A Multiple-ascending-dose Study to Evaluate the Efficacy,... | NCT02548585 | Trialant
NCT02548585
Sponsor
MedImmune LLC
Status
Completed
Last Update Posted
Apr 5, 2019Actual
Enrollment
113Actual
Phase
Phase 1Phase 2
Conditions
Type 2 Diabetes Mellitus
Interventions
MEDI0382
Placebo
Countries
Germany
Protocol Section
Identification Module
NCT ID
NCT02548585
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D5670C00002
Secondary IDs
Not provided
Brief Title
A Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of MEDI0382 in Overweight and Obese Participants With Type 2 Diabetes Mellitus
Official Title
A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MEDI0382 in Overweight and Obese Subjects With a History of Type 2 Diabetes Mellitus
Acronym
Not provided
Organization
MedImmune LLCINDUSTRY
Status Module
Record Verification Date
Jan 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 9, 2015Actual
Primary Completion Date
Feb 24, 2017Actual
Completion Date
Feb 24, 2017Actual
First Submitted Date
Sep 4, 2015
First Submission Date that Met QC Criteria
Sep 10, 2015
First Posted Date
Sep 14, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
May 24, 2018
Results First Submitted that Met QC Criteria
Jan 8, 2019
Results First Posted Date
Apr 5, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 8, 2019
Last Update Posted Date
Apr 5, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MedImmune LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
A Phase 1/2, multiple dose study with 6 cohorts of ascending doses designed to evaluate the efficacy, safety and pharmacokinetics (PK) of MEDI0382 in participants with Type 2 Diabetes Mellitus (T2DM).
Detailed Description
This is a randomized, double-blind, placebo controlled study designed to evaluate the efficacy, safety, and PK of MEDI0382 administered as multiple daily SC doses to participants with T2DM. Approximately one hundred and seven participants will be enrolled across 6 cohorts. In cohorts 1-3 the participants will be randomized to MEDI0382 or placebo (2:1). In Cohort 4, participants will be randomized to MEDI0382 or placebo (1:1). In cohort 5 and 6 participants will be randomized to MEDI0382 or placebo (3:1).
Conditions Module
Conditions
Type 2 Diabetes Mellitus
Keywords
MEDI0382, diabetes
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
113Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Participants will receive placebo (matched to either 100 micrograms [mcg], or 150 mcg or 200 mcg or 300 mcg of MEDI0382) subcutaneously (SC) once daily from Day 1 to Day 7 (Cohort 1); or Day 1 to Day 11 (Cohort 2); or Day 1 to Day 15 (Cohort 3); or Day 1 to Day 41 (Cohort 4); or Day 1 to Day 22 (Cohort 5); or Day 1 to Day 17 (Cohort 6).
Drug: Placebo
Cohort 1: MEDI0382 100 mcg
Experimental
Participants will receive MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
Drug: MEDI0382
Cohort 2: MEDI0382 150 mcg
Experimental
Participants will receive MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
Drug: MEDI0382
Cohort 3: MEDI0382 200 mcg
Experimental
Participants will receive MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
Drug: MEDI0382
Cohort 4: MEDI0382 200 mcg
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MEDI0382
Drug
MEDI0382 administered subcutaneously.
Cohort 1: MEDI0382 100 mcg
Cohort 2: MEDI0382 150 mcg
Cohort 3: MEDI0382 200 mcg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Mixed-meal Test (MMT) Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours to the End of Treatment (EOT) (Cohort 4)
Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hours (hrs) after consumption of the standardized meal (with no additional food intake during this time).
0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post standardized meal intake (SMI) on Baseline (Day -1) and EOT (Day 41)
Change From Baseline in Body Weight to the EOT (Cohort 4)
Baseline (Day 1) and EOT (Day 42)
Secondary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in MMT Glucose AUC0-4h to the EOT (Cohorts 1, 2, 3, 5, and 6)
Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of T2DM
Must provide written informed consent
Body mass index greater than (>) 27 and less than (<) 40 kg/m^2, inclusive
Venous access suitable for multiple cannulations
Vital signs within normal specified ranges
Females must be non-lactating and non-childbearing potential
Males must practice 2 effective contraceptive measures if sexually active
Exclusion Criteria:
Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
History of cancer within the last 10 years, with the exception of non-melanoma skin cancer
Any clinically important illness (except for T2DM), medical/surgical procedure, or trauma within 4 weeks prior to dosing
Fasting glucose greater than or equal to (>=) 200 mg/dL
Positive Hepatitis B, Hepatitis C or human immunodeficiency virus test or use of antiretroviral medications at screening.
Concurrent or previous use of a glucagon-like peptide 1 receptor agonist
Current or previous use of systemic corticosteroids within the past 28 days prior to screening
Use of any medicinal products or herbal preparations licensed for control of body weight or appetite is prohibited.
Known or suspected history of alcohol or drug abuse within the past 3 years.
Bosch R, Petrone M, Arends R, Vicini P, Sijbrands EJG, Hoefman S, Snelder N. Characterisation of cotadutide's dual GLP-1/glucagon receptor agonistic effects on glycaemic control using an in vivo human glucose regulation quantitative systems pharmacology model. Br J Pharmacol. 2024 Jun;181(12):1874-1885. doi: 10.1111/bph.16336. Epub 2024 Feb 25.
A total of 422 participants were screened, of which 113 participants were randomized in the study.
Recruitment Details
The study was conducted from 09 Dec 2015 to 24 Feb 2017 in Germany.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants received placebo (matched to either 100 micrograms [mcg], or 150 mcg or 200 mcg or 300 mcg of MEDI0382) subcutaneously (SC) once daily from Day 1 to Day 7 (Cohort 1); or Day 1 to Day 11 (Cohort 2); or Day 1 to Day 15 (Cohort 3); or Day 1 to Day 41 (Cohort 4); or Day 1 to Day 22 (Cohort 5); or Day 1 to Day 17 (Cohort 6).
Participants will receive MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
Drug: MEDI0382
Cohort 5: MEDI0382 300 mcg
Experimental
Participants will receive MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
Drug: MEDI0382
Cohort 6: MEDI0382 300 mcg
Experimental
Participants will receive MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Drug: MEDI0382
Cohort 4: MEDI0382 200 mcg
Cohort 5: MEDI0382 300 mcg
Cohort 6: MEDI0382 300 mcg
Placebo
Drug
Placebo administered subcutaneously.
Placebo
0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 22 for Cohort 5; and Day 17 for Cohort 6)
Change From Baseline in Body Weight to the EOT (Cohorts 1, 2, 3, 5, and 6)
Cohort 1: Baseline (Day 1) to EOT (Day 8); Cohort 2: Baseline (Day 1) to EOT (Day 12); Cohort 3: Baseline (Day 1) to EOT (Day 16); Cohort 5: Baseline (Day 1) to EOT (Day 22); Cohort 6: Baseline (Day 1) to EOT (Day 17)
Percent Change From Baseline in Hemoglobin A1c (HbA1c) to the EOT (Cohorts 4, 5, and 6)
Cohort 4: Baseline (Day -2) to EOT (Day 42); Cohort 5: Baseline (Day -2) to EOT (Day 22); Cohort 6: Baseline (Day -2) to EOT (Day 17)
Change From Baseline in Fructosamine to the EOT (Cohorts 4, 5, and 6)
Cohort 4: Baseline (Day -2) to EOT (Day 41); Cohort 5: Baseline (Day -2) to EOT (Day 22); Cohort 6: Baseline (Day -2) to EOT (Day 17)
Change From Baseline in Fasting Glucose Prior to MMT to the EOT (Cohorts 1, 2, 3, 4, 5, and 6)
Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time).
