A Study of LY3143753 and LY3185643 in Healthy Participants | NCT02342314 | Trialant
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Studies A Study of LY3143753 and LY3185643 in Healthy Participants NCT02342314 Show options LY3143753 (Part A) LY3185643 (Part B) Placebo (Part A and Part B) rGlucagon (Part B) Obsolete or Duplicate NCT IDs Not provided
ID Type Description Link I7U-MC-GAHA Other Identifier Eli Lilly and Company
A Study of LY3143753 and LY3185643 in Healthy Participants
A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3143753 and LY3185643 in Healthy Subjects
Eli Lilly and Company INDUSTRY
Overall Recruitment Status or Expanded Access Status Completed
First Submission Date that Met QC Criteria Jan 14, 2015
Results First Submitted Date Feb 17, 2018
Results First Submitted that Met QC Criteria Mar 11, 2019
Results First Posted Date Mar 13, 2019 Actual
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 Mar 11, 2019
Responsible Party, by Official Title Sponsor
Eli Lilly and Company INDUSTRY
Has Data Monitoring Committee (DMC) No
Pediatric Postmarket Surveillance of a Device Product Not provided
The study involves a single dose of LY3143753 or LY3185643, given as an injection into the abdomen. The study will evaluate the effects of the LY3143753 or LY3185643 on your body. The study is approximately 12 weeks for each participant, not including screening. Screening is required within 28 days prior to the start of the study. This study involves Part A (LY3143753) and Part B (LY3185643). Participants may only enroll in one part and at one dose level.
Number of References to an Expanded Access Study Not provided
Target Follow-Up Duration Not provided
No data available
No data is available for this block.
Label Type Description Intervention Names LY3143753 (Part A) Experimental Single subcutaneous (SC) injection of ascending doses of LY3143753 on Day 1
LY3185643 (Part B) Experimental Single SC injection of ascending doses of LY3185643 on Day 1
Placebo (Part A) Placebo Comparator Single SC injection of normal saline on Day 1
Drug: Placebo (Part A and Part B) rGlucagon (Part B) Active Comparator Single SC injection on Day 1
Placebo (Part B) Placebo Comparator Single SC injection of normal saline on Day 1
Drug: Placebo (Part A and Part B)
Name Type Description Arm Group Labels Other Names LY3143753 (Part A) Drug Administered via SC injection
Measure Description Time Frame Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Baseline to Study Completion (Up to 84 Days)
Measure Description Time Frame Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Part A Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours PK: Cmax of Part B Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
Inclusion Criteria:
Overtly healthy males or females
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Exclusion Criteria:
Are investigator site personnel directly affiliated with this study and their immediate families
Are currently enrolled in a clinical trial involving an investigational product (IP) or off-label use of a drug or device
Have participated, within the last 3 months, in a clinical trial
Have known or ongoing psychiatric disorders
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Show evidence of hepatitis C and/or positive hepatitis C antibody
Show evidence of hepatitis B and/or positive hepatitis B surface antigen
History of/current phaeochromocytoma
History of/current insulinoma
Accepts Healthy Volunteers Yes
Name Affiliation Role Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company Study Director
Facility Status City State ZIP Country Contacts For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Leeds LS2 9LH
No data available
No data is available for this block.
No data available
No data is available for this block.
ID Title Description FG000 Placebo (Part A) Single subcutaneous (SC) injection of normal saline on Day 1.
FG001 0.05 mg of LY3143753 (Part A) Part A: 0.05 milligram (mg) of LY3143753 given as a single SC injection on Day 1.
FG002 0.1 mg of LY3143753 (Part A) Part A: 0.1 mg of LY3143753 given as a single SC injection on Day 1.
FG003 0.2 mg of LY3143753 (Part A) Part A: 0.2 mg of LY3143753 given as a single SC injection on Day 1.
FG004 0.4 mg of LY3143753 (Part A) Part A: 0.4 mg of LY3143753 given as a single SC injection on Day 1.
FG005 1.0 mg of LY3143753 (Part A) Part A: 1.0 mg of LY3143753 given as a SC injection on Day 1.
FG006 Placebo (Part B) Part B: Single SC injection of normal saline on Day 1.
FG007 0.01 mg of LY3185643 (Part B) Part B: 0.01 mg of LY3185643 given as a single SC injection on Day 1.
FG008 0.03 mg of LY3185643 (Part B) Part B: 0.03 mg of LY3185643 given as a single SC injection on Day 1.
FG009 0.05 mg of LY3185643 (Part B) Part B: 0.05 mg of LY3185643 given as a single SC injection on Day 1.
FG010 0.06 mg of LY3185643 (Part B) Part B: 0.06 mg of LY3185643 given as a single SC injection on Day 1.
FG011 0.1 mg of LY3185643 (Part B) Part B: 0.1 mg of LY3185643 given as a single SC injection on Day 1.
FG012 0.2 mg of LY3185643 (Part B) Part B: 0.2 mg of LY3185643 given as a single SC injection on Day 1.
FG013 0.3 mg of LY3185643 (Part B) Part B: 0.3 mg of LY3185643 given as a single SC injection on Day 1.
FG014 0.48 mg of LY3185643 (Part B) Part B: 0.48 mg of LY3185643 given as a single SC injection on Day 1.
FG015 0.72 mg of LY3185643 (Part B) Part B: 0.72 mg of LY3185643 given as a single SC injection on Day 1.
FG016 rGlucagon (Part B) Part B: 1.0 mg of rGlucagon given as a single SC injection. (Part B).
