Trial Outcomes & Findings for Efficacy, Safety, and Tolerability, of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis (NCT NCT05152173)
NCT ID: NCT05152173
Last Updated: 2026-03-27
Results Overview
FFI pain subscale consisted of 9 items which were scored on a scale of 0 ("None") to 4 ("Extreme") with a total score ranging from 0 to 36. Lower scores indicated better foot function, while higher scores reflected greater impairment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
176 participants
Primary outcome timeframe
Baseline (Day 1), Day 57
Results posted on
2026-03-27
Participant Flow
Participant milestones
| Measure |
EN3835 Group
Participants received a maximum dose of up to 1.8 milligrams (mg) EN3835 intralesional injection on Day 1.
|
Placebo Group
Participants received a placebo matched to EN3835 intralesional injection on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
88
|
|
Overall Study
Intent to Treat Set
|
88
|
88
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
87
|
87
|
|
Overall Study
COMPLETED
|
83
|
83
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
EN3835 Group
Participants received a maximum dose of up to 1.8 milligrams (mg) EN3835 intralesional injection on Day 1.
|
Placebo Group
Participants received a placebo matched to EN3835 intralesional injection on Day 1.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Sponsor decision
|
0
|
1
|
|
Overall Study
Other
|
2
|
3
|
Baseline Characteristics
Here, number analyzed signifies those participants who were evaluable for this parameter.
Baseline characteristics by cohort
| Measure |
EN3835 Group
n=88 Participants
Participants received a maximum dose of up to 1.8 mg EN3835 intralesional injection on Day 1.
|
Placebo Group
n=88 Participants
Participants received a placebo matched to EN3835 intralesional injection on Day 1.
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 10.93 • n=88 Participants
|
56.3 years
STANDARD_DEVIATION 10.58 • n=88 Participants
|
55.5 years
STANDARD_DEVIATION 10.75 • n=176 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=88 Participants
|
61 Participants
n=88 Participants
|
119 Participants
n=176 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=88 Participants
|
27 Participants
n=88 Participants
|
57 Participants
n=176 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=88 Participants
|
9 Participants
n=88 Participants
|
22 Participants
n=176 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=88 Participants
|
77 Participants
n=88 Participants
|
151 Participants
n=176 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=88 Participants
|
2 Participants
n=88 Participants
|
3 Participants
n=176 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=88 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=176 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=88 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=176 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=88 Participants
|
1 Participants
n=88 Participants
|
1 Participants
n=176 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=88 Participants
|
17 Participants
n=88 Participants
|
33 Participants
n=176 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=88 Participants
|
69 Participants
n=88 Participants
|
140 Participants
n=176 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=88 Participants
|
0 Participants
n=88 Participants
|
1 Participants
n=176 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=88 Participants
|
1 Participants
n=88 Participants
|
1 Participants
n=176 Participants
|
|
Foot Function Index (FFI) Total Pain Subscale Score
|
25.30 score on a scale
STANDARD_DEVIATION 5.199 • n=87 Participants • Here, number analyzed signifies those participants who were evaluable for this parameter.
|
24.84 score on a scale
STANDARD_DEVIATION 5.401 • n=87 Participants • Here, number analyzed signifies those participants who were evaluable for this parameter.
|
25.07 score on a scale
STANDARD_DEVIATION 5.291 • n=174 Participants • Here, number analyzed signifies those participants who were evaluable for this parameter.
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 57Population: The ITT Population included all randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.
FFI pain subscale consisted of 9 items which were scored on a scale of 0 ("None") to 4 ("Extreme") with a total score ranging from 0 to 36. Lower scores indicated better foot function, while higher scores reflected greater impairment.
Outcome measures
| Measure |
EN3835 Group
n=82 Participants
Participants received a maximum dose of up to 1.8 mg EN3835 intralesional injection on Day 1.
|
Placebo Group
n=83 Participants
Participants received a placebo matched to EN3835 intralesional injection on Day 1.
|
|---|---|---|
|
Change From Baseline to Day 57 in the Foot Function Index (FFI) Pain Subscale Score
|
-9.844 score on a scale
Standard Error 0.91
|
-8.417 score on a scale
Standard Error 0.89
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 57Population: The ITT Population included all randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.
The FFI pain subscale consisted of 9 items which were scored on a scale of 0 ("None") to 4 ("Extreme") with a total score ranging from 0 to 36. The FFI difficulty subscale consisted of 9 items which were scored on a scale of 0 ("No difficulty") to 4 ("A lot of difficulty") with a total score ranging from 0 to 36. The Total Combined score of pain and difficulty comprised scores of answered items in each subscale with a maximum total score range of 0 to 72. Lower scores indicated better foot function, while higher scores reflected greater impairment.