Cohort 1: Baseline (Day-1) to EOT (Day7); Cohort 2: Baseline (Day-1) to EOT (Day11); Cohort 3: Baseline (Day-1) to EOT (Day15); Cohort 4: Baseline (Day-1) to EOT (Day41); Cohort 5: Baseline (Day-1) to EOT (Day22); Cohort 6: Baseline (Day-1) to EOT (Day17)
Percent Change From Baseline in Glucose Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24h) After MMT to the EOT (Cohorts 1, 2, 3, 4, 5, and 6)
Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time).
0 minutes before; and 15, 30, 45, 60, 90, 120, 180, 240 minutes, and 24 hrs post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4; Day 22 for Cohort 5; and Day 17 for Cohort 6)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. Serious adverse events (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, life-threatening, a congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 28 days after the last study dose of each cohort (approximately 60 days).
From Day 1 to follow-up period (28 days after the last study dose for each cohort [approximately 60 days])
Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs
TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 28 days after the last study dose of each cohort (approximately 60 days). Number of participants with TEAEs related to vital signs and physical examination abnormalities were reported.
From Day 1 to follow-up period (28 days after the last study dose for each cohort [approximately 60 days])
Number of Participants With Abnormal 12 Lead Electrocardiogram (ECG) Reported as TEAEs
TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 28 days after the last study dose of each cohort (approximately 60 days). Number of participants with TEAEs related to ECG abnormalities were reported.
From Day 1 to follow-up period (28 days after the last study dose for each cohort [approximately 60 days])
Number of Participants With Abnormal Clinical Laboratory Reported as TEAEs
TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 28 days after the last study dose of each cohort (approximately 60 days). Number of participants with TEAEs related to laboratory abnormalities were reported.
From Day 1 to follow-up period (28 days after the last study dose for each cohort [approximately 60 days])
Number of Participants With Any Suicidal Ideation as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score (Cohorts 4, 5, and 6)
The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behaviour of participants. Yes/No responses are mapped to C-SSRS to assess whether participant experienced suicidal behaviour and suicidal ideation. Suicidal behaviour questions includes preparatory acts or behaviour, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation questions includes wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act (without specific plan), and active suicidal ideation with specific plan and intent. Participants with yes response to any category for suicidal ideation were reported below.
Cohort 4: Day -1, and Days 13, 20, 27, 34, and 40; Cohort 5: Day -1 and Day 7-14 post last dose of MEDI0382 (approximately 36 days); Cohort 6: Day -1 and Day 7-14 post last dose of MEDI0382 (approximately 31 days)
Number of Participants With Any Suicidal Behaviour as Assessed by C-SSRS Score (Cohorts 4, 5, and 6)
The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behaviour of participants. Yes/No responses are mapped to C-SSRS to assess whether participant experienced suicidal behaviour and suicidal ideation. Suicidal behaviour questions includes preparatory acts or behaviour, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation questions includes wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act (without specific plan), and active suicidal ideation with specific plan and intent. Participants with yes response to any category for suicidal behaviour were reported below.
Cohort 4: Day -1, and Days 13, 20, 27, 34, and 40; Cohort 5: Day -1 and Day 7-14 post last dose of MEDI0382 (approximately 36 days); Cohort 6: Day -1 and Day 7-14 post last dose of MEDI0382 (approximately 31 days)
Terminal Elimination Half Life (t1/2) of MEDI0382 (Cohorts 1, 2, and 3)
Terminal elimination half Life is the time measured for the plasma concentration of MEDI0382 to decrease by one half.
Cohort (C) 1 (Day [D] 1 and [&] D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose; and additional 48 hr post C1D7, C2D11, C3D15 dose
Accumulation Ratio (Rac) of MEDI0382 (Cohorts 1, 2, and 3)
Accumulation ratio was calculated as, Rac obtained from area under the curve from time zero to end of dosing interval (AUC[0-tau]) of Nth day divided by AUC(0-tau) of Day 1.
C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose; and additional 48 hr post C1D7, C2D11, C3D15 dose
Area Under the Concentration Time Curve From Time Zero to End of Dosing Interval (AUC[0-tau]) of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)
C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)
C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and additional 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose
Maximum Observed Plasma Concentration (Cmax) of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)
C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and additional 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose
Minimum Observed Plasma Concentration (Cmin) of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)
C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and additional 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)
C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and additional 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose
Number of Participants With Positive Anti-drug Antibodies to MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)
Day 1 up to 7-14 days post-last dose of MEDI0382 for all cohorts (Approximately 60 days)
Percent Change From Baseline in Insulin AUC0-4h After MMT to EOT (Cohorts 1, 2, 3, 4, 5, and 6)
Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time).
0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4; Day 22 for Cohort 5; and Day 17 for Cohort 6)
Percent Change From Baseline in Proinsulin AUC0-4h After MMT to EOT (Cohorts 1, 2, 3, and 4)
Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time).
0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4)
Percent Change From Baseline in C-peptide AUC0-4h After MMT to EOT (Cohorts 1, 2, 3, and 4)
Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time).
0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4)
Percent Change From Baseline in Incretin AUC0-4h After MMT to EOT (Cohorts 1, 2, 3, and 4)
Mixes-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time). Incretins included glucagon-like peptide-1 (GLP-1; active and inactive both), glucagon, and gastric inhibitory peptide (GIP).
0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4)
Erfurt
99084
Germany
Research Site
Kiel
24105
Germany
Research Site
Leipzig
04103
Germany
Research Site
Lübeck
23538
Germany
Research Site
Magdeburg
39120
Germany
Research Site
Mainz
55116
Germany
Research Site
Mannheim
68167
Germany
Research Site
München
81241
Germany
Research Site
Neu-Ulm
89231
Germany
Research Site
Neuss
41460
Germany
Derived
Ambery P, Parker VE, Stumvoll M, Posch MG, Heise T, Plum-Moerschel L, Tsai LF, Robertson D, Jain M, Petrone M, Rondinone C, Hirshberg B, Jermutus L. MEDI0382, a GLP-1 and glucagon receptor dual agonist, in obese or overweight patients with type 2 diabetes: a randomised, controlled, double-blind, ascending dose and phase 2a study. Lancet. 2018 Jun 30;391(10140):2607-2618. doi: 10.1016/S0140-6736(18)30726-8. Epub 2018 Jun 23.
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
FG002
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
FG003
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
FG004
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
FG005
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
FG006
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
FG00045 subjects
FG0016 subjects
FG0026 subjects
FG0037 subjects
FG00425 subjects
FG00512 subjects
FG00612 subjects
Treated
FG00045 subjects
FG0016 subjects
FG0026 subjects
FG0037 subjects
FG00425 subjects
FG00511 subjects
FG00612 subjects
COMPLETED
FG00043 subjects
FG0016 subjects
FG0026 subjects
FG0035 subjects
FG00422 subjects
FG00510 subjects
FG00611 subjects
NOT COMPLETED
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0043 subjects
FG0052 subjects
FG0061 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Randomized but not treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
As-treated Population (ATP) included all participants who received any study drug and analyzed according to the treatment they actually received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received placebo (matched to either 100 micrograms [mcg], or 150 mcg or 200 mcg or 300 mcg of MEDI0382) subcutaneously (SC) once daily from Day 1 to Day 7 (Cohort 1); or Day 1 to Day 11 (Cohort 2); or Day 1 to Day 15 (Cohort 3); or Day 1 to Day 41 (Cohort 4); or Day 1 to Day 22 (Cohort 5); or Day 1 to Day 17 (Cohort 6).
