Trial Outcomes & Findings for A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus. (NCT NCT03244800)
NCT ID: NCT03244800
Last Updated: 2019-11-19
Results Overview
The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) to Day 49 is reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal
Results posted on
2019-11-19
Participant Flow
The study was conducted across 5 sites in Germany between 04Sep2017 and 23Jan2018.
A total of 120 participants consented to participate in the study. Of which 55 were screen failures; 65 participants were randomised (46 to MEDI0382 and 19 to placebo).
Participant milestones
| Measure |
Placebo Cohort 1
Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.
|
MEDI0382 Cohort 1
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
26
|
6
|
20
|
|
Overall Study
COMPLETED
|
13
|
25
|
6
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo Cohort 1
Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.
|
MEDI0382 Cohort 1
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrew treatment
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
Baseline characteristics by cohort
| Measure |
Placebo Cohort 1
n=13 Participants
Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.
|
MEDI0382 Cohort 1
n=26 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
n=6 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
n=20 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
TOTAL
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
60.2 Years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
58.7 Years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
60.3 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
61.9 Years
STANDARD_DEVIATION 6.0 • n=4 Participants
|
60.1 Years
STANDARD_DEVIATION 7.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid mealPopulation: Pharmacodynamic (PD) population included all participants who received at least one dose of study drug and had at least one post-baseline MMTT PD sample or PD evaluation.
The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) to Day 49 is reported.
Outcome measures
| Measure |
Placebo Cohort 1
n=13 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
n=26 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 1: Percent Change From Baseline in Plasma Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours (AUC0-4h) by Mixed-meal Tolerance Test (MMTT) to Day 49
|
6.32 Percent change
Interval -0.74 to 13.38
|
-21.52 Percent change
Interval -26.51 to -16.54
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 50Population: Intent-to-treat (ITT) population included all participants who received any study drug and were analyzed according to their randomized treatment group.
The percent change in body weight from baseline to Day 50 is reported.
Outcome measures
| Measure |
Placebo Cohort 1
n=13 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
n=26 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 1: Percent Change From Baseline in Body Weight to Day 50
|
-0.21 Percent change
Interval -1.88 to 1.46
|
-3.59 Percent change
Interval -4.77 to -2.41
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) through Day 49Population: The ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.
The change from baseline in Glycated haemoglobin (HbA1c) to Day 49 is reported.
Outcome measures
| Measure |
Placebo Cohort 1
n=13 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
n=26 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 1: Change From Baseline in Glycated Haemoglobin (HbA1c) to Day 49
|
-0.07 Percentage change
Interval -0.27 to 0.14
|
-0.67 Percentage change
Interval -0.82 to -0.53
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) through Day 49Population: The ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.
The changes in the fasting plasma glucose level during the study period from baseline to Day 49 is reported.
Outcome measures
| Measure |
Placebo Cohort 1
n=13 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
n=26 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 1: Change From Baseline in Fasting Plasma Glucose to Day 49
|
-2.31 mg/dL
Interval -12.74 to 8.13
|
-35.37 mg/dL
Interval -42.75 to -27.99
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 50Population: The ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.
The changes in the body weight during the study period from baseline to Day 50 is reported.
Outcome measures
| Measure |
Placebo Cohort 1
n=13 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
n=26 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 1: Change From Baseline in Body Weight to Day 50
|
-0.08 Kilogram
Interval -1.45 to 1.28
|
-3.41 Kilogram
Interval -4.37 to -2.44
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 50Population: The ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.
Participants achieving greater than or equal to 5% body weight loss from baseline to Day 50 is reported.
Outcome measures
| Measure |
Placebo Cohort 1
n=13 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
n=26 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 1: Percentage of Participants Achieving Greater Than or Equal to 5% Body Weight Loss From Baseline to Day 50
|
7.7 Percentage of Participants
|
42.3 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid mealPopulation: The PD population included all participants who received at least one dose of study drug and had at least one post-baseline MMTT PD sample or PD evaluation. The number of participants analyzed at the specified time point for this outcome measure are reported.
The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) evaluation to Day 7 is reported.
Outcome measures
| Measure |
Placebo Cohort 1
n=13 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
n=26 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
n=6 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
n=19 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 1 and Cohort 2: Percent Change From Baseline in MMTT Plasma Glucose AUC 0-4h to Day 7
|
-2.02 Percent change
Standard Deviation 11.70
|
-27.17 Percent change
Standard Deviation 9.83
|
1.77 Percent change
Standard Deviation 23.43
|
-31.80 Percent change
Standard Deviation 7.16
|
SECONDARY outcome
Timeframe: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)Population: As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first doses of study drug through 7 to 14 days after the last dose of study drug (approximately 64 days).
