Trial Outcomes & Findings for A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes (NCT NCT01928329)

NCT ID: NCT01928329

Last Updated: 2020-03-19

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

79 participants

Primary outcome timeframe

6 months

Results posted on

2020-03-19

Participant Flow

Participant milestones

Participant milestones
Measure	Exenatide (Bydureon) 2 mg, of drug administration 1 per week via subcutaneous self injection Exenatide (Bydureon®)	Placebo 2 mg, 1 per week via subcutaneous placebo self injection Placebo
Overall Study STARTED	40	39
Overall Study COMPLETED	28	25
Overall Study NOT COMPLETED	12	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Exenatide (Bydureon) 2 mg, of drug administration 1 per week via subcutaneous self injection Exenatide (Bydureon®)	Placebo 2 mg, 1 per week via subcutaneous placebo self injection Placebo
Overall Study Withdrew Consent Prior to Receiving Drug	1	3
Overall Study Removed from Study Prior to Receiving Dr	0	1
Overall Study Adverse Event	5	3
Overall Study Stopping Rule: Lost Greater than 5kg	4	1
Overall Study Withdrawal by Subject	1	5
Overall Study Physician Decision	1	1

Baseline Characteristics

A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exenatide (Bydureon) n=40 Participants 2 mg, of drug administration 1 per week via subcutaneous self injection Exenatide (Bydureon®)	Placebo n=39 Participants 2 mg, 1 per week via subcutaneous placebo self injection Placebo	Total n=79 Participants Total of all reporting groups
Age, Continuous	38.55 years STANDARD_DEVIATION 12.06 • n=99 Participants	33.49 years STANDARD_DEVIATION 11.39 • n=107 Participants	36.05 years STANDARD_DEVIATION 11.94 • n=206 Participants
Sex: Female, Male Female	29 Participants n=99 Participants	25 Participants n=107 Participants	54 Participants n=206 Participants
Sex: Female, Male Male	11 Participants n=99 Participants	14 Participants n=107 Participants	25 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) White	34 Participants n=99 Participants	35 Participants n=107 Participants	69 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=99 Participants	2 Participants n=107 Participants	6 Participants n=206 Participants
Region of Enrollment United States	40 participants n=99 Participants	39 participants n=107 Participants	79 participants n=206 Participants
C-Peptide Production Negative (< 0.05 ng/ml)	24 Participants n=99 Participants	22 Participants n=107 Participants	46 Participants n=206 Participants
C-Peptide Production Positive (>= 0.05 ng/ml)	16 Participants n=99 Participants	17 Participants n=107 Participants	33 Participants n=206 Participants
BMI (kg/m^2)	29.31 kg/m^2 STANDARD_DEVIATION 6.35 • n=99 Participants	29.41 kg/m^2 STANDARD_DEVIATION 6.34 • n=107 Participants	29.36 kg/m^2 STANDARD_DEVIATION 6.31 • n=206 Participants
Study Site Yale University	13 Participants n=99 Participants	17 Participants n=107 Participants	30 Participants n=206 Participants
Study Site University of Michigan	6 Participants n=99 Participants	4 Participants n=107 Participants	10 Participants n=206 Participants
Study Site University of Miami	0 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants
Study Site University of Colorado: Denver	6 Participants n=99 Participants	7 Participants n=107 Participants	13 Participants n=206 Participants
Study Site University of Chicago	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Study Site University of California San Francisco	5 Participants n=99 Participants	3 Participants n=107 Participants	8 Participants n=206 Participants
Study Site SUNY Upstate Medical University	4 Participants n=99 Participants	0 Participants n=107 Participants	4 Participants n=206 Participants
Study Site Joslin Diabetes Center at HMS	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Intention to treat analysis

Outcome measures

Outcome measures
Measure	Exenatide (Bydureon) n=40 Participants 2 mg, of drug administration 1 per week via subcutaneous self injection Exenatide (Bydureon®)	Placebo n=39 Participants 2 mg, 1 per week via subcutaneous placebo self injection Placebo
Change From Baseline in HbA1c Levels	-0.12 mmol/mol Standard Error 0.08	0.11 mmol/mol Standard Error 0.10

SECONDARY outcome

Timeframe: 12 months

Population: Intention to treat analysis.

Outcome measures

Outcome measures
Measure	Exenatide (Bydureon) n=40 Participants 2 mg, of drug administration 1 per week via subcutaneous self injection Exenatide (Bydureon®)	Placebo n=39 Participants 2 mg, 1 per week via subcutaneous placebo self injection Placebo
Change From Baseline in HbA1c Levels	0.08 mmol/mol Standard Error 0.09	0.10 mmol/mol Standard Error 0.10

SECONDARY outcome

Timeframe: Up to 6 months

Population: Only those randomized that received study drug.

The hypoglycemic event rate was calculated for patients while on and off study drug. The event rate is calculated using the number of events divided by the number of months either on or off study drug. Major hypoglycemic events are categorized as an event with a blood glucose level \< 55 mg/dL.

