Trial Outcomes & Findings for A Study of Arformoterol Tartrate Inhalation Solution and Tiotropium Bromide on Re-hospitalization in Chronic Obstructive Pulmonary Disease (COPD) Subjects (NCT NCT02275481)
NCT ID: NCT02275481
Last Updated: 2018-06-27
Results Overview
Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only summary tables and listings, disposition, demographics, vital signs, AEs and listings of safety data were generated.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
66 participants
Primary outcome timeframe
Up to 90 days
Results posted on
2018-06-27
Participant Flow
Before recruitment and enrollment, each prospective subject was given a full explanation of the study, allowed to read the approved informed consent form and was provided ample time and the opportunity to ask any questions that may have arose.
Once all questions had been answered and the Investigator was assured that the prospective subject understood the implications of participating in the study, the prospective subject was asked to give consent to participate in the study by signing the informed consent form.
Participant milestones
| Measure |
BROVANA
Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor
Arformoterol tartrate inhalation solution: Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor
|
SPIRIVA
Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
Tiotropium: Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
34
|
|
Overall Study
COMPLETED
|
23
|
31
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
| Measure |
BROVANA
Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor
Arformoterol tartrate inhalation solution: Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor
|
SPIRIVA
Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
Tiotropium: Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
|
|---|---|---|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
all other reasons combined
|
2
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
A Study of Arformoterol Tartrate Inhalation Solution and Tiotropium Bromide on Re-hospitalization in Chronic Obstructive Pulmonary Disease (COPD) Subjects
Baseline characteristics by cohort
| Measure |
BROVANA
n=32 Participants
Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor
Arformoterol tartrate inhalation solution: Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor
|
SPIRIVA
n=34 Participants
Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
Tiotropium: Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Age, Continuous
|
71.9 years
STANDARD_DEVIATION 6.86 • n=99 Participants
|
72.1 years
STANDARD_DEVIATION 6.65 • n=107 Participants
|
72.0 years
STANDARD_DEVIATION 6.70 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 90 daysPopulation: Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol.
Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only summary tables and listings, disposition, demographics, vital signs, AEs and listings of safety data were generated.
Outcome measures
Outcome data not reported
Adverse Events
BROVANA
Serious events: 15 serious events
Other events: 19 other events
Deaths: 2 deaths
SPIRIVA
Serious events: 13 serious events
Other events: 23 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
BROVANA
n=32 participants at risk
Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor
Arformoterol tartrate inhalation solution: Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor
|
SPIRIVA
n=34 participants at risk
Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
Tiotropium: Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
|
|---|---|---|
|
Cardiac disorders
atrial fibrillation
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Cardiac disorders
cardiac failure
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Cardiac disorders
cardia failure congestive
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Cardiac disorders
supraventricular tachycardia
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
5.9%
2/34 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
|
Gastrointestinal disorders
impaired gastric emptying
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Gastrointestinal disorders
intestinal obstruction
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
General disorders
death
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Infections and infestations
acute sinusitis
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Infections and infestations
clostridium difficile colitis
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Infections and infestations
escherichia urinary tract infection
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Infections and infestations
pneumonia
|
18.8%
6/32 • Number of events 6 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Infections and infestations
pneumonia pneumococcal
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Infections and infestations
sepsis
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Infections and infestations
septic shock
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Infections and infestations
streptococcal bacteraemia
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Infections and infestations
upper respiratory tract infection
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Investigations
blood testosterone decreased
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
5.9%
2/34 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
|
Metabolism and nutrition disorders
hyponatraemia
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Nervous system disorders
metabolic encephalopathy
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Renal and urinary disorders
renal failure acute
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory distress syndrome
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
3.1%
1/32 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
bronchiectasis
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
31.2%
10/32 • Number of events 13 • The AE reporting period lasts ~ 19 months
|
29.4%
10/34 • Number of events 13 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
chronic respiratory failure
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
9.4%
3/32 • Number of events 3 • The AE reporting period lasts ~ 19 months
|
5.9%
2/34 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
|
Skin and subcutaneous tissue disorders
dermal cyst
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
Other adverse events
| Measure |
BROVANA
n=32 participants at risk
Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor
Arformoterol tartrate inhalation solution: Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor
|
SPIRIVA
n=34 participants at risk
Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
Tiotropium: Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
|
|---|---|---|
|
Blood and lymphatic system disorders
anaemia
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
|
Blood and lymphatic system disorders
leukocytosis
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Blood and lymphatic system disorders
normochromic normocytic anaemia
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Cardiac disorders
artial fibrillation
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Cardiac disorders
cardiac failure congestive
|
6.2%
2/32 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Cardiac disorders
myocardial infarction
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Cardiac disorders
tachycardia
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Eye disorders
dry eye
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Gastrointestinal disorders
abdominal distension
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Gastrointestinal disorders
abdominal pain
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Gastrointestinal disorders
consitpation
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
11.8%
4/34 • Number of events 4 • The AE reporting period lasts ~ 19 months
|
|
Gastrointestinal disorders
diarrhoea
|
9.4%
3/32 • Number of events 3 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
5.9%
2/34 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
