Trial Outcomes & Findings for A Study of NIDO-361 in Patients With SBMA (NCT NCT06411912)
NCT ID: NCT06411912
Last Updated: 2026-03-03
Results Overview
Analysis of thigh included adductors, hamstrings, and quadriceps and total (whole-body) included muscles in the rotator cuff, arm, torso, and leg muscle regions (38 muscles in total). Muscles were categorized according to their fat content as follows: A-muscles were defined as muscle fat fraction (MFF) \< 50% and muscle fat infiltration (MFI) \< 10%. A-muscles have a low or slightly elevated fat content to a level that can be present in individuals without a neuromuscular disease. B-muscles were defined as MFF \< 50% and MFI ≥ 10%. B-muscles have a muscle fat content at a level where disease involvement is likely. C-muscles were defined as MFF ≥ 50%. C-muscles have a muscle fat content where more than 50% of the muscle tissue has been replaced by fat and most of the functional capacity is likely lost.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Baseline, Day 180, Days 360-374 (Last Visit)
Results posted on
2026-03-03
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received matched dose placebo given orally once daily for 12 months.
|
NIDO-361
Participants received NIDO-361, 100 mg for at least 2 months and 200 mg for the remainder of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
28
|
|
Overall Study
COMPLETED
|
26
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of NIDO-361 in Patients With SBMA
Baseline characteristics by cohort
| Measure |
Placebo
n=26 Participants
Participants received matched dose placebo given orally once daily for 12 months.
|
NIDO-361
n=28 Participants
Participants received NIDO-361, 100 mg for at least 2 months and 200 mg for the remainder of the study.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age Group at Informed Consent · 18 to 44 years
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
6 Participants
n=76 Participants
|
|
Age, Customized
Age Group at Informed Consent · 45 to 70 years
|
24 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
48 Participants
n=76 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
54 Participants
n=76 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
19 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
35 Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
53 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 180, Days 360-374 (Last Visit)Population: All randomized patients with at least one post baseline MRI assessment were included in this analysis. Only muscles assessed with no major quality issues were included in the analysis.
Analysis of thigh included adductors, hamstrings, and quadriceps and total (whole-body) included muscles in the rotator cuff, arm, torso, and leg muscle regions (38 muscles in total). Muscles were categorized according to their fat content as follows: A-muscles were defined as muscle fat fraction (MFF) \< 50% and muscle fat infiltration (MFI) \< 10%. A-muscles have a low or slightly elevated fat content to a level that can be present in individuals without a neuromuscular disease. B-muscles were defined as MFF \< 50% and MFI ≥ 10%. B-muscles have a muscle fat content at a level where disease involvement is likely. C-muscles were defined as MFF ≥ 50%. C-muscles have a muscle fat content where more than 50% of the muscle tissue has been replaced by fat and most of the functional capacity is likely lost.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants received matched dose placebo given orally once daily for 12 months.
|
NIDO-361
n=28 Participants
Participants received NIDO-361, 100 mg for at least 2 months and 200 mg for the remainder of the study.
