Trial Outcomes & Findings for To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel (NCT NCT02005666)
NCT ID: NCT02005666
Last Updated: 2020-10-14
Results Overview
Mean percent change from baseline to week 11 (study Day 77) for inflammatory (papules and pustules) lesions in PP populations. The primary endpoint of the study is mean percent change from baseline to week 11 (study Day 77) in the inflammatory (papules and pustules) lesion count. Papule was Inflammatory lesion; small (\< 5mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule was Inflammatory lesion; small (\< 5mm in diameter), inflamed skin swelling that is filled with pus. The test product was judged therapeutically equivalent to the reference product in the reduction of inflammatory lesions if the 90% confidence interval was contained within the interval (0.80, 1.25)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
850 participants
Primary outcome timeframe
week 11
Results posted on
2020-10-14
Participant Flow
Participant milestones
| Measure |
Test-Cadila Healthcare Limited
1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
|
Reference-DUAC® Gel
DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
|
Placebo
Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
|
|---|---|---|---|
|
Overall Study
STARTED
|
338
|
343
|
169
|
|
Overall Study
COMPLETED
|
311
|
299
|
160
|
|
Overall Study
NOT COMPLETED
|
27
|
44
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel
Baseline characteristics by cohort
| Measure |
Test-Cadila Healthcare Limited
n=338 Participants
1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
|
Reference-DUAC® Gel
n=343 Participants
DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
|
Placebo
n=169 Participants
Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
|
Total
n=850 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<18
|
86 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
220 Participants
n=4 Participants
|
|
Age, Customized
18 - 40
|
252 Participants
n=5 Participants
|
256 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
630 Participants
n=4 Participants
|
|
Age, Customized
41 - 65
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Customized
>65
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
186 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
481 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
152 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
369 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
240 Participants
n=5 Participants
|
245 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
606 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
83 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
216 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
44 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic/Latino
|
294 Participants
n=5 Participants
|
293 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
733 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: week 11Mean percent change from baseline to week 11 (study Day 77) for inflammatory (papules and pustules) lesions in PP populations. The primary endpoint of the study is mean percent change from baseline to week 11 (study Day 77) in the inflammatory (papules and pustules) lesion count. Papule was Inflammatory lesion; small (\< 5mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule was Inflammatory lesion; small (\< 5mm in diameter), inflamed skin swelling that is filled with pus. The test product was judged therapeutically equivalent to the reference product in the reduction of inflammatory lesions if the 90% confidence interval was contained within the interval (0.80, 1.25)
Outcome measures
| Measure |
Test-Cadila Healthcare Limited
n=236 Participants
1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
|
Reference-DUAC® Gel
n=233 Participants
DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
|
Placebo
n=128 Participants
Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
|
|---|---|---|---|
|
Mean Percent Change From Baseline to Week 11 (Study Day 77) for Inflammatory (Papules and Pustules) Lesions.
