Trial Outcomes & Findings for PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY (NCT NCT02811302)

Last Updated: 2019-06-12

Results Overview

Continuous respiratory monitoring using a Capnostream monitor will be included for collecting data for end tidal carbon dioxide (etCO2) and Oxygen saturation (SpO2). Positive RD determination was provided by an independent Clinical Event Committee, by assessing the following parameters: * etCO2 ≤ 15 or ≥ 60 mmHg for ≥ 3 minutes, or * RR ≤ 5 breaths for ≥ 3 minutes, or * SpO2 ≤ 85% for ≥ 3 minutes, or * Apnea episode lasting \> 30 seconds, or * Any respiratory Opioid-Related Adverse Event (rORADE).

Recruitment status

COMPLETED

Study phase

Target enrollment

1495 participants

Primary outcome timeframe

48 hours

Results posted on

2019-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	Full Analysis Set Blinded capnography monitoring - all subjects enrolled
Overall Study STARTED	1495
Overall Study COMPLETED	1282
Overall Study NOT COMPLETED	213

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

1 subject missing data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Cohort n=1495 Participants Blinded capnography monitoring - all subjects enrolled
Age, Continuous	58.1 years STANDARD_DEVIATION 14.1 • n=1495 Participants
Sex: Female, Male Female	859 Participants n=1494 Participants • 1 subject missing data
Sex: Female, Male Male	635 Participants n=1494 Participants • 1 subject missing data
Race/Ethnicity, Customized Race/Ethnic Origin · American Indian or Alaska Native	5 Participants n=1495 Participants
Race/Ethnicity, Customized Race/Ethnic Origin · Asian	325 Participants n=1495 Participants
Race/Ethnicity, Customized Race/Ethnic Origin · Black or African American	174 Participants n=1495 Participants
Race/Ethnicity, Customized Race/Ethnic Origin · Hispanic or Latino	10 Participants n=1495 Participants
Race/Ethnicity, Customized Race/Ethnic Origin · Native Hawaiian or Other Pacific Islander	1 Participants n=1495 Participants
Race/Ethnicity, Customized Race/Ethnic Origin · Other	36 Participants n=1495 Participants
Race/Ethnicity, Customized Race/Ethnic Origin · White	839 Participants n=1495 Participants
Race/Ethnicity, Customized Race/Ethnic Origin · Missing Data	105 Participants n=1495 Participants
Region of Enrollment Netherlands	92 participants n=1495 Participants
Region of Enrollment Singapore	100 participants n=1495 Participants
Region of Enrollment United States	878 participants n=1495 Participants
Region of Enrollment Japan	219 participants n=1495 Participants
Region of Enrollment France	52 participants n=1495 Participants
Region of Enrollment Germany	57 participants n=1495 Participants
Region of Enrollment Spain	97 participants n=1495 Participants
Weight	83.2 kg STANDARD_DEVIATION 25.2 • n=1495 Participants
Height	167.1 cm STANDARD_DEVIATION 10.9 • n=1495 Participants
Shirt Collar Neck Size Male - shirt collar <17 in/43 cm	377 Participants n=1495 Participants
Shirt Collar Neck Size Male - shirt collar >= 17 in/43 cm	221 Participants n=1495 Participants
Shirt Collar Neck Size Female - shirt collar <16 in/41 cm	561 Participants n=1495 Participants
Shirt Collar Neck Size Female - shirt collar >=16 in/41 cm	259 Participants n=1495 Participants
Shirt Collar Neck Size Missing Data	77 Participants n=1495 Participants
ASA Score Class I	122 Participants n=1495 Participants
ASA Score Class II	703 Participants n=1495 Participants
ASA Score Class III	610 Participants n=1495 Participants
ASA Score Class IV	33 Participants n=1495 Participants
ASA Score Missing Data	27 Participants n=1495 Participants
Altitude At or Below Sea Level	72 Participants n=1495 Participants
Altitude Above Sea Level to Below High Alititude	1228 Participants n=1495 Participants
Altitude High Altitude (1500-3500 meters)	105 Participants n=1495 Participants
Altitude Very High Altitude (above 3500 meters)	3 Participants n=1495 Participants
Altitude Missing Data	87 Participants n=1495 Participants
STOP-BANG Score	2.8 units on a scale STANDARD_DEVIATION 1.7 • n=1495 Participants
Body Mass Index	29.7 kg/m^2 STANDARD_DEVIATION 8.3 • n=1495 Participants
Apnea History Snore Loudly · Yes	445 Participants n=1495 Participants
Apnea History Snore Loudly · No	955 Participants n=1495 Participants
Apnea History Snore Loudly · Missing Data	95 Participants n=1495 Participants
Apnea History Tired, Fatigued, Sleepy During the Day · Yes	267 Participants n=1495 Participants
Apnea History Tired, Fatigued, Sleepy During the Day · No	1132 Participants n=1495 Participants
Apnea History Tired, Fatigued, Sleepy During the Day · Missing Data	96 Participants n=1495 Participants
Apnea History Stop Breathing or Choking/Gasping During Sleep · Yes	152 Participants n=1495 Participants
Apnea History Stop Breathing or Choking/Gasping During Sleep · No	1249 Participants n=1495 Participants
Apnea History Stop Breathing or Choking/Gasping During Sleep · Missing Data	94 Participants n=1495 Participants
Apnea History Treated for High Blood Pressure · Yes	678 Participants n=1495 Participants
Apnea History Treated for High Blood Pressure · No	812 Participants n=1495 Participants
Apnea History Treated for High Blood Pressure · Missing Data	5 Participants n=1495 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: A modified dataset (mFAS) was used to derive and validate the risk assessment tool. Subjects with major deviations or consent withdrawals; subjects which had no continuous monitoring data were also excluded. A total of 1336 patients were included in the derivation and validation of the tool.