|
|---|---|---|
|
Analysis of Thigh and Total Lean Muscle Volume (LMV) [A+B+C]
Total LMV [A+B+C] - Baseline
|
9.8473 cm³
Standard Deviation 3.4210
|
9.1409 cm³
Standard Deviation 3.4097
|
|
Analysis of Thigh and Total Lean Muscle Volume (LMV) [A+B+C]
Total LMV [A+B+C] - Day 180
|
-0.2723 cm³
Standard Deviation 0.4268
|
-0.2853 cm³
Standard Deviation 0.3296
|
|
Analysis of Thigh and Total Lean Muscle Volume (LMV) [A+B+C]
Thigh LMV [A+B+C] - Baseline
|
4.1402 cm³
Standard Deviation 1.7780
|
3.8580 cm³
Standard Deviation 1.5878
|
|
Analysis of Thigh and Total Lean Muscle Volume (LMV) [A+B+C]
Thigh LMV [A+B+C] - Day 180
|
-0.0871 cm³
Standard Deviation 0.1354
|
-0.1042 cm³
Standard Deviation 0.1496
|
|
Analysis of Thigh and Total Lean Muscle Volume (LMV) [A+B+C]
Thigh LMV [A+B+C] - Last Visit
|
-0.1363 cm³
Standard Deviation 0.1648
|
-0.1511 cm³
Standard Deviation 0.2453
|
|
Analysis of Thigh and Total Lean Muscle Volume (LMV) [A+B+C]
Total LMV [A+B+C] - Last Visit
|
-0.3120 cm³
Standard Deviation 0.4020
|
-0.4147 cm³
Standard Deviation 0.6160
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
Adverse events were coded with MedDRA Dictionary Version 26.1.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants received matched dose placebo given orally once daily for 12 months.
|
NIDO-361
n=28 Participants
Participants received NIDO-361, 100 mg for at least 2 months and 200 mg for the remainder of the study.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Number of Participants with AEs · Any Treatment-Emergent Adverse Events (TEAEs)
|
25 participants
|
26 participants
|
|
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Number of Participants with Drug-Related AEs · Any Treatment-Emergent Adverse Events (TEAEs)
|
9 participants
|
17 participants
|
|
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Number of Participants with SAEs · Any Treatment-Emergent Adverse Events (TEAEs)
|
3 participants
|
3 participants
|
|
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Number of Participants with Drug-Related SAEs · Any Treatment-Emergent Adverse Events (TEAEs)
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearOutcome measures
| Measure |
Placebo
n=26 Participants
Participants received matched dose placebo given orally once daily for 12 months.
|
NIDO-361
n=28 Participants
Participants received NIDO-361, 100 mg for at least 2 months and 200 mg for the remainder of the study.
|
|---|---|---|
|
Number of Participants Discontinuing Study Drug and Number of Participants' Deaths
Number of Participants Discontinuing Study Drug · Any TEAE Leading to Study Drug Discontinutation
|
0 participants
|
1 participants
|
|
Number of Participants Discontinuing Study Drug and Number of Participants' Deaths
Number of Participants' Deaths · Any TEAE Leading to Study Drug Discontinutation
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
Adverse events were coded with MedDRA Dictionary Version 26.1.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants received matched dose placebo given orally once daily for 12 months.
|
NIDO-361
n=28 Participants
Participants received NIDO-361, 100 mg for at least 2 months and 200 mg for the remainder of the study.
|
|---|---|---|
|
Total Number of Mild, Moderate, and Severe Adverse Events (AEs) Across All Participants
Mild (Grade 1) AEs · Any Grade 3 or Above TEAEs
|
65 adverse events
|
98 adverse events
|
|
Total Number of Mild, Moderate, and Severe Adverse Events (AEs) Across All Participants
Moderate (Grade 2) AEs · Any Grade 3 or Above TEAEs
|
27 adverse events
|
36 adverse events
|
|
Total Number of Mild, Moderate, and Severe Adverse Events (AEs) Across All Participants
Severe (Grade 3) AEs · Any Grade 3 or Above TEAEs
|
2 adverse events
|
10 adverse events
|
SECONDARY outcome
Timeframe: Baseline, Day 180, Day 360Population: Patients, who received at least 1 dose of study treatment (placebo or NIDO-361) and had at least 1 post-baseline assessment of efficacy parameters, were considered included in analysis.
The modified Spinal and Bulbar Muscular Atrophy Functional Rating Scale (m-SBMAFRS) is calculated as the sum of the items for the truncal and lower-limb domains from the SBMAFRS, which is a validated functional rating scale developed from the Amyotrophic Lateral Sclerosis Functional Rating Scale. Each item has five responses options scoring 0 (worst) to 4 (normal). A higher score indicates better functioning. Total range is 0 (worst) to 30 (normal).