BG001
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
BG002
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
BG003
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
BG004
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
BG005
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
BG006
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
BG007
TOTAL
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00045
BG0016
BG0026
BG0037
BG00425
BG00511
BG00612
BG007112
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00057.2± 6.0
BG00162.5± 2.9
BG00260.2± 4.2
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00018
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percent Change From Baseline in Mixed-meal Test (MMT) Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours to the End of Treatment (EOT) (Cohort 4)
Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hours (hrs) after consumption of the standardized meal (with no additional food intake during this time).
Pharmacodynamic (PD) population included all participants who received at least 1 dose of study drug and had at least 1 post-MMT PD blood sample.
Posted
Mean
Standard Deviation
Percent change
0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post standardized meal intake (SMI) on Baseline (Day -1) and EOT (Day 41)
ID
Title
Description
OG000
Cohort 4: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
OG001
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
Units
Counts
Participants
OG00026
OG00125
Title
Denominators
Categories
Title
Measurements
OG000-9.24± 12.30
OG001-33.81± 18.62
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
p-value was based on pairwise comparison using analysis of covariance (ANCOVA) adjusted by baseline value.
< 0.0001
Superiority
Primary
Change From Baseline in Body Weight to the EOT (Cohort 4)
Intent-to-treat (ITT) population included all participants who were randomized and received any study drug and analyzed according to the initial randomization.
Posted
Mean
Standard Deviation
Kilograms (Kg)
Baseline (Day 1) and EOT (Day 42)
ID
Title
Description
OG000
Cohort 4: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
OG001
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
Secondary
Percent Change From Baseline in MMT Glucose AUC0-4h to the EOT (Cohorts 1, 2, 3, 5, and 6)
Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time).
PD population included all participants who received at least 1 dose of study drug and had at least 1 post-MMT PD blood sample.
Posted
Mean
Standard Deviation
Percent change
0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 22 for Cohort 5; and Day 17 for Cohort 6)
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo matched to (MEDI0382 100 mcg) SC once daily from Day 1 to Day 7.
OG001
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
OG002
Cohort 2: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 7 days (Day 5 to Day 11).
Secondary
Change From Baseline in Body Weight to the EOT (Cohorts 1, 2, 3, 5, and 6)
ITT population included all participants who were randomized and received any study drug and analyzed according to the initial randomization. Participants who did not complete the treatment were not included in this analysis.
Posted
Mean
Standard Deviation
Kg
Cohort 1: Baseline (Day 1) to EOT (Day 8); Cohort 2: Baseline (Day 1) to EOT (Day 12); Cohort 3: Baseline (Day 1) to EOT (Day 16); Cohort 5: Baseline (Day 1) to EOT (Day 22); Cohort 6: Baseline (Day 1) to EOT (Day 17)
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo matched to (MEDI0382 100 mcg) SC once daily from Day 1 to Day 7.
OG001
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
OG002
Cohort 2: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 7 days (Day 5 to Day 11).
OG003
Cohort 2: MEDI0382 150 mcg
Secondary
Percent Change From Baseline in Hemoglobin A1c (HbA1c) to the EOT (Cohorts 4, 5, and 6)
ITT population included all participants who were randomized and received any study drug and analyzed according to the initial randomization. Participants who did not complete the treatment were not included in this analysis.
Posted
Mean
Standard Deviation
Percent change
Cohort 4: Baseline (Day -2) to EOT (Day 42); Cohort 5: Baseline (Day -2) to EOT (Day 22); Cohort 6: Baseline (Day -2) to EOT (Day 17)
ID
Title
Description
OG000
Cohort 4: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
OG001
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
Secondary
Change From Baseline in Fructosamine to the EOT (Cohorts 4, 5, and 6)
ITT population included all participants who were randomized and received any study drug and analyzed according to the initial randomization. Participants who did not complete the treatment were not included in this analysis.
Posted
Mean
Standard Deviation
micromol/L
Cohort 4: Baseline (Day -2) to EOT (Day 41); Cohort 5: Baseline (Day -2) to EOT (Day 22); Cohort 6: Baseline (Day -2) to EOT (Day 17)
ID
Title
Description
OG000
Cohort 4: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
OG001
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
Secondary
Change From Baseline in Fasting Glucose Prior to MMT to the EOT (Cohorts 1, 2, 3, 4, 5, and 6)
Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time).
PD population included all participants who received at least 1 dose of study drug and had at least 1 post-MMT PD blood sample.
Posted
Mean
Standard Deviation
mg/dL
Cohort 1: Baseline (Day-1) to EOT (Day7); Cohort 2: Baseline (Day-1) to EOT (Day11); Cohort 3: Baseline (Day-1) to EOT (Day15); Cohort 4: Baseline (Day-1) to EOT (Day41); Cohort 5: Baseline (Day-1) to EOT (Day22); Cohort 6: Baseline (Day-1) to EOT (Day17)
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo matched to (MEDI0382 100 mcg) SC once daily from Day 1 to Day 7.
OG001
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
OG002
Cohort 2: Placebo
Secondary
Percent Change From Baseline in Glucose Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24h) After MMT to the EOT (Cohorts 1, 2, 3, 4, 5, and 6)
Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time).
PD population included all participants who received at least 1 dose of study drug and had at least 1 post-MMT PD blood sample.
Posted
Mean
Standard Deviation
Percent change
0 minutes before; and 15, 30, 45, 60, 90, 120, 180, 240 minutes, and 24 hrs post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4; Day 22 for Cohort 5; and Day 17 for Cohort 6)
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo matched to (MEDI0382 100 mcg) SC once daily from Day 1 to Day 7.
OG001
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
OG002
Cohort 2: Placebo
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. Serious adverse events (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, life-threatening, a congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 28 days after the last study dose of each cohort (approximately 60 days).
As-treated Population (ATP) included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
From Day 1 to follow-up period (28 days after the last study dose for each cohort [approximately 60 days])
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo matched to (MEDI0382 100 mcg) SC once daily from Day 1 to Day 7.
OG001
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
Secondary
Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs
TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 28 days after the last study dose of each cohort (approximately 60 days). Number of participants with TEAEs related to vital signs and physical examination abnormalities were reported.
ATP included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
From Day 1 to follow-up period (28 days after the last study dose for each cohort [approximately 60 days])
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo matched to (MEDI0382 100 mcg) SC once daily from Day 1 to Day 7.
OG001
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
OG002
Cohort 2: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 7 days (Day 5 to Day 11).
Secondary
Number of Participants With Abnormal 12 Lead Electrocardiogram (ECG) Reported as TEAEs
TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 28 days after the last study dose of each cohort (approximately 60 days). Number of participants with TEAEs related to ECG abnormalities were reported.
