent change in inflammatory, noninflammatory and total lesions at Month 12 was measured from baseline lesions. The noninflammatory lesion count was the sum of open comedones (a mass of sebaceous material that is impacted behind an open follicular orifice (blackhead) and closed comedones (a mass of sebaceous material that is impacted behind a closed follicular orifice (whitehead). The inflammatory lesion count was the sum of papules (a small, solid elevation less than 1.0 cm in diameter) and pustules (a small, circumscribed elevation of the skin that contains yellow-white exudate). The total lesion count was the sum of inflammatory and noninflammatory lesions. Missing adapalene and benzoyl peroxide data were imputed using last observation carried forward (LOCF).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
452 participants
Primary outcome timeframe
Baseline, Month 12 LOCF
Results posted on
2023-07-11
Participant Flow
A total of 452 participants were enrolled at 28 study centers in the United States from 17 February 2004 to 23 May 2005.
Participant milestones
| Measure |
Adapalene/Benzoyl Peroxide
Participants were treated with adapalene 0.1 percent (%) \[weight by weight (W/W)\] and benzoyl peroxide 2.5% (W/W) gel topically to the face and trunk area as applicable once daily in the evening.
|
|---|---|
|
Overall Study
STARTED
|
452
|
|
Overall Study
COMPLETED
|
327
|
|
Overall Study
NOT COMPLETED
|
125
|
Reasons for withdrawal
| Measure |
Adapalene/Benzoyl Peroxide
Participants were treated with adapalene 0.1 percent (%) \[weight by weight (W/W)\] and benzoyl peroxide 2.5% (W/W) gel topically to the face and trunk area as applicable once daily in the evening.
|
|---|---|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Withdrawal by Subject
|
70
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Lost to Follow-up
|
42
|
|
Overall Study
Pregnancy
|
2
|
Baseline Characteristics
Long-term Study of Efficacy/Safety of Adapalene/Benzoyl Peroxide Topical Gel in Acne Vulgaris Subjects
Baseline characteristics by cohort
| Measure |
Adapalene/Benzoyl Peroxide
n=452 Participants
Participants were treated with adapalene 0.1 % (W/W) and benzoyl peroxide 2.5 % (W/W) gel topically to the face and trunk area as applicable once daily in the evening.
|
|---|---|
|
Age, Continuous
|
18.3 years
STANDARD_DEVIATION 6.62 • n=99 Participants
|
|
Sex: Female, Male
Female
|
230 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
222 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
345 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
53 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
10 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
31 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
13 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 12 LOCFPopulation: ITT population included all participants who were enrolled and treated to whom medication was dispensed.
Percent change in inflammatory, noninflammatory and total lesions at Month 12 was measured from baseline lesions. The noninflammatory lesion count was the sum of open comedones (a mass of sebaceous material that is impacted behind an open follicular orifice (blackhead) and closed comedones (a mass of sebaceous material that is impacted behind a closed follicular orifice (whitehead). The inflammatory lesion count was the sum of papules (a small, solid elevation less than 1.0 cm in diameter) and pustules (a small, circumscribed elevation of the skin that contains yellow-white exudate). The total lesion count was the sum of inflammatory and noninflammatory lesions. Missing adapalene and benzoyl peroxide data were imputed using last observation carried forward (LOCF).
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide
n=452 Participants
Participants were treated with adapalene 0.1% (W/W) and benzoyl peroxide 2.5 % (W/W) gel topically to the face and trunk area, as applicable, once daily in the evening.
|
|---|---|
|
Percent Change From Baseline in Inflammatory, Noninflammatory and Total Lesion Count at Month 12 LOCF
Inflammatory Lesion Counts
|
-59.70 percent change
Standard Deviation 34.268
|
|
Percent Change From Baseline in Inflammatory, Noninflammatory and Total Lesion Count at Month 12 LOCF
Noninflammatory Lesion Counts
|
-58.80 percent change
Standard Deviation 33.206
|
|
Percent Change From Baseline in Inflammatory, Noninflammatory and Total Lesion Count at Month 12 LOCF
Total Lesion Counts
|
-58.85 percent change
Standard Deviation 29.273
|
PRIMARY outcome
Timeframe: At Month 6Population: ITT population included all participants who were enrolled and to whom medication was dispensed. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse.