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants received matched dose placebo given orally once daily for 12 months.
|
NIDO-361
n=28 Participants
Participants received NIDO-361, 100 mg for at least 2 months and 200 mg for the remainder of the study.
|
|---|---|---|
|
Change From Baseline to Day 180 and Day 360 in Modified-SBMAFRS (m-SBMAFRS)
m-SBMAFRS Scores - Day 180
|
0.7 scores on a scale
Standard Deviation 1.69
|
0.5 scores on a scale
Standard Deviation 1.26
|
|
Change From Baseline to Day 180 and Day 360 in Modified-SBMAFRS (m-SBMAFRS)
m-SBMAFRS Scores - Day 360
|
1.2 scores on a scale
Standard Deviation 1.88
|
0.1 scores on a scale
Standard Deviation 2.01
|
|
Change From Baseline to Day 180 and Day 360 in Modified-SBMAFRS (m-SBMAFRS)
m-SBMAFRS Scores - Baseline
|
15.9 scores on a scale
Standard Deviation 2.83
|
15.2 scores on a scale
Standard Deviation 2.00
|
SECONDARY outcome
Timeframe: Baseline, Day 180, Day 360Population: Patients, who received at least 1 dose of study treatment (placebo or NIDO-361) and had at least 1 post-baseline assessment of efficacy parameters, were considered included in analysis.
2-minute walk test (2MWT) measures the distance traveled (meters) in 2 minutes.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants received matched dose placebo given orally once daily for 12 months.
|
NIDO-361
n=28 Participants
Participants received NIDO-361, 100 mg for at least 2 months and 200 mg for the remainder of the study.
|
|---|---|---|
|
Change From Baseline to Day 180 and Day 360 in Two-Minute Walk Test (2MWT)
2MWT - Baseline
|
128.4 meters
Standard Deviation 43.23
|
112.8 meters
Standard Deviation 35.90
|
|
Change From Baseline to Day 180 and Day 360 in Two-Minute Walk Test (2MWT)
2MWT - Day 180
|
-0.4 meters
Standard Deviation 9.31
|
4.5 meters
Standard Deviation 16.80
|
|
Change From Baseline to Day 180 and Day 360 in Two-Minute Walk Test (2MWT)
2MWT - Day 360
|
-1.8 meters
Standard Deviation 13.45
|
3.3 meters
Standard Deviation 14.52
|
SECONDARY outcome
Timeframe: Baseline, Day 180, Day 360Population: Patients, who received at least 1 dose of study treatment (placebo or NIDO-361) and had at least 1 post-baseline assessment of efficacy parameters, were considered included in analysis.
6-minute walk test (6MWT) measures the distance traveled (meters) in 6 minutes.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants received matched dose placebo given orally once daily for 12 months.
|
NIDO-361
n=28 Participants
Participants received NIDO-361, 100 mg for at least 2 months and 200 mg for the remainder of the study.
|
|---|---|---|
|
Change From Baseline to Day 180 and Day 360 in 6-Minute Walk Test (6MWT)
6MWT - Day 180
|
1.5 meters
Standard Deviation 24.77
|
13.7 meters
Standard Deviation 30.48
|
|
Change From Baseline to Day 180 and Day 360 in 6-Minute Walk Test (6MWT)
6MWT - Baseline
|
363.3 meters
Standard Deviation 134.71
|
314.2 meters
Standard Deviation 113.23
|
|
Change From Baseline to Day 180 and Day 360 in 6-Minute Walk Test (6MWT)
6MWT - Day 360
|
-4.6 meters
Standard Deviation 38.90
|
8.9 meters
Standard Deviation 41.61
|
SECONDARY outcome
Timeframe: Baseline, Day 180, Day 360Population: Patients, who received at least 1 dose of study treatment (placebo or NIDO-361) and had at least 1 post-baseline assessment of efficacy parameters, were considered included in analysis.