Outcome measures

Outcome measures
Measure	Full Analysis Set n=1495 Participants Blinded Capnography Monitoring - All subjects enrolled
Determine Number of Subjects With RD While on Opioid Therapy No RD	840 Participants
Determine Number of Subjects With RD While on Opioid Therapy RD	655 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: A modified dataset (mFAS) was used to derive and validate the risk assessment tool. Subjects excluded from the mFAS had major deviations or consent withdrawals or had no continuous monitoring data.

A risk assessment tool will be derived and validated using the incidence of RD episodes captured by continuous capnography and pulse oximetry measurements recorded on the Capnostream device memory data in conjunction with the clinical data as reported by the investigator.

Outcome measures

Outcome measures
Measure	Full Analysis Set n=1266 Participants Blinded Capnography Monitoring - All subjects enrolled
To Derive and Validate a Risk Assessment Tool to Identify Subjects at Risk of Having RD While Undergoing Opioid Therapy on the Hospital Ward Low Risk for RD	351 Participants
To Derive and Validate a Risk Assessment Tool to Identify Subjects at Risk of Having RD While Undergoing Opioid Therapy on the Hospital Ward Intermediate Risk for RD	457 Participants
To Derive and Validate a Risk Assessment Tool to Identify Subjects at Risk of Having RD While Undergoing Opioid Therapy on the Hospital Ward High Risk for RD	458 Participants