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide
n=359 Participants
Participants were treated with adapalene 0.1% (W/W) and benzoyl peroxide 2.5 % (W/W) gel topically to the face and trunk area, as applicable, once daily in the evening.
|
|---|---|
|
Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 6
0=Complete Improvement
|
17 Participants
|
|
Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 6
1=Marked Improvement
|
149 Participants
|
|
Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 6
2=Moderate Improvement
|
147 Participants
|
|
Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 6
3=Minimal Improvement
|
31 Participants
|
|
Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 6
4=No Change
|
11 Participants
|
|
Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 6
5=Worse
|
4 Participants
|
PRIMARY outcome
Timeframe: At Month 12Population: ITT population included all participants who were enrolled and to whom medication was dispensed. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Participant's assessment of acne improvement was graded as 0; complete improvement, 1; marked improvement, 2; moderate improvement, 3; minimal improvement, 4; no change, 5; worse.
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide
n=327 Participants
Participants were treated with adapalene 0.1% (W/W) and benzoyl peroxide 2.5 % (W/W) gel topically to the face and trunk area, as applicable, once daily in the evening.
|
|---|---|
|
Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 12
0=Complete Improvement
|
40 Participants
|
|
Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 12
1=Marked Improvement
|
164 Participants
|
|
Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 12
2=Moderate Improvement
|
77 Participants
|
|
Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 12
3=Minimal Improvement
|
37 Participants
|
|
Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 12
4=No Change
|
6 Participants
|
|
Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 12
5=Worse
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12Population: The safety population was defined as all participants enrolled who had applied study medication at least once. Here, 'number analyzed' signifies participants who were evaluable at each post-baseline timepoint.
Local tolerability assessment for erythema (abnormal redness of the skin) was graded on a "0" (none) to "3" (severe) scale as follows; none (0- no erythema), mild (1- slight pinkness present), moderate (2- definite redness, easily recognized), severe (3- intense redness). The worst severity scores were generally mild or moderate, and rarely severe.
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide
n=452 Participants
Participants were treated with adapalene 0.1% (W/W) and benzoyl peroxide 2.5 % (W/W) gel topically to the face and trunk area, as applicable, once daily in the evening.
|
|---|---|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 1 · 2=Moderate
|
18 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 4 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 8 · 1 = Mild
|
57 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 8 · 2=Moderate
|
8 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 10 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Baseline · 0 = None
|
348 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Baseline · 1 = Mild
|
94 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Baseline · 2=Moderate
|
10 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Baseline · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Week 1 · 0 = None
|
233 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Week 1 · 1 = Mild
|
157 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Week 1 · 2=Moderate
|
32 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Week 1 · 3=Severe
|
1 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Week 2 · 0 = None
|
277 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Week 2 · 1 = Mild
|
133 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Week 2 · 2=Moderate
|
17 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Week 2 · 3=Severe
|
2 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 1 · 0 = None
|
292 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 1 · 1 = Mild
|
105 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 1 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 2 · 0 = None
|
320 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 2 · 1 = Mild
|
90 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 2 · 2=Moderate
|
16 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 2 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 4 · 0 = None
|
334 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 4 · 1 = Mild
|
48 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 4 · 2=Moderate
|
7 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 6 · 0 = None
|
296 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 6 · 1 = Mild
|
59 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 6 · 2=Moderate
|
6 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 6 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 8 · 0 = None
|
276 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 8 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 10 · 0 = None
|
270 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 10 · 1 = Mild
|
56 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 10 · 2=Moderate
|
3 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 12 · 0 = None
|
284 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 12 · 1 = Mild
|
39 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 12 · 2=Moderate
|
4 Participants
|
|
Number of Participants With Local Tolerability Assessment For Erythema
Month 12 · 3=Severe
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12Population: The safety population was defined as all participants enrolled who had applied study medication at least once. Here, 'number analyzed' signifies participants who were evaluable at each post-baseline timepoint.
Local tolerability assessment for scaling (abnormal shedding of the stratum corneum) was graded on a "0" (none) to "3" (severe) scale as follow; none (0- no Scaling), mild (1- barely perceptible shedding, noticeable only on light scratching or rubbing), moderate (2- obvious but not profuse shedding), severe (3- heavy scale production).