The Timed Up and Go Test (TUG) is used to assess mobility and to provide an estimate on balance and risk of falling. Patients are asked to rise from a chair, walk 3 meters, turn around, return to the chair, and sit. The time that it takes to complete the task is recorded. Assistive devices, orthoses, and ankle braces are allowed.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants received matched dose placebo given orally once daily for 12 months.
|
NIDO-361
n=28 Participants
Participants received NIDO-361, 100 mg for at least 2 months and 200 mg for the remainder of the study.
|
|---|---|---|
|
Change From Baseline to Day 180 and Day 360 in Timed Up and Go (TUG) Test
TUG - Baseline
|
9.927 seconds
Standard Deviation 4.2887
|
11.859 seconds
Standard Deviation 4.5537
|
|
Change From Baseline to Day 180 and Day 360 in Timed Up and Go (TUG) Test
TUG - Day 180
|
0.133 seconds
Standard Deviation 1.1469
|
-0.044 seconds
Standard Deviation 2.6667
|
|
Change From Baseline to Day 180 and Day 360 in Timed Up and Go (TUG) Test
TUG - Day 360
|
-0.179 seconds
Standard Deviation 1.8053
|
0.126 seconds
Standard Deviation 3.4572
|
SECONDARY outcome
Timeframe: Baseline, Treatment (Days 331 to 360)Population: A minimum daily wear time requirement of 16 hrs. was used to filter out days from the aggregation. Days that met the minimum wear requirement were considered valid days and days that did not meet this criterion were considered invalid days. For each time period, a minimum of 15 valid days were required for the time period to be considered valid. For valid time periods, the aggregation was performed over all valid days. The value for invalid time periods was set to missing.
The Actigraph device is a non-invasive research-grade accelerometer based wearable device that was used to objectively measure free-living physical activity. The data from these devices was used to assess and detect changes in physical activity intensity, upper arm movements, and walking patterns.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants received matched dose placebo given orally once daily for 12 months.
|
NIDO-361
n=28 Participants
Participants received NIDO-361, 100 mg for at least 2 months and 200 mg for the remainder of the study.
|
|---|---|---|
|
Change From Baseline to Treatment (Days 331 to 360) in Actigraphy-Derived Measurement: Non-Sedentary Behavior
Baseline (Days -28 to -1)
|
231.824 minutes
Standard Deviation 101.0097
|
262.087 minutes
Standard Deviation 94.2092
|
|
Change From Baseline to Treatment (Days 331 to 360) in Actigraphy-Derived Measurement: Non-Sedentary Behavior
Treatment (Days 331 to 360)
|
-19.569 minutes
Standard Deviation 35.0447
|
-39.777 minutes
Standard Deviation 37.3390
|
SECONDARY outcome
Timeframe: Baseline, Treatment (Days 331 to 360)Population: A minimum daily wear time requirement of 16 hrs. was used to filter out days from the aggregation. Days that met the minimum wear requirement were considered valid days and days that did not meet this criterion were considered invalid days. For each time period, a minimum of 15 valid days were required for the time period to be considered valid. For valid time periods, the aggregation was performed over all valid days. The value for invalid time periods was set to missing.
The Actigraph device is a non-invasive research-grade accelerometer based wearable device that was used to objectively measure free-living physical activity. The data from these devices was used to assess and detect changes in physical activity intensity, upper arm movements, and walking patterns.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants received matched dose placebo given orally once daily for 12 months.
|
NIDO-361
n=28 Participants
Participants received NIDO-361, 100 mg for at least 2 months and 200 mg for the remainder of the study.