ATP included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
From Day 1 to follow-up period (28 days after the last study dose for each cohort [approximately 60 days])
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo matched to (MEDI0382 100 mcg) SC once daily from Day 1 to Day 7.
OG001
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
OG002
Cohort 2: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 7 days (Day 5 to Day 11).
Secondary
Number of Participants With Abnormal Clinical Laboratory Reported as TEAEs
TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 28 days after the last study dose of each cohort (approximately 60 days). Number of participants with TEAEs related to laboratory abnormalities were reported.
ATP included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
From Day 1 to follow-up period (28 days after the last study dose for each cohort [approximately 60 days])
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo matched to (MEDI0382 100 mcg) SC once daily from Day 1 to Day 7.
OG001
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
OG002
Cohort 2: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 7 days (Day 5 to Day 11).
Secondary
Number of Participants With Any Suicidal Ideation as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score (Cohorts 4, 5, and 6)
The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behaviour of participants. Yes/No responses are mapped to C-SSRS to assess whether participant experienced suicidal behaviour and suicidal ideation. Suicidal behaviour questions includes preparatory acts or behaviour, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation questions includes wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act (without specific plan), and active suicidal ideation with specific plan and intent. Participants with yes response to any category for suicidal ideation were reported below.
ATP included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Cohort 4: Day -1, and Days 13, 20, 27, 34, and 40; Cohort 5: Day -1 and Day 7-14 post last dose of MEDI0382 (approximately 36 days); Cohort 6: Day -1 and Day 7-14 post last dose of MEDI0382 (approximately 31 days)
ID
Title
Description
OG000
Cohort 4: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
Secondary
Number of Participants With Any Suicidal Behaviour as Assessed by C-SSRS Score (Cohorts 4, 5, and 6)
The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behaviour of participants. Yes/No responses are mapped to C-SSRS to assess whether participant experienced suicidal behaviour and suicidal ideation. Suicidal behaviour questions includes preparatory acts or behaviour, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation questions includes wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act (without specific plan), and active suicidal ideation with specific plan and intent. Participants with yes response to any category for suicidal behaviour were reported below.
ATP included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Cohort 4: Day -1, and Days 13, 20, 27, 34, and 40; Cohort 5: Day -1 and Day 7-14 post last dose of MEDI0382 (approximately 36 days); Cohort 6: Day -1 and Day 7-14 post last dose of MEDI0382 (approximately 31 days)
ID
Title
Description
OG000
Cohort 4: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
Secondary
Terminal Elimination Half Life (t1/2) of MEDI0382 (Cohorts 1, 2, and 3)
Terminal elimination half Life is the time measured for the plasma concentration of MEDI0382 to decrease by one half.
Pharmacokinetic (PK) population included all participants who received at least 1 dose of study drug and had at least one PK sample taken that was above the lower limit of quantitation.
Posted
Geometric Mean
95% Confidence Interval
hr
Cohort (C) 1 (Day [D] 1 and [&] D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose; and additional 48 hr post C1D7, C2D11, C3D15 dose
ID
Title
Description
OG000
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
OG001
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
OG002
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
Secondary
Accumulation Ratio (Rac) of MEDI0382 (Cohorts 1, 2, and 3)
Accumulation ratio was calculated as, Rac obtained from area under the curve from time zero to end of dosing interval (AUC[0-tau]) of Nth day divided by AUC(0-tau) of Day 1.
PK population included all participants who received at least 1 dose of study drug and had at least one PK sample taken that was above the lower limit of quantitation.
Posted
Geometric Mean
95% Confidence Interval
Ratio
C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose; and additional 48 hr post C1D7, C2D11, C3D15 dose
ID
Title
Description
OG000
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
OG001
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
OG002
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
Secondary
Area Under the Concentration Time Curve From Time Zero to End of Dosing Interval (AUC[0-tau]) of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)
PK population included all participants who received at least 1 dose of study drug and had at least one PK sample taken that was above the lower limit of quantitation.
Posted
Geometric Mean
95% Confidence Interval
ng*hr/mL
C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose
ID
Title
Description
OG000
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
OG001
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
OG002
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)
PK population included all participants who received at least 1 dose of study drug and had at least one PK sample taken that was above the lower limit of quantitation.
Posted
Geometric Mean
95% Confidence Interval
ng*hr/mL
C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and additional 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose
ID
Title
Description
OG000
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
OG001
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
OG002
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
Secondary
Maximum Observed Plasma Concentration (Cmax) of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)
PK population included all participants who received at least 1 dose of study drug and had at least one PK sample taken that was above the lower limit of quantitation.
Posted
Geometric Mean
95% Confidence Interval
ng/mL
C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and additional 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose
ID
Title
Description
OG000
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
OG001
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
OG002
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
Secondary
Minimum Observed Plasma Concentration (Cmin) of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)
PK population included all participants who received at least 1 dose of study drug and had at least one PK sample taken that was above the lower limit of quantitation.
Posted
Geometric Mean
95% Confidence Interval
ng/mL
C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and additional 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose
ID
Title
Description
OG000
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
OG001
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
OG002
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax) of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)
PK population included all participants who received at least 1 dose of study drug and had at least one PK sample taken that was above the lower limit of quantitation.
Posted
Median
Full Range
hr
C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and additional 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose
ID
Title
Description
OG000
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
OG001
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
OG002
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
Secondary
Number of Participants With Positive Anti-drug Antibodies to MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)
ATP included all participants who received any study drug and analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Day 1 up to 7-14 days post-last dose of MEDI0382 for all cohorts (Approximately 60 days)
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo matched to (MEDI0382 100 mcg) SC once daily from Day 1 to Day 7.
OG001
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
OG002
Cohort 2: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 7 days (Day 5 to Day 11).
OG003
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
Secondary
Percent Change From Baseline in Insulin AUC0-4h After MMT to EOT (Cohorts 1, 2, 3, 4, 5, and 6)
Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time).
PD population included all participants who received at least 1 dose of study drug and had at least 1 post-MMT PD blood sample.
Posted
Mean
Standard Deviation
Percent change
0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4; Day 22 for Cohort 5; and Day 17 for Cohort 6)
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo matched to (MEDI0382 100 mcg) SC once daily from Day 1 to Day 7.
OG001
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
OG002
Cohort 2: Placebo
Secondary
Percent Change From Baseline in Proinsulin AUC0-4h After MMT to EOT (Cohorts 1, 2, 3, and 4)
Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time).
PD population included all participants who received at least 1 dose of study drug and had at least 1 post-MMT PD blood sample.
Posted
Mean
Standard Deviation
Percent change
0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4)
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo matched to (MEDI0382 100 mcg) SC once daily from Day 1 to Day 7.
OG001
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
OG002
Cohort 2: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 7 days (Day 5 to Day 11).
Secondary
Percent Change From Baseline in C-peptide AUC0-4h After MMT to EOT (Cohorts 1, 2, 3, and 4)
Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time).
PD population included all participants who received at least 1 dose of study drug and had at least 1 post-MMT PD blood sample.
Posted
Mean
Standard Deviation
Percent change
0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4)
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo matched to (MEDI0382 100 mcg) SC once daily from Day 1 to Day 7.
OG001
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
OG002
Cohort 2: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 7 days (Day 5 to Day 11).