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide
n=452 Participants
Participants were treated with adapalene 0.1% (W/W) and benzoyl peroxide 2.5 % (W/W) gel topically to the face and trunk area, as applicable, once daily in the evening.
|
|---|---|
|
Number of Participants With Local Tolerability Assessment For Scaling
Week 2 · 2=Moderate
|
14 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 8 · 2=Moderate
|
2 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 12 · 2=Moderate
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Baseline · 0=None
|
410 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Baseline · 1=Mild
|
41 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Baseline · 2=Moderate
|
1 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Baseline · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Week 1 · 0=None
|
228 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Week 1 · 1=Mild
|
164 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Week 1 · 2=Moderate
|
30 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Week 1 · 3=Severe
|
1 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Week 2 · 0=None
|
284 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Week 2 · 1=Mild
|
130 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Week 2 · 3=Severe
|
1 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 1 · 0=None
|
312 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 1 · 1=Mild
|
93 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 1 · 2=Moderate
|
10 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 1 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 2 · 0=None
|
338 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 2 · 1=Mild
|
84 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 2 · 2=Moderate
|
4 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 2 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 4 · 0=None
|
351 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 4 · 1=Mild
|
38 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 4 · 2=Moderate
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 4 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 6 · 0=None
|
330 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 6 · 1=Mild
|
28 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 6 · 2=Moderate
|
3 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 6 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 8 · 0=None
|
301 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 8 · 1=Mild
|
38 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 8 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 10 · 0=None
|
294 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 10 · 1=Mild
|
33 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 10 · 2=Moderate
|
2 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 10 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 12 · 0=None
|
308 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 12 · 1=Mild
|
19 Participants
|
|
Number of Participants With Local Tolerability Assessment For Scaling
Month 12 · 3=Severe
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12Population: The safety population was defined as all participants enrolled who had applied study medication at least once. Here, 'number analyzed' signifies participants who were evaluable at each post-baseline timepoint.
Local tolerability assessment for dryness (brittle and/or tight sensation) was graded on a "0" (none) to "3" (severe) scale as follows; none (0- no dryness), mild (1- slight but definite roughness), moderate (2 -moderate roughness), severe (3- marked roughness).
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide
n=452 Participants
Participants were treated with adapalene 0.1% (W/W) and benzoyl peroxide 2.5 % (W/W) gel topically to the face and trunk area, as applicable, once daily in the evening.
|
|---|---|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 4 · 2=Moderate
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Baseline · 0=None
|
385 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Baseline · 1=Mild
|
65 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Baseline · 2=Moderate
|
2 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Baseline · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Week 1 · 0=None
|
195 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Week 1 · 1=Mild
|
190 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Week 1 · 2=Moderate
|
35 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Week 1 · 3=Severe
|
3 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Week 2 · 0=None
|
264 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Week 2 · 1=Mild
|
152 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Week 2 · 2=Moderate
|
12 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Week 2 · 3=Severe
|
1 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 1 · 0=None
|
281 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 1 · 1=Mild
|
121 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 1 · 2=Moderate
|
12 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 1 · 3=Severe
|
1 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 2 · 0=None
|
311 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 2 · 1=Mild
|
109 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 2 · 2=Moderate
|
6 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 2 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 4 · 0=None
|
337 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 4 · 1=Mild
|
52 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 4 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 6 · 0=None
|
320 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 6 · 1=Mild
|
37 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 6 · 2=Moderate
|
4 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 6 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 8 · 0=None
|
281 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 8 · 1=Mild
|
58 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 8 · 2=Moderate
|
2 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 8 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 10 · 0=None
|
278 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 10 · 1=Mild
|
48 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 10 · 2=Moderate
|
3 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 10 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 12 · 0=None
|
291 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 12 · 1=Mild
|
36 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 12 · 2=Moderate
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Dryness
Month 12 · 3=Severe
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1 and 2, Months 1, 2, 4, 6, 8, 10 and 12Population: ITT safety population was defined as all participants enrolled who had applied study medication at least once. Here, 'number analyzed' signifies participants who were evaluable at each post-baseline timepoint.
Local tolerability assessment for stinging/burning \[prickling pain sensation immediately after (within 5 minutes of) dosing\] was graded on a "0" (none) to "3" (severe) scale as follows; none (0- no stinging/ burning), mild (1- slight warm, tingling/stinging sensation; not really bothersome), moderate (2- definite warm, tingling/stinging sensation that is somewhat), severe (3- hot, tingling/stinging sensation that has caused definite discomfort).