|
-67.6 percentage of mean change from baseline
Standard Deviation 28.39
|
-71.3 percentage of mean change from baseline
Standard Deviation 25.98
|
-51.9 percentage of mean change from baseline
Standard Deviation 33.99
|
SECONDARY outcome
Timeframe: week 11Population: Total randomized subjects 850,in 2:2:1 ratio(Test:338,Reference:343,Placebo:169).80 subjects withdrawn,770 subjects completed study.Efficacy analysis done in Per Protocol (PP)Population, total 253 subjects were excluded from total randomized subjects.For efficacy analysis,597 subjects considered in PP population (Test:236,Reference:233,Placebo:128)
Mean percent change from baseline to week 11 in the non-inflammatory lesion count. The mean percent change from baseline to week 11 in the non-inflammatory (open and closed comedones) lesion count in per protocol population . The analysis was same as the analysis performed for the mean percent reduction from baseline to Day 77 in the number of inflammatory lesion count. Closed Comedone was Non-inflammatory lesion; whitehead, skin-colored or slightly inflamed "bump" in the skin. Open Comedone was Non-inflammatory lesion; blackhead, surface of the plugged sebaceous follicle has a blackish appearance. The test product was judged therapeutically equivalent to the reference product in the reduction of Non inflammatory lesions if the 90% confidence interval was contained within the interval (0.80, 1.25)
Outcome measures
| Measure |
Test-Cadila Healthcare Limited
n=236 Participants
1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
|
Reference-DUAC® Gel
n=233 Participants
DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
|
Placebo
n=128 Participants
Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
|
|---|---|---|---|
|
Mean Percent Change From Baseline to Week 11 in the Non-inflammatory Lesion Count
|
-61.7 percentage of change
Standard Deviation 29.50
|
-61.3 percentage of change
Standard Deviation 28.46
|
-42.0 percentage of change
Standard Deviation 34.99
|
SECONDARY outcome
Timeframe: Week 11Success was defined as an Investigator Global Assessment (IGA) score that is at least 2 grades less than the baseline assessment. Percentage of subjects with at least 2 grades improvement in IGA scoring from baseline to week 11 for test, reference and placebo in Per protocol population. IGA is evaluated in the range of 0 to 4. Grade 0=Clear skin with no inflammatory or non-inflammatory lesions;Grade 1=Almost clear;rare non-inflammatory lesions with no more than one small inflammatory lesion; Grade 2 = Mild severity; greater than grade 1;some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions);Grade 3 = Moderate severity; greater than Grade 2; up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion;Grade 4= Severe; greater than Grade 3;up to many non-inflammatory lesions and may have some inflammatory lesions,but no more than a few nodular lesions
Outcome measures
| Measure |
Test-Cadila Healthcare Limited
n=236 Participants
1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
|
Reference-DUAC® Gel
n=233 Participants
DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
|
Placebo
n=128 Participants
Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
|
|---|---|---|---|
|
Proportion of Subjects With a Clinical Response of "Success" at Week 11
Success Rate
|
40 Participants
|
32 Participants
|
10 Participants
|
|
Proportion of Subjects With a Clinical Response of "Success" at Week 11
Failure Rate
|
196 Participants
|
201 Participants
|
118 Participants
|
Adverse Events
Test-Cadila Healthcare Limited
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
Reference-DUAC® Gel
Serious events: 0 serious events
Other events: 61 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test-Cadila Healthcare Limited
n=338 participants at risk
1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days Other Name: 1.2% Clindamycin Phosphate/ 5%
|
Reference-DUAC® Gel
n=343 participants at risk
DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
|
Placebo
n=169 participants at risk
Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
|
|---|---|---|---|
|
General disorders
Application site dryness
|
2.1%
7/338 • Number of events 7 • Day 1 to Day 78
|
2.0%
7/343 • Number of events 7 • Day 1 to Day 78
|
1.2%
2/169 • Number of events 2 • Day 1 to Day 78
|
|
General disorders
Application site erythema
|
0.59%
2/338 • Number of events 2 • Day 1 to Day 78
|
0.58%
2/343 • Number of events 2 • Day 1 to Day 78
|
2.4%
4/169 • Number of events 4 • Day 1 to Day 78
|
|
General disorders
Application site oedema
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.59%
1/169 • Number of events 1 • Day 1 to Day 78
|
|
General disorders
Application site pain
|
0.59%
2/338 • Number of events 2 • Day 1 to Day 78
|
0.87%
3/343 • Number of events 3 • Day 1 to Day 78
|
1.2%
2/169 • Number of events 2 • Day 1 to Day 78
|
|
General disorders
Application site pruritus
|
0.59%
2/338 • Number of events 2 • Day 1 to Day 78
|
1.2%
4/343 • Number of events 4 • Day 1 to Day 78
|
1.8%
3/169 • Number of events 3 • Day 1 to Day 78
|
|
General disorders
Facial pain
|
0.00%
0/338 • Day 1 to Day 78
|
0.58%
2/343 • Number of events 2 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
General disorders
Fatigue
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
General disorders
Pain
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
General disorders
Pyrexia
|
2.1%
7/338 • Number of events 7 • Day 1 to Day 78
|
0.58%
2/343 • Number of events 2 • Day 1 to Day 78
|
1.2%
2/169 • Number of events 2 • Day 1 to Day 78
|
|
Infections and infestations
Bronchitis
|
0.00%
