Trial Outcomes & Findings for Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes (NCT NCT00378508)
NCT ID: NCT00378508
Last Updated: 2021-08-13
Results Overview
C-peptide secretory response was calculated as ln\[(Area Under the Curve of the C-peptide from the 240 minute MMTT/240 +1\] For presentation, the C-peptide data were converted to the AUC as pmol/ml. This is adjusted for baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
At month 12 post-treatment
Results posted on
2021-08-13
Participant Flow
Subjects were recruited from 4 clinical sites and were eligible if they were between the ages of 8-30 and diagnosed with Type 1 Diabetes for at least 4 months, but not more than 12 months prior to enrollment.
Participant milestones
| Measure |
Saline Infusions (Placebo)
The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
Teplizumab Infusion (Active)
The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
34
|
|
Overall Study
Randomized
|
29
|
34
|
|
Overall Study
Received Intervention/Placebo
|
28
|
31
|
|
Overall Study
COMPLETED
|
27
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Saline Infusions (Placebo)
The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
Teplizumab Infusion (Active)
The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Saline Infusions (Placebo)
n=27 Participants
The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
Teplizumab Infusions (Active)
n=31 Participants
The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<15 years
|
20 participants
n=5 Participants
|
18 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Age, Customized
>=15 years
|
7 participants
n=5 Participants
|
13 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
10 participants
n=5 Participants
|
15 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At month 12 post-treatmentPopulation: This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)
C-peptide secretory response was calculated as ln\[(Area Under the Curve of the C-peptide from the 240 minute MMTT/240 +1\] For presentation, the C-peptide data were converted to the AUC as pmol/ml. This is adjusted for baseline.
Outcome measures
| Measure |
Teplizumab Infusions (Active)
n=31 Participants
The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
Saline Infusions (Placebo)
n=27 Participants
The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
|---|---|---|
|
C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at 12 Months
|
0.451 pmol/ml
Interval 0.4 to 0.505
|
0.371 pmol/ml
Interval 0.319 to 0.424
|
PRIMARY outcome
Timeframe: At Baseline (before treatment)Population: This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)
C-peptide secretory response was calculated as ln\[(Area Under the Curve of the C-peptide from the 240 minute MMTT/240 +1\] For presentation, the C-peptide data were converted to the AUC as pmol/ml. This baseline data was used to adjust for the C-peptide AUC primary endpoint measure at 12 months.
Outcome measures
| Measure |
Teplizumab Infusions (Active)
n=31 Participants
The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
Saline Infusions (Placebo)
n=27 Participants
The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
|---|---|---|
|
C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at Baseline
|
0.593 pmol/ml
Interval 0.493 to 0.699
|
0.554 pmol/ml
Interval 0.417 to 0.705
|
SECONDARY outcome
Timeframe: At 12 months post-treatmentOutcome measures
| Measure |
Teplizumab Infusions (Active)
n=31 Participants
The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
Saline Infusions (Placebo)
n=27 Participants
The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
|---|---|---|
|
Hemoglobin A1c
|
6.85 percentage of hemogloblin A1c
Interval 6.47 to 7.23
|
7.35 percentage of hemogloblin A1c
Interval 6.87 to 7.83
|
SECONDARY outcome
Timeframe: After 12 months post-treatmentPopulation: This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)
Outcome measures
| Measure |
Teplizumab Infusions (Active)
n=31 Participants
The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
Saline Infusions (Placebo)
n=27 Participants
The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
|---|---|---|
|
Average Insulin Use Over 12 Months
|
0.475 U/kg/d
Interval 0.428 to 0.521
|
0.574 U/kg/d
Interval 0.0526 to 0.622
|
SECONDARY outcome
Timeframe: At baseline (before treatment)Population: This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)
Outcome measures
| Measure |
Teplizumab Infusions (Active)
n=31 Participants
The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
Saline Infusions (Placebo)
n=27 Participants
The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
|---|---|---|
|
Baseline Insulin Use
|
0.405 U/kg/d
Interval 0.354 to 0.456
|
0.386 U/kg/d
Interval 0.308 to 0.464
|
SECONDARY outcome
Timeframe: At baseline (before treatment)Outcome measures
| Measure |
Teplizumab Infusions (Active)
n=31 Participants
The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
Saline Infusions (Placebo)
n=27 Participants
The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
|---|---|---|
|
Baseline Hemoglobin A1c
|
6.32 percentage of hemoglobin A1c
Interval 6.04 to 6.6
|
7.1 percentage of hemoglobin A1c
Interval 6.66 to 7.64
|
Adverse Events
Saline Infusions (Placebo)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Teplizumab Infusion (Active)
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Saline Infusions (Placebo)
n=29 participants at risk
The course of a saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
Teplizumab Infusion (Active)
n=34 participants at risk
The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
|---|---|---|
|
Immune system disorders
Drug Related Hypersensitivity
|
0.00%
0/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
3.0%
1/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
Other adverse events
| Measure |
Saline Infusions (Placebo)
n=29 participants at risk
The course of a saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
Teplizumab Infusion (Active)
n=34 participants at risk
The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Discomfort
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
2.9%
1/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.7%
6/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
8.8%
3/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Gastrointestinal disorders
Abdominal Pain (Upper)
|
31.0%
9/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
5.9%
2/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.4%
1/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
5.9%
2/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
10.3%
3/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
11.8%
4/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Alanine Aminotransferase Decreased
|
0.00%
0/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
5.9%
2/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Alanine Aminotransferase Increased
|
17.2%
5/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
14.7%
5/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Psychiatric disorders
Anxiety
|
34.5%
10/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
32.4%
11/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Gastrointestinal disorders
Aphthous Stomatitis
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
2.9%
1/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.8%
4/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
8.8%
3/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
2.9%
1/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Aspartate Aminotransferase Increased
|
17.2%
5/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
11.8%
4/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Blood Albumin Decreased
|
24.1%
7/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
20.6%
7/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
10.3%
3/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
8.8%
3/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Blood Bicarbonate Decreased
|
10.3%
3/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
2.9%
1/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Blood Calcium Decreased
|
3.4%
1/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
8.8%
3/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Blood Calcium Increased
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
0.00%
0/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Blood Creatinine Increased
|
13.8%
4/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
5.9%
2/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Blood Potassium Decreased
|
0.00%
0/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
5.9%
2/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Blood Sodium Decreased
|
13.8%
4/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
5.9%
2/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Blood Urea Increased
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
0.00%
0/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Carbon Dioxide Abnormal
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
0.00%