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide
n=452 Participants
Participants were treated with adapalene 0.1% (W/W) and benzoyl peroxide 2.5 % (W/W) gel topically to the face and trunk area, as applicable, once daily in the evening.
|
|---|---|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Week 1 · 0=None
|
201 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Week 1 · 1=Mild
|
154 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Week 1 · 3=Severe
|
5 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 6 · 2=Moderate
|
4 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 6 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 8 · 0=None
|
312 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 8 · 3=Severe
|
1 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 10 · 0=None
|
303 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 10 · 1=Mild
|
22 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 10 · 2=Moderate
|
4 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 12 · 0=None
|
306 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Baseline · 0=None
|
440 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Baseline · 1=Mild
|
10 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Baseline · 2=Moderate
|
2 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Baseline · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Week 1 · 2=Moderate
|
63 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Week 2 · 0=None
|
319 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Week 2 · 1=Mild
|
84 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Week 2 · 2=Moderate
|
21 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Week 2 · 3=Severe
|
5 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 1 · 0=None
|
331 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 1 · 1=Mild
|
66 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 1 · 2=Moderate
|
14 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 1 · 3=Severe
|
4 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 2 · 0=None
|
373 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 2 · 1=Mild
|
42 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 2 · 2=Moderate
|
10 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 2 · 3=Severe
|
1 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 4 · 0=None
|
364 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 4 · 1=Mild
|
23 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 4 · 2=Moderate
|
2 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 4 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 6 · 0=None
|
337 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 6 · 1=Mild
|
20 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 8 · 1=Mild
|
23 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 8 · 2=Moderate
|
5 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 10 · 3=Severe
|
0 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 12 · 1=Mild
|
19 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 12 · 2=Moderate
|
1 Participants
|
|
Number of Participants With Local Tolerability Assessment For Stinging/Burning
Month 12 · 3=Severe
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 14Population: The safety population was defined as all participants enrolled who had applied study medication at least once.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide
n=452 Participants
Participants were treated with adapalene 0.1% (W/W) and benzoyl peroxide 2.5 % (W/W) gel topically to the face and trunk area, as applicable, once daily in the evening.
|
|---|---|
|
Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE)
Participants (N) With At least one AE
|
288 Participants
|
|
Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE)
Participants (N) With At Least one SAE
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 14Population: The safety population was defined as all participants enrolled who had applied study medication at least once.
Clinical laboratory parameters included hematology, blood chemistry, urinalysis. Number of participants with clinically significant abnormalities in laboratory parameters which were deemed clinically significant by the investigator were reported.
Outcome measures
| Measure |
Adapalene/Benzoyl Peroxide
n=452 Participants
Participants were treated with adapalene 0.1% (W/W) and benzoyl peroxide 2.5 % (W/W) gel topically to the face and trunk area, as applicable, once daily in the evening.
|
|---|---|
|
Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Hematology
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Blood Chemistry
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Urine Analysis
|
0 Participants
|
Adverse Events
Adapalene/Benzoyl Peroxide
Serious events: 5 serious events
Other events: 288 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adapalene/Benzoyl Peroxide
n=452 participants at risk
Participants were treated with adapalene 0.1 % (W/W) and benzoyl peroxide 2.5 % (W/W) gel topically to the face and truck area, as applicable, once daily in the evening.
