Trial Outcomes & Findings for Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (NCT NCT00633880)
NCT ID: NCT00633880
Last Updated: 2014-05-20
Results Overview
OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
COMPLETED
PHASE3
181 participants
14 days
2014-05-20
Participant Flow
Participant milestones
| Measure |
Open Label Titration
All patients titrated to their optimal dose of droxidopa during an initial open label phase for 7-14 days
|
Droxidopa
Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|---|
|
Open Label Titration
STARTED
|
181
|
0
|
0
|
|
Open Label Titration
COMPLETED
|
101
|
0
|
0
|
|
Open Label Titration
NOT COMPLETED
|
80
|
0
|
0
|
|
Randomized Double Blind
STARTED
|
0
|
50
|
51
|
|
Randomized Double Blind
COMPLETED
|
0
|
50
|
51
|
|
Randomized Double Blind
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Open Label Titration
All patients titrated to their optimal dose of droxidopa during an initial open label phase for 7-14 days
|
Droxidopa
Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|---|
|
Open Label Titration
Lack of Efficacy
|
1
|
0
|
0
|
|
Open Label Titration
Adverse Event
|
13
|
0
|
0
|
|
Open Label Titration
Treatment Failure
|
55
|
0
|
0
|
|
Open Label Titration
Protocol Violation
|
6
|
0
|
0
|
|
Open Label Titration
Physician Decision
|
1
|
0
|
0
|
|
Open Label Titration
Withdrawal by Subject
|
4
|
0
|
0
|
Baseline Characteristics
Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)
Baseline characteristics by cohort
| Measure |
Not Randomized
n=80 Participants
Entered open-label droxidopa dose titration, but did not randomize
|
Droxidopa
n=50 Participants
Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=51 Participants
Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69.5 years
STANDARD_DEVIATION 9.74 • n=99 Participants
|
63.1 years
STANDARD_DEVIATION 13.76 • n=107 Participants
|
66.6 years
STANDARD_DEVIATION 11.25 • n=206 Participants
|
66.9 years
STANDARD_DEVIATION 11.62 • n=7 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
74 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
107 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
178 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=99 Participants
|
25 participants
n=107 Participants
|
32 participants
n=206 Participants
|
110 participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=99 Participants
|
9 participants
n=107 Participants
|
2 participants
n=206 Participants
|
19 participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=99 Participants
|
3 participants
n=107 Participants
|
2 participants
n=206 Participants
|
10 participants
n=7 Participants
|
|
Region of Enrollment
Poland
|
5 participants
n=99 Participants
|
10 participants
n=107 Participants
|
8 participants
n=206 Participants
|
23 participants
n=7 Participants
|
|
Region of Enrollment
Australia
|
8 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
16 participants
n=7 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Primary Clinical Diagnosis
Parkinson's Disease
|
38 participants
n=99 Participants
|
21 participants
n=107 Participants
|
23 participants
n=206 Participants
|
82 participants
n=7 Participants
|
|
Primary Clinical Diagnosis
Multiple System Atrophy
|
21 participants
n=99 Participants
|
17 participants
n=107 Participants
|
13 participants
n=206 Participants
|
51 participants
n=7 Participants
|
|
Primary Clinical Diagnosis
Pure Autonomic Failure
|
18 participants
n=99 Participants
|
8 participants
n=107 Participants
|
10 participants
n=206 Participants
|
36 participants
n=7 Participants
|
|
Primary Clinical Diagnosis
Dopamine Beta-Hydroxylase Deficiency
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Primary Clinical Diagnosis
Non-Diabetic Autonomic Neuropathy
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
7 participants
n=7 Participants
|
|
Primary Clinical Diagnosis
Other
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
4 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Missing data were imputed using the last observation carry forward method.
OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
Outcome measures
| Measure |
Droxidopa
n=50 Participants
Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=51 Participants
Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)
|
1.3 units on a scale
Standard Deviation 2.75
|
1.9 units on a scale
Standard Deviation 3.16
|
SECONDARY outcome
Timeframe: 14 daysOHSA item 4 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
Outcome measures
| Measure |
Droxidopa
n=50 Participants
Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=51 Participants
Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Change in Fatigue (OHSA Item 4)
|
0.7 units on a scale
Standard Deviation 2.61
|
1.5 units on a scale
Standard Deviation 2.72
|
SECONDARY outcome
Timeframe: 14 daysOHSA item 3 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
Outcome measures
| Measure |
Droxidopa
n=50 Participants
Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=51 Participants
Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Change in Weakness (OHSA Item 3)
|
0.3 units on a scale
Standard Deviation 2.88
|
1.2 units on a scale
Standard Deviation 2.70
|
SECONDARY outcome
Timeframe: 14 daysOHSA item 2 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
Outcome measures
| Measure |
Droxidopa
n=50 Participants
Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=51 Participants
Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Change in Vision (OHSA Item 2)
|
1.1 units on a scale
Standard Deviation 2.79
|
0.8 units on a scale
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: 14 daysOHSA item 5 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
Outcome measures
| Measure |
Droxidopa
n=50 Participants
Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=51 Participants
Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Change in Concentration (OHSA Item 5)
|
0.1 units on a scale
Standard Deviation 2.74
|
0.9 units on a scale
Standard Deviation 2.67
|
SECONDARY outcome
Timeframe: 14 daysOHSA item 6 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
Outcome measures
| Measure |
Droxidopa
n=50 Participants
Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=51 Participants
Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Change in Head/Neck Discomfort (OHSA Item 6)
|
-0.1 units on a scale
Standard Deviation 2.45
|
1.2 units on a scale
Standard Deviation 3.19
|
SECONDARY outcome
Timeframe: 14 daysPopulation: One placebo patient excluded from analysis because OHDAS values were not evaluable.