|
|---|---|---|
|
Change From Baseline to Treatment (Days 331 to 360) in Actigraphy-Derived Measurement: 95th Percentile of 6-Minute Physical Activity Windows
Baseline (Days -28 to -1)
|
31293.3393 activity counts per 6 minute window
Standard Deviation 6487.9872
|
30905.5742 activity counts per 6 minute window
Standard Deviation 5152.1469
|
|
Change From Baseline to Treatment (Days 331 to 360) in Actigraphy-Derived Measurement: 95th Percentile of 6-Minute Physical Activity Windows
Treatment (Days 331 to 360)
|
-1517.7024 activity counts per 6 minute window
Standard Deviation 2902.3800
|
-1091.4469 activity counts per 6 minute window
Standard Deviation 1477.2074
|
SECONDARY outcome
Timeframe: Baseline, Treatment (Days 331 to 360)Population: A minimum daily wear time requirement of 16 hrs. was used to filter out days from the aggregation. Days that met the minimum wear requirement were considered valid days and days that did not meet this criterion were considered invalid days. For each time period, a minimum of 15 valid days were required for the time period to be considered valid. For valid time periods, the aggregation was performed over all valid days. The value for invalid time periods was set to missing.
The Actigraph device is a non-invasive research-grade accelerometer based wearable device that was used to objectively measure free-living physical activity. The data from these devices was used to assess and detect changes in physical activity intensity, upper arm movements, and walking patterns.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants received matched dose placebo given orally once daily for 12 months.
|
NIDO-361
n=28 Participants
Participants received NIDO-361, 100 mg for at least 2 months and 200 mg for the remainder of the study.
|
|---|---|---|
|
Change From Baseline to Treatment (Days 331 to 360) in Acitgraphy-Derived Measurement: Maximum Walking Bout Duration
Baseline (Days -28 to -1)
|
268.0350 minutes
Standard Deviation 242.4235
|
184.3490 minutes
Standard Deviation 228.2918
|
|
Change From Baseline to Treatment (Days 331 to 360) in Acitgraphy-Derived Measurement: Maximum Walking Bout Duration
Treatment (Days 331 to 360)
|
17.1187 minutes
Standard Deviation 130.0056
|
-47.2082 minutes
Standard Deviation 224.5570
|
SECONDARY outcome
Timeframe: Baseline, Treatment (Days 331 to 360)Population: A minimum daily wear time requirement of 16 hrs. was used to filter out days from the aggregation. Days that met the minimum wear requirement were considered valid days and days that did not meet this criterion were considered invalid days. For each time period, a minimum of 15 valid days were required for the time period to be considered valid. For valid time periods, the aggregation was performed over all valid days. The value for invalid time periods was set to missing.
The Actigraph device is a non-invasive research-grade accelerometer based wearable device that was used to objectively measure free-living physical activity. The data from these devices was used to assess and detect changes in physical activity intensity, upper arm movements, and walking patterns.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants received matched dose placebo given orally once daily for 12 months.
|
NIDO-361
n=28 Participants
Participants received NIDO-361, 100 mg for at least 2 months and 200 mg for the remainder of the study.
|
|---|---|---|
|
Change From Baseline to Treatment (Days 331 to 360) in Actigraphy-Derived Measurement: Peak 95th Percentile Cadence
Baseline (Days -28 to -1)
|
168.637 steps/minutes
Standard Deviation 9.7957
|
166.144 steps/minutes
Standard Deviation 7.6962
|
|
Change From Baseline to Treatment (Days 331 to 360) in Actigraphy-Derived Measurement: Peak 95th Percentile Cadence
Treatment (Days 331 to 360)
|
-2.382 steps/minutes
Standard Deviation 8.3746
|
2.382 steps/minutes
Standard Deviation 8.6374
|
SECONDARY outcome
Timeframe: Baseline, Treatment (Days 331 to 360)Population: A minimum daily wear time requirement of 16 hrs. was used to filter out days from the aggregation. Days that met the minimum wear requirement were considered valid days and days that did not meet this criterion were considered invalid days. For each time period, a minimum of 15 valid days were required for the time period to be considered valid. For valid time periods, the aggregation was performed over all valid days. The value for invalid time periods was set to missing.