Outcome measures
| Measure |
Placebo Cohort 1
n=13 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
n=26 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
n=6 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
n=20 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 1 and Cohort 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs
|
6 Participants
|
22 Participants
|
3 Participants
|
15 Participants
|
|
Cohort 1 and Cohort 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)Population: As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.
Treatment-emergent adverse events observed in participants with clinically significant vital signs abnormalities are reported. Vital sign parameters included blood pressure, heart rate, body temperature, and respiration rate.
Outcome measures
| Measure |
Placebo Cohort 1
n=13 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
n=26 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
n=6 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
n=20 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 1 and Cohort 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)Population: As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.
Treatment-emergent adverse events observed in participants with clinically significant ECG abnormalities are reported.
Outcome measures
| Measure |
Placebo Cohort 1
n=13 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
n=26 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
n=6 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
n=20 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 1 and Cohort 2: Number of Participants With Abnormal Electrocardiogram Reported as TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)Population: As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator as medically significant was reported as an AE. Laboratory evaluations included haematology, serum chemistry, and urinalysis.
Outcome measures
| Measure |
Placebo Cohort 1
n=13 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
n=26 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
n=6 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
n=20 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 1 and Cohort 2: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Thrombocytopenia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohort 1 and Cohort 2: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Hypoglycaemia
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)Population: As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.
The injection site reactions observed during study visits were reported. Injection site reactions included (but are not limited to) local erythema, pain, tenderness, induration, swelling, pruritus, ulceration, and pigmentation.
Outcome measures
| Measure |
Placebo Cohort 1
n=13 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
n=26 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
n=6 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
n=20 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 1 and Cohort 2: Number of Participants With Injection Site Erythema
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49Population: Pharmacokinetic (PK) population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The "Number Analyzed" denotes the number of participants analyzed at the specified time point for this outcome measure.
The area under the concentration-time curve during the dosing interval of MEDI0382 is reported.
Outcome measures
| Measure |
Placebo Cohort 1
n=26 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 1: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382
Day 22
|
226.31 ng*hr/mL
Interval 103.95 to 488.98
|
—
|
—
|
—
|
|
Cohort 1: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382
Day 49
|
248.83 ng*hr/mL
Interval 86.57 to 558.57
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14Population: The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The "Number Analyzed" denotes the number of participants analyzed at the specified time point for this outcome measure.
The area under the concentration-time curve during the dosing interval of MEDI0382 is reported.
Outcome measures
| Measure |
Placebo Cohort 1
n=20 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 2: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382
Day 1
|
38.67 ng*hr/mL
Interval 34.05 to 47.25
|
—
|
—
|
—
|
|
Cohort 2: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382
Day 7
|
37.51 ng*hr/mL
Interval 8.99 to 69.82
|
—
|
—
|
—
|
|
Cohort 2: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382
Day 14
|
46.75 ng*hr/mL
Interval 26.38 to 65.61
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49Population: The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The "Number Analyzed" denotes the number of participants analyzed at the specified time point for this outcome measure.
The maximum observed concentration of MEDI0382 is reported.
Outcome measures
| Measure |
Placebo Cohort 1
n=26 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 1: Maximum Observed Concentration (Cmax) of MEDI0382
Day 22
|
13.24 ng/mL
Interval 4.89 to 30.3
|
—
|
—
|
—
|
|
Cohort 1: Maximum Observed Concentration (Cmax) of MEDI0382
Day 49
|
14.8 ng/mL
Interval 5.76 to 33.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14Population: The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The "Number Analyzed" denotes the number of participants analyzed at the specified time point for this outcome measure.
The maximum observed concentration of MEDI0382 is reported.
Outcome measures
| Measure |
Placebo Cohort 1
n=20 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 2: Maximum Observed Concentration (Cmax) of MEDI0382
Day 1
|
2.00 ng/mL
Interval 1.09 to 3.25
|
—
|
—
|
—
|
|
Cohort 2: Maximum Observed Concentration (Cmax) of MEDI0382
Day 7
|
2.53 ng/mL
Interval 0.85 to 4.14
|
—
|
—
|
—
|
|
Cohort 2: Maximum Observed Concentration (Cmax) of MEDI0382
Day 14
|
2.65 ng/mL
Interval 1.5 to 3.77
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49Population: The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The "Number Analyzed" denotes the number of participants analyzed at the specified time point for this outcome measure.