The OHDAS scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each asks the patient to rate their disease impact over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
Outcome measures
| Measure |
Droxidopa
n=50 Participants
Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=50 Participants
Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Change in Ability to Conduct Activities of Daily Living Score (OHDAS Composite Score)
|
-0.24 units on a scale
Standard Deviation 2.35
|
0.91 units on a scale
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: 14 daysThe OHSA scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. Each asks the patient to rate their symptoms over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
Outcome measures
| Measure |
Droxidopa
n=50 Participants
Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=51 Participants
Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Change in Orthostatic Hypotension Symptom Assessment Score (OHSA Composite)
|
0.6 units on a scale
Standard Deviation 2.27
|
1.35 units on a scale
Standard Deviation 2.53
|
SECONDARY outcome
Timeframe: 14 daysPopulation: One placebo patient excluded from analysis per the SAP because all baseline values in the composite were zero. LOCF was used to impute values for patients who did not have an end of study visit.
OHSA composite scale (items 2-6) is the average of five OHSA items: 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. Each asks the patient to rate their symptoms over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
Outcome measures
| Measure |
Droxidopa
n=50 Participants
Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=50 Participants
Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Change in Orthostatic Hypotension Symptom Scores Excluding Dizziness (OHSA Composite Items 2-6)
|
0.44 units on a scale
Standard Deviation 2.29
|
1.07 units on a scale
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: 14 daysPopulation: three placebo patients excluded from the analysis due to missing standing blood pressure values at either randomization or end of study.
Change: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. In this withdrawal design, a negative score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
Outcome measures
| Measure |
Droxidopa
n=50 Participants
Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=48 Participants
Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing;
|
-7.6 mmHg
Standard Deviation 19.71
|
-5.2 mmHg
Standard Deviation 26.83
|
POST_HOC outcome
Timeframe: 14 daysPopulation: 3 droxidopa patients and 2 placebo patients were excluded from the analysis due to missing randomization values.
The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .
Outcome measures
| Measure |
Droxidopa
n=47 Participants
Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=49 Participants
Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
|---|---|---|
|
Change in Orthostatic Hypotension Questionnaire Score (OHQ)
|
0.11 units on a scale
Standard Deviation 2.176
|
1.22 units on a scale
Standard Deviation 2.390
|
Adverse Events
Droxidopa
Placebo
Open Label Phase
Serious adverse events
| Measure |
Droxidopa
n=50 participants at risk
Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=51 participants at risk
Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Open Label Phase
n=181 participants at risk
All patient titrated on droxidopa during open-label phase
|
|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/50
|
0.00%
0/51
|
0.55%
1/181 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/50
|
0.00%
0/51
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/50
|
0.00%
0/51
|
0.55%
1/181 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/50
|
2.0%
1/51 • Number of events 1
|
0.00%
0/181
|
|
Blood and lymphatic system disorders
leukopenia
|
0.00%
0/50
|
0.00%
0/51
|
0.55%
1/181 • Number of events 1
|
|
Psychiatric disorders
Mental status change
|
0.00%
0/50
|
2.0%
1/51 • Number of events 1
|
0.00%
0/181
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/50
|
0.00%
0/51
|
0.55%
1/181 • Number of events 1
|
Other adverse events
| Measure |
Droxidopa
n=50 participants at risk
Double-blind
Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Placebo
n=51 participants at risk
Double-blind
Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
|
Open Label Phase
n=181 participants at risk
All patient titrated on droxidopa during open-label phase
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
4.0%
2/50 • Number of events 2
|
7.8%
4/51 • Number of events 4
|
11.0%
20/181 • Number of events 28
|
|
Nervous system disorders
Dizziness
|
4.0%
2/50 • Number of events 2
|
2.0%
1/51 • Number of events 1
|
8.3%
15/181 • Number of events 18
|
|
General disorders
Fatigue
|
0.00%
0/50
|
2.0%
1/51 • Number of events 1
|
5.5%
10/181 • Number of events 10
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/50 • Number of events 2
|
11.8%
6/51 • Number of events 7
|
5.0%
9/181 • Number of events 12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60