Secondary
Percent Change From Baseline in Incretin AUC0-4h After MMT to EOT (Cohorts 1, 2, 3, and 4)
Mixes-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time). Incretins included glucagon-like peptide-1 (GLP-1; active and inactive both), glucagon, and gastric inhibitory peptide (GIP).
PD population included all participants who received at least 1 dose of study drug and had at least 1 post-MMT PD blood sample.
Posted
Mean
Standard Deviation
Percent change
0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4)
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo matched to (MEDI0382 100 mcg) SC once daily from Day 1 to Day 7.
OG001
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
OG002
Cohort 2: Placebo
Time Frame
From Day 1 to follow-up period (28 days after the last study dose for each cohort [approximately 60 days])
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1: Placebo
Participants received placebo matched to (MEDI0382 100 mcg) SC once daily from Day 1 to Day 7.
0
3
0
3
2
3
EG001
Cohort 1: MEDI0382 100 mcg
Participants received MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
0
6
0
6
6
6
EG002
Cohort 2: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 7 days (Day 5 to Day 11).
0
3
0
3
3
3
EG003
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
0
6
0
6
5
6
EG004
Cohort 3: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 7 days (Day 9 to Day 15).
0
3
0
3
3
3
EG005
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15). )
0
7
1
7
7
7
EG006
Cohort 4: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
0
26
1
26
23
26
EG007
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
0
25
0
25
22
25
EG008
Cohort 5: Placebo
Participants received placebo (matched to MEDI0382 100 mcg ) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 16 to Day 22).
0
5
0
5
4
5
EG009
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
0
11
0
11
10
11
EG010
Cohort 6: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 11 to Day 17).
0
5
0
5
2
5
EG011
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
0
12
0
12
10
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diplopia
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
Pneumonia mycoplasmal
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected3 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0007 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Abnormal sensation in eye
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events3 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Faeces hard
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Infrequent bowel movements
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Intra-abdominal haematoma
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pancreatolithiasis
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Regurgitation
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Early satiety
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Feeling hot
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Injection site discolouration
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Injection site erythema
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Injection site haematoma
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Injection site pain
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Injection site pruritus
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Injection site reaction
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Malaise
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Medical device site erosion
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Medical device site erythema
General disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Medical device site injury
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Medical device site irritation
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Medical device site pain
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Medical device site pruritus
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Medical device site rash
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Medical device site reaction
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Allergic oedema
Immune system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Influenza
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Burns second degree
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Blood pressure diastolic increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Blood pressure increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Blood pressure systolic increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Body temperature increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Electrocardiogram st segment depression
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Heart rate increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Lipase increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Ankle deformity
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Nasal mucosal ulcer
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Skin reaction
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going 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.
p-value was based on pairwise comparison using ANCOVA adjusted by baseline value.
0.0008
Superiority
OG003
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
OG004
Cohort 3: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 7 days (Day 9 to Day 15).
OG005
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
OG006
Cohort 5: Placebo
Participants received placebo (matched to MEDI0382 100 mcg ) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 16 to Day 22).
OG007
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
OG008
Cohort 6: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 11 to Day 17).
OG009
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0036
OG0043
OG0057
OG0065
OG00711
OG0085
OG00912
Title
Denominators
Categories
Title
Measurements
OG000-14.60± 5.56
OG001-41.80± 11.07
OG002-15.07± 13.46
OG003-36.73± 10.09
OG004-0.47± 15.16
OG005-39.58± 5.27
OG006-14.52± 8.12
OG007-41.66± 9.97
OG008-4.80± 3.45
OG009-38.19± 12.51
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
OG004
Cohort 3: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 7 days (Day 9 to Day 15).
OG005
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
OG006
Cohort 5: Placebo
Participants received placebo (matched to MEDI0382 100 mcg ) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 16 to Day 22).
OG007
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
OG008
Cohort 6: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 11 to Day 17).
OG009
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0036
OG0043
OG0057
OG0065
OG00711
OG0085
OG00912
Title
Denominators
Categories
Title
Measurements
OG000-1.20± 0.44
OG001-2.32± 1.29
OG002-1.00± 1.13
OG003-1.52± 0.57
OG004-2.90± 1.05
OG005-4.63± 1.98
OG006-0.98± 2.12
OG007-3.26± 1.99
OG008-0.94± 3.09
OG009-2.04± 1.52
OG002
Cohort 5: Placebo
Participants received placebo (matched to MEDI0382 100 mcg ) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 16 to Day 22).
OG003
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
OG004
Cohort 6: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 11 to Day 17).
OG005
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Units
Counts
Participants
OG00026
OG00125
OG0025
OG00311
OG0045
OG00512
Title
Denominators
Categories
Title
Measurements
OG000-0.58± 0.30
OG001-0.92± 0.41
OG002-0.10± 0.29
OG003-0.55± 0.35
OG004-0.18± 0.19
OG005-0.42± 0.27
OG002
Cohort 5: Placebo
Participants received placebo (matched to MEDI0382 100 mcg ) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 16 to Day 22).
OG003
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
OG004
Cohort 6: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 11 to Day 17).
OG005
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Units
Counts
Participants
OG00026
OG00125
OG0025
OG00311
OG0045
OG00512
Title
Denominators
Categories
Title
Measurements
OG000-33.7± 44.6
OG001-67.9± 44.4
OG002-27.8± 25.8
OG003-47.4± 15.7
OG004-48.8± 43.7
OG005-47.5± 55.3
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 7 days (Day 5 to Day 11).
OG003
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
OG004
Cohort 3: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 7 days (Day 9 to Day 15).
OG005
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
OG006
Cohort 4: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
OG007
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
OG008
Cohort 5: Placebo
Participants received placebo (matched to MEDI0382 100 mcg ) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 16 to Day 22).
OG009
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
OG010
Cohort 6: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 11 to Day 17).
OG011
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0036
OG0043
OG0057
OG00626
OG00725
OG0085
OG00911
OG0105
OG01112
Title
Denominators
Categories
Title
Measurements
OG000-32.44± 17.19
OG001-74.48± 24.59
OG002-49.86± 23.24
OG003-54.06± 19.51
OG004-4.20± 33.73
OG005-63.67± 11.93
OG006-18.52± 18.88
OG007-50.62± 33.61
OG008-32.08± 17.49
OG009-54.42± 19.75
OG010-16.58± 12.45
OG011-55.21± 31.13
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 7 days (Day 5 to Day 11).
OG003
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
OG004
Cohort 3: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 7 days (Day 9 to Day 15).
OG005
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
OG006
Cohort 4: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
OG007
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
OG008
Cohort 5: Placebo
Participants received placebo (matched to MEDI0382 100 mcg ) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 16 to Day 22).
OG009
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
OG010
Cohort 6: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 11 to Day 17).
OG011
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0036
OG0043
OG0057
OG00626
OG00725
OG0085
OG00911
OG0105
OG01112
Title
Denominators
Categories
Title
Measurements
OG000-21.80± 1.41
OG001-28.34± 13.52
OG0020.80± 39.55
OG003-29.32± 17.24
OG004-13.80± 15.95
OG005-27.07± 10.82
OG006-1.06± 11.47
OG007-13.50± 18.19
OG008-4.20± 28.58
OG009-34.51± 11.25
OG010-10.10± 14.69
OG011-26.95± 9.45
OG002
Cohort 2: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 7 days (Day 5 to Day 11).