Title Milestones Reasons Not Completed Part A Type Comment Milestone Data STARTED FG000 6 subjects FG001 3 subjects FG002 3 subjects FG003 3 subjects FG004 6 subjects FG005 3 subjects FG006 0 subjects FG007 0 subjects FG008 0 subjects FG009 0 subjects FG010 0 subjects FG011 0 subjects FG012 0 subjects FG013 0 subjects FG014 0 subjects FG015 0 subjects FG016 0 subjects COMPLETED FG000 6 subjects FG001 3 subjects FG002 3 subjects FG003 3 subjects FG004 NOT COMPLETED FG000 0 subjects FG001 0 subjects FG002 0 subjects FG003 0 subjects FG004
Part B Type Comment Milestone Data STARTED FG000 0 subjects Participants received placebo in Part A. FG001 0 subjects Participants received LY3143753 in Part A. FG002 0 subjects Participants received LY3143753 in Part A. FG003
Baseline Analysis Population Description Not provided
ID Title Description BG000 LY3143753 (Part A) Single subcutaneous (SC) injection of ascending doses of LY3143753 on Day 1.
BG001 LY3185643 (Part B) Single SC injection of ascending doses of LY3185643 on Day 1.
Title Description Population Description Parameter Type Dispersion Type Unit of Measure Calculate Percentage Denominator Units Selected Denominators Classes Age, Categorical Count of Participants
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 Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
All randomized participants who received at least one dose of study drug.
Posted Count of Participants Participants No Baseline to Study Completion (Up to 84 Days) ID Title Description OG000 Placebo (Part A) Single SC injection on Day 1.
OG001 0.05 mg of LY3143753 (Part A) 0.05 mg of LY3143753 given as a single SC injection.
All-Cause Mortality Comment Not provided
ID Title Description Deaths (Affected) Deaths (At Risk) Serious Events (Affected) Serious Events (At Risk) Other Events (Affected) Other Events (At Risk) EG000 Placebo (Part A) Single SC injection on Day 1.
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Atrioventricular block second degree Cardiac disorders MedDRA 17.1 Systematic Assessment
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Tachycardia Cardiac disorders MedDRA 17.1 Systematic Assessment
Are all PI(s) employees of the sponsor? No
Title Organization Phone Extension Email Chief Medical Officer Eli Lilly and Company 800-545-5979
No data available
No data is available for this block.
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No data is available for this block.
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No data is available for this block.
Randomized
Intervention Model Description Not provided
Administered via SC injection
Placebo (Part A and Part B) Drug Administered via SC injection
Placebo (Part A) Placebo (Part B)
rGlucagon (Part B) Drug Administered via SC injection
PK: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Part A Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: AUC(0-∞) of Part B Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: Time to Maximum Drug Concentration (Tmax) of Part A Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: Tmax of Part B Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
Pharmacodynamic (PD): Absolute Maximum Blood Glucose of Part A Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD Absolute Maximum Blood Glucose of Part B Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD: Maximum Glucose Increase (Gmax) of Part A Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD: Gmax of Part B Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD: Time to Maximum Blood Glucose (Gtmax) of Part A Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD: Gtmax of Part B Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
QT Interval as Corrected by the Fridericia Method (QTcF) Change From Baseline of Part A Baseline, 8 hours after drug administration
QTcF Change From Baseline of Part B Baseline, 8 hours after drug administration
6 subjects
FG005 3 subjects
FG006 0 subjects
FG007 0 subjects
FG008 0 subjects
FG009 0 subjects
FG010 0 subjects
FG011 0 subjects
FG012 0 subjects
FG013 0 subjects
FG014 0 subjects
FG015 0 subjects
FG016 0 subjects 0 subjects
FG005 0 subjects
FG006 0 subjects
FG007 0 subjects
FG008 0 subjects
FG009 0 subjects
FG010 0 subjects
FG011 0 subjects
FG012 0 subjects
FG013 0 subjects
FG014 0 subjects
FG015 0 subjects
FG016 0 subjects 0 subjects
Participants received LY3143753 in Part A.
FG004 0 subjects Participants received LY3143753 in Part A.
FG005 0 subjects Participants received LY3143753 in Part A.
FG006 11 subjects Participants received placebo in Part B.
FG007 3 subjects Participants received LY3185643 in Part B.
FG008 3 subjects Participants received LY3185643 in Part B.
FG009 3 subjects Participants received LY3185643 in Part B.
FG010 3 subjects Participants received LY3185643 in Part B.
FG011 3 subjects Participants received LY3185643 in Part B.
FG012 3 subjects Participants received LY3185643 in Part B.
FG013 3 subjects Participants received LY3185643 in Part B.
FG014 3 subjects Participants received LY3185643 in Part B.
FG015 3 subjects Participants received LY3185643 in Part B.
FG016 6 subjects Participants received rGlucagon in Part B. COMPLETED FG000 0 subjects FG001 0 subjects FG002 0 subjects FG003 0 subjects FG004 0 subjects FG005 0 subjects FG006 11 subjects FG007 3 subjects FG008 3 subjects FG009 3 subjects FG010 3 subjects FG011 3 subjects FG012 3 subjects FG013 3 subjects FG014 3 subjects FG015 3 subjects FG016 6 subjects
NOT COMPLETED FG000 0 subjects FG001 0 subjects FG002 0 subjects FG003 0 subjects FG004 0 subjects FG005 0 subjects FG006 0 subjects FG007 0 subjects FG008 0 subjects FG009 0 subjects FG010 0 subjects FG011 0 subjects FG012 0 subjects FG013 0 subjects FG014 0 subjects FG015 0 subjects FG016 0 subjects
BG002 Total Total of all reporting groups
24
BG001 44
BG002 68 Title Denominators Categories Title Measurements <=18 years Between 18 and 65 years >=65 years
Sex: Female, Male Count of Participants Participants No Title Denominators Categories Title Measurements Female Male
Ethnicity (NIH/OMB) Count of Participants Participants No Title Denominators Categories Title Measurements Hispanic or Latino Not Hispanic or Latino Unknown or Not Reported
Race (NIH/OMB) Count of Participants Participants No Title Denominators Categories Title Measurements American Indian or Alaska Native Asian Native Hawaiian or Other Pacific Islander Black or African American White More than one race Unknown or Not Reported
Region of Enrollment Count of Participants Participants No Title Denominators Categories United Kingdom
OG002 0.1 mg of LY3143753 (Part A) 0.1 mg of LY3143753 given as a single SC injection.
