Trial Outcomes & Findings for Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20) (NCT NCT02580877)
NCT ID: NCT02580877
Last Updated: 2020-07-27
Results Overview
Change in T-lymphocyte (GAD65) biomarker of beta cell specific immune response
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
92 participants
Primary outcome timeframe
13 and 26 weeks after first dose versus baseline
Results posted on
2020-07-27
Participant Flow
Participant milestones
| Measure |
67.5 mg Oral Insulin Crystals Daily
67.5 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given daily for six months
67.5 mg oral insulin crystals daily: human insulin crystals in capsules
|
500 mg Oral Insulin Crystals Every Other Week
500 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given every other week for six months
500 mg oral insulin crystals every other week: human insulin crystals in capsules
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
47
|
|
Overall Study
COMPLETED
|
44
|
43
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
67.5 mg Oral Insulin Crystals Daily
67.5 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given daily for six months
67.5 mg oral insulin crystals daily: human insulin crystals in capsules
|
500 mg Oral Insulin Crystals Every Other Week
500 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given every other week for six months
500 mg oral insulin crystals every other week: human insulin crystals in capsules
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)
Baseline characteristics by cohort
| Measure |
67.5 mg Oral Insulin Crystals Daily
n=45 Participants
67.5 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given daily for six months
67.5 mg oral insulin crystals daily: human insulin crystals in capsules
|
500mg Oral Insulin Crystals Every Other Week
n=47 Participants
500 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given every other week for six months
500mg oral insulin crystals every other week: human insulin crystals in capsules
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.9 years
n=5 Participants
|
7.9 years
n=7 Participants
|
8.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Relationship to person with type 1 diabetes
Sibling
|
34 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Relationship to person with type 1 diabetes
Parent
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Relationship to person with type 1 diabetes
Child
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Relationship to person with type 1 diabetes
Other
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Glucose Tolerance
Normal Glucose Tolerance
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Glucose Tolerance
Abnormal Glucose Tolerance
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
HLA DR3
Absent
|
31 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
HLA DR3
Present
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
HLA DR3
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
HLA DR4
Absent
|
22 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
HLA DR4
Present
|
23 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
HLA DR4
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 13 and 26 weeks after first dose versus baselineChange in T-lymphocyte (GAD65) biomarker of beta cell specific immune response
Outcome measures
| Measure |
67.5 mg Oral Insulin Crystals Daily
n=45 Participants
67.5 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given daily for six months
67.5 mg oral insulin crystals daily: human insulin crystals in capsules
|
500 mg Oral Insulin Crystals Every Other Week
n=47 Participants
500 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given every other week for six months
500 mg oral insulin crystals every other week: human insulin crystals in capsules
|
|---|---|---|
|
Change in GAD65 Autoantibody Titer (DK Units/mL)
26 weeks
|
193 DK Units/mL
Interval 118.0 to 313.0
|
196 DK Units/mL
Interval 121.0 to 318.0
|
|
Change in GAD65 Autoantibody Titer (DK Units/mL)
13 weeks
|
247 DK Units/mL
Interval 168.0 to 363.0
|
234 DK Units/mL
Interval 138.0 to 396.0
|
PRIMARY outcome
Timeframe: 13 and 26 weeks after first dose versus baselineMicro-islet autoantibodies (mIAA) autoantibody titers are a measure of of beta cell immune response
Outcome measures
| Measure |
67.5 mg Oral Insulin Crystals Daily
n=45 Participants
67.5 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given daily for six months
67.5 mg oral insulin crystals daily: human insulin crystals in capsules
|
500 mg Oral Insulin Crystals Every Other Week
n=47 Participants
500 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given every other week for six months
500 mg oral insulin crystals every other week: human insulin crystals in capsules
|
|---|---|---|
|
Change in mIAA Autoantibody Titer From Baseline
13 weeks
|
0.021 DK Units/mL
Interval 0.016 to 0.028
|
0.020 DK Units/mL
Interval 0.015 to 0.028
|
|
Change in mIAA Autoantibody Titer From Baseline
26 weeks
|
0.020 DK Units/mL
Interval 0.015 to 0.028
|
0.017 DK Units/mL
Interval 0.013 to 0.023
|
Adverse Events
67.5 mg Oral Insulin Crystals Daily
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
500 mg Oral Insulin Crystals Every Other Week
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
67.5 mg Oral Insulin Crystals Daily
n=45 participants at risk
67.5 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given daily for six months
67.5 mg oral insulin crystals daily: human insulin crystals in capsules
|
500 mg Oral Insulin Crystals Every Other Week
n=47 participants at risk
500 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given every other week for six months
500 mg oral insulin crystals every other week: human insulin crystals in capsules
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/47 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/45 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/45 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
8.5%
4/47 • Number of events 5 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
2.2%
1/45 • Number of events 2 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/47 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Endocrine disorders
Hypothyroidism
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/47 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/45 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/45 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/45 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Gastrointestinal disorders
Toothache
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/47 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Gastrointestinal disorders
Vomiting
|
8.9%
4/45 • Number of events 4 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
4.3%
2/47 • Number of events 2 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
General disorders
Fever
|
8.9%
4/45 • Number of events 6 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
General disorders
Flu like symptoms
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/47 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/45 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/45 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/45 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Infections and infestations
Bronchial infection
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Infections and infestations
Infections and infestations - Other, specify
|
8.9%
4/45 • Number of events 5 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
4.3%
2/47 • Number of events 2 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Infections and infestations
Lung infection
|
0.00%
0/45 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 2 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Infections and infestations
Otitis externa
|
0.00%
0/45 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Infections and infestations
Otitis media
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
4.3%
2/47 • Number of events 2 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Infections and infestations
Pharyngitis
|
15.6%
7/45 • Number of events 10 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
4.3%
2/47 • Number of events 2 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Infections and infestations
Sinusitis
|
8.9%
4/45 • Number of events 5 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/47 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/45 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Infections and infestations
Tooth infection
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/47 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Infections and infestations
Upper respiratory infection
|
6.7%
3/45 • Number of events 3 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
4.3%
2/47 • Number of events 2 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/45 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/45 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Investigations
Neutrophil count decreased
|
8.9%
4/45 • Number of events 7 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
8.5%
4/47 • Number of events 8 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Investigations
White blood cell decreased
|
2.2%
1/45 • Number of events 2 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/45 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/47 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Nervous system disorders
Headache
|
0.00%
0/45 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/45 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/47 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/47 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/47 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
4.4%
2/45 • Number of events 2 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/47 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.9%
4/45 • Number of events 4 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 2 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/47 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/47 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/47 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
2.2%
1/45 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
6.7%
3/45 • Number of events 4 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
2.1%
1/47 • Number of events 1 • Adverse events were collected over 1 year
Adverse Events were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place