The Actigraph device is a non-invasive research-grade accelerometer based wearable device that was used to objectively measure free-living physical activity. The data from these devices was used to assess and detect changes in physical activity intensity, upper arm movements, and walking patterns.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants received matched dose placebo given orally once daily for 12 months.
|
NIDO-361
n=28 Participants
Participants received NIDO-361, 100 mg for at least 2 months and 200 mg for the remainder of the study.
|
|---|---|---|
|
Change From Baseline to Treatment (Days 331 to 360) in Actigraphy Derived Measurement: Average Breathing Rate
Baseline (Days -28 to -1)
|
16.856 breaths/minutes
Standard Deviation 1.4595
|
16.428 breaths/minutes
Standard Deviation 3.1323
|
|
Change From Baseline to Treatment (Days 331 to 360) in Actigraphy Derived Measurement: Average Breathing Rate
Treatment (Days 331 to 360)
|
0.433 breaths/minutes
Standard Deviation 1.2947
|
-0.278 breaths/minutes
Standard Deviation 0.9197
|
SECONDARY outcome
Timeframe: Baseline, Day 180, Day 360Population: Patients, who received at least 1 dose of study treatment (placebo or NIDO-361) and had at least 1 post-baseline assessment of efficacy parameters, were considered included in analysis.
Grip strength (lbs) is averaged across three trials for the right and left hands separately using a handheld dynamometer (HHD).
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants received matched dose placebo given orally once daily for 12 months.
|
NIDO-361
n=28 Participants
Participants received NIDO-361, 100 mg for at least 2 months and 200 mg for the remainder of the study.
|
|---|---|---|
|
Change From Baseline to Day 180 and Day 360 in Grip Strength as Measured by Handheld Dynamometer (HHD)
Left HHD - Day 180
|
-0.74 lbs
Standard Deviation 4.647
|
-2.00 lbs
Standard Deviation 6.668
|
|
Change From Baseline to Day 180 and Day 360 in Grip Strength as Measured by Handheld Dynamometer (HHD)
Left HHD - Day 360
|
-1.36 lbs
Standard Deviation 4.437
|
-2.02 lbs
Standard Deviation 7.600
|
|
Change From Baseline to Day 180 and Day 360 in Grip Strength as Measured by Handheld Dynamometer (HHD)
Right HHD - Baseline
|
46.51 lbs
Standard Deviation 21.828
|
41.20 lbs
Standard Deviation 19.042
|
|
Change From Baseline to Day 180 and Day 360 in Grip Strength as Measured by Handheld Dynamometer (HHD)
Right HHD - Day 180
|
-1.55 lbs
Standard Deviation 4.253
|
-2.05 lbs
Standard Deviation 6.045
|
|
Change From Baseline to Day 180 and Day 360 in Grip Strength as Measured by Handheld Dynamometer (HHD)
Right HHD - Day 360
|
-1.50 lbs
Standard Deviation 4.413
|
-1.37 lbs
Standard Deviation 5.817
|
|
Change From Baseline to Day 180 and Day 360 in Grip Strength as Measured by Handheld Dynamometer (HHD)
Left HHD - Baseline
|
44.66 lbs
Standard Deviation 19.718
|
40.21 lbs
Standard Deviation 16.405
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
NIDO-361
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=26 participants at risk
Participants receive matched dose placebo given orally once daily for 12 months.
|
NIDO-361
n=28 participants at risk
Participants receive NIDO-361, 100 mg for at least 2 months and 200 mg for the remainder of the study.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
Other adverse events
| Measure |
Placebo
n=26 participants at risk
Participants receive matched dose placebo given orally once daily for 12 months.