OG003 0.2 mg of LY3143753 (Part A) 0.2 mg of LY3143753 given as a single SC injection.
OG004 0.4 mg of LY3143753 (Part A) 0.4 mg of LY3143753 given as a single SC injection.
OG005 1 mg of LY3143753 (Part A) 1 mg of LY3143753 given as a single SC injection.
OG006 Placebo (Part B) Single SC injection on Day 1.
OG007 0.01 mg of LY3185643 (Part B) 0.01 mg of LY3185643 given as a single SC injection on Day 1.
OG008 0.03 mg of LY3185643 (Part B) 0.03 mg of LY3185643 given as a single SC injection on Day 1.
OG009 0.05 mg of LY3185643 (Part B) 0.05 mg of LY3185643 given as a single SC injection on Day 1.
OG010 0.06 mg of LY3185643 (Part B) 0.06 mg of LY3185643 given as a single SC injection on Day 1.
OG011 0.1 mg of LY3185643 (Part B) 0.1 mg of LY3185643 given as a single SC injection on Day 1.
OG012 0.2 mg of LY3185643 (Part B) 0.2 mg of LY3185643 given as a single SC injection on Day 1.
OG013 0.3 mg of LY3185643 (Part B) 0.3 mg of LY3185643 given as a single SC injection on Day 1.
OG014 Part B 0.48 mg of LY3185643 0.48 mg of LY3185643 given as a single SC injection on Day 1.
OG015 0.72 mg of LY3185643 (Part B) 0.72 mg of LY3185643 given as a single SC injection on Day 1.
OG016 r Glucagon (Part B) 1 mg of rGlucagon given as a single SC injection. (Part B).
Units Counts Participants OG000 6 OG001 3 OG002 3 OG003 3 OG004 6 OG005 3 OG006 11 OG007 3 OG008 3 OG009 3 OG010 3 OG011 3 OG012 3 OG013 3 OG014 3 OG015 3 OG016 6
Title Denominators Categories Title Measurements OG000 0 OG001 0 OG002 0 OG003 0 OG004 1 OG005 1 OG006 1 OG007 0 OG008 0 OG009 0 OG010 0 OG011 0 OG012 0 OG013 0 OG014 0 OG015 0 OG016 0
Secondary Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Part A All randomized participants who received at least one dose of study drug and had evaluable PK data.
Posted Geometric Mean Geometric Coefficient of Variation nanogram/milliliter (ng/mL) Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours ID Title Description OG000 0.05 mg of LY3143753 (Part A) 0.05 mg of LY3143753 given as a single SC injection on Day 1.
OG001 0.1 mg of LY3143753 (Part A) 0.1 mg of LY3143753 given as a single SC injection on Day 1.
OG002 0.2 mg of LY3143753 (Part A) 0.2 mg of LY3143753 given as a single SC injection on Day 1.
OG003 0.4 mg of LY3143753 (Part A) 0.4 mg of LY3143753 given as a single SC injection on Day 1.
OG004 1.0 mg of LY3143753 (Part A) 1.0 mg of LY3143753 given as a single SC injection on Day 1.
Title Denominators Categories Title Measurements OG000 0.726 ± 81 OG001 1.05 ± 73 OG002 2.95 ± 13 OG003
Secondary PK: Cmax of Part B All randomized participants who received at least one dose of study drug and had evaluable PK data.
Posted Geometric Mean Geometric Coefficient of Variation ng/mL Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours ID Title Description OG000 0.01 mg of LY3185643 (Part B) 0.01 mg of LY3185643 given as a single SC injection on Day 1.
OG001 0.03 mg of LY3185643 (Part B) 0.03 mg of LY3185643 given as a single SC injection on Day 1.
OG002 0.05 mg of LY3185643 (Part B) 0.05 mg of LY3185643 given as a single SC injection on Day 1.
OG003 0.06 mg of LY3185643 (Part B) 0.06 mg of LY3185643 given as a single SC injection on Day 1.
OG004 0.1 mg of LY3185643 (Part B) 0.1 mg of LY3185643 given as a single SC injection on Day 1.
OG005 0.2 mg of LY3185643 (Part B) 0.2 mg of LY3185643 given as a single SC injection on Day 1.
OG006 0.3 mg of LY3185643 (Part B) 0.3 mg of LY3185643 given as a single SC injection on Day 1.
OG007 0.48 mg of LY3185643 (Part B) 0.48 mg of LY3185643 given as a single SC injection on Day 1.
OG008 0.72 mg of LY3185643 (Part B) 0.72 mg of LY3185643 given as a single SC injection on Day 1.
Title Denominators Categories Title Measurements OG000 0.126 ± 12 OG001 0.367 ± 51 OG002 1.19 ± 70 OG003
Secondary PK: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Part A All randomized participants who received at least one dose of study drug and had evaluable PK data.
Posted Geometric Mean Geometric Coefficient of Variation nanogram*hour/milliliter (ng*hr/mL) Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours ID Title Description OG000 0.05 mg of LY3143753 (Part A) 0.05 mg of LY3143753 given as a single SC injection on Day 1.
OG001 0.1 mg of LY3143753 (Part A) 0.1 mg of LY3143753 given as a single SC injection on Day 1.