OG003
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
OG004
Cohort 3: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 7 days (Day 9 to Day 15).
OG005
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
OG006
Cohort 4: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
OG007
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
OG008
Cohort 5: Placebo
Participants received placebo (matched to MEDI0382 100 mcg ) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 16 to Day 22).
OG009
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
OG010
Cohort 6: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 11 to Day 17).
OG011
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0036
OG0043
OG0057
OG00626
OG00725
OG0085
OG00911
OG0105
OG01112
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0002
OG0016
OG0023
OG0035
OG0043
OG0057
OG00623
OG00722
OG0084
OG00910
OG0102
OG01110
TESAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
OG004
Cohort 3: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 7 days (Day 9 to Day 15).
OG005
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
OG006
Cohort 4: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
OG007
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
OG008
Cohort 5: Placebo
Participants received placebo (matched to MEDI0382 100 mcg ) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 16 to Day 22).
OG009
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
OG010
Cohort 6: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 11 to Day 17).
OG011
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0036
OG0043
OG0057
OG00626
OG00725
OG0085
OG00911
OG0105
OG01112
Title
Denominators
Categories
Blood Pressure increased
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0062
OG0071
OG0080
OG0090
OG0100
OG0110
Blood pressure systolic increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood pressure diastolic increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Physical Examinations
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
OG004
Cohort 3: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 7 days (Day 9 to Day 15).
OG005
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
OG006
Cohort 4: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
OG007
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
OG008
Cohort 5: Placebo
Participants received placebo (matched to MEDI0382 100 mcg ) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 16 to Day 22).
OG009
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
OG010
Cohort 6: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 11 to Day 17).
OG011
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0036
OG0043
OG0057
OG00626
OG00725
OG0085
OG00911
OG0105
OG01112
Title
Denominators
Categories
Arrhythmia
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
Atrial fibrillation
Title
Measurements
OG0000
OG0010
OG0020
OG003
Atrioventricular block first degree
Title
Measurements
OG0000
OG0011
OG0020
OG003
Atrioventricular block second degree
Title
Measurements
OG0000
OG0011
OG0020
OG003
Electrocardiogram ST segment depression
Title
Measurements
OG0000
OG0010
OG0020
OG003
Extrasystoles
Title
Measurements
OG0000
OG0010
OG0021
OG003
Sinus tachycardia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Supraventricular extrasystoles
Title
Measurements
OG0000
OG0010
OG0020
OG003
Supraventricular tachycardia
Title
Measurements
OG0001
OG0011
OG0021
OG003
Tachycardia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Ventricular extrasystoles
Title
Measurements
OG0000
OG0011
OG0021
OG003
Ventricular tachycardia
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
OG004
Cohort 3: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 7 days (Day 9 to Day 15).
OG005
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
OG006
Cohort 4: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
OG007
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
OG008
Cohort 5: Placebo
Participants received placebo (matched to MEDI0382 100 mcg ) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 16 to Day 22).
OG009
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
OG010
Cohort 6: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 11 to Day 17).
OG011
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0036
OG0043
OG0057
OG00626
OG00725
OG0085
OG00911
OG0105
OG01112
Title
Denominators
Categories
Lipase increased
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0071
OG0080
OG0092
OG0100
OG0111
Hypokalemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
C-reactive protein increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypoglycemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Chromaturia
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
OG002
Cohort 5: Placebo
Participants received placebo (matched to MEDI0382 100 mcg ) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 16 to Day 22).
OG003
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
OG004
Cohort 6: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 11 to Day 17).
OG005
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Units
Counts
Participants
OG00026
OG00125
OG0025
OG00311
OG0045
OG00512
Title
Denominators
Categories
Day -1
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG0025
ParticipantsOG00311
ParticipantsOG0045
ParticipantsOG00512
Title
Measurements
OG0001
OG0014
OG0020
OG003
Day 13
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG0020
ParticipantsOG0030
Day 20
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG0020
ParticipantsOG0030
Day 27
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG0020
ParticipantsOG0030
Day 34
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG0020
ParticipantsOG0030
Day 40
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG0020
ParticipantsOG0030
Days 7-14 post last dose of MEDI0382
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG00311
OG001
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
OG002
Cohort 5: Placebo
Participants received placebo (matched to MEDI0382 100 mcg ) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 16 to Day 22).
OG003
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
OG004
Cohort 6: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 11 to Day 17).
OG005
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Units
Counts
Participants
OG00026
OG00125
OG0025
OG00311
OG0045
OG00512
Title
Denominators
Categories
Day -1
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG0025
ParticipantsOG00311
ParticipantsOG0045
ParticipantsOG00512
Title
Measurements
OG0002
OG0012
OG0020
OG003
Day 13
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG0020
ParticipantsOG0030
Day 20
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG0020
ParticipantsOG0030
Day 27
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG0020
ParticipantsOG0030
Day 34
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG0020
ParticipantsOG0030
Day 40
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG0020
ParticipantsOG0030
Days 7-14 post last dose of MEDI0382
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG00311
Units
Counts
Participants
OG0006
OG0016
OG0027
Title
Denominators
Categories
Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG0008.5(NA to NA)95% confidence interval (CI) was not reported as only one participant was evaluable for the specified time point.
Day 5
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0020
Title
Measurements
OG001
Day 7
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Day 9
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
Title
Measurements
OG002
Day 11
ParticipantsOG0000
ParticipantsOG0016
ParticipantsOG0020
Title
Measurements
OG001
Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0025
Title
Measurements
OG002
Units
Counts
Participants
OG0006
OG0016
OG0027
Title
Denominators
Categories
Day 1
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000NA(NA to NA)Data is not applicable since accumulation ratio, as described by the formula could not be derived for Cohort 1 Day 1.
Day 5
ParticipantsOG0000
ParticipantsOG0016
ParticipantsOG0020
Title
Measurements
OG001
Day 7
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Day 9
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0026
Title
Measurements
OG002
Day 11
ParticipantsOG0000
ParticipantsOG0016
ParticipantsOG0020
Title
Measurements
OG001
Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0025
Title
Measurements
OG002
OG003
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
OG004
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
OG005
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Units
Counts
Participants
OG0006
OG0016
OG0027
OG00325
OG00411
OG00512
Title
Denominators
Categories
Day 1
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00082.21(44.56 to 151.69)
Day 5
ParticipantsOG0000
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0030
Day 7
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 9
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG00323
Day 11
ParticipantsOG0000
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0030
Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0030
Day 16
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 17
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 22
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 41
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00322
OG003
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
OG004
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
OG005
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Units
Counts
Participants
OG0006
OG0016
OG0027
OG00325
OG00411
OG00512
Title
Denominators
Categories
Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000103.46(NA to NA)95% CI data not applicable as only one participant was evaluable for this time point.