0/338 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.59%
1/169 • Number of events 1 • Day 1 to Day 78
|
|
Infections and infestations
Conjunctivitis
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Infections and infestations
Cystitis
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Infections and infestations
Ear infection
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Infections and infestations
Gastroenteritis
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/338 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.59%
1/169 • Number of events 1 • Day 1 to Day 78
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/338 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.59%
1/169 • Number of events 1 • Day 1 to Day 78
|
|
Infections and infestations
Influenza
|
0.00%
0/338 • Day 1 to Day 78
|
0.58%
2/343 • Number of events 2 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
11/338 • Number of events 11 • Day 1 to Day 78
|
2.9%
10/343 • Number of events 10 • Day 1 to Day 78
|
1.2%
2/169 • Number of events 2 • Day 1 to Day 78
|
|
Infections and infestations
Otitis media
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/338 • Day 1 to Day 78
|
0.58%
2/343 • Number of events 2 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Infections and infestations
Sinusitis
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Infections and infestations
Upper respiratory tract infection
|
0.59%
2/338 • Number of events 2 • Day 1 to Day 78
|
0.58%
2/343 • Number of events 2 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Infections and infestations
Urinary tract infection
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.59%
1/169 • Number of events 1 • Day 1 to Day 78
|
|
Nervous system disorders
Dizziness
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Nervous system disorders
Headache
|
2.7%
9/338 • Number of events 9 • Day 1 to Day 78
|
4.4%
15/343 • Number of events 15 • Day 1 to Day 78
|
3.6%
6/169 • Number of events 6 • Day 1 to Day 78
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.59%
1/169 • Number of events 1 • Day 1 to Day 78
|
|
Gastrointestinal disorders
Chapped lips
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
4/338 • Number of events 4 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Gastrointestinal disorders
Dry mouth
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.59%
2/338 • Number of events 2 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Gastrointestinal disorders
Nausea
|
0.89%
3/338 • Number of events 3 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Gastrointestinal disorders
Toothache
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Gastrointestinal disorders
Vomiting
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.59%
1/169 • Number of events 1 • Day 1 to Day 78
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.59%
2/338 • Number of events 2 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.59%
1/169 • Number of events 1 • Day 1 to Day 78
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.89%
3/338 • Number of events 3 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.59%
2/338 • Number of events 2 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
1.2%
2/169 • Number of events 2 • Day 1 to Day 78
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.89%
3/338 • Number of events 3 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.59%
1/169 • Number of events 1 • Day 1 to Day 78
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.59%
1/169 • Number of events 1 • Day 1 to Day 78
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.58%
2/343 • Number of events 2 • Day 1 to Day 78
|
0.59%
1/169 • Number of events 1 • Day 1 to Day 78
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.59%
1/169 • Number of events 1 • Day 1 to Day 78
|
|
Skin and subcutaneous tissue disorders
Mechanical urticaria
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.59%
1/169 • Number of events 1 • Day 1 to Day 78
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/338 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.59%
1/169 • Number of events 1 • Day 1 to Day 78
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/338 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.59%
1/169 • Number of events 1 • Day 1 to Day 78
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.59%
2/338 • Number of events 2 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Eye disorders
Scleral cyst
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/338 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.59%
1/169 • Number of events 1 • Day 1 to Day 78
|
|
Immune system disorders
Seasonal allergy
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Investigations
Alanine aminotransferase increased
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Investigations
Aspartate aminotransferase increased
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Investigations
Eosinophil count increased
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Ear and labyrinth disorders
Ear deformity acquired
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Product Issues
Device dislocation
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Psychiatric disorders
Depression
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Vascular disorders
Haematoma
|
0.30%
1/338 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/343 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/338 • Day 1 to Day 78
|
0.29%
1/343 • Number of events 1 • Day 1 to Day 78
|
0.00%
0/169 • Day 1 to Day 78
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place