Trial Outcomes & Findings for Safety and Effectiveness Study of Imiquimod Creams for Treatment of Actinic Keratoses (AKs) (NCT NCT00605176)
NCT ID: NCT00605176
Last Updated: 2010-06-29
Results Overview
Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 14 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or 'subclinical' lesion that had not been identified at Baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
479 participants
Primary outcome timeframe
End of Study the Week 14 visit
Results posted on
2010-06-29
Participant Flow
Recruitment started on January 15, 2008 all subjects were randomized by March 17, 2008. The studies were performed at 26 investigational centers in the United States.
Subjects were screened and had to meet eligibility requirements for randomization. The most frequent reason for screen failure (104 of screen failures) was that the subject did not have between 5 and 20 visible or palpable Actinic Keratosis (AK) lesions on either the face or the balding scalp.
Participant milestones
| Measure |
3.75% Imiquimod Cream
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
2.5% Imiquimod Cream
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
Placebo Cream
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
160
|
160
|
159
|
|
Overall Study
COMPLETED
|
149
|
154
|
150
|
|
Overall Study
NOT COMPLETED
|
11
|
6
|
9
|
Reasons for withdrawal
| Measure |
3.75% Imiquimod Cream
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
2.5% Imiquimod Cream
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
Placebo Cream
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
1
|
|
Overall Study
Non-complicance with study procedures
|
1
|
0
|
0
|
|
Overall Study
Use of concomitant therapy
|
1
|
0
|
1
|
|
Overall Study
Other (not due to AE)
|
1
|
1
|
0
|
Baseline Characteristics
Safety and Effectiveness Study of Imiquimod Creams for Treatment of Actinic Keratoses (AKs)
Baseline characteristics by cohort
| Measure |
3.75% Imiquimod Cream
n=160 Participants
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
2.5% Imiquimod Cream
n=160 Participants
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
Placebo Cream
n=159 Participants
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
Total
n=479 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
82 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
260 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
78 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
219 Participants
n=4 Participants
|
|
Age Continuous
|
64.5 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
64.3 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
389 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
160 participants
n=5 Participants
|
160 participants
n=7 Participants
|
159 participants
n=5 Participants
|
479 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: End of Study the Week 14 visitPopulation: Efficacy analyses were conducted on the intent-to-treat (ITT) population. For the primary efficacy variable, imputations were made for missing data points using last observation carried forward (LOCF, primary analysis), taking all missed observations as failure (sensitivity analysis), and using observed cases only (supportive analysis).
Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 14 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or 'subclinical' lesion that had not been identified at Baseline.
Outcome measures
| Measure |
3.75% Imiquimod Cream
n=160 Participants
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
2.5% Imiquimod Cream
n=160 Participants
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
Placebo Cream
n=159 Participants
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
|---|---|---|---|
|
Number of Participants With Complete Clearance of AK Lesions
|
57 participants
|
49 participants
|
10 participants
|
SECONDARY outcome
Timeframe: End of Study the Week 14 visitPopulation: Efficacy analyses were conducted on the intent-to-treat (ITT) population. Imputations were made for missing data points using last observation carried forward (LOCF).
Subject status with respect to partial clearance of AK lesions at end of study (EOS), defined as at least a 75% reduction in the number of AK lesions in the treatment area compared with Baseline.
Outcome measures
| Measure |
3.75% Imiquimod Cream
n=160 Participants
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
2.5% Imiquimod Cream
n=160 Participants
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
Placebo Cream
n=159 Participants
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
|---|---|---|---|
|
Number of Participants With Partial Clearance of AK Lesions
|
95 participants
|
77 participants
|
36 participants
|
SECONDARY outcome
Timeframe: From baseline to End of Study the Week 14 visitPopulation: Intent to treat (ITT) Last Observation Carried Forward (LOCF)
Percent change from Baseline to end of study (EOS) in investigator counts of AK lesions.