|
NIDO-361
n=28 participants at risk
Participants receive NIDO-361, 100 mg for at least 2 months and 200 mg for the remainder of the study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphocytosis
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Cardiac disorders
Bradycardia
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Eye disorders
Vision blurred
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Eye disorders
Chalazion
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
7.1%
2/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
7.1%
2/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Gastrointestinal disorders
Gastroespohageal reflux disease
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
7.1%
2/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
7.1%
2/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Gastrointestinal disorders
Dysphagia
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Gastrointestinal disorders
Haematochezia
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Gastrointestinal disorders
Tooth disorder
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
General disorders
Fatigue
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
7.1%
2/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
General disorders
Influenza like illness
|
15.4%
4/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
7.1%
2/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
General disorders
Asthenia
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
General disorders
Chest pain
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
General disorders
Peripheral swelling
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
General disorders
Pyrexia
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
General disorders
Vessel puncture site paraesthesia
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
General disorders
Pain
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
General disorders
Polyp
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
10.7%
3/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Infections and infestations
Nasopharyngitis
|
26.9%
7/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
10.7%
3/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Infections and infestations
Urinary tract infection
|
15.4%
4/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
10.7%
3/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
7.1%
2/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
7.1%
2/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Infections and infestations
Bronchitis
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Infections and infestations
COVID-19
|
7.7%
2/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Infections and infestations
Ear infection
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Infections and infestations
Dysentery
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Infections and infestations
Influenza
|
7.7%
2/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Infections and infestations
Nail infection
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Infections and infestations
Tonsillitis
|
7.7%
2/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
10.7%
3/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Injury, poisoning and procedural complications
Limb injury
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
35.7%
10/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
Aspartate aminotransferase increased
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
32.1%
9/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
28.6%
8/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
Blood cholesterol increased
|
11.5%
3/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
7.1%
2/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
Blood sodium increased
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
7.1%
2/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
Blood triglycerides increased
|
15.4%
4/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
7.1%
2/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
Monocyte count increased
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
7.1%
2/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
Blood calcium increased
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
Blood creatinine phosphokinase increased
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
Blood sodium decreased
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
Blood urea increased
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
Cardiac murmur
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
Crystal urine present
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
Neutrophil/lymphocyte ratio decreased
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
Platelet count decreased
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
White blood cell count decreased
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
Blood potassium increased
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
Blood pressure increased
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
Electroencephalogram abnormal
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Investigations
White blood cells urine positive
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Metabolism and nutrition disorders
Gout
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
7.1%
2/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Musculoskeletal and connective tissue disorders
Joint range or motion decreased
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Nervous system disorders
Headache
|
19.2%
5/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
14.3%
4/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Nervous system disorders
Dizziness
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
7.1%
2/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Nervous system disorders
Hypoaesthesia
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Nervous system disorders
Post-traumatic headache
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Nervous system disorders
Tremor
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
17.9%
5/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
7.1%
2/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Vascular disorders
Hypertension
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
7.1%
2/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Vascular disorders
Flushing
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Vascular disorders
Hot flush
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Infections and infestations
Pneumonia
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Vascular disorders
Peripheral coldness
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
3.6%
1/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
|
Nervous system disorders
Sciatica
|
3.8%
1/26 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
0.00%
0/28 • From enrollment until end of study (up to 1 year)
The safety analysis set was defined as all randomized patients, who received at least 1 dose of study treatment (placebo or NIDO-361). If a patient experienced more than 1 event in a given system organ class (SOC), that patient was counted once for the SOC. If a patient experienced more than 1 event with a given preferred term (PT), that patient was counted only once for that PT.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI agrees that any publication of the results of the study conducted at their research site shall not be made before the first multi-center publication. In the event there is no multi-center publication within 12 months after the study has been completed, the PI has the right to publish the results of the study at their site. The PI shall provide the Sponsor with 60 days to review the manuscript or presentation. PI is under no obligation to incorporate any suggestions provided by Sponsor.
- Publication restrictions are in place
Restriction type: OTHER