Trial Outcomes & Findings for Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC) (NCT NCT00914186)
NCT ID: NCT00914186
Last Updated: 2011-12-01
Results Overview
Patient reported outcome of pruritis measurement (0-100 mm/min-max)on a change in visual analog scale
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
Baseline through Study Day 36 (Visit 7)
Results posted on
2011-12-01
Participant Flow
Recruitment period for the study started 03Jun09. It was the responsibility of the PI for advertisement and recruitment of the study.
There was a seven day run-in-period in which subjects self-applied the Vehicle control twice daily.
Participant milestones
| Measure |
Vehicle
once daily
|
TS-022 0.005%
lotion/once daily
|
TS-022 0.010%
lotion/once daily
|
TS-022 0.020%
lotion/once daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
31
|
30
|
|
Overall Study
COMPLETED
|
28
|
28
|
29
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
2
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC)
Baseline characteristics by cohort
| Measure |
Vehicle
n=31 Participants
once daily
|
TS-022 0.005%
n=30 Participants
lotion/once daily
|
TS-022 0.010%
n=31 Participants
lotion/once daily
|
TS-022 0.020%
n=30 Participants
lotion/once daily
|
Total
n=122 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
122 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age Continuous
|
37.5 years
STANDARD_DEVIATION 13.53 • n=5 Participants
|
38.0 years
STANDARD_DEVIATION 11.63 • n=7 Participants
|
35.1 years
STANDARD_DEVIATION 13.78 • n=5 Participants
|
39.0 years
STANDARD_DEVIATION 13.89 • n=4 Participants
|
36.4 years
STANDARD_DEVIATION 13.23 • n=21 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
30 participants
n=7 Participants
|
31 participants
n=5 Participants
|
30 participants
n=4 Participants
|
122 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline through Study Day 36 (Visit 7)Population: Intent To Treat (ITT) analysis
Patient reported outcome of pruritis measurement (0-100 mm/min-max)on a change in visual analog scale
Outcome measures
| Measure |
Vehicle
n=29 Participants
once daily
|
TS-022 0.005%
n=28 Participants
lotion/once daily
|
TS-022 0.010%
n=29 Participants
lotion/once daily
|
TS-022 0.020%
n=21 Participants
lotion/once daily
|
|---|---|---|---|---|
|
Change in Pruritis Visual Analog Scale (VAS)
|
-12.4 mm
Standard Deviation 14.09
|
-15.5 mm
Standard Deviation 18.38
|
-13.9 mm
Standard Deviation 21.11
|
-6.2 mm
Standard Deviation 18.82
|
PRIMARY outcome
Timeframe: Baseline through Study Day 36 (Visit 7)Population: total number of subjects who received study drug.
Safety assessment of all subjects who received investigational product. Outcome measure is number of subjects with an adverse event. Measures of adverse events in participants included vital signs, laboratory findings, physical exams, electrocardiograms
Outcome measures
| Measure |
Vehicle
n=31 Participants
once daily
|
TS-022 0.005%
n=30 Participants
lotion/once daily
|
TS-022 0.010%
n=30 Participants
lotion/once daily
|
TS-022 0.020%
n=31 Participants
lotion/once daily
|
|---|---|---|---|---|
|
Safety and Tolerability of TS-022 Topical Lotion as Measured by Participants Who Demonstrated Adverse Events
|
9 participants
|
11 participants
|
10 participants
|
11 participants
|
PRIMARY outcome
Timeframe: baseline through Study Day 36 (Visit 7)Population: ITT