Adverse Events

Blinded Capnography Monitoring

Serious events: 145 serious events

Other events: 181 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Blinded Capnography Monitoring n=1495 participants at risk Subjects were clinically monitored through standard methods (standard clinical practice at the site), as well as with continuous data collection from the Capnostream monitor for a maximum of 48 hours. The monitoring period started for subjects once they arrived on the ward, for those subjects where opioid therapy was initiated prior to arrival on the hospital ward. Monitoring was permitted to be discontinued after a minimum of 4 hours from the last dose of opioid therapy received or if the subject was discharged from the hospital ward. No treatments were administered for this study. This study was observational in nature for all subjects. The capnography monitor served primarily as a data collection method. The capnography monitor screen was blinded, and alarms silenced for all subjects.
Cardiac disorders Arrythmia	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Cardiac disorders Atrial Fibrillation	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Cardiac disorders Atrial Tachycardia	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Cardiac disorders Bradycardia	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Cardiac disorders Cardiac Failure	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Cardiac disorders Cardiac Failure Congestive	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Cardiac disorders Coronary Artery Disease	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Congenital, familial and genetic disorders Pyloric Stenosis	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Gastrointestinal disorders Abdominal Hernia	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Gastrointestinal disorders Abdominal Pain	0.20% 3/1495 • Number of events 3 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Gastrointestinal disorders Ascites	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Gastrointestinal disorders Colitis Ulcerative	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Gastrointestinal disorders Constipation	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Gastrointestinal disorders Duodenal Ulcer	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Gastrointestinal disorders Enterocutaneous fistula	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Gastrointestinal disorders Gastrointestinal Wall Thickening	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Gastrointestinal disorders Ileus	0.40% 6/1495 • Number of events 6 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Gastrointestinal disorders Impaired Gastric Emptying	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Gastrointestinal disorders Intestinal obstruction	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Gastrointestinal disorders Pancreatitis Acute	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Gastrointestinal disorders Peritoneal Haemorrhage	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Gastrointestinal disorders Small Intestinal Obstruction	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Gastrointestinal disorders Subileus	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
General disorders Adverse drug reaction	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
General disorders Chest Pain	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
General disorders Oedema peripheral	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
General disorders Systematic inflammatory response syndrome	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Hepatobiliary disorders Hepatic Function Abnormal	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Hepatobiliary disorders Portal Vein Thrombosis	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Abdominal Abscess	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Abdominal Infection	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Abdominal wall abscess	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Abscess	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Abscess soft tissue	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Cellulitis	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Colonic Abscess	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Device related infection	0.20% 3/1495 • Number of events 3 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Incision Site Cellulitis	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Infection	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Perineal Abscess	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Peritonitis	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Pneumonia	0.54% 8/1495 • Number of events 8 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Post Procedural Infection	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Post Procedural Sepsis	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Postoperative Wound Infection	0.40% 6/1495 • Number of events 6 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Polynephritis Acute	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Sepsis	0.20% 3/1495 • Number of events 3 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Sepsis Syndrome	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Staphylococcal Infection	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Stoma Site Cellulitis	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Urinary Tract Infection	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Urosepsis	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Viral Upper Respiratory Tract Infection	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Wound Abscess	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Infections and infestations Wound Infection	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Injury, poisoning and procedural complications Anastomotic complication	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Injury, poisoning and procedural complications Anastomotic lead	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Injury, poisoning and procedural complications Arterial injury	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Injury, poisoning and procedural complications Infusion related reaction	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Injury, poisoning and procedural complications Joint Dislocation	0.20% 3/1495 • Number of events 3 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Injury, poisoning and procedural complications Pancreatic Leak	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Injury, poisoning and procedural complications Post procedural bile leak	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Injury, poisoning and procedural complications Post Procedural complication	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Injury, poisoning and procedural complications Post procedural haematoma	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Injury, poisoning and procedural complications Postoperative ileus	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Injury, poisoning and procedural complications Procedural complication	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Injury, poisoning and procedural complications Procedural Pain	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Injury, poisoning and procedural complications Procedural Vomiting	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Injury, poisoning and procedural complications Seroma	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Injury, poisoning and procedural complications Stoma Site ischaemia	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Injury, poisoning and procedural complications Wound Complication	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Injury, poisoning and procedural complications Wound evisceration	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Investigations Breath sounds abnormal	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Investigations Liver Function Test Abnormal	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Investigations Oxygen Saturation decreased	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Metabolism and nutrition disorders Hypercalcaemia	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Metabolism and nutrition disorders Hyperglycaemia	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Investigations Hypokalaemia	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Metabolism and nutrition disorders Hypomagnesaemia	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Metabolism and nutrition disorders Metabolic acidosis	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Musculoskeletal and connective tissue disorders Arthritis	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Musculoskeletal and connective tissue disorders Spinal instability	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Nervous system disorders Cerebral small vessel ischaemic disease	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Nervous system disorders Cerebrovascular accident	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Nervous system disorders Paraesthesia	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Nervous system disorders Somnolence	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Nervous system disorders Syncope	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Product Issues Device Disclocation	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Psychiatric disorders Delirium	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Renal and urinary disorders Haematuria	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Renal and urinary disorders Renal Injury	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Renal and urinary disorders Urinary retention	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Reproductive system and breast disorders Menorrhagia	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.20% 3/1495 • Number of events 3 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Respiratory, thoracic and mediastinal disorders Respiratory depression	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Surgical and medical procedures Colostomy closure	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Surgical and medical procedures Hospitalisation	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Surgical and medical procedures Wound closure	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Vascular disorders Deep vein thrombosis	0.07% 1/1495 • Number of events 1 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
Vascular disorders Hypotension	0.13% 2/1495 • Number of events 2 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.

Other adverse events

Other adverse events
Measure	Blinded Capnography Monitoring n=1495 participants at risk Subjects were clinically monitored through standard methods (standard clinical practice at the site), as well as with continuous data collection from the Capnostream monitor for a maximum of 48 hours. The monitoring period started for subjects once they arrived on the ward, for those subjects where opioid therapy was initiated prior to arrival on the hospital ward. Monitoring was permitted to be discontinued after a minimum of 4 hours from the last dose of opioid therapy received or if the subject was discharged from the hospital ward. No treatments were administered for this study. This study was observational in nature for all subjects. The capnography monitor served primarily as a data collection method. The capnography monitor screen was blinded, and alarms silenced for all subjects.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.1% 17/1495 • Number of events 20 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.
General disorders Medical Device Discomfort	11.2% 167/1495 • Number of events 168 • 1 month (+/- 10 days) ISO 14155:2001 definitions were applied to this study. Adverse Event rates for subjects with and without RD were characterized and compared. All subjects were considered in the Adverse Event evaluations (Full Analysis Dataset, 1495). Adverse Events were collecte if they had an underlying respiratory cause, was an adverse device effect (ADE) or was a Serious Adverse Event.

Additional Information

Melanie Crystal, Sr. Clinical Program Manager

Medtronic - MITG, RGI

Phone: 720-435-5737

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place