The time to reach the maximum observed concentration of MEDI0382 is reported.
Outcome measures
| Measure |
Placebo Cohort 1
n=26 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382
Day 22
|
6 Hours
Interval 4.0 to 12.0
|
—
|
—
|
—
|
|
Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382
Day 49
|
4 Hours
Interval 2.0 to 8.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14Population: The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The "Number Analyzed" denotes the number of participants analyzed at the specified time point for this outcome measure.
The time to reach the maximum observed concentration of MEDI0382 is reported.
Outcome measures
| Measure |
Placebo Cohort 1
n=20 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 2: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382
Day 1
|
8 Hours
Interval 4.0 to 12.0
|
—
|
—
|
—
|
|
Cohort 2: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382
Day 7
|
6 Hours
Interval 0.0 to 8.0
|
—
|
—
|
—
|
|
Cohort 2: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382
Day 14
|
6 Hours
Interval 4.0 to 12.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49Population: The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The "Number Analyzed" denotes the number of participants analyzed at the specified time point for this outcome measure.
The t1/2 is the time measured for the concentration to decrease by one half after the dose of MEDI0382.
Outcome measures
| Measure |
Placebo Cohort 1
n=6 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 1: Terminal Half Life (t1/2) of MEDI0382
Day 22
|
9.67 Hours
Interval 9.67 to 9.67
|
—
|
—
|
—
|
|
Cohort 1: Terminal Half Life (t1/2) of MEDI0382
Day 49
|
8.4 Hours
Interval 7.7 to 9.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14Population: The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The "Number Analyzed" denotes the number of participants analyzed at the specified time point for this outcome measure.
The t1/2 is the time measured for the concentration to decrease by one half after the dose of MEDI0382.
Outcome measures
| Measure |
Placebo Cohort 1
n=5 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 2: Terminal Half Life (t1/2) of MEDI0382
Day 1
|
9.7 Hours
Interval 8.9 to 10.2
|
—
|
—
|
—
|
|
Cohort 2: Terminal Half Life (t1/2) of MEDI0382
Day 7
|
8.8 Hours
Interval 8.6 to 9.0
|
—
|
—
|
—
|
|
Cohort 2: Terminal Half Life (t1/2) of MEDI0382
Day 14
|
9.4 Hours
Interval 8.7 to 10.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49Population: The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The "Number Analyzed" denotes the number of participants analyzed at the specified time point for this outcome measure.
The Racc was calculated using the AUC method which account for the overall exposure measured using the specified time points on Day 22 and Day 49. Racc was calculated using the formula, Racc of Day 49 = AUCt of Day 49/AUCt of Day 22.
Outcome measures
| Measure |
Placebo Cohort 1
n=21 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 1: Accumulation Ratio (Racc) of MEDI0382
|
1.46 Ratio
Interval 1.13 to 2.98
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14Population: The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The "Number Analyzed" denotes the number of participants analyzed at the specified time point for this outcome measure.
The Racc was calculated using the AUC method which account for the overall exposure measured using the specified time points on Day 1, Day 7 and Day 14. Racc was calculated using the formulas: Racc of Day 7 = AUCt of Day 7/AUCt of Day 1; Racc of Day 14 = AUCt of Day 14/AUCt of Day 1.
Outcome measures
| Measure |
Placebo Cohort 1
n=20 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 2: Accumulation Ratio of MEDI0382
Day 7
|
1.36 Ratio
Interval 1.2 to 1.6
|
—
|
—
|
—
|
|
Cohort 2: Accumulation Ratio of MEDI0382
Day 14
|
1.46 Ratio
Interval 1.2 to 1.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49Population: The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The "Number Analyzed" denotes the number of participants analyzed at the specified time point for this outcome measure.
Trough plasma concentration is the measured concentration from the plasma concentration-time data at the end of a dosing interval at steady state.
Outcome measures
| Measure |
Placebo Cohort 1
n=26 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 1: Trough Plasma Concentration (Ctrough) of MEDI0382
Day 22
|
3.566 ng/mL
Interval 0.5 to 9.27
|
—
|
—
|
—
|
|
Cohort 1: Trough Plasma Concentration (Ctrough) of MEDI0382
Day 49
|
5.762 ng/mL
Interval 1.53 to 11.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14Population: The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The "Number Analyzed" denotes the number of participants analyzed at the specified time point for this outcome measure.