|
|---|---|
|
Psychiatric disorders
Major Depression
|
0.22%
1/452 • Baseline up to 14 months
|
|
Psychiatric disorders
Bipolar Disorder
|
0.22%
1/452 • Baseline up to 14 months
|
|
Infections and infestations
Staphylococcal Infection
|
0.22%
1/452 • Baseline up to 14 months
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.22%
1/452 • Baseline up to 14 months
|
|
Nervous system disorders
Syncope
|
0.22%
1/452 • Baseline up to 14 months
|
|
Social circumstances
Drug Abuser
|
0.22%
1/452 • Baseline up to 14 months
|
Other adverse events
| Measure |
Adapalene/Benzoyl Peroxide
n=452 participants at risk
Participants were treated with adapalene 0.1 % (W/W) and benzoyl peroxide 2.5 % (W/W) gel topically to the face and truck area, as applicable, once daily in the evening.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.6%
30/452 • Baseline up to 14 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.8%
26/452 • Baseline up to 14 months
|
|
Infections and infestations
Influenza
|
4.0%
18/452 • Baseline up to 14 months
|
|
Infections and infestations
Sinusitis
|
3.3%
15/452 • Baseline up to 14 months
|
|
Infections and infestations
Pharyngitis Streptococcal
|
2.9%
13/452 • Baseline up to 14 months
|
|
Infections and infestations
Urinary Tract Infection
|
1.8%
8/452 • Baseline up to 14 months
|
|
Infections and infestations
Gastroenteritis Viral
|
1.5%
7/452 • Baseline up to 14 months
|
|
Infections and infestations
Bronchitis
|
1.5%
7/452 • Baseline up to 14 months
|
|
Infections and infestations
Pharyngitis
|
0.88%
4/452 • Baseline up to 14 months
|
|
Infections and infestations
Herpes Simplex
|
0.88%
4/452 • Baseline up to 14 months
|
|
Infections and infestations
Gastroenteritis
|
0.66%
3/452 • Baseline up to 14 months
|
|
Infections and infestations
Otitis Externa
|
0.66%
3/452 • Baseline up to 14 months
|
|
Infections and infestations
Labyrinthitis
|
0.66%
3/452 • Baseline up to 14 months
|
|
Infections and infestations
Otitis Media
|
0.44%
2/452 • Baseline up to 14 months
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.44%
2/452 • Baseline up to 14 months
|
|
Infections and infestations
Gingival Infection
|
0.44%
2/452 • Baseline up to 14 months
|
|
Infections and infestations
Ear Infection
|
0.44%
2/452 • Baseline up to 14 months
|
|
Infections and infestations
Tonsillitis
|
0.44%
2/452 • Baseline up to 14 months
|
|
Infections and infestations
Vaginal Mycosis
|
0.44%
2/452 • Baseline up to 14 months
|
|
Infections and infestations
Tinea Pedis
|
0.22%
1/452 • Baseline up to 14 months
|
|
Infections and infestations
Subcutaneous Abscess
|
0.22%
1/452 • Baseline up to 14 months
|
|
Infections and infestations
Salmonellosis
|
0.22%
1/452 • Baseline up to 14 months
|
|
Infections and infestations
Pneumonia
|
0.22%
1/452 • Baseline up to 14 months
|
|
Infections and infestations
Body Tinea
|
0.22%
1/452 • Baseline up to 14 months
|
|
Infections and infestations
Nail Infection
|
0.22%
1/452 • Baseline up to 14 months
|
|
Infections and infestations
Tooth Infection
|
0.22%
1/452 • Baseline up to 14 months
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.22%
1/452 • Baseline up to 14 months
|
|
Infections and infestations
Infection
|
0.22%
1/452 • Baseline up to 14 months
|
|
Infections and infestations
Helicobacter Gastritis
|
0.22%
1/452 • Baseline up to 14 months
|
|
Infections and infestations
Folliculitis
|
0.22%
1/452 • Baseline up to 14 months
|
|
Infections and infestations
Eye Infection
|
0.22%
1/452 • Baseline up to 14 months
|
|
Infections and infestations
Conjunctivitis Infective
|
0.22%
1/452 • Baseline up to 14 months
|
|
Infections and infestations
Cellulitis
|
0.22%
1/452 • Baseline up to 14 months
|
|
Infections and infestations
Abdominal Infection
|
0.22%
1/452 • Baseline up to 14 months
|
|
Infections and infestations
Upper Respiratory Tract Infection Bacterial
|
0.22%
1/452 • Baseline up to 14 months
|
|
Infections and infestations
Varicella
|
0.22%
1/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
17.7%
80/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.5%
25/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Skin Desquamation
|
5.1%
23/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
3.8%
17/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
7/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.1%
5/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
1.1%
5/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Skin Discomfort
|
1.1%
5/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.88%
4/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis Exfoliative
|
0.66%
3/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.66%
3/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.44%
2/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic Dermatitis
|
0.44%
2/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Acne Cystic
|
0.44%
2/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.22%
