Trial Outcomes & Findings for Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk" (NCT NCT01030861)
NCT ID: NCT01030861
Last Updated: 2020-08-05
Results Overview
Rate at which criteria are met for diabetes onset as defined by the American Diabetes Association (ADA) based on glucose testing or the presence of unequivocal hyperglycemia with acute metabolic decompensation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
During follow-up, median 745 days, range 74 to 2683
Results posted on
2020-08-05
Participant Flow
Participant milestones
| Measure |
Teplizumab
Intravenous infusions of teplizumab given for 14 consecutive days. Each infusion takes about 30 minutes and is followed by a 2 hour observation period.
Teplizumab: intravenous infusions
|
Placebo Infusion
Intravenous infusion of placebo (saline) will be given for 14 consecutive days. Infusions will take approximately 30 minutes and will be followed by a two hour observation period.
Placebo infusion: Placebo for Teplizumab
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
32
|
|
Overall Study
COMPLETED
|
44
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"
Baseline characteristics by cohort
| Measure |
Teplizumab
n=44 Participants
Intravenous infusions of teplizumab given for 14 consecutive days. Each infusion takes about 30 minutes and is followed by a 2 hour observation period.
Teplizumab: intravenous infusions
|
Placebo Infusion
n=32 Participants
Intravenous infusion of placebo (saline) will be given for 14 consecutive days. Infusions will take approximately 30 minutes and will be followed by a two hour observation period.
Placebo infusion: Placebo for Teplizumab
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14 years
n=5 Participants
|
13 years
n=7 Participants
|
13.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=7 Participants
|
2 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Relationship to person with type 1 diabetes
Sibling(s)
|
24 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Relationship to person with type 1 diabetes
Identical twin
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Relationship to person with type 1 diabetes
Offspring
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Relationship to person with type 1 diabetes
Parent
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Relationship to person with type 1 diabetes
Sibling and another first degree relative
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Relationship to person with type 1 diabetes
Second degree relative
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Relationship to person with type 1 diabetes
Third degree relative or further removed
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Autoantibodies Positive
Anti-GAD65 harmonized
|
40 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Autoantibodies Positive
Micro insulin
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Autoantibodies Positive
Anti-IA-2 harmonized
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Autoantibodies Positive
Islet Cell Cytoplasmic Autoantibodies (ICA)
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Autoantibodies Positive
Anti-ZnT8
|
32 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Glycated hemoglobin level
|
5.2 percentage of glycated hemoglobin
n=5 Participants
|
5.3 percentage of glycated hemoglobin
n=7 Participants
|
5.2 percentage of glycated hemoglobin
n=5 Participants
|
PRIMARY outcome
Timeframe: During follow-up, median 745 days, range 74 to 2683Population: Relatives of patients with type 1 diabetes who did not have diabetes but were at high risk for development of clinical disease.
Rate at which criteria are met for diabetes onset as defined by the American Diabetes Association (ADA) based on glucose testing or the presence of unequivocal hyperglycemia with acute metabolic decompensation.
Outcome measures
| Measure |
Teplizumab
n=44 Participants
Intravenous infusions of teplizumab given for 14 consecutive days. Each infusion takes about 30 minutes and is followed by a 2 hour observation period.
Teplizumab: intravenous infusions
|
Placebo Infusion
n=32 Participants
Intravenous infusion of placebo (saline) will be given for 14 consecutive days. Infusions will take approximately 30 minutes and will be followed by a two hour observation period.
Placebo infusion: Placebo for Teplizumab
|
|---|---|---|
|
Rate of New Diabetes Per Year
|
43 N diabetes per 100 participant years
|
72 N diabetes per 100 participant years
|
SECONDARY outcome
Timeframe: Baseline Visit to Diagnosis of Type 1 Diabetes median 745 days, range 74 to 2683Adverse events categorized and graded via CTCAE.
Outcome measures
| Measure |
Teplizumab
n=44 Participants
Intravenous infusions of teplizumab given for 14 consecutive days. Each infusion takes about 30 minutes and is followed by a 2 hour observation period.
Teplizumab: intravenous infusions
|
Placebo Infusion
n=32 Participants
Intravenous infusion of placebo (saline) will be given for 14 consecutive days. Infusions will take approximately 30 minutes and will be followed by a two hour observation period.
Placebo infusion: Placebo for Teplizumab
|
|---|---|---|
|
Number of Participants With Adverse Events
|
43 Participants
|
23 Participants
|
Adverse Events
Teplizumab
Serious events: 8 serious events
Other events: 43 other events
Deaths: 0 deaths
Placebo Infusion
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Teplizumab
n=44 participants at risk
Intravenous infusions of teplizumab given for 14 consecutive days. Each infusion takes about 30 minutes and is followed by a 2 hour observation period.
Teplizumab: intravenous infusions
|
Placebo Infusion
n=32 participants at risk
Intravenous infusion of placebo (saline) will be given for 14 consecutive days. Infusions will take approximately 30 minutes and will be followed by a two hour observation period.
Placebo infusion: Placebo for Teplizumab
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fracture
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Gastrointestinal disorders
Gastroenteritis
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Skin and subcutaneous tissue disorders
Infection - Skin
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Infections and infestations
Infection with unknown ANC
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Gastrointestinal disorders
Obstruction, GI
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Nervous system disorders
Dizziness
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Gastrointestinal disorders
Obstruction, GU
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Pain
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
Other adverse events
| Measure |
Teplizumab
n=44 participants at risk
Intravenous infusions of teplizumab given for 14 consecutive days. Each infusion takes about 30 minutes and is followed by a 2 hour observation period.
Teplizumab: intravenous infusions
|
Placebo Infusion
n=32 participants at risk
Intravenous infusion of placebo (saline) will be given for 14 consecutive days. Infusions will take approximately 30 minutes and will be followed by a two hour observation period.
Placebo infusion: Placebo for Teplizumab
|
|---|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
6.8%
3/44 • Number of events 4 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
4.5%
2/44 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Immune system disorders
Alpha-Gal Allergy
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
4.5%
2/44 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Blood and lymphatic system disorders
Lymphopenia
|
68.2%
30/44 • Number of events 73 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
6.2%
2/32 • Number of events 5 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
9.1%
4/44 • Number of events 4 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.8%
3/44 • Number of events 5 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Immune system disorders
Cytokine release syndrome/acute infusion reaction
|
2.3%
1/44 • Number of events 3 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Gastrointestinal disorders
Dental: periodontal disease
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
2/44 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
4.5%
2/44 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
4.5%
2/44 • Number of events 3 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
General disorders
Flu-like syndrome
|
4.5%
2/44 • Number of events 7 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
6.8%
3/44 • Number of events 6 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Gastrointestinal disorders
Stomach Pain
|
2.3%
1/44 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
2.3%
1/44 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Blood and lymphatic system disorders
Hemoglobin
|
4.5%
2/44 • Number of events 6 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Eye disorders
Vitreous hemorrhage
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Cardiac disorders
Hypertension
|
4.5%
2/44 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Infections and infestations
Infection with Normal ANC
|
27.3%
12/44 • Number of events 34 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
12.5%
4/32 • Number of events 13 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Infections and infestations
Infection with unknown ANC
|
11.4%
5/44 • Number of events 9 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 3 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
18.2%
8/44 • Number of events 13 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Blood and lymphatic system disorders
Leukocytes
|
4.5%
2/44 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Nervous system disorders
Mood alteration
|
4.5%
2/44 • Number of events 4 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
6.2%
2/32 • Number of events 6 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
9.4%
3/32 • Number of events 5 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Myositis (inflammation/damage of muscle)
|
2.3%
1/44 • Number of events 4 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
4.5%
2/44 • Number of events 4 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Gastrointestinal disorders
Nausea
|
4.5%
2/44 • Number of events 3 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Nervous system disorders
Cognitive Disturbance
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Nervous system disorders
Neuropathy: motor
|
2.3%
1/44 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
9.1%
4/44 • Number of events 5 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 6 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Gastrointestinal disorders
Obstruction, GI
|
2.3%
1/44 • Number of events 3 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Eye disorders
Ocular surface disease
|
4.5%
2/44 • Number of events 4 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
General disorders
Pain
|
22.7%
10/44 • Number of events 13 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
12.5%
4/32 • Number of events 6 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
9.1%
4/44 • Number of events 5 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory Infection
|
9.1%
4/44 • Number of events 5 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
29.5%
13/44 • Number of events 41 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
|
4.5%
2/44 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
2.3%
1/44 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Renal and urinary disorders
Kidney Stones
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Nervous system disorders
Seizure
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
2.3%
1/44 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Vascular disorders
Thrombosis
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
2/44 • Number of events 3 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
6.2%
2/32 • Number of events 3 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
General disorders
Weight gain
|
2.3%
1/44 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
0.00%
0/32 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
6.2%
2/32 • Number of events 3 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Reproductive system and breast disorders
Breast function/lactation
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
6.2%
2/32 • Number of events 4 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Cardiac disorders
Cardiac Arrhythmia - Other (Specify in Event Details)
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Cardiac disorders
Cardiac Arrhythmia
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Gastrointestinal disorders
Dental: teeth
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
6.2%
2/32 • Number of events 4 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Gastrointestinal disorders
Dental: teeth development
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
6.2%
2/32 • Number of events 3 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Eye disorders
Eyelid dysfunction
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Hepatobiliary disorders
Elevated Bilirubin
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Cardiac disorders
Hypotension
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Nervous system disorders
Neuropathy: sensory
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Ear and labyrinth disorders
Otitis, middle ear (non-infectious)
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Cardiac disorders
Palpitations
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Nervous system disorders
Personality/behavioral
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Vascular disorders
Phlebitis (including superficial thrombosis)
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 2 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/44 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
3.1%
1/32 • Number of events 1 • Adverse Event data were collected for individual participants, beginning with the Baseline Visit and ending with the documented Diagnosis of Type 1 Diabetes (the primary study endpoint), median 745 days, range 74 to 2683.
CTCAE
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place