OG002 0.2 mg of LY3143753 (Part A) 0.2 mg of LY3143753 given as a single SC injection on Day 1.
OG003 0.4 mg of LY3143753 (Part A) 0.4 mg of LY3143753 given as a single SC injection on Day 1.
OG004 1.0 mg of LY3143753 (Part A) 1.0 mg of LY3143753 given as a single SC injection on Day 1.
Title Denominators Categories Title Measurements OG000 1.44 ± 46 OG001 1.57 ± 97 OG002 5.76 ± 38 OG003
Secondary PK: AUC(0-∞) of Part B All randomized participants who received at least one dose of study drug and had evaluable PK data.
Posted Geometric Mean Geometric Coefficient of Variation ng*hr/mL Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours ID Title Description OG000 0.01 mg of LY3185643 (Part B) 0.01 mg of LY3185643 given as a single SC injection on Day 1.
OG001 0.03 mg of LY3185643 (Part B) 0.03 mg of LY3185643 given as a single SC injection on Day 1.
OG002 0.05 mg of LY3185643 (Part B) 0.05 mg of LY3185643 given as a single SC injection on Day 1.
OG003 0.06 mg of LY3185643 (Part B) 0.06 mg of LY3185643 given as a single SC injection on Day 1.
OG004 0.1 mg of LY3185643 (Part B) 0.1 mg of LY3185643 given as a single SC injection on Day 1.
OG005 0.2 mg of LY3185643 (Part B) 0.2 mg of LY3185643 given as a single SC injection on Day 1.
OG006 0.3 mg of LY3185643 (Part B) 0.3 mg of LY3185643 given as a single SC injection on Day 1.
OG007 0.48 mg of LY3185643 (Part B) 0.48 mg of LY3185643 given as a single SC injection on Day 1.
OG008 0.72 mg of LY3185643 (Part B) 0.72 mg of LY3185643 given as a single SC injection on Day 1.
Title Denominators Categories Title Measurements OG000 NA ± NA PK data from 3 participants at this lowest LY3185643 dose was very limited with few measurable data points which led to the inability to estimate the AUC(0-infinity) PK parameter. OG001 0.564 ± 8 OG002
Secondary PK: Time to Maximum Drug Concentration (Tmax) of Part A All randomized participants who received at least one dose of study drug and had evaluable PK data.
Posted Median Full Range hour Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours ID Title Description OG000 0.05 mg of LY3143753 (Part A) 0.05 mg of LY3143753 given as a single SC injection on Day 1.
OG001 0.1 mg of LY3143753 (Part A) 0.1 mg of LY3143753 given as a single SC injection on Day 1.
OG002 0.2 mg of LY3143753 (Part A) 0.2 mg of LY3143753 given as a single SC injection on Day 1.
OG003 0.4 mg of LY3143753 (Part A) 0.4 mg of LY3143753 given as a single SC injection on Day 1.
OG004 1.0 mg of LY3143753 (Part A) 1.0 mg of LY3143753 given as a single SC injection on Day 1.
Title Denominators Categories Title Measurements OG000 0.67 (0.67 to 1.00) OG001 0.83 (0.33 to 1.00) OG002 0.67 (0.67 to 0.67) OG003
Secondary PK: Tmax of Part B All randomized participants who received at least one dose of study drug and had evaluable PK data.
Posted Median Full Range hour Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours ID Title Description OG000 0.01 mg of LY3185643 (Part B) 0.01 mg of LY3185643 given as a single SC injection on Day 1.
OG001 0.03 mg of LY3185643 (Part B) 0.03 mg of LY3185643 given as a single SC injection on Day 1.
OG002 0.05 mg of LY3185643 (Part B) 0.05 mg of LY3185643 given as a single SC injection on Day 1.
OG003 0.06 mg of LY3185643 (Part B) 0.06 mg of LY3185643 given as a single SC injection on Day 1.
OG004 0.1 mg of LY3185643 (Part B) 0.1 mg of LY3185643 given as a single SC injection on Day 1.
OG005 0.2 mg of LY3185643 (Part B) 0.2 mg of LY3185643 given as a single SC injection on Day 1.
OG006 0.3 mg of LY3185643 (Part B) 0.3 mg of LY3185643 given as a single SC injection on Day 1.
OG007 0.48 mg of LY3185643 (Part B) 0.48 mg of LY3185643 given as a single SC injection on Day 1.
OG008 0.72 mg of LY3185643 (Part B) 0.72 mg of LY3185643 given as a single SC injection on Day 1.
Title Denominators Categories Title Measurements OG000 0.83 (0.83 to 0.83) OG001 0.67 (0.50 to 1.00) OG002 0.83 (0.83 to 1.00) OG003
Secondary Pharmacodynamic (PD): Absolute Maximum Blood Glucose of Part A All participants who received at least one dose of study drug or placebo and have evaluable PD data.
Posted Geometric Mean Geometric Coefficient of Variation milligram/deciliter (mg/dL) Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours ID Title Description OG000 Placebo (Part A) Single SC injection of normal saline on Day 1.
OG001 0.05 mg of LY3143753 (Part A) 0.05 mg of LY3143753 given as a single SC injection on Day 1.
OG002 0.1 mg of LY3143753 (Part A) 0.1 mg of LY3143753 given as a single SC injection on Day 1.
OG003 0.2 mg of LY3143753 (Part A) 0.2 mg of LY3143753 given as a single SC injection on Day 1.
OG004 0.4 mg of LY3143753 (Part A) 0.4 mg of LY3143753 given as a single SC injection on Day 1.
OG005 1.0 mg of LY3143753 (Part A) 1.0 mg of LY3143753 given as a single SC injection on Day 1.
Title Denominators Categories Title Measurements OG000 101 ± 10 OG001 168 ± 26 OG002 197 ± 17 OG003
Secondary PD Absolute Maximum Blood Glucose of Part B All participants who received at least one dose of study drug or placebo and have evaluable PD data.
Posted Geometric Mean Geometric Coefficient of Variation mg/dL Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours ID Title Description OG000 Placebo (Part B) Single SC injection of normal saline on Day 1.
OG001 0.01 mg of LY3185643 (Part B) 0.01 mg of LY3185643 given as a single SC injection on Day 1.
OG002 0.03 mg of LY3185643 (Part B) 0.03 mg of LY3185643 given as a single SC injection on Day 1.
OG003 0.05 mg of LY3185643 (Part B) 0.05 mg of LY3185643 given as a single SC injection on Day 1.
OG004 0.06 mg of LY3185643 (Part B) 0.06 mg of LY3185643 given as a single SC injection on Day 1.
OG005 0.1 mg of LY3185643 (Part B) 0.1 mg of LY3185643 given as a single SC injection on Day 1.
OG006 0.2 mg of LY3185643 (Part B) 0.2 mg of LY3185643 given as a single SC injection on Day 1.
OG007 0.3 mg of LY3185643 (Part B) 0.3 mg of LY3185643 given as a single SC injection on Day 1.
OG008 0.48 mg of LY3185643 (Part B) 0.48 mg of LY3185643 given as a single SC injection on Day 1.
OG009 Part B 0.72 mg of LY3185643 (Part B) 0.72 mg of LY3185643 given as a single SC injection on Day 1.
OG010 1.0 mg of rGlucagon (Part B) 1.0 mg of rGlucagon given as a single SC injection.
Title Denominators Categories Title Measurements OG000 95.1 ± 5 OG001 103 ± 11 OG002 98.1 ± 10 OG003
Secondary PD: Maximum Glucose Increase (Gmax) of Part A All randomized participants who received at least one dose of study drug and had evaluable PD data.
Posted Geometric Mean Geometric Coefficient of Variation mg/dL Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours ID Title Description OG000 Placebo (Part A) Single SC injection of normal saline on Day 1.
OG001 0.05 mg of LY3143753 (Part A) 0.05 mg of LY3143753 given as a single SC injection on Day 1.
OG002 0.1 mg of LY3143753 (Part A) 0.1 mg of LY3143753 given as a single SC injection on Day 1.
OG003 0.2 mg of LY3143753 (Part A) 0.2 mg of LY3143753 given as a single SC injection on Day 1.
OG004 0.4 mg of LY3143753 (Part A) 0.4 mg of LY3143753 given as a single SC injection on Day 1.
OG005 1.0 mg of LY3143753 (Part A) 1.0 mg of LY3143753 given as a single SC injection on Day 1.
Title Denominators Categories Title Measurements OG000 4.14 ± 112 OG001 66.1 ± 63 OG002 103 ± 17 OG003
Secondary PD: Gmax of Part B All randomized participants who received at least one dose of study drug and had evaluable PD data.
Posted Geometric Mean Geometric Coefficient of Variation mg/dL Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours ID Title Description OG000 Placebo (Part B) Single SC injection of normal saline on Day 1.
OG001 0.01 mg of LY3185643 (Part B) 0.01 mg of LY3185643 given as a single SC injection on Day 1.
OG002 0.03 mg of LY3185643 (Part B) 0.03 mg of LY3185643 given as a single SC injection on Day 1.
OG003 0.05 mg of LY3185643 (Part B) 0.05 mg of LY3185643 given as a single SC injection on Day 1.
OG004 0.06 mg of LY3185643 (Part B) 0.06 mg of LY3185643 given as a single SC injection on Day 1.
OG005 0.1 mg of LY3185643 (Part B) 0.1 mg of LY3185643 given as a single SC injection on Day 1.
OG006 0.2 mg of LY3185643 (Part B) 0.2 mg of LY3185643 given as a single SC injection on Day 1.
OG007 0.3 mg of LY3185643 (Part B) 0.3 mg of LY3185643 given as a single SC injection on Day 1.
OG008 0.48 mg of LY3185643 (Part B) 0.48 mg of LY3185643 given as a single SC injection on Day 1.
OG009 0.72 mg of LY3185643 (Part B) 0.72 mg of LY3185643 given as a single SC injection on Day 1.
OG010 1.0 mg of rGlucagon (Part B) 1.0 mg of rGlucagon given as a single SC injection. (Part B).
Title Denominators Categories Title Measurements OG000 4.69 ± 54 OG001 7.2 ± 12.6 OG002 5.04 ± 189 OG003
Secondary PD: Time to Maximum Blood Glucose (Gtmax) of Part A All randomized participants who received at least one dose of study drug and had evaluable PD data.
Posted Median Full Range hour Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours ID Title Description OG000 Placebo (Part A) Single SC injection of normal saline on Day 1.
OG001 0.05 mg of LY3143753 (Part A) 0.05 mg of LY3143753 given as a single SC injection on Day 1.
OG002 0.1 mg of LY3143753 (Part A) 0.1 mg of LY3143753 given as a single SC injection on Day 1.
OG003 0.2 mg of LY3143753 (Part A) 0.2 mg of LY3143753 given as a single SC injection on Day 1.
OG004 0.4 mg of LY3143753 (Part A) 0.4 mg of LY3143753 given as a single SC injection on Day 1.
OG005 1.0 mg of LY3143753 (Part A) 1.0 mg of LY3143753 given as a single SC injection on Day 1.
Title Denominators Categories Title Measurements OG000 0.96 (0.00 to 4.00) OG001 1.00 (0.75 to 1.00) OG002 1.00 (0.58 to 1.00) OG003
Secondary PD: Gtmax of Part B All randomized participants who received at least one dose of study drug and had evaluable PD data.
Posted Median Full Range hour Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours ID Title Description OG000 Placebo (Part B) Single SC injection of normal saline on Day 1.
OG001 0.01 mg of LY3185643 (Part B) 0.01 mg of LY3185643 given as a single SC injection on Day 1.
OG002 0.03 mg of LY3185643 (Part B) 0.03 mg of LY3185643 given as a single SC injection on Day 1.
OG003 0.05 mg of LY3185643 (Part B) 0.05 mg of LY3185643 given as a single SC injection on Day 1.
OG004 0.06 mg of LY3185643 (Part B) 0.06 mg of LY3185643 given as a single SC injection on Day 1.
OG005 0.1 mg of LY3185643 (Part B) 0.1 mg of LY3185643 given as a single SC injection on Day 1.
OG006 0.2 mg of LY3185643 (Part B) 0.2 mg of LY3185643 given as a single SC injection on Day 1.
OG007 0.3 mg of LY3185643 (Part B) 0.3 mg of LY3185643 given as a single SC injection on Day 1.
OG008 0.48 mg of LY3185643 (Part B) 0.48 mg of LY3185643 given as a single SC injection on Day 1.
OG009 0.72 mg of LY3185643 (Part B) 0.72 mg of LY3185643 given as a single SC injection on Day 1.
OG010 1.0 mg of rGlucagon (Part B) 1.0 mg of rGlucagon given as a single SC injection. (Part B).
Title Denominators Categories Title Measurements OG000 0.5 (0.0 to 1.5) OG001 0.5 (0.0 to 0.5) OG002 0.67 (0.25 to 0.83) OG003
Secondary QT Interval as Corrected by the Fridericia Method (QTcF) Change From Baseline of Part A All randomized participants who received at least one dose of study drug and who had evaluable QTcF data.
Posted Mean Standard Deviation milliseconds (msec) Baseline, 8 hours after drug administration ID Title Description OG000 Placebo (Part A) Single SC injection of normal saline on Day 1.
OG001 0.05 mg of LY3143753 (Part A) 0.05 mg of LY3143753 given as a single SC injection on Day 1.
OG002 0.1 mg of LY3143753 (Part A) 0.01 mg of LY3143753 given as a single SC injection on Day 1.
OG003 0.2 mg of LY3143753 (Part A) 0.2 mg of LY3143753 given as a single SC injection on Day 1.
OG004 0.4 mg of LY3143753 (Part A) 0.4 mg of LY3143753 given as a single SC injection on Day 1.
OG005 1.0 mg of LY3143753 (Part A) 1.0 mg of LY3143753 given as a single SC injection on Day 1.
Title Denominators Categories Title Measurements OG000 0.6 ± 6.4 OG001 NA ± NA Data was not available for one participant at each of these time points so the mean and standard deviation (SD) were not applicable. OG002 0.2
Secondary QTcF Change From Baseline of Part B All randomized participants who received at least one dose of study drug and had evaluable QTcF data.
Posted Mean Standard Deviation milliseconds (msec) Baseline, 8 hours after drug administration ID Title Description OG000 Placebo (Part B) Single SC injection of normal saline on Day 1.
OG001 0.01 mg of LY3185643 (Part B) 0.01 mg of LY3185643 given as a single SC injection on Day 1.
OG002 0.03 mg of LY3185643 (Part B) 0.03 mg of LY3185643 given as a single SC injection on Day 1.
OG003 0.05 mg of LY3185643 (Part B) 0.05 mg of LY3185643 given as a single SC injection on Day 1.
OG004 0.06 mg of LY3185643 (Part B) 0.06 mg of LY3185643 given as a single SC injection on Day 1.
OG005 0.1 mg of LY3185643 (Part B) 0.1 mg of LY3185643 given as a single SC injection on Day 1.
OG006 0.2 mg of LY3185643 (Part B) 0.2 mg of LY3185643 given as a single SC injection on Day 1.
OG007 0.3 mg of LY3185643 (Part B) 0.3 mg of LY3185643 given as a single SC injection on Day 1.
OG008 0.48 mg of LY3185643 (Part B) 0.48 mg of LY3185643 given as a single SC injection on Day 1.
OG009 0.72 mg of LY3185643 (Part B) 0.72 mg of LY3185643 given as a single SC injection on Day 1.
OG010 rGlucagon (Part B) 1 mg of rGlucagon given as a single SC injection. (Part B).
Title Denominators Categories Title Measurements OG000 -1.4 ± 8.3 OG001 -2.9 ± 8.5 OG002 -10.2 ± 3.3 OG003
EG001 0.05 mg of LY3143753 (Part A) 0.05 mg of LY3143753 given as a single SC injection.
0 3 2 3
EG002 0.1 mg of LY3143753 (Part A) 0.1 mg of LY3143753 given as a single SC injection.
0 3 3 3
EG003 0.2 mg of LY3143753 (Part A) 0.2 mg of LY3143753 given as a single SC injection.
0 3 3 3
EG004 0.4 mg of LY3143753 (Part A) 0.4 mg of LY3143753 given as a single SC injection.
1 6 4 6
EG005 1 mg of LY3143753 (Part A) 1 mg of LY3143753 given as a single SC injection.
1 3 3 3
EG006 Placebo (Part B) Single SC injection on Day 1.
1 11 5 11
EG007 0.01 mg of LY3185643 (Part B) 0.01 mg of LY3185643 given as a single SC injection on Day 1.
0 3 3 3
EG008 0.03 mg of LY3185643 (Part B) 0.03 mg of LY3185643 given as a single SC injection on Day 1.
0 3 1 3
EG009 0.05 mg of LY3185643 (Part B) 0.05 mg of LY3185643 given as a single SC injection on Day 1.
0 3 1 3
EG010 0.06 mg of LY3185643 (Part B) 0.06 mg of LY3185643 given as a single SC injection on Day 1.
0 3 2 3
EG011 0.1 mg of LY3185643 (Part B) 0.1 mg of LY3185643 given as a single SC injection on Day 1.
0 3 3 3
EG012 0.2 mg of LY3185643 (Part B) 0.2 mg of LY3185643 given as a single SC injection on Day 1.
0 3 3 3
EG013 0.3 mg of LY3185643 (Part B) 0.3 mg of LY3185643 given as a single SC injection on Day 1.
0 3 2 3
EG014 Part B 0.48 mg of LY3185643 0.48 mg of LY3185643 given as a single SC injection on Day 1.
0 3 3 3
EG015 0.72 mg of LY3185643 (Part B) 0.72 mg of LY3185643 given as a single SC injection on Day 1.
0 3 3 3
EG016 r Glucagon (Part B) 1 mg of rGlucagon given as a single SC injection. (Part B).
0 6 2 6
EG000 0 events 0 affected 6 at risk
EG001 0 events 0 affected 3 at risk
EG002 0 events 0 affected 3 at risk
EG003 0 events 0 affected 3 at risk
EG004 1 events 1 affected 6 at risk
EG005 1 events 1 affected 3 at risk
EG006 1 events 1 affected 11 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 3 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 3 at risk
EG011 0 events 0 affected 3 at risk
EG012 0 events 0 affected 3 at risk
EG013 0 events 0 affected 3 at risk
EG014 0 events 0 affected 3 at risk
EG015 0 events 0 affected 3 at risk
EG016 0 events 0 affected 6 at risk
EG000 0 events 0 affected 6 at risk
EG001 0 events 0 affected 3 at risk
EG002 0 events 0 affected 3 at risk
EG003 0 events 0 affected 3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 3 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 3 at risk
EG008 0 events 0 affected 3 at risk
EG009 0 events 0 affected 3 at risk
EG010 0 events 0 affected 3 at risk
EG011 0 events 0 affected 3 at risk
EG012 0 events 0 affected 3 at risk
EG013 0 events 0 affected 3 at risk
EG014 0 events 0 affected 3 at risk
EG015 1 events 1 affected 3 at risk
EG016 0 events 0 affected 6 at risk Abdominal discomfort Gastrointestinal disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 1 events 1 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Abdominal pain Gastrointestinal disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 1 events 1 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Abdominal pain upper Gastrointestinal disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 1 events 1 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 1 events 1 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 1 events 1 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Diarrhoea Gastrointestinal disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 1 events 1 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 2 events 2 affected 3 at risk EG011 1 events 1 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Frequent bowel movements Gastrointestinal disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 1 events 1 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Nausea Gastrointestinal disorders MedDRA 17.1 Systematic Assessment EG000 2 events 1 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 2 events 2 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 1 events 1 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 1 events 1 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 1 events 1 affected 3 at risk EG012 2 events 2 affected 3 at risk EG013 2 events 2 affected 3 at risk EG014 2 events 2 affected 3 at risk EG015 2 events 2 affected 3 at risk EG016 1 events 1 affected 6 at risk
Swollen tongue Gastrointestinal disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 1 events 1 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Vomiting Gastrointestinal disorders MedDRA 17.1 Systematic Assessment EG000 1 events 1 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 1 events 1 affected 3 at risk EG004 1 events 1 affected 6 at risk EG005 1 events 1 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 1 events 1 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 1 events 1 affected 3 at risk EG015 4 events 3 affected 3 at risk EG016 1 events 1 affected 6 at risk
Chest discomfort General disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 1 events 1 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 1 events 1 affected 3 at risk EG016 0 events 0 affected 6 at risk
Fatigue General disorders MedDRA 17.1 Systematic Assessment EG000 1 events 1 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Feeling hot General disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 1 events 1 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Feeling of body temperature change General disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 1 events 1 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Injection site erythema General disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 1 events 1 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 1 events 1 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Thirst General disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 1 events 1 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Seasonal allergy Immune system disorders MedDRA 17.1 Systematic Assessment EG000 1 events 1 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Cystitis Infections and infestations MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 1 events 1 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Nasopharyngitis Infections and infestations MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 2 events 2 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 2 events 2 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 2 events 2 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 1 events 1 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 1 events 1 affected 3 at risk EG013 2 events 1 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Urinary tract infection Infections and infestations MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 1 events 1 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 1 events 1 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Arthropod bite Injury, poisoning and procedural complications MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 1 events 1 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Head injury Injury, poisoning and procedural complications MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 1 events 1 affected 6 at risk
Laceration Injury, poisoning and procedural complications MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 1 events 1 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 1 events 1 affected 6 at risk
Ligament sprain Injury, poisoning and procedural complications MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 1 events 1 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Limb injury Injury, poisoning and procedural complications MedDRA 17.1 Systematic Assessment EG000 1 events 1 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Muscle strain Injury, poisoning and procedural complications MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 1 events 1 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Thermal burn Injury, poisoning and procedural complications MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 1 events 1 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Decreased appetite Metabolism and nutrition disorders MedDRA 17.1 Systematic Assessment EG000 1 events 1 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Dehydration Metabolism and nutrition disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 1 events 1 affected 3 at risk EG016 0 events 0 affected 6 at risk
Increased appetite Metabolism and nutrition disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 1 events 1 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Muscle spasms Musculoskeletal and connective tissue disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 1 events 1 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Pain in extremity Musculoskeletal and connective tissue disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 1 events 1 affected 3 at risk EG008 1 events 1 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Depressed level of consciousness Nervous system disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 1 events 1 affected 3 at risk EG016 0 events 0 affected 6 at risk
Dizziness Nervous system disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 2 events 2 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 1 events 1 affected 3 at risk EG014 1 events 1 affected 3 at risk EG015 5 events 2 affected 3 at risk EG016 0 events 0 affected 6 at risk
Dizziness postural Nervous system disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 1 events 1 affected 6 at risk
Headache Nervous system disorders MedDRA 17.1 Systematic Assessment EG000 2 events 2 affected 6 at risk EG001 1 events 1 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 2 events 2 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 1 events 1 affected 3 at risk EG015 1 events 1 affected 3 at risk EG016 0 events 0 affected 6 at risk
Presyncope Nervous system disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 1 events 1 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Somnolence Nervous system disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 1 events 1 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 2 events 2 affected 3 at risk EG016 0 events 0 affected 6 at risk
Syncope Nervous system disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 1 events 1 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Cough Respiratory, thoracic and mediastinal disorders MedDRA 17.1 Systematic Assessment EG000 1 events 1 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 1 events 1 affected 6 at risk
Nasal congestion Respiratory, thoracic and mediastinal disorders MedDRA 17.1 Systematic Assessment EG000 1 events 1 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 1 events 1 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Oropharyngeal pain Respiratory, thoracic and mediastinal disorders MedDRA 17.1 Systematic Assessment EG000 1 events 1 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Productive cough Respiratory, thoracic and mediastinal disorders MedDRA 17.1 Systematic Assessment EG000 1 events 1 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Cold sweat Skin and subcutaneous tissue disorders MedDRA 17.1 Systematic Assessment EG000 0 events 0 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 1 events 1 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Rash erythematous Skin and subcutaneous tissue disorders MedDRA 17.1 Systematic Assessment EG000 1 events 1 affected 6 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 3 at risk EG003 0 events 0 affected 3 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 3 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 3 at risk EG008 0 events 0 affected 3 at risk EG009 0 events 0 affected 3 at risk EG010 0 events 0 affected 3 at risk EG011 0 events 0 affected 3 at risk EG012 0 events 0 affected 3 at risk EG013 0 events 0 affected 3 at risk EG014 0 events 0 affected 3 at risk EG015 0 events 0 affected 3 at risk EG016 0 events 0 affected 6 at risk
Results Disclosure Restriction on PI(s)? Yes
6
OG004 3 5.73
± 47
OG004 11.4 ± 38 3
OG004 3
OG005 3
OG006 3
OG007 3
OG008 3 0.951
± 32
OG004 2.34 ± 48
OG005 4.25 ± 53
OG006 4.67 ± 51
OG007 6.49 ± 58
OG008 9.67 ± 14 6
OG004 3 12.6
± 33
OG004 22.6 ± 62 3
OG004 3
OG005 3
OG006 3
OG007 3
OG008 3 2.61
± 42
OG003 1.34 ± 24
OG004 3.73 ± 22
OG005 8.87 ± 18
OG006 10.8 ± 14
OG007 16.2 ± 55
OG008 21.5 ± 9 6
OG004 3 1.04
(0.67 to 1.50)
OG004 1.25 (0.67 to 1.25) 3
OG004 3
OG005 3
OG006 3
OG007 3
OG008 3 0.67
(0.55 to 0.83)
OG004 0.50 (0.50 to 1.00)
OG005 1.25 (1.00 to 1.25)
OG006 1.23 (0.83 to 1.25)
OG007 1.75 (0.67 to 1.75)
OG008 0.83 (0.67 to 1.00) 3
OG004 6
OG005 3 179
± 13
OG004 188 ± 10
OG005 177 ± 19 3
OG004 3
OG005 3
OG006 3
OG007 3
OG008 3
OG009 3
OG010 6 128
± 36
OG004 117 ± 7
OG005 167 ± 16
OG006 186 ± 7
OG007 146 ± 16
OG008 192 ± 16
OG009 188 ± 3
OG010 162 ± 11 3
OG004 6
OG005 3 84.9
± 18
OG004 91.5 ± 20
OG005 79.8 ± 40 3
OG004 3
OG005 3
OG006 3
OG007 3
OG008 3
OG009 3
OG010 6 28.1
± 144
OG004 21.8 ± 66
OG005 76.1 ± 35
OG006 89.4 ± 14
OG007 58.4 ± 35
OG008 102 ± 25
OG009 105 ± 6
OG010 71.8 ± 23 3
OG004 6
OG005 3 0.67
(0.5 to 0.67)
OG004 0.79 (0.75 to 2.5)
OG005 0.58 (0.50 to 1.33) 3
OG004 3
OG005 3
OG006 3
OG007 3
OG008 3
OG009 3
OG010 6 1.0
(0.83 to 1.33)
OG004 0.67 (0.67 to 0.75)
OG005 0.75 (0.75 to 1.17)
OG006 1.17 (0.92 to 1.33)
OG007 0.58 (0.5 to 0.75)
OG008 1.17 (0.83 to 1.33)
OG009 0.75 (0.67 to 1.0)
OG010 0.46 (0.33 to 0.75) 2
OG004 5
OG005 3 ± 18.6
OG003 NA ± NA Data was not available for one participant at each of these time points so the mean and SD were not applicable.
OG004 6.1 ± 14.5
OG005 6.1 ± 13.3 3
OG004 3
OG005 3
OG006 3
OG007 3
OG008 3
OG009 2
OG010 6 -5.9
± 12.5
OG004 -4.1 ± 7.8
OG005 0.5 ± 11.3
OG006 -4.7 ± 7.6
OG007 2.5 ± 13.0
OG008 -2.1 ± 2.7
OG009 NA ± NA Data was not available for one participant at each of these time points so the mean and SD were not applicable.
OG010 -7.7 ± 5.8