Day 5
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
Day 7
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 9
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG00313
Day 11
ParticipantsOG0000
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0030
Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0030
Day 16
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 17
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 22
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 41
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00311
OG003
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
OG004
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
OG005
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Units
Counts
Participants
OG0006
OG0016
OG0027
OG00325
OG00411
OG00512
Title
Denominators
Categories
Day 1
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0004.97(0.33 to 7.41)
Day 5
ParticipantsOG0000
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0030
Day 7
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 9
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG00323
Day 11
ParticipantsOG0000
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0030
Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0030
Day 16
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 17
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 22
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 41
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00322
OG003
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
OG004
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
OG005
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Units
Counts
Participants
OG0006
OG0016
OG0027
OG00325
OG00411
OG00512
Title
Denominators
Categories
Day 1
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0000.705(0.33 to 1.49)
Day 5
ParticipantsOG0000
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0030
Day 7
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 9
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG00323
Day 11
ParticipantsOG0000
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0030
Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0030
Day 16
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 17
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 22
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 41
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00322
OG003
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
OG004
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
OG005
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Units
Counts
Participants
OG0006
OG0016
OG0027
OG00325
OG00411
OG00512
Title
Denominators
Categories
Day 1
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0008(6 to 8)
Day 5
ParticipantsOG0000
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0030
Day 7
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 9
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG00323
Day 11
ParticipantsOG0000
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0030
Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0030
Day 16
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 17
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 22
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 41
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00322
OG004
Cohort 3: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 7 days (Day 9 to Day 15).
OG005
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
OG006
Cohort 4: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
OG007
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
OG008
Cohort 5: Placebo
Participants received placebo (matched to MEDI0382 100 mcg ) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 16 to Day 22).
OG009
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
OG010
Cohort 6: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 11 to Day 17).
OG011
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0036
OG0043
OG0057
OG00626
OG00725
OG0085
OG00911
OG0105
OG01112
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 7 days (Day 5 to Day 11).
OG003
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
OG004
Cohort 3: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 7 days (Day 9 to Day 15).
OG005
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
OG006
Cohort 4: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
OG007
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
OG008
Cohort 5: Placebo
Participants received placebo (matched to MEDI0382 100 mcg ) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 16 to Day 22).
OG009
Cohort 5: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
OG010
Cohort 6: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of placebo (matched to MEDI0382 300 mcg) SC once daily for 7 days (Day 11 to Day 17).
OG011
Cohort 6: MEDI0382 300 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0036
OG0043
OG0057
OG00626
OG00725
OG0085
OG00911
OG0105
OG01112
Title
Denominators
Categories
Title
Measurements
OG00010.83± 21.33
OG001-9.37± 29.17
OG002-3.67± 13.76
OG00336.32± 35.21
OG004-20.43± 68.82
OG005-17.47± 38.84
OG006-8.63± 32.33
OG007-1.17± 44.20
OG008-17.70± 16.47
OG0091.01± 31.00
OG010-8.18± 28.34
OG011-7.72± 37.03
OG003
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
OG004
Cohort 3: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 7 days (Day 9 to Day 15).
OG005
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
OG006
Cohort 4: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
OG007
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0036
OG0043
OG0057
OG00626
OG00725
Title
Denominators
Categories
Title
Measurements
OG000-3.27± 38.92
OG001-52.10± 36.29
OG002-33.13± 40.07
OG003-36.77± 19.62
OG00481.27± 77.21
OG005-54.13± 26.40
OG006-29.72± 31.13
OG007-47.93± 22.12
OG003
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
OG004
Cohort 3: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 7 days (Day 9 to Day 15).
OG005
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
OG006
Cohort 4: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
OG007
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0036
OG0043
OG0057
OG00626
OG00725
Title
Denominators
Categories
Title
Measurements
OG00010.17± 5.05
OG001-3.82± 21.29
OG002-1.43± 6.02
OG00339.78± 32.88
OG00479.37± 91.56
OG005-9.07± 27.27
OG0068.08± 32.12
OG00715.66± 42.35
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 7 days (Day 5 to Day 11).
OG003
Cohort 2: MEDI0382 150 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
OG004
Cohort 3: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 7 days (Day 9 to Day 15).
OG005
Cohort 3: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
OG006
Cohort 4: Placebo
Participants received placebo (matched to MEDI0382 100 mcg) SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of placebo (matched to MEDI0382 150 mcg) SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of placebo (matched to MEDI0382 200 mcg) SC once daily for 4 days (Day 9 to Day 12), then a further placebo (matched to MEDI0382 200 mcg) SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by placebo (matched to MEDI0382 200 mcg) SC once daily for 1 day in hospital (Day 41).
OG007
Cohort 4: MEDI0382 200 mcg
Participants received MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0036
OG0043
OG0057
OG00626
OG00725
Title
Denominators
Categories
GLP-1, Active: Change at EOT
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG0036
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG00624
ParticipantsOG00719
Title
Measurements
OG0008.30± 13.15
OG001-33.67± 16.84
OG002-10.40± 10.47
OG003
GLP-1, Inactive: Change at EOT
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0033
Glucagon: Change at EOT
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0035
GIP: Change at EOT
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
1 events
1 affected
6 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
3 events
1 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0073 events3 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected26 at risk
EG0079 events6 affected25 at risk
EG0080 events0 affected5 at risk
EG0092 events2 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected7 at risk
EG0061 events1 affected26 at risk
EG0074 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected12 at risk
2 events
2 affected
6 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected7 at risk
EG0065 events3 affected26 at risk
EG0077 events6 affected25 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected12 at risk
0 events
0 affected
6 at risk
EG0048 events1 affected3 at risk
EG0052 events1 affected7 at risk
EG0064 events3 affected26 at risk
EG0076 events4 affected25 at risk
EG0081 events1 affected5 at risk
EG0092 events1 affected11 at risk
EG0100 events0 affected5 at risk
EG0112 events2 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0053 events3 affected7 at risk
EG0061 events1 affected26 at risk
EG0077 events7 affected25 at risk
EG0080 events0 affected5 at risk
EG0097 events4 affected11 at risk
EG0100 events0 affected5 at risk
EG0112 events2 affected12 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0074 events4 affected25 at risk
EG0080 events0 affected5 at risk
EG0093 events3 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0092 events2 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0063 events2 affected26 at risk
EG0072 events2 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
7 events
3 affected
6 at risk
EG0040 events0 affected3 at risk
EG0054 events3 affected7 at risk
EG0067 events5 affected26 at risk
EG00739 events13 affected25 at risk
EG0082 events1 affected5 at risk
EG0096 events3 affected11 at risk
EG0100 events0 affected5 at risk
EG0117 events5 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
2 events
2 affected
6 at risk
EG0040 events0 affected3 at risk
EG0058 events3 affected7 at risk
EG0060 events0 affected26 at risk
EG00740 events8 affected25 at risk
EG0080 events0 affected5 at risk
EG0099 events3 affected11 at risk
EG0100 events0 affected5 at risk