1/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
0.22%
1/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
0.22%
1/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Pigmentation Disorder
|
0.22%
1/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
0.22%
1/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Pain of Skin
|
0.22%
1/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Heat Rash
|
0.22%
1/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Face Odema
|
0.22%
1/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Dyshidrosis
|
0.22%
1/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.22%
1/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Skin Hypopigmentation
|
0.22%
1/452 • Baseline up to 14 months
|
|
Skin and subcutaneous tissue disorders
Skin Burning Sensation
|
0.22%
1/452 • Baseline up to 14 months
|
|
General disorders
Application Site Burning
|
14.2%
64/452 • Baseline up to 14 months
|
|
General disorders
Application Site Irritation
|
4.0%
18/452 • Baseline up to 14 months
|
|
General disorders
Pyrexia
|
0.44%
2/452 • Baseline up to 14 months
|
|
General disorders
Oedema Peripheral
|
0.22%
1/452 • Baseline up to 14 months
|
|
General disorders
Fatique
|
0.22%
1/452 • Baseline up to 14 months
|
|
Injury, poisoning and procedural complications
Sunburn
|
4.6%
21/452 • Baseline up to 14 months
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
1.1%
5/452 • Baseline up to 14 months
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.66%
3/452 • Baseline up to 14 months
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.66%
3/452 • Baseline up to 14 months
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.44%
2/452 • Baseline up to 14 months
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.44%
2/452 • Baseline up to 14 months
|
|
Injury, poisoning and procedural complications
Post Procedural Pain
|
0.44%
2/452 • Baseline up to 14 months
|
|
Injury, poisoning and procedural complications
Tendon Injury
|
0.44%
2/452 • Baseline up to 14 months
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.22%
1/452 • Baseline up to 14 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.22%
1/452 • Baseline up to 14 months
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.22%
1/452 • Baseline up to 14 months
|
|
Injury, poisoning and procedural complications
Chemical Injury
|
0.22%
1/452 • Baseline up to 14 months
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.22%
1/452 • Baseline up to 14 months
|
|
Injury, poisoning and procedural complications
Tooth Injury
|
0.22%
1/452 • Baseline up to 14 months
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.22%
1/452 • Baseline up to 14 months
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.22%
1/452 • Baseline up to 14 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.22%
1/452 • Baseline up to 14 months
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.22%
1/452 • Baseline up to 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
3.1%
14/452 • Baseline up to 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Conjection
|
1.1%
5/452 • Baseline up to 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.66%
3/452 • Baseline up to 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.66%
3/452 • Baseline up to 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Odema
|
0.22%
1/452 • Baseline up to 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhitinis
|
0.22%
1/452 • Baseline up to 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.22%
1/452 • Baseline up to 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.22%
1/452 • Baseline up to 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Infection
|
0.22%
1/452 • Baseline up to 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Sinusitis
|
0.22%
1/452 • Baseline up to 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.22%
1/452 • Baseline up to 14 months
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
6/452 • Baseline up to 14 months
|
|
Gastrointestinal disorders
Nausea
|
1.3%
6/452 • Baseline up to 14 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.88%
4/452 • Baseline up to 14 months
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.88%
4/452 • Baseline up to 14 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.66%
3/452 • Baseline up to 14 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.44%
2/452 • Baseline up to 14 months
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.44%
2/452 • Baseline up to 14 months
|
|
Gastrointestinal disorders
Gastrointestinal Upset
|
0.22%
1/452 • Baseline up to 14 months
|
|
Gastrointestinal disorders
Gastritis
|
0.22%
1/452 • Baseline up to 14 months
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.22%
1/452 • Baseline up to 14 months
|
|
Gastrointestinal disorders
Flatulence
|
0.22%
1/452 • Baseline up to 14 months
|
|
Gastrointestinal disorders
Toothache
|
0.22%
1/452 • Baseline up to 14 months
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.22%