|
Gastrointestinal disorders
dysphagia
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Gastrointestinal disorders
flatulence
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Gastrointestinal disorders
gastrooesophageal reflux disease
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Gastrointestinal disorders
haematemesis
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Gastrointestinal disorders
nausea
|
6.2%
2/32 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
5.9%
2/34 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
|
Gastrointestinal disorders
toothache
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
General disorders
asthenia
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
5.9%
2/34 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
|
General disorders
chest discomfort
|
6.2%
2/32 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
General disorders
fatigue
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
8.8%
3/34 • Number of events 3 • The AE reporting period lasts ~ 19 months
|
|
General disorders
generalised oedema
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
General disorders
non-cardiac chest pain
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
5.9%
2/34 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
|
General disorders
odema peripheral
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
General disorders
pyrexia
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
5.9%
2/34 • Number of events 3 • The AE reporting period lasts ~ 19 months
|
|
Hepatobiliary disorders
cholelithiasis
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
|
Infections and infestations
acute sinusitis
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
5.9%
2/34 • Number of events 3 • The AE reporting period lasts ~ 19 months
|
|
Infections and infestations
bronchitis
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
5.9%
2/34 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
|
Infections and infestations
cellulitis
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Infections and infestations
oral candidiasis
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Infections and infestations
pneumonia
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Infections and infestations
sepsis
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Infections and infestations
sinusitis
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Infections and infestations
urinary tract infection
|
6.2%
2/32 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
|
Injury, poisoning and procedural complications
arthropod sting
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Injury, poisoning and procedural complications
contusion
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
8.8%
3/34 • Number of events 3 • The AE reporting period lasts ~ 19 months
|
|
Injury, poisoning and procedural complications
fall
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
8.8%
3/34 • Number of events 3 • The AE reporting period lasts ~ 19 months
|
|
Injury, poisoning and procedural complications
laceration
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 4 • The AE reporting period lasts ~ 19 months
|
|
Injury, poisoning and procedural complications
wound
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Investigations
brain natriuretic peptide increased
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Investigations
oxygen saturation decreased
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Investigations
troponin increased
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Investigations
white blood cell count increased
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Metabolism and nutrition disorders
gout
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Metabolism and nutrition disorders
hyperglycaemia
|
6.2%
2/32 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
11.8%
4/34 • Number of events 5 • The AE reporting period lasts ~ 19 months
|
|
Metabolism and nutrition disorders
hyperkalaemia
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Metabolism and nutrition disorders
hypocalcaemia
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Metabolism and nutrition disorders
hypokalaemia
|
6.2%
2/32 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
5.9%
2/34 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
|
Metabolism and nutrition disorders
hypomagnesaemia
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Metabolism and nutrition disorders
lactic acidosis
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Metabolism and nutrition disorders
malnutrition
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Metabolism and nutrition disorders
type 2 diabetes mellitus
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
5.9%
2/34 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
|
Musculoskeletal and connective tissue disorders
joint swelling
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
3.1%
1/32 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
5.9%
2/34 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
|
Nervous system disorders
dizziness
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Nervous system disorders
headache
|
6.2%
2/32 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
8.8%
3/34 • Number of events 3 • The AE reporting period lasts ~ 19 months
|
|
Nervous system disorders
mental iimpairment
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Nervous system disorders
migraine
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Nervous system disorders
parkinson's disease
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Psychiatric disorders
confusional state
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
5.9%
2/34 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
|
Psychiatric disorders
delirium
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Psychiatric disorders
insomnia
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
5.9%
2/34 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
|
Psychiatric disorders
mental status changes
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Renal and urinary disorders
renial failure acute
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Renal and urinary disorders
renal infarct
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
aspiration
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
28.1%
9/32 • Number of events 11 • The AE reporting period lasts ~ 19 months
|
23.5%
8/34 • Number of events 9 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 3 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
17.6%
6/34 • Number of events 6 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea exertional
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
hypercapnia
|
6.2%
2/32 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
8.8%
3/34 • Number of events 3 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
respiratory acidosis
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 2 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhoea
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
sneezing
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
11.8%
4/34 • Number of events 4 • The AE reporting period lasts ~ 19 months
|
|
Skin and subcutaneous tissue disorders
pruritus generalised
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
|
Skin and subcutaneous tissue disorders
purpura
|
0.00%
0/32 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Skin and subcutaneous tissue disorders
rash
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
2.9%
1/34 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
|
Vascular disorders
deep vein thrombosis
|
3.1%
1/32 • Number of events 1 • The AE reporting period lasts ~ 19 months
|
0.00%
0/34 • The AE reporting period lasts ~ 19 months
|
Additional Information
Respiratory Medical Director
Sunovion Pharmaceuticals Inc.
Phone: 1-866-503-6351
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming with twenty-four (24) months following completion of the study at all sites, institution and investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER