A Study of Galcanezumab in Participants With Chronic Clus... | NCT02438826 | Trialant
NCT02438826
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Aug 25, 2020Actual
Enrollment
240Actual
Phase
Phase 3
Conditions
Chronic Cluster Headache
Interventions
Galcanezumab 300 mg
Placebo
Countries
United States
Belgium
Canada
Denmark
Finland
France
Germany
Greece
Italy
Netherlands
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02438826
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
15781
Secondary IDs
ID
Type
Description
Link
I5Q-MC-CGAM
Other Identifier
Eli Lilly and Company
2014-005429-11
EudraCT Number
Brief Title
A Study of Galcanezumab in Participants With Chronic Cluster Headache
Official Title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of : Galcanezumab (LY2951742) With a Long-Term Open-Label Extension in Patients With Chronic Cluster Headache
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jun 2020
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
Jun 18, 2015Actual
Primary Completion Date
Mar 27, 2018Actual
Completion Date
Aug 14, 2019Actual
First Submitted Date
May 6, 2015
First Submission Date that Met QC Criteria
May 6, 2015
First Posted Date
May 8, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 2, 2019
Results First Submitted that Met QC Criteria
May 17, 2019
Results First Posted Date
Jun 11, 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
Aug 14, 2020
Last Update Posted Date
Aug 25, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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
The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Cluster Headache
Keywords
Not provided
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
240Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Galcanezumab 300 mg
Experimental
Double-Blind Treatment Phase: Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Open-Label Treatment Phase: Participants received 300 mg galcanezumab by subcutaneous injections every 30 days, for up to a total of 12 administrations.
Drug: Galcanezumab 300 mg
Placebo
Placebo Comparator
Double-Blind Treatment Phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
Open-Label Treatment Phase: Participants received 300 mg galcanezumab by subcutaneous injections every 30 days, for up to a total of 12 administrations.
Drug: Galcanezumab 300 mg
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Galcanezumab 300 mg
Drug
Administered SC
Galcanezumab 300 mg
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Overall Mean Change From Baseline in Weekly Cluster Headache Attack Frequency
Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary, Baseline and 12 weeks of daily data during double-blind treatment phase will be converted into 14-calendar day intervals: the baseline 14-day interval, Weeks 1/2, 3/4, 5/6, 7/8, 9/10, and 11/12. Next, the biweekly interval results were adjusted to 7-day (weekly) interval in order to report the outcome as weekly frequency. Overall mean change from baseline is derived from mixed model repeated measures (MMRM) analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, verapamil use, pooled investigative site, week, baseline, and treatment by week as fixed effects.
Baseline, Week 1 through Week 12
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks
A 50% responder is any participant who has a ≥50% reduction from baseline in the weekly number of cluster headache attacks in a 14-day interval: Weeks 1/2, Weeks 3/4, Weeks 5/6, Weeks 7/8, Weeks 9/10, and Weeks 11/12. Mean percentage of participants is derived from the average of weeks 1/2 to weeks 11/12 from generalized linear mixed model repeated measures method with treatment, sex, verapamil use, week, treatment by week, and baseline as fixed effects.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants with a history of chronic cluster headache occurring without a remission period, or with remissions lasting <1 month, for at least 1 year.
Participants are able to distinguish cluster headache attacks from other headaches.
Exclusion Criteria:
Current enrollment in or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device.
Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP) antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).
Are taking indomethacin and/or are suspected of having another distinct trigeminal autonomic cephalalgia.
A history of migraine variants that could implicate or could be confused with ischemia.
Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins.
A history or presence of other medical illness that indicates a medical problem that would preclude study participation.
Evidence of significant active or unstable psychiatric disease, in the opinion of the investigator.
Women who are pregnant or nursing.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
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)
Jensen RH, Tassorelli C, Myers Oakes TM, Bardos JN, Zhou C, Dong Y, Aurora SK, Martinez JM. Baseline demographics and disease characteristics of patients with episodic or chronic cluster headache: data from two phase 3 randomized clinical trials in Europe and North America. Front Neurol. 2023 Dec 15;14:1293163. doi: 10.3389/fneur.2023.1293163. eCollection 2023.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Study consists of a 12-week double-blind treatment phase; an optional 1-year open-label treatment phase; and a 16-week post-treatment phase (washout).
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo/Galcanezumab (GMB) 300 mg
Double-Blind Treatment Phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
Open-Label Treatment Phase: Participants from placebo group received 300 milligrams (mg) of galcanezumab (GMB) by subcutaneous injection every 30 days, for up to a total of 12 administrations.
Post-Treatment Phase: Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.
Periods
Title
Milestones
Reasons Not Completed
Double-Blind Treatment Phase
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 28, 2018
Mar 26, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
LY2951742
Placebo
Drug
Administered SC
Placebo
Baseline, Week 1 through Week 12
Percentage of Participants With a Sustained Response of 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks
Sustained Response is defined as a 50% or greater reduction in the weekly cluster attack frequency from baseline to Weeks 3/4 and maintained at Weeks 5/6, Weeks 7/8, Weeks 9/10, and Weeks 11/12. Percentage of participants with a sustained response was analyzed using Koch's nonparametric randomization-based analysis of covariance method. This method adjusted for pooled investigative site by including it as a stratification variable. It also adjusted for sex, verapamil use and baseline value.
Baseline, Week 3 through Week 12
Percentage of Participants With a 30% Reduction in the Weekly Number of Cluster Headache Attacks
A 30% responder is any participant who has a ≥30% reduction from baseline in the weekly number of cluster headache attacks in a 14-day interval. Weeks 1/2, 3/4, 5/6, 7/8, 9/10, and 11/12. Mean percentage of participants is derived from the average of weeks 1/2 to weeks 11/12 from generalized linear mixed model repeated measures method with treatment, sex, verapamil use, week, treatment by week, and baseline as fixed effects. .
Baseline, Week 1 through Week 12
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects.
Week 4
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects.
Week 8
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects.
Week 12
Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal ideation: a "yes" answer to any of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent.
Week 1 through Week 12
Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
Week 1 through Week 12
Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab (LY2951742)
Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject has at least one post-baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post-baseline result of ADA present with titer >= 1: 20.
Baseline, Week 1 through Week 12
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Week 2
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Week 4
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Week 8
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Week 12
Santa Monica
California
90404
United States
Stanford University Hospital
Stanford
California
94304
