Trial Outcomes & Findings for Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease (NCT NCT00642616)
NCT ID: NCT00642616
Last Updated: 2017-04-14
Results Overview
Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is measured at the pulmonary function laboratory.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
34 participants
Primary outcome timeframe
52 Weeks
Results posted on
2017-04-14
Participant Flow
A total of 517 participants were screened in 5 countries . First participant was screened in March 2009.
2 week screening period followed by a 2 week run-in period. After the screening period, 51 participants were randomized and 34 participants met eligibility criteria after the 2 week run-in period and were treated . Study was terminated based on data safety monitoring board recommendations.
Participant milestones
| Measure |
Technosphere® Insulin (Asthma)
Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
|
Usual Care (Asthma)
Usual and anti diabetic care in diabetic participants with Asthma.
|
Technosphere® Insulin (COPD)
Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
|
Usual Care (COPD)
Usual and anti diabetic care in diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
9
|
8
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
9
|
7
|
Reasons for withdrawal
| Measure |
Technosphere® Insulin (Asthma)
Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
|
Usual Care (Asthma)
Usual and anti diabetic care in diabetic participants with Asthma.
|
Technosphere® Insulin (COPD)
Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
|
Usual Care (COPD)
Usual and anti diabetic care in diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
7
|
6
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Technosphere® Insulin (Asthma)
n=9 Participants
Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic patients with Asthma
|
Usual Care (Asthma)
n=8 Participants
Usual and anti diabetic care in diabetic participants with Asthma.
|
Technosphere® Insulin (COPD)
n=9 Participants
Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic patients with COPD
|
Usual Care (COPD)
n=8 Participants
Usual and anti diabetic care in diabetic participants with COPD.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
69.00 years
STANDARD_DEVIATION 7.26 • n=113 Participants
|
49.75 years
STANDARD_DEVIATION 15.73 • n=163 Participants
|
67.44 years
STANDARD_DEVIATION 8.38 • n=160 Participants
|
68.88 years
STANDARD_DEVIATION 8.20 • n=483 Participants
|
64.03 years
STANDARD_DEVIATION 12.71 • n=36 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=113 Participants
|
4 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
1 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=113 Participants
|
4 Participants
n=163 Participants
|
7 Participants
n=160 Participants
|
7 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 52 WeeksPopulation: Only two participants completed both time points (one in the Usual Care (Asthma) Arm and one in the Usual Care (COPD) Arm); data are not provided due to privacy concerns.
Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is measured at the pulmonary function laboratory.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Safety population: Participants who received at least one dose of study medication. The outcome applies only to participants with underlying Asthma
Number of participants who experienced worsening of asthma symptoms
Outcome measures
| Measure |
Technosphere® Insulin (Asthma)
n=9 Participants
Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
|
Usual Care (Asthma)
n=8 Participants
Usual and anti diabetic care in diabetic participants with Asthma.
|
Technosphere® Insulin (COPD)
Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
|
Usual Care (COPD)
Usual and anti diabetic care in diabetic participants with COPD
|
|---|---|---|---|---|
|
Number of Participants With Asthma Exacerbation by Treatment Arm
Exacerbation of Asthma
|
1 participants
|
1 participants
|
—
|
—
|
|
Number of Participants With Asthma Exacerbation by Treatment Arm
No Exacerbation of Asthma
|
8 participants
|
7 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Safety population: Participants who received at least one dose of study medication. The outcome applies only to participants with underlying COPD
Number of participants who experienced worsening of COPD symptoms
Outcome measures
| Measure |
Technosphere® Insulin (Asthma)
Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
|
Usual Care (Asthma)
Usual and anti diabetic care in diabetic participants with Asthma.
|
Technosphere® Insulin (COPD)
n=9 Participants
Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
|
Usual Care (COPD)
n=8 Participants
Usual and anti diabetic care in diabetic participants with COPD
|
|---|---|---|---|---|
|
Number of Participants With COPD Exacerbation by Treatment Arm
COPD Exacerbation
|
—
|
—
|
3 participants
|
1 participants
|
|
Number of Participants With COPD Exacerbation by Treatment Arm
No Exacerbation
|
—
|
—
|
6 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Baseline, week 52Population: Only two participants completed both time points (one in the Usual Care (Asthma) Arm and one in the Usual Care (COPD) Arm); data are not provided due to privacy concerns
Outcome measures
Outcome data not reported
Adverse Events
Technosphere® Insulin (Asthma)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Usual Care With Anti-diabetic Agents (Asthma)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Technosphere® Insulin (COPD)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Usual Care With Anti-diabetic Agents (COPD)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Technosphere® Insulin (Asthma)
n=9 participants at risk
Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
|
Usual Care With Anti-diabetic Agents (Asthma)
n=8 participants at risk
Usual anti diabetic care in diabetic participants with Asthma
|
Technosphere® Insulin (COPD)
n=9 participants at risk
Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
|
Usual Care With Anti-diabetic Agents (COPD)
n=8 participants at risk
Usual anti diabetic care in diabetic participants with COPD
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Gastrointestinal disorders
Intestinal obstruction
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
Other adverse events
| Measure |
Technosphere® Insulin (Asthma)
n=9 participants at risk
Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
|
Usual Care With Anti-diabetic Agents (Asthma)
n=8 participants at risk
Usual anti diabetic care in diabetic participants with Asthma
|
Technosphere® Insulin (COPD)
n=9 participants at risk
Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
|
Usual Care With Anti-diabetic Agents (COPD)
n=8 participants at risk
Usual anti diabetic care in diabetic participants with COPD
|
|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
22.2%
2/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
22.2%
2/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
37.5%
3/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
22.2%
2/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Infections and infestations
Influenza
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
General disorders
Influenza like illness
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal spasm
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Infections and infestations
Respiratory tract infection
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Infections and infestations
Respiratory tract infection viral
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
General disorders
Asthenia
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Vascular disorders
Hot flush
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Investigations
Pulmonary function test decreased
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Infections and infestations
Tracheitis
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Metabolism and nutrition disorders
Type 1 Diabetes Mellitus
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
25.0%
2/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Infections and infestations
Viral infection
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
33.3%
3/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
General disorders
Chest discomfort
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Investigations
Monocyte count increased
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
11.1%
1/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Skin and subcutaneous tissue disorders
Echymosis
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
General disorders
Oedema peripheral
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
0.00%
0/9 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
12.5%
1/8 • All Adverse Events (AE) were collected from signature of the informed consent form up to 30 days after the last study visit or study related procedure was performed regardless of seriousness or relationship to investigational product
Analysis was done on safety population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MannKind has right to 1st joint multicenter publication. After 1st publication PI may publish data only if PI submits proposed publication to MNKD for review 60 days prior to publication date. MNKD may remove any confidential information. If a multicenter publication is not submitted 12 months after conclusion, abandonment, or termination of the Study at all sites, or if MNKD confirms there will be no multicenter Study publication, PI may publish the Study results subject to MNKD rights herein.
- Publication restrictions are in place
Restriction type: OTHER