EG0112 events1 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0112 events1 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0092 events2 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected26 at risk
EG0075 events5 affected25 at risk
EG0080 events0 affected5 at risk
EG0092 events2 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0074 events3 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0045 events1 affected3 at risk
EG0050 events0 affected7 at risk
EG0062 events2 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0073 events2 affected25 at risk
EG0080 events0 affected5 at risk
EG0092 events2 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0076 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0072 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0062 events2 affected26 at risk
EG0073 events3 affected25 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0063 events3 affected26 at risk
EG0074 events3 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0062 events2 affected26 at risk
EG0073 events3 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0067 events6 affected26 at risk
EG0074 events4 affected25 at risk
EG0081 events1 affected5 at risk
EG0092 events2 affected11 at risk
EG0101 events1 affected5 at risk
EG0113 events3 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected12 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0066 events2 affected26 at risk
EG0075 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected11 at risk
EG0104 events1 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0093 events2 affected11 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected12 at risk
2 events
2 affected
6 at risk
EG0041 events1 affected3 at risk
EG0056 events6 affected7 at risk
EG0060 events0 affected26 at risk
EG0075 events5 affected25 at risk
EG0081 events1 affected5 at risk
EG0094 events4 affected11 at risk
EG0100 events0 affected5 at risk
EG0113 events3 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0062 events1 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected7 at risk
EG0061 events1 affected26 at risk
EG0072 events2 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0072 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected7 at risk
EG0061 events1 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0066 events5 affected26 at risk
EG0076 events4 affected25 at risk
EG0080 events0 affected5 at risk
EG0092 events1 affected11 at risk
EG0100 events0 affected5 at risk
EG0112 events2 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0072 events2 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected12 at risk
3 events
1 affected
6 at risk
EG0046 events1 affected3 at risk
EG0056 events4 affected7 at risk
EG0066 events2 affected26 at risk
EG00710 events9 affected25 at risk
EG0081 events1 affected5 at risk
EG0093 events3 affected11 at risk
EG0101 events1 affected5 at risk
EG0111 events1 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
2 events
1 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0112 events2 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0064 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0072 events2 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0071 events1 affected25 at risk
EG0081 events1 affected5 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected5 at risk
EG0114 events3 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected5 at risk
EG0112 events2 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0073 events3 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0061 events1 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected26 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected12 at risk
0
OG0040
OG0051
OG0061
OG0070
OG0080
OG0090
OG0100
OG0110
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0091
OG0101
OG0110
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0111
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
0
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
OG0100
OG0110
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
0
OG0040
OG0051
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
0
OG0041
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
0
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
OG0100
OG0110
0
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
OG0100
OG0110
0
OG0041
OG0051
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
1
OG0040
OG0051
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
1
OG0040
OG0050
OG0061
OG0071
OG0080
OG0090
OG0100
OG0110
0
OG0041
OG0051
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
0
OG0040
OG0050
OG0061
OG0071
OG0080
OG0090
OG0100
OG0111
0
OG0040
OG0051
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
0
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
OG0100
OG0110
0
OG0040
OG0050
OG0060
OG0071
OG0080
OG0091
OG0100
OG0110
2
OG0040
OG0052
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0001
OG0010
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
ParticipantsOG0045
ParticipantsOG00512
Title
Measurements
OG0020
OG0031
OG0040
OG0050
1
OG0040
OG0051
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0001
OG0010
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000
OG0010
ParticipantsOG0045
ParticipantsOG00512
Title
Measurements
OG0020
OG0030
OG0040
OG0050
10.3
(7.8 to 13.5)
11.7
(5.5 to 25.1)
8.3
(NA to NA)
95% CI was not reported as only one participant was evaluable for the specified time point.
11.3
(5.9 to 21.7)
11.3
(8.2 to 15.5)
NA
(NA to NA)
Data is not applicable since accumulation ratio, as described by the formula could not be derived for Cohort 2 Day 5.
1.3
(1.1 to 1.5)
NA
(NA to NA)
Data is not applicable since accumulation ratio, as described by the formula could not be derived for Cohort 3 Day 9.
1.1
(0.9 to 1.8)
1.3
(1.1 to 1.5)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG001174.58(87.41 to 348.67)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG000107.01(54.10 to 211.64)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG002194.78(146.17 to 259.56)
OG003164.05(42.67 to 630.76)
Participants
OG004
0
ParticipantsOG00511
Title
Measurements
OG001157.31(82.45 to 421.12)
OG005275.29(169.33 to 447.48)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG002195.40(89.8 to 425.17)
Participants
OG004
11
ParticipantsOG0050
Title
Measurements
OG004261.90(166.58 to 411.74)
Participants
OG004
0
ParticipantsOG00511
Title
Measurements
OG005246.06(130.34 to 464.51)
Participants
OG004
10
ParticipantsOG0050
Title
Measurements
OG004254.35(196.10 to 329.9)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG003199.10(84.57 to 468.75)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG001207.15(11.98 to 3580.41)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG000184.68(107.76 to 316.51)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG002242.60(NA to NA)95% CI data not applicable as only one participant was evaluable for this time point.
OG003238.22(80.99 to 700.67)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG001215.80(112.90 to 412.47)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG002271.84(119.33 to 619.24)
Participants
OG004
6
ParticipantsOG0050
Title
Measurements
OG004317.93(182.24 to 554.64)
Participants
OG004
0
ParticipantsOG0054
Title
Measurements
OG005327.28(249.98 to 428.49)
Participants
OG004
4
ParticipantsOG0050
Title
Measurements
OG004294.60(172.52 to 503.05)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG003262.17(99.79 to 688.77)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0019.66(4.68 to 19.95)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0006.26(3.36 to 11.67)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG00210.57(6.33 to 17.66)
OG00311.64(3.16 to 42.94)
Participants
OG004
0
ParticipantsOG00511
Title
Measurements
OG0019.57(4.63 to 19.79)
OG00513.69(5.73 to 32.71)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG00210.97(4.62 to 26.06)
Participants
OG004
11
ParticipantsOG0050
Title
Measurements
OG00417.65(8.82 to 35.29)
Participants
OG004
0
ParticipantsOG00511
Title
Measurements
OG00515.55(7.55 to 32.01)
Participants
OG004
10
ParticipantsOG0050
Title
Measurements
OG00415.77(10.02 to 24.8)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG00313.42(4.77 to 37.75)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0012.685(1.06 to 6.79)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0002.372(1.18 to 4.78)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0023.521(2.16 to 5.75)
OG0032.635(0.79 to 8.83)
Participants
OG004
0
ParticipantsOG00511
Title
Measurements
OG0013.59(1.62 to 7.94)
OG0053.586(1.45 to 8.88)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0024.973(2.24 to 11.05)
Participants
OG004
11
ParticipantsOG0050
Title
Measurements
OG0044.062(1.68 to 9.84)
Participants
OG004
0
ParticipantsOG00511
Title
Measurements
OG0054.766(2.74 to 8.3)
Participants
OG004
10
ParticipantsOG0050
Title
Measurements
OG0045.21(1.97 to 13.81)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0033.38(1.03 to 11.04)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0016(4 to 8)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0006(4 to 6)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0026(6 to 8)
OG0034(1 to 6)
Participants
OG004
0
ParticipantsOG00511
Title
Measurements
OG0016(4 to 6)
OG0056(4 to 12)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0026(4 to 8)
Participants
OG004
11
ParticipantsOG0050
Title
Measurements
OG0044(2 to 8)
Participants
OG004
0
ParticipantsOG00511
Title
Measurements
OG0054(2 to 6)
Participants
OG004
10
ParticipantsOG0050
Title
Measurements
OG0044(4 to 8)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0034(4 to 8)
-50.45
± 12.30
OG004-2.87± 20.32
OG005-40.36± 26.90
OG0061.63± 26.43
OG007-49.73± 22.88
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG00614
ParticipantsOG0078
Title
Measurements
OG000-20.30± NAStandard deviation (SD) data not applicable as only one participant was evaluable for the specified parameter.
OG0010.70± NASD data not applicable as only one participant was evaluable for the specified parameter.
OG002-22.90± NASD data not applicable as only one participant was evaluable for the specified parameter.