Outcome measures

Outcome measures
Measure	Exenatide (Bydureon) n=39 Participants 2 mg, of drug administration 1 per week via subcutaneous self injection Exenatide (Bydureon®)	Placebo n=35 Participants 2 mg, 1 per week via subcutaneous placebo self injection Placebo
Major Hypoglycemic Event Rate On Drug	0.67 events per month Interval 0.0 to 13.0	0.80 events per month Interval 0.0 to 10.5

SECONDARY outcome

Timeframe: Up to 12 months

Population: Only those randomized that received study drug and were followed through study completion.

Outcome measures

Outcome measures
Measure	Exenatide (Bydureon) n=37 Participants 2 mg, of drug administration 1 per week via subcutaneous self injection Exenatide (Bydureon®)	Placebo n=26 Participants 2 mg, 1 per week via subcutaneous placebo self injection Placebo
Major Hypoglycemic Event Rate Off Drug	0.33 events per month Interval 0.0 to 5.0	0.50 events per month Interval 0.0 to 13.17

Adverse Events

Exenatide (Bydureon)

Serious events: 6 serious events

Other events: 39 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Exenatide (Bydureon) n=39 participants at risk 2 mg, of drug administration 1 per week via subcutaneous self injection Exenatide (Bydureon®)	Placebo n=35 participants at risk 2 mg, 1 per week via subcutaneous placebo self injection Placebo
Infections and infestations Infections and infestations - Other	2.6% 1/39 • Number of events 1 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	0.00% 0/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Metabolism and nutrition disorders Acidosis	2.6% 1/39 • Number of events 2 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	0.00% 0/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Metabolism and nutrition disorders Hyperglycemia	2.6% 1/39 • Number of events 1 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	0.00% 0/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Metabolism and nutrition disorders Hypoglycemia	7.7% 3/39 • Number of events 6 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	0.00% 0/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
General disorders Anaphylaxis	0.00% 0/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	2.9% 1/35 • Number of events 1 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Infections and infestations Pelvic infection	0.00% 0/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	2.9% 1/35 • Number of events 1 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Infections and infestations Urinary tract infection	0.00% 0/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	2.9% 1/35 • Number of events 1 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.

Other adverse events

Additional Information

Kevan Herold, MD

C.N.H. Long Professor of Immunobiology and of Medicine (Endocrinology)

Phone: (203) 785-6507

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Exenatide (Bydureon) n=39 participants at risk 2 mg, of drug administration 1 per week via subcutaneous self injection Exenatide (Bydureon®)	Placebo n=35 participants at risk 2 mg, 1 per week via subcutaneous placebo self injection Placebo
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	5.1% 2/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	0.00% 0/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Eye disorders Conjunctivitis	5.1% 2/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	0.00% 0/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Gastrointestinal disorders Abdominal Bloating	2.6% 1/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	11.4% 4/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Gastrointestinal disorders Bloating	5.1% 2/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	5.7% 2/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Gastrointestinal disorders Diarrhea	7.7% 3/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	8.6% 3/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Gastrointestinal disorders Dyspepsia	7.7% 3/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	0.00% 0/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Gastrointestinal disorders Gastrointestinal disorders - Other	17.9% 7/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	8.6% 3/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Gastrointestinal disorders Nausea	33.3% 13/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	14.3% 5/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Gastrointestinal disorders Vomiting	20.5% 8/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	2.9% 1/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
General disorders General disorders and administration site conditions - Other	35.9% 14/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	20.0% 7/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
General disorders Injection site reaction	10.3% 4/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	8.6% 3/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
General disorders Tremors	5.1% 2/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	0.00% 0/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Infections and infestations Infections and infestations - Other	2.6% 1/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	8.6% 3/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Infections and infestations Upper respiratory infection	17.9% 7/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	14.3% 5/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Infections and infestations Vaginal infection	5.1% 2/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	5.7% 2/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Investigations Aspartate aminotransferase increased	2.6% 1/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	5.7% 2/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Metabolism and nutrition disorders Hyperglycemia	5.1% 2/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	0.00% 0/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Metabolism and nutrition disorders Hypoglycemia	71.8% 28/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	65.7% 23/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Metabolism and nutrition disorders Major Hypoglycemia	5.1% 2/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	2.9% 1/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	15.4% 6/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	11.4% 4/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 3/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	0.00% 0/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Nervous system disorders Dizziness	5.1% 2/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	0.00% 0/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Nervous system disorders Headache	7.7% 3/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	17.1% 6/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	8.6% 3/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	11.4% 4/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	5.1% 2/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	2.9% 1/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Skin and subcutaneous tissue disorders Pruritus	5.1% 2/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	11.4% 4/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	8.6% 3/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	35.9% 14/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	17.1% 6/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Skin and subcutaneous tissue disorders Surgical and medical procedures - Other	5.1% 2/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	0.00% 0/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
Eye disorders Eye disorders - Other	0.00% 0/39 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.	5.7% 2/35 • Up to 12 months. Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.