Trough plasma concentration is the measured concentration from the plasma concentration time data at the end of a dosing interval at steady state.
Outcome measures
| Measure |
Placebo Cohort 1
n=20 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 2: Trough Plasma Concentration (Ctrough) of MEDI0382
Day 7
|
1.147 ng/mL
Interval 0.79 to 2.36
|
—
|
—
|
—
|
|
Cohort 2: Trough Plasma Concentration (Ctrough) of MEDI0382
Day 14
|
1.147 ng/mL
Interval 0.69 to 1.92
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 29, Day 50, and Follow-up Visit 2 (28 days after the last dose [approximately 64 days])Population: As-treated population included all participants who received any study drug and were analyzed according to the treatment they received. The "Number Analyzed" denotes the number of participants analyzed at the specified time point for this outcome measure.
Participants with positive serum antibodies to MEDI0382 are reported.
Outcome measures
| Measure |
Placebo Cohort 1
n=13 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 1
n=26 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
n=6 Participants
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
n=20 Participants
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Cohort 1 and Cohort 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0382
Follow-up Visit 2 (ADA positive)
|
1 Participants
|
6 Participants
|
0 Participants
|
6 Participants
|
|
Cohort 1 and Cohort 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0382
Baseline (ADA positive)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 1 and Cohort 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0382
Day 29 (ADA positive)
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Cohort 1 and Cohort 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0382
Day 50 (ADA positive)
|
0 Participants
|
7 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
Placebo Cohort 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
MEDI0382 Cohort 1
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MEDI0382 Cohort 2
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Cohort 1
n=13 participants at risk
Participants received placebo matching with MEDI0382 subcutaneously (SC) once daily for 49 days.
|
MEDI0382 Cohort 1
n=26 participants at risk
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 7 days, followed by Dose 2 for 7 days, Dose 3 for 7 days, and Dose 4 for 28 days.
|
Placebo Cohort 2
n=6 participants at risk
Participants received placebo matching with MEDI0382 SC once daily for 49 days.
|
MEDI0382 Cohort 2
n=20 participants at risk
Participants received subcutaneous injection of MEDI0382 once daily for 49 days as Dose 1 for 14 days, followed by Dose 2 for 14 days, Dose 3 for 14 days, and Dose 4 for 7 days.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Eye disorders
Visual impairment
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
7.7%
1/13 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
15.4%
4/26 • Number of events 4 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
1/13 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
11.5%
3/26 • Number of events 4 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
15.4%
4/26 • Number of events 8 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
10.0%
2/20 • Number of events 3 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
11.5%
3/26 • Number of events 4 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
19.2%
5/26 • Number of events 8 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
35.0%
7/20 • Number of events 11 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Gastrointestinal disorders
Tongue discomfort
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 2 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
7.7%
2/26 • Number of events 3 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
11.5%
3/26 • Number of events 6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
20.0%
4/20 • Number of events 11 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
General disorders
Face oedema
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 2 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
General disorders
Fatigue
|
7.7%
1/13 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
General disorders
Induration
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
General disorders
Injection site erythema
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
25.0%
5/20 • Number of events 7 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
General disorders
Injection site haematoma
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
General disorders
Injection site reaction
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 2 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
General disorders
Malaise
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
General disorders
Medical device site pain
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
General disorders
Medical device site swelling
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
General disorders
Oedema peripheral
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
General disorders
Pyrexia
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Infections and infestations
Nasal herpes
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
10.0%
2/20 • Number of events 2 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
23.1%
3/13 • Number of events 4 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
11.5%
3/26 • Number of events 4 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
15.0%
3/20 • Number of events 4 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Injury, poisoning and procedural complications
Contusion
|
7.7%
1/13 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.4%
2/13 • Number of events 2 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
50.0%
13/26 • Number of events 17 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
16.7%
1/6 • Number of events 2 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
7.7%
2/26 • Number of events 2 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
33.3%
2/6 • Number of events 2 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
20.0%
4/20 • Number of events 6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Nervous system disorders
Tremor
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 5 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Psychiatric disorders
Loss of libido
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
16.7%
1/6 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
16.7%
1/6 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
16.7%
1/6 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/26 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
5.0%
1/20 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/13 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
3.8%
1/26 • Number of events 1 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/6 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
0.00%
0/20 • From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER