Trial Outcomes & Findings for Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies (NCT NCT00551642)

Last Updated: 2021-02-05

Results Overview

Survival without BPD is defined as the number of preterm infants of 36 weeks gestational age who survived the treatment period without the need for supplemental oxygen

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

800 participants

Primary outcome timeframe

21 days

Results posted on

2021-02-05

Participant Flow

Thirty-five Medical Centers participated and enrolled a total of 800 participants (Intent to treat population).

800 participants were enrolled at 35 medical centers around the world for the Treatment period, and 305 had data at the 7-year Follow-up period.

Participant milestones

Participant milestones
Measure	Inhaled Nitric Oxide (INO) INO administered by nasal continuous positive airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for between 7 and 21 days during the Treatment period, but no intervention during the 7-year Follow-up	Placebo Placebo gas administered by nasal continuous positive airway pressure, nasal cannula or face mask, for a maximum of 21 days during the Treatment period, but no intervention during the 7-year Follow-up
Treatment Period STARTED	399	401
Treatment Period Safety Population	395	397
Treatment Period COMPLETED	338	338
Treatment Period NOT COMPLETED	61	63
7-Year Follow-up STARTED	152	153
7-Year Follow-up COMPLETED	152	153
7-Year Follow-up NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Inhaled Nitric Oxide (INO) INO administered by nasal continuous positive airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for between 7 and 21 days during the Treatment period, but no intervention during the 7-year Follow-up	Placebo Placebo gas administered by nasal continuous positive airway pressure, nasal cannula or face mask, for a maximum of 21 days during the Treatment period, but no intervention during the 7-year Follow-up
Treatment Period Protocol Deviation	6	11
Treatment Period Delivery device failure	1	3
Treatment Period Physician Decision	0	1
Treatment Period Death	33	31
Treatment Period Inclusion/Exclusion criteria	4	4
Treatment Period Adverse Event	15	12
Treatment Period Withdrawal by Subject	2	1

Baseline Characteristics

Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inhaled Nitric Oxide (INO) n=399 Participants INO administered by nasal continuous positive airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for between 7 and 21 days during the Treatment period, but no intervention during the 7-year Follow-up	Placebo n=401 Participants Placebo gas administered by nasal continuous positive airway pressure, nasal cannula or face mask, for a maximum of 21 days during the Treatment period, but no intervention during the 7-year Follow-up	Total n=800 Participants Total of all reporting groups
Age, Customized Preterm newborn infants (gestational age < 37 wks)	399 Participants n=5 Participants	401 Participants n=7 Participants	800 Participants n=5 Participants
Sex: Female, Male Female	192 Participants n=5 Participants	181 Participants n=7 Participants	373 Participants n=5 Participants
Sex: Female, Male Male	207 Participants n=5 Participants	220 Participants n=7 Participants	427 Participants n=5 Participants

PRIMARY outcome

Timeframe: 21 days

Population: All participants with efficacy data

Survival without BPD is defined as the number of preterm infants of 36 weeks gestational age who survived the treatment period without the need for supplemental oxygen

Outcome measures

Outcome measures
Measure	Inhaled Nitric Oxide (INO) n=395 Participants INO administered by nasal continuous positive airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for between 7 and 21 days during the Treatment period, but no intervention during the 7-year Follow-up	Placebo n=400 Participants Placebo gas administered by nasal continuous positive airway pressure, nasal cannula or face mask, for a maximum of 21 days during the Treatment period, but no intervention during the 7-year Follow-up
Survival Without Bronchopulmonary Dysplasia (BPD) in Preterm Infants With Respiratory Distress	258 Participants	262 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: at 7-year Follow-up

Population: Participants with 7-year follow-up data

Number of participants who died between 2 years and the 7-year Follow-up Period

Outcome measures

Outcome measures
Measure	Inhaled Nitric Oxide (INO) n=152 Participants INO administered by nasal continuous positive airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for between 7 and 21 days during the Treatment period, but no intervention during the 7-year Follow-up	Placebo n=153 Participants Placebo gas administered by nasal continuous positive airway pressure, nasal cannula or face mask, for a maximum of 21 days during the Treatment period, but no intervention during the 7-year Follow-up
Mortality at 7-year Follow-up	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At 7-year Follow-up

Population: Participants with Questionnaire Results at the 7-year follow-up

The Strengths and Difficulties Questionnaire contained 25 questions that were used to create 5 scales (ranging from 10=most normal to 0=most abnormal) for emotional symptoms, conduct problems, hyperactivity, peer problems, and (10=most abnormal, 0=most normal) for prosocial.