0/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Cardiac Murmur
|
0.00%
0/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
5.9%
2/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
General disorders
Catheter Related Complication
|
10.3%
3/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
2.9%
1/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
General disorders
Catheter Site Pain
|
10.3%
3/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
0.00%
0/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
General disorders
Catheter Site Rash
|
10.3%
3/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
2.9%
1/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
General disorders
Chills
|
3.4%
1/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
8.8%
3/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Eye disorders
Conjunctivitis
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
2.9%
1/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Gastrointestinal disorders
Constipation
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
0.00%
0/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.4%
1/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
11.8%
4/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.8%
4/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
11.8%
4/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Immune system disorders
Cytokine Release Syndrome
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
2.9%
1/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Gastrointestinal disorders
Diarrhea
|
20.7%
6/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
8.8%
3/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Nervous system disorders
Dizziness
|
17.2%
5/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
11.8%
4/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.4%
1/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
11.8%
4/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
5.9%
2/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
General disorders
Edema Peripheral
|
0.00%
0/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
8.8%
3/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
2.9%
1/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Injury, poisoning and procedural complications
Excoriation
|
13.8%
4/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
5.9%
2/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
General disorders
Fatigue
|
10.3%
3/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
23.5%
8/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Gamma-glutamyltransferase Increased
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
2.9%
1/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Glycosylated Hemoglobin Increased
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
8.8%
3/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Nervous system disorders
Headache
|
69.0%
20/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
44.1%
15/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Renal and urinary disorders
Hematuria
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
0.00%
0/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Hemoglobin Decreased
|
24.1%
7/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
29.4%
10/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
5.9%
2/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.3%
3/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
8.8%
3/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.3%
3/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
17.6%
6/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
0.00%
0/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Vascular disorders
Hypotension
|
10.3%
3/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
5.9%
2/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
General disorders
Influenza Like Illness
|
24.1%
7/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
12.1%
4/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
International Normalized Ratio Increased
|
13.8%
4/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
6.1%
2/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Renal and urinary disorders
Ketonuria
|
10.3%
3/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
0.00%
0/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Laboratory Test Abnormal
|
10.3%
3/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
3.0%
1/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Blood and lymphatic system disorders
Leukopenia
|
31.0%
9/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
30.3%
10/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
3.4%
1/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
9.1%
3/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
15.2%
5/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Lymphocyte Count Increased
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
0.00%
0/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
34.5%
10/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
45.5%
15/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Mean Cell Hemoglobin Increased
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
0.00%
0/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
9.1%
3/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
0.00%
0/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
15.2%
5/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Infections and infestations
Nasopharyngitis
|
13.8%
4/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
6.1%
2/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Gastrointestinal disorders
Nausea
|
37.9%
11/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
42.4%
14/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
0.00%
0/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Blood and lymphatic system disorders
Neutropenia
|
24.1%
7/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
21.2%
7/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
General disorders
Nodule
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
0.00%
0/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Gastrointestinal disorders
Oral Pain
|
10.3%
3/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
6.1%
2/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
General disorders
Pain
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
3.0%
1/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
13.8%
4/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
15.2%
5/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
0.00%
0/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
6.1%
2/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
20.7%
6/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
18.2%
6/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Platelet Count Decreased
|
3.4%
1/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
18.2%
6/33 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Protein Total Decreased
|
10.3%
3/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
2.9%
1/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
31.0%
9/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
32.4%
11/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
General disorders
Pyrexia
|
20.7%
6/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
23.5%
8/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
55.2%
16/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
52.9%
18/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Skin and subcutaneous tissue disorders
Rash Generalized
|
0.00%
0/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
11.8%
4/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
8.8%
3/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
Red Blood Cell Count Decreased
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
0.00%
0/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
17.2%
5/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
5.9%
2/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
0.00%
0/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
5.9%
2/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
13.8%
4/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
17.6%
6/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
2.9%
1/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Cardiac disorders
Tachycardia
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
8.8%
3/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
24.1%
7/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
29.4%
10/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.9%
2/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
5.9%
2/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Gastrointestinal disorders
Vomiting
|
41.4%
12/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
17.6%
6/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/29 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
8.8%
3/34 • The adverse event data was collected throughout the duration of the study which was approximately 6 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place