Outcome measures
| Measure |
3.75% Imiquimod Cream
n=160 Participants
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
2.5% Imiquimod Cream
n=160 Participants
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
Placebo Cream
n=159 Participants
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
|---|---|---|---|
|
Percent Change From Baseline in AK Lesion Count
|
-81.8 percent change
Interval -100.0 to 188.9
|
-71.8 percent change
Interval -100.0 to 90.0
|
-25.0 percent change
Interval -100.0 to 300.0
|
SECONDARY outcome
Timeframe: At all visits - from Baseline to End of study (Week 14)Population: All participants were evaluated for local skin reactions (LSR) at every visit. Summary of LSR - area under the curve (AUC) of sum of LSR Scores (days). ITT population. The time period for the AUC extends to 8 weeks after the end of treatment (Week 14). Only subjects who received treatment in both treatment cycles are included in this analysis.
Six local skin reaction (LSR) signs were predefined and were assessed for presence and intensity at each study visit. These included: Erythema, Edema, Weeping/Exudate, Flaking/Scaling/Dryness, Scabbing/Crusting and Erosion/Ulceration. The LSRs were scored as 0=none, 1=mild, 2=moderate, 3=severe. Mean scores were summated over time (14 weeks) to yield a mean LSR AUC (area under the curve)
Outcome measures
| Measure |
3.75% Imiquimod Cream
n=148 Participants
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
2.5% Imiquimod Cream
n=158 Participants
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
Placebo Cream
n=153 Participants
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
|---|---|---|---|
|
Local Skin Reactions
|
272.0 units on a scale * days
Standard Deviation 123.0
|
242.5 units on a scale * days
Standard Deviation 126.2
|
139.8 units on a scale * days
Standard Deviation 104.1
|
Adverse Events
3.75% Imiquimod Cream
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
2.5% Imiquimod Cream
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo Cream
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3.75% Imiquimod Cream
n=160 participants at risk
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
2.5% Imiquimod Cream
n=160 participants at risk
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
Placebo Cream
n=159 participants at risk
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
|---|---|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
0.62%
1/160 • Number of events 1 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.00%
0/160 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.00%
0/159 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
|
Cardiac disorders
Atrial fibrillation
|
0.62%
1/160 • Number of events 1 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.62%
1/160 • Number of events 1 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.00%
0/159 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
|
Gastrointestinal disorders
Small intestine obstruction
|
0.62%
1/160 • Number of events 2 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.00%
0/160 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.00%
0/159 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
|
Psychiatric disorders
Anxiety
|
0.62%
1/160 • Number of events 1 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.00%
0/160 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.00%
0/159 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
|
Cardiac disorders
Chest pain
|
0.62%
1/160 • Number of events 1 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.00%
0/160 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.00%
0/159 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
|
Gastrointestinal disorders
Diarrhea
|
0.62%
1/160 • Number of events 1 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.00%
0/160 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.00%
0/159 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/160 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.62%
1/160 • Number of events 1 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.00%
0/159 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/160 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.62%
1/160 • Number of events 1 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.00%
0/159 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/160 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.62%
1/160 • Number of events 1 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.00%
0/159 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/160 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.62%
1/160 • Number of events 1 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.00%
0/159 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/160 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.62%
1/160 • Number of events 1 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.00%
0/159 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/160 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.00%
0/160 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.63%
1/159 • Number of events 1 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/160 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.00%
0/160 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
0.63%
1/159 • Number of events 1 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
Other adverse events
| Measure |
3.75% Imiquimod Cream
n=160 participants at risk
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
2.5% Imiquimod Cream
n=160 participants at risk
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
Placebo Cream
n=159 participants at risk
250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
6.2%
10/160 • Number of events 10 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
1.9%
3/160 • Number of events 3 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
3.1%
5/159 • Number of events 5 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
4/160 • Number of events 4 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
2.5%
4/160 • Number of events 4 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
5.0%
8/159 • Number of events 8 • From study screening through the last study visit. Day 1 (first study visit) through the end of study (Week 14 visit)
Subjects were queried indirectly regarding AEs during each study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place