Outcome measures

Outcome measures
Measure	Inhaled Nitric Oxide (INO) n=147 Participants INO administered by nasal continuous positive airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for between 7 and 21 days during the Treatment period, but no intervention during the 7-year Follow-up	Placebo n=147 Participants Placebo gas administered by nasal continuous positive airway pressure, nasal cannula or face mask, for a maximum of 21 days during the Treatment period, but no intervention during the 7-year Follow-up
Strengths and Difficulties Questionnaire Results for Participants at 7-year Follow-up Emotional (0=most normal, 10=most abnormal)	1.9 score on a scale Standard Deviation 1.79	2.1 score on a scale Standard Deviation 1.96
Strengths and Difficulties Questionnaire Results for Participants at 7-year Follow-up Peer problems (0=most normal, 10=most abnormal)	1.2 score on a scale Standard Deviation 1.41	1.5 score on a scale Standard Deviation 1.74
Strengths and Difficulties Questionnaire Results for Participants at 7-year Follow-up Prosocial (10=most abnormal, 0=most normal)	8.6 score on a scale Standard Deviation 1.73	8.4 score on a scale Standard Deviation 1.81
Strengths and Difficulties Questionnaire Results for Participants at 7-year Follow-up Conduct (0=most normal, 10=most abnormal)	1.4 score on a scale Standard Deviation 1.55	1.4 score on a scale Standard Deviation 1.58
Strengths and Difficulties Questionnaire Results for Participants at 7-year Follow-up Hyperactivity (0=most normal, 10=most abnormal)	3.8 score on a scale Standard Deviation 2.64	3.4 score on a scale Standard Deviation 2.66

Adverse Events

Inhaled Nitric Oxide (INO)

Serious events: 170 serious events

Other events: 358 other events

Deaths: 56 deaths

Placebo

Serious events: 177 serious events

Other events: 334 other events

Deaths: 48 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Inhaled Nitric Oxide (INO) n=395 participants at risk INO administered by nasal continuous positive airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for between 7 and 21 days during the Treatment period, but no intervention during the 7-year Follow-up	Placebo n=397 participants at risk Placebo gas administered by nasal continuous positive airway pressure (nasal cannula or face mask) for a maximum of 21 days during the Treatment period, but no intervention during the 7-year Follow-up
Blood and lymphatic system disorders Anaemia	47.8% 189/395 • Number of events 253 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.	42.3% 168/397 • Number of events 226 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.
Blood and lymphatic system disorders Thrombocytopenia	7.3% 29/395 • Number of events 29 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.	7.1% 28/397 • Number of events 31 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.
Congenital, familial and genetic disorders Patent ductus arteriosus	46.3% 183/395 • Number of events 187 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.	39.8% 158/397 • Number of events 163 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.
Hepatobiliary disorders Hyperbilirubinaemia	30.9% 122/395 • Number of events 138 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.	30.2% 120/397 • Number of events 130 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.
Hepatobiliary disorders Jaundice	24.8% 98/395 • Number of events 107 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.	22.4% 89/397 • Number of events 97 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.
Infections and infestations Sepsis	17.2% 68/395 • Number of events 75 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.	15.1% 60/397 • Number of events 66 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.
Metabolism and nutrition disorders Hyperglycaemia	22.8% 90/395 • Number of events 100 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.	17.1% 68/397 • Number of events 75 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.
Metabolism and nutrition disorders Hyponatraemia	5.3% 21/395 • Number of events 22 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.	4.8% 19/397 • Number of events 21 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.
Metabolism and nutrition disorders Metabolic acidosis	12.4% 49/395 • Number of events 53 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.	13.1% 52/397 • Number of events 62 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.
Nervous system disorders Haemorrhage intracranial	18.5% 73/395 • Number of events 81 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.	13.9% 55/397 • Number of events 58 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.
Respiratory, thoracic and mediastinal disorders Apnoea	18.5% 73/395 • Number of events 78 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.	19.6% 78/397 • Number of events 79 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.
Vascular disorders Hypotension	13.9% 55/395 • Number of events 57 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.	12.6% 50/397 • Number of events 54 • Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality. In a previous submission of this record, "Survival", "Vital Signs", "Arterial Oxygen Saturation by Pulse Oximetry", "Adverse Events" and "Methemoglobin Level" were incorrectly included as Outcome Measures, but have been deleted from the current version, because clinically significant changes in these parameters were counted under adverse events and/or all-cause mortality presented in this adverse events module.

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