1/452 • Baseline up to 14 months
|
|
Gastrointestinal disorders
Gingivitis
|
0.22%
1/452 • Baseline up to 14 months
|
|
Nervous system disorders
Headache
|
4.6%
21/452 • Baseline up to 14 months
|
|
Nervous system disorders
Migraine
|
0.44%
2/452 • Baseline up to 14 months
|
|
Nervous system disorders
Convulsion
|
0.22%
1/452 • Baseline up to 14 months
|
|
Psychiatric disorders
Depression
|
2.0%
9/452 • Baseline up to 14 months
|
|
Psychiatric disorders
Anxiety
|
0.88%
4/452 • Baseline up to 14 months
|
|
Psychiatric disorders
Attention Deficit/Hyperactivity Disorder
|
0.66%
3/452 • Baseline up to 14 months
|
|
Psychiatric disorders
Insomnia
|
0.44%
2/452 • Baseline up to 14 months
|
|
Psychiatric disorders
Drug Dependence
|
0.22%
1/452 • Baseline up to 14 months
|
|
Psychiatric disorders
Stress Symptoms
|
0.22%
1/452 • Baseline up to 14 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.3%
6/452 • Baseline up to 14 months
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.44%
2/452 • Baseline up to 14 months
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.44%
2/452 • Baseline up to 14 months
|
|
Musculoskeletal and connective tissue disorders
Tendon Disorder
|
0.22%
1/452 • Baseline up to 14 months
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.22%
1/452 • Baseline up to 14 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.22%
1/452 • Baseline up to 14 months
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.22%
1/452 • Baseline up to 14 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.22%
1/452 • Baseline up to 14 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.22%
1/452 • Baseline up to 14 months
|
|
Investigations
Laboratory Test Abnormal
|
0.44%
2/452 • Baseline up to 14 months
|
|
Investigations
Mean Cell Hemoglobin Decreased
|
0.22%
1/452 • Baseline up to 14 months
|
|
Investigations
Liver Function Test Abnormal
|
0.22%
1/452 • Baseline up to 14 months
|
|
Investigations
Hepatic Enzyme Increased
|
0.22%
1/452 • Baseline up to 14 months
|
|
Investigations
Heart Rate Increased
|
0.22%
1/452 • Baseline up to 14 months
|
|
Investigations
Haemoglobin Increased
|
0.22%
1/452 • Baseline up to 14 months
|
|
Investigations
Haemoglobin Decreased
|
0.22%
1/452 • Baseline up to 14 months
|
|
Infections and infestations
Haematocrit Increased
|
0.22%
1/452 • Baseline up to 14 months
|
|
Investigations
Haematocrit Decreased
|
0.22%
1/452 • Baseline up to 14 months
|
|
Investigations
Blood Creatinine Increased
|
0.22%
1/452 • Baseline up to 14 months
|
|
Investigations
Alanine Aminotransferase Increased
|
0.22%
1/452 • Baseline up to 14 months
|
|
Investigations
White Blood Cell Count Increased
|
0.22%
1/452 • Baseline up to 14 months
|
|
Investigations
Protein Urine Present
|
0.22%
1/452 • Baseline up to 14 months
|
|
Investigations
Platelet Count Abnormal
|
0.22%
1/452 • Baseline up to 14 months
|
|
Investigations
Mean Cell Volume Abnormal
|
0.22%
1/452 • Baseline up to 14 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.5%
7/452 • Baseline up to 14 months
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.88%
4/452 • Baseline up to 14 months
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.22%
1/452 • Baseline up to 14 months
|
|
Reproductive system and breast disorders
Ovarian Cyst Ruptured
|
0.22%
1/452 • Baseline up to 14 months
|
|
Reproductive system and breast disorders
Cervical Dysplasia
|
0.22%
1/452 • Baseline up to 14 months
|
|
Immune system disorders
Seasonal Allergy
|
0.66%
3/452 • Baseline up to 14 months
|
|
Immune system disorders
Food Allergy
|
0.22%
1/452 • Baseline up to 14 months
|
|
Immune system disorders
Drug Hypersensitivity
|
0.22%
1/452 • Baseline up to 14 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
0.66%
3/452 • Baseline up to 14 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic Keratosis
|
0.22%
1/452 • Baseline up to 14 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic Naevus Syndrome
|
0.22%
1/452 • Baseline up to 14 months
|
|
Ear and labyrinth disorders
Ear Pain
|
0.22%
1/452 • Baseline up to 14 months
|
|
Ear and labyrinth disorders
Ear Discomfort
|
0.22%
1/452 • Baseline up to 14 months
|
|
Ear and labyrinth disorders
Tympanic Membrane Perforation
|
0.22%
1/452 • Baseline up to 14 months
|
|
Eye disorders
Eyelid Oedema
|
0.44%
2/452 • Baseline up to 14 months
|
|
Eye disorders
Myopia
|
0.22%
1/452 • Baseline up to 14 months
|
|
Eye disorders
Eye Discharge
|
0.22%
1/452 • Baseline up to 14 months
|
|
Renal and urinary disorders
Proteinuria
|
0.22%
1/452 • Baseline up to 14 months
|
|
Renal and urinary disorders
Haematuria
|
0.22%
1/452 • Baseline up to 14 months
|
|
Renal and urinary disorders
Calcus Urinary
|
0.22%
1/452 • Baseline up to 14 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.22%
1/452 • Baseline up to 14 months
|
|
Vascular disorders
Hypertension
|
0.22%
1/452 • Baseline up to 14 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place