Trial Outcomes & Findings for Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis (NCT NCT01622348)
NCT ID: NCT01622348
Last Updated: 2018-01-09
Results Overview
The change from pre-treatment baseline to End-of-Treatment (EOT) in the epidermal thickness of the index lesion
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
8 weeks
Results posted on
2018-01-09
Participant Flow
This was a multicenter study conducted at 13 study centers in the Unites States (US).
48 patients met inclusion/exclusion criteria; 4 were not randomized. The reasons for not randomizing these patients were: 2 patients withdrew consent, 1 whose calcium levels did not meet the criteria for randomization, and 1 for whom the study was closed prior to randomization
Participant milestones
| Measure |
IMO-3100 at 0.16 mg/kg
IMO-3100 at 0.16 mg/kg SC once weekly based on body weight at screening, not to exceed 20 mg per injection
IMO-3100 at 0.16 mg/kg: IMO-3100 at 0.16 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 20 mg per injection
|
IMO-3100 at 0.32 mg/kg
IMO-3100 at 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection
IMO-3100 at 0.32 mg/kg: IMO-3100 at 0.32 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 40 mg per injection
|
Placebo
Saline for Injection
Saline for Injection: Saline for Injection 0.01 mL/kg SC q wk x 4 wk based on body weight at screening, not to exceed 1.25 mL
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
15
|
|
Overall Study
COMPLETED
|
14
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
IMO-3100 at 0.16 mg/kg
IMO-3100 at 0.16 mg/kg SC once weekly based on body weight at screening, not to exceed 20 mg per injection
IMO-3100 at 0.16 mg/kg: IMO-3100 at 0.16 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 20 mg per injection
|
IMO-3100 at 0.32 mg/kg
IMO-3100 at 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection
IMO-3100 at 0.32 mg/kg: IMO-3100 at 0.32 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 40 mg per injection
|
Placebo
Saline for Injection
Saline for Injection: Saline for Injection 0.01 mL/kg SC q wk x 4 wk based on body weight at screening, not to exceed 1.25 mL
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
Baseline Characteristics
Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
IMO-3100 at 0.16 mg/kg
n=15 Participants
IMO-3100 at 0.16 mg/kg SC once weekly based on body weight at screening, not to exceed 20 mg per injection
IMO-3100 at 0.16 mg/kg: IMO-3100 at 0.16 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 20 mg per injection
|
IMO-3100 at 0.32 mg/kg
n=14 Participants
IMO-3100 at 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection
IMO-3100 at 0.32 mg/kg: IMO-3100 at 0.32 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 40 mg per injection
|
Placebo
n=15 Participants
Saline for Injection
Saline for Injection: Saline for Injection 0.01 mL/kg SC q wk x 4 wk based on body weight at screening, not to exceed 1.25 mL
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 13.76 • n=99 Participants
|
41.9 years
STANDARD_DEVIATION 12.54 • n=107 Participants
|
39.6 years
STANDARD_DEVIATION 13.15 • n=206 Participants
|
39.6 years
STANDARD_DEVIATION 13.16 • n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: ITT population
The change from pre-treatment baseline to End-of-Treatment (EOT) in the epidermal thickness of the index lesion
Outcome measures
| Measure |
IMO-3100 at 0.16 mg/kg
n=15 Participants
IMO-3100 at 0.16 mg/kg SC once weekly based on body weight at screening, not to exceed 20 mg per injection
IMO-3100 at 0.16 mg/kg: IMO-3100 at 0.16 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 20 mg per injection
|
IMO-3100 at 0.32 mg/kg
n=14 Participants
IMO-3100 at 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection
IMO-3100 at 0.32 mg/kg: IMO-3100 at 0.32 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 40 mg per injection
|
Placebo
n=15 Participants
Saline for Injection
Saline for Injection: Saline for Injection 0.01 mL/kg SC q wk x 4 wk based on body weight at screening, not to exceed 1.25 mL
|
|---|---|---|---|
|
Mean Epidermal Thickness at End-of-Treatment (EOT) Compared to Pre-treatment
|
-8.8 Millimeters
Standard Deviation 85.9
|
-48.5 Millimeters
Standard Deviation 91.0
|
17.3 Millimeters
Standard Deviation 102.8
|
Adverse Events
IMO-3100 at 0.16 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
IMO-3100 at 0.32 mg/kg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IMO-3100 at 0.16 mg/kg
n=15 participants at risk
IMO-3100 at 0.16 mg/kg SC once weekly based on body weight at screening, not to exceed 20 mg per injection
IMO-3100 at 0.16 mg/kg: IMO-3100 at 0.16 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 20 mg per injection
|
IMO-3100 at 0.32 mg/kg
n=14 participants at risk
IMO-3100 at 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection
IMO-3100 at 0.32 mg/kg: IMO-3100 at 0.32 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 40 mg per injection
|
Placebo
n=15 participants at risk
Saline for Injection
Saline for Injection: Saline for Injection 0.01 mL/kg SC q wk x 4 wk based on body weight at screening, not to exceed 1.25 mL
|
|---|---|---|---|
|
Eye disorders
Sclera hemorrhage
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
7.1%
1/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Gastrointestinal disorders
Abdominal pain lower
|
6.7%
1/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
14.3%
2/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
6.7%
1/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
General disorders
Chills
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
6.7%
1/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
General disorders
Injection site discoloration
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
7.1%
1/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
General disorders
Injection site erythema
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
7.1%
1/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
General disorders
Injection site pain
|
6.7%
1/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
7.1%
1/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
6.7%
1/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
General disorders
Pyrexia
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
7.1%
1/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Infections and infestations
Infected bites
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
7.1%
1/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Infections and infestations
Nasopharynghitis
|
6.7%
1/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Infections and infestations
Tinea pedis
|
6.7%
1/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Injury, poisoning and procedural complications
Anthropod bite
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
7.1%
1/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
7.1%
1/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Investigations
Albumin urine present
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
7.1%
1/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
1/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
14.3%
2/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
13.3%
2/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
7.1%
1/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.7%
1/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.7%
1/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
7.1%
1/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Nervous system disorders
Hypoasthenia
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
7.1%
1/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
7.1%
1/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Nervous system disorders
Tension headache
|
6.7%
1/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
6.7%
1/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
1/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
6.7%
1/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
6.7%
1/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
7.1%
1/14 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
0.00%
0/15 • AEs were collected from the first screening visit (Day -28) through the end of study visit (Day 60).
An Adverse Event was defined as any untoward medical occurrence temporally associated with the use of a medical product in a subject. An AE could be a new occurrence or an existing process that increased significantly in intensity or frequency. * Unfavorable and unintended symptom reported by the subject; * Clinical sign detected by the Investigator; * Abnormal result from a laboratory study or other diagnostic procedure;
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place