investigator assessment of disease status rated on 0-5 scale (0 = clear to 5 = very severe) based on a change in score from baseline to Study Day 36 (Visit 7)
Outcome measures
| Measure |
Vehicle
n=29 Participants
once daily
|
TS-022 0.005%
n=28 Participants
lotion/once daily
|
TS-022 0.010%
n=29 Participants
lotion/once daily
|
TS-022 0.020%
n=21 Participants
lotion/once daily
|
|---|---|---|---|---|
|
Investigator's Global Assessment (IGA) Based on a Dermatologist's Evalution of the Change in Subject's Score of Target Treatment Areas
|
-0.6 units on a scale
Interval -0.9 to -0.3
|
-0.5 units on a scale
Interval -0.8 to -0.2
|
-0.6 units on a scale
Interval -0.8 to -0.2
|
-0.6 units on a scale
Interval -0.8 to -0.2
|
PRIMARY outcome
Timeframe: Baseline, which is Day -7 (Visit 2), through Day 36 (Visit 7)Population: ITT
self-assessment using a five point scale of pruritus state based on a change in scale from none (0) to very severe (4), interfering with daily or sleep activities. Subjects will complete the Five-Point Pruritus Scale once at Screening (Visit 1), then twice daily beginning at baseline, which occurs on the morning of Study Day -7 (Visit 2), through Study Day 36 (Visit 7)
Outcome measures
| Measure |
Vehicle
n=29 Participants
once daily
|
TS-022 0.005%
n=28 Participants
lotion/once daily
|
TS-022 0.010%
n=29 Participants
lotion/once daily
|
TS-022 0.020%
n=21 Participants
lotion/once daily
|
|---|---|---|---|---|
|
Five Point Pruritus Scale for Self-Assessment of Target Treatment Area Based on a Change in Score
|
-0.4 units on a scale
Interval -0.7 to -0.2
|
-0.5 units on a scale
Interval -0.6 to -0.1
|
-0.6 units on a scale
Interval -0.9 to -0.3
|
-0.2 units on a scale
Interval -0.5 to -0.1
|
PRIMARY outcome
Timeframe: baseline through Study Day 36 (Visit 7)Population: ITT analysis
The head and neck \[10%\], trunk \[30%\], upper extremities \[20%\] and lower extremities \[40%\] were assessed separately for erythema (E), infiltration/papulation (I), excoriation (Ex) and lichenification (L) represented by a numeric coded value of (0, No eruption) to (6, 90% - 100% eruption). One score given to each part of the body on a scale from 1-6 based on the four attributes (E, I, Ex, L) and then a proportional average is taken to get a total score of 1-6.
Outcome measures
| Measure |
Vehicle
n=29 Participants
once daily
|
TS-022 0.005%
n=28 Participants
lotion/once daily
|
TS-022 0.010%
n=29 Participants
lotion/once daily
|
TS-022 0.020%
n=21 Participants
lotion/once daily
|
|---|---|---|---|---|
|
Eczema Area and Severity Index (EASI) Based on a Change in Score of Eruption in Proportionate Body Surface Areas
|
-3.1 units on a scale
Standard Deviation 4.75
|
-2.1 units on a scale
Standard Deviation 5.09
|
-2.7 units on a scale
Standard Deviation 3.87
|
-2.3 units on a scale
Standard Deviation 4.50
|
PRIMARY outcome
Timeframe: Study Day -7 through Study Day 22Population: ITT
Assessment of subject's activities of daily living using the SKINDEX-29 questionnaire to measure the subject's overall quality of life based on a change in scale from baseline. The SKINDEX scoring scale has a range of 29-145. The smaller the number the better the patient feels. The results are the difference of the SKINDEX scoring scale at treatment discharge (day 22) minus baseline (day-7). Hence the results should be negative, as the patient's emotion, symptoms and functioning of the skin should feel better at treatment discharge as opposed to baseline.
Outcome measures
| Measure |
Vehicle
n=31 Participants
once daily
|
TS-022 0.005%
n=30 Participants
lotion/once daily
|
TS-022 0.010%
n=30 Participants
lotion/once daily
|
TS-022 0.020%
n=29 Participants
lotion/once daily
|
|---|---|---|---|---|
|
Skindex-29 Questionnaire to Measure the Subject's Overall Quality of Life Based on Activities of Daily Living That Affect Change in Emotion (10 to 50 Points), Symptoms (7 to 35 Points) and Functioning (12 to 60 Points) to Skin Over One Week Period.
|
-11.7 units on a scale
Standard Deviation 11.61
|
-12.1 units on a scale
Standard Deviation 14.79
|
-12.3 units on a scale
Standard Deviation 17.56
|
-4.1 units on a scale
Standard Deviation 12.43
|
PRIMARY outcome
Timeframe: Baseline through Study Day 36 (Visit 7)Pruritis Visual Analog Scale (VAS) based on patient reported outcome of pruritis measurement on a VAS indicating the amount of pruritus (itchiness) experienced from the time of last dose application through the time just before current dose application. Change in pruritus is assessed twice daily beginning at baseline, Study Day -7 (Visit 2), through Study Day 36 (Visit 7). Subjects determine measurable pruritis using a visual horizontal analog scale ranging from "No Itch", even the slightest itch or "Slight Itch", to "Worst Itch Imaginable" to denote the increase in severity of itching.
Outcome measures
| Measure |
Vehicle
n=29 Participants
once daily
|
TS-022 0.005%
n=78 Participants
lotion/once daily
|
TS-022 0.010%
lotion/once daily
|
TS-022 0.020%
lotion/once daily
|
|---|---|---|---|---|
|
Number of Participants Who Had Measurable Pruritis Based on a Visual Horizontal Analog Scale
|
29 participants
Interval 12.4 to 14.09
|
78 participants
Interval 15.5 to 18.82
|
—
|
—
|
Adverse Events
Vehicle
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
TS-022 0.005%
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
TS-022 0.010%
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
TS-022 0.020%
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vehicle
n=31 participants at risk
once daily
|
TS-022 0.005%
n=30 participants at risk
lotion/once daily
|
TS-022 0.010%
n=31 participants at risk
lotion/once daily
|
TS-022 0.020%
n=30 participants at risk
lotion/once daily
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Stomach Discomfort
|
0.00%
0/31 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
6.7%
2/30 • Number of events 2 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
0.00%
0/31 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
3.3%
1/30 • Number of events 1 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
|
General disorders
Pyrexia
|
0.00%
0/31 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
6.7%
2/30 • Number of events 3 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
0.00%
0/31 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
0.00%
0/30 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
|
Nervous system disorders
Headache
|
9.7%
3/31 • Number of events 3 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
6.7%
2/30 • Number of events 3 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
6.5%
2/31 • Number of events 2 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
3.3%
1/30 • Number of events 2 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
3.2%
1/31 • Number of events 1 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
6.7%
2/30 • Number of events 3 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
6.5%
2/31 • Number of events 2 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
16.7%
5/30 • Number of events 5 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
|
Investigations
ECG Abnormal
|
0.00%
0/31 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
0.00%
0/30 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
3.2%
1/31 • Number of events 1 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
6.7%
2/30 • Number of events 2 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
1/31 • Number of events 1 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
0.00%
0/30 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
6.5%
2/31 • Number of events 2 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
0.00%
0/30 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/31 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
3.3%
1/30 • Number of events 1 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
0.00%
0/31 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
6.7%
2/30 • Number of events 2 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
|
Infections and infestations
Uppper respiratory infection
|
0.00%
0/31 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
0.00%
0/30 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
9.7%
3/31 • Number of events 3 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
0.00%
0/30 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
|
Gastrointestinal disorders
Nausea
|
6.5%
2/31 • Number of events 2 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
0.00%
0/30 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
6.5%
2/31 • Number of events 2 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
0.00%
0/30 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.5%
2/31 • Number of events 2 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
6.7%
2/30 • Number of events 2 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
0.00%
0/31 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
0.00%
0/30 • Safety and tolerability were assessed daily starting at Study Day -7 (Visit 2) through Study Day 52 (End of Study)
Safety variables for evaluation included: * adverse events (AEs) * clinical laboratory assessments (blood chemistry, hematology, and urinalysis) * vital signs * physical examinations * electrocardiograms * pregnancy testing for females of child-bearing potential at specified times throughout the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60