Trial Outcomes & Findings for Normobaric Oxygen Therapy in Acute Ischemic Stroke Trial (NCT NCT00414726)
NCT ID: NCT00414726
Last Updated: 2017-10-20
Results Overview
The NIHSS score ranges from 0 (best score) to 42 (worst score).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
85 participants
Primary outcome timeframe
24 hours
Results posted on
2017-10-20
Participant Flow
February 2007-June 2009
Participant milestones
| Measure |
Normobaric Oxygen
Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
|
Room Air
Room Air, inhaled at 30-45L/min via a facemask for 8 hours
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
42
|
|
Overall Study
COMPLETED
|
43
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Normobaric Oxygen
Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
|
Room Air
Room Air, inhaled at 30-45L/min via a facemask for 8 hours
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Normobaric Oxygen Therapy in Acute Ischemic Stroke Trial
Baseline characteristics by cohort
| Measure |
Normobaric Oxygen
n=43 Participants
Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
|
Room Air
n=42 Participants
Room Air, inhaled at 30-45L/min via a facemask for 8 hours
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.1 years
STANDARD_DEVIATION 14 • n=5 Participants
|
73.4 years
STANDARD_DEVIATION 14 • n=7 Participants
|
73.7 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursThe NIHSS score ranges from 0 (best score) to 42 (worst score).
Outcome measures
| Measure |
Normobaric Oxygen
n=43 Participants
Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
|
Room Air
n=42 Participants
Room Air, inhaled at 30-45L/min via a facemask for 8 hours
|
|---|---|---|
|
Primary Safety Outcome Measure is a Comparison of the Change in National Institutes of Health Stroke Scale (NIHSS) Scores From Baseline to 24 Hours (After Therapy) in the Two Groups.
|
0.17 0-24 hour change in NIHSS score
Interval -1.07 to 1.41
|
-0.73 0-24 hour change in NIHSS score
Interval -2.31 to 0.86
|
PRIMARY outcome
Timeframe: 4 hours after starting treatmentThe NIHSS score ranges from 0 (best score) to 42 (worst score).
Outcome measures
| Measure |
Normobaric Oxygen
n=43 Participants
Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
|
Room Air
n=42 Participants
Room Air, inhaled at 30-45L/min via a facemask for 8 hours
|
|---|---|---|
|
Primary Efficacy Outcome Measure is a Comparison of the Change in National Institutes of Health Stroke Scale (NIHSS) Scores From Baseline to 4 Hours (During Therapy) in the Two Groups.
|
-0.37 0-4 hour change in NIHSS score
Interval -1.2 to 0.46
|
-0.43 0-4 hour change in NIHSS score
Interval -1.43 to 0.58
|
Adverse Events
Normobaric Oxygen
Serious events: 24 serious events
Other events: 42 other events
Deaths: 0 deaths
Room Air
Serious events: 20 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Normobaric Oxygen
n=43 participants at risk
Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
|
Room Air
n=41 participants at risk
Room Air, inhaled at 30-45L/min via a facemask for 8 hours
|
|---|---|---|
|
Cardiac disorders
Cardiac Arrhythmia
|
2.3%
1/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
7.3%
3/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
Cardiac disorders
Cardiac General
|
7.0%
3/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
4.9%
2/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
General disorders
Constitutional Symptoms
|
0.00%
0/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
2.4%
1/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
General disorders
Death
|
39.5%
17/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
17.1%
7/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
General disorders
Hemorrhage/Bleeding
|
9.3%
4/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
0.00%
0/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas
|
2.3%
1/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
0.00%
0/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
Infections and infestations
Infection
|
4.7%
2/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
2.4%
1/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
Investigations
Metabolic/Laboratory
|
0.00%
0/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
2.4%
1/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
Nervous system disorders
Neurology
|
18.6%
8/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
7.3%
3/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
General disorders
Pain
|
2.3%
1/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
0.00%
0/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory
|
7.0%
3/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
4.9%
2/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
Renal and urinary disorders
Renal/Genitourinary
|
0.00%
0/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
4.9%
2/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
Vascular disorders
Vascular
|
0.00%
0/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
4.9%
2/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
Other adverse events
| Measure |
Normobaric Oxygen
n=43 participants at risk
Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
|
Room Air
n=41 participants at risk
Room Air, inhaled at 30-45L/min via a facemask for 8 hours
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood/Bone Marrow
|
11.6%
5/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
7.3%
3/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
Cardiac disorders
Cardiac Arrhythmia
|
20.9%
9/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
17.1%
7/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
Cardiac disorders
Cardiac General
|
27.9%
12/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
14.6%
6/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
General disorders
Constitutional Symptoms
|
37.2%
16/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
24.4%
10/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
32.6%
14/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
26.8%
11/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
Gastrointestinal disorders
Gastrointestinal
|
32.6%
14/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
43.9%
18/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
General disorders
Hemorrhage/Bleeding
|
32.6%
14/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
36.6%
15/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
Infections and infestations
Infection
|
37.2%
16/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
31.7%
13/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
Blood and lymphatic system disorders
Lymphatics
|
20.9%
9/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
17.1%
7/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
Investigations
Metabolic/Laboratory
|
9.3%
4/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
7.3%
3/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue
|
0.00%
0/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
7.3%
3/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
Nervous system disorders
Neurology
|
62.8%
27/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
43.9%
18/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
General disorders
Pain
|
41.9%
18/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
36.6%
15/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory
|
53.5%
23/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
31.7%
13/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
|
Renal and urinary disorders
Renal/Genitourinary
|
23.3%
10/43 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
26.8%
11/41 • AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place