Outcome measures
| Measure |
EN3835 Group
n=82 Participants
Participants received a maximum dose of up to 1.8 mg EN3835 intralesional injection on Day 1.
|
Placebo Group
n=83 Participants
Participants received a placebo matched to EN3835 intralesional injection on Day 1.
|
|---|---|---|
|
Change From Baseline to Day 57 in the FFI Total Combined (Pain and Difficulty) Score
|
-19.145 score on a scale
Standard Error 1.893
|
-16.530 score on a scale
Standard Error 1.858
|
SECONDARY outcome
Timeframe: Day 57Population: The ITT Population included all randomized participants.
The responder (by foot/feet) was defined as a participant with a response of "Minimal Improvement", "Much Improvement" or "Very Much Improvement" in the CGIC Scale. All participants who withdrew early from the study were considered as non-responders. If participant was treated for both feet, then the assessment could be combined at participant level using worst case approach, if one foot response was recorded as 'Minimal Improvement' and 'Very Much Improvement' in another foot, then response was considered as 'Minimal Improvement'.
Outcome measures
| Measure |
EN3835 Group
n=88 Participants
Participants received a maximum dose of up to 1.8 mg EN3835 intralesional injection on Day 1.
|
Placebo Group
n=88 Participants
Participants received a placebo matched to EN3835 intralesional injection on Day 1.
|
|---|---|---|
|
Percentage of Participants With a Response of "Minimal Improvement", "Much Improvement" or "Very Much Improvement" (Responders) in the Clinician Global Impression of Change Scale
|
61 Percentage of participants
Interval 59.0 to 78.0
|
48 Percentage of participants
Interval 44.2 to 64.5
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 57Population: The ITT Population included all randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.
A durometer was used to measure the hardness of treated nodules, on a scale ranging from 0 to 100. Higher scores indicated a greater hardness.
Outcome measures
| Measure |
EN3835 Group
n=83 Participants
Participants received a maximum dose of up to 1.8 mg EN3835 intralesional injection on Day 1.
|
Placebo Group
n=83 Participants
Participants received a placebo matched to EN3835 intralesional injection on Day 1.
|
|---|---|---|
|
Change From Baseline to Day 57 in the Nodular Hardness of the Treated Nodules by Durometer Measurement
|
-13.537 score on a scale
Standard Error 1.76
|
-7.660 score on a scale
Standard Error 1.75
|
Adverse Events
Placebo Group
Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths
EN3835 Group
Serious events: 0 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Group
n=87 participants at risk
Participants received a placebo matched to EN3835 intralesional injection on Day 1.
|
EN3835 Group
n=87 participants at risk
Participants received a maximum dose of up to 1.8 mg EN3835 intralesional injection on Day 1.
|
|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
Other adverse events
| Measure |
Placebo Group
n=87 participants at risk
Participants received a placebo matched to EN3835 intralesional injection on Day 1.
|
EN3835 Group
n=87 participants at risk
Participants received a maximum dose of up to 1.8 mg EN3835 intralesional injection on Day 1.
|
|---|---|---|
|
General disorders
Injection site pain
|
10.3%
9/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
44.8%
39/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
General disorders
Injection site bruising
|
2.3%
2/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
42.5%
37/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
General disorders
Injection site swelling
|
3.4%
3/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
28.7%
25/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
General disorders
Nodule
|
5.7%
5/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
3.4%
3/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
General disorders
Injection site pruritis
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
5.7%
5/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
General disorders
Injection site oedema
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
4.6%
4/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
General disorders
Injection site discomfort
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
2.3%
2/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
2.3%
2/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
General disorders
Asthenia
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
General disorders
Injection site discolouration
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
General disorders
Injection site erythema
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
General disorders
Injection site exfoliation
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
General disorders
Injection site haematoma
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
General disorders
Injection site reaction
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
General disorders
Oedema peripheral
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
General disorders
Pain
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
General disorders
Peripheral swelling
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
General disorders
Pyrexia
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
General disorders
Tenderness
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
3.4%
3/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
2.3%
2/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Infections and infestations
COVID-19
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
3.4%
3/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Injury, poisoning and procedural complications
Fascial rupture
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
2.3%
2/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
3/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Musculoskeletal and connective tissue disorders
Plantar fascial fibromatosis
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Infections and infestations
Ear infection
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Infections and infestations
Fungal infection
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Investigations
Protein urine present
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Investigations
SARS-CoV-2 test positive
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Investigations
Urine leukocyte esterase positive
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Investigations
Alanine aminotransferase increased
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Investigations
Platelet count increased
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Investigations
Precancerous cells present
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
2.3%
2/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Metabolism and nutrition disorders
Gout
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Nervous system disorders
Burning sensation
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Nervous system disorders
Dizziness
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Eye disorders
Chorioretinopathy
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
|
Vascular disorders
Hypertension
|
1.1%
1/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
0.00%
0/87 • Day 1 to Day 57
Treatment emergent adverse events were defined as any adverse events (AEs) that occur or worsen (increase in severity) on same day or after study intervention administration on Day 1. All cause-mortality was assessed with ITT population (all randomized) and serious AEs and other AEs were assessed using safety population (received at least 1 dose of study drug). 1 participant in EN3835 group and 1 participant in placebo group did not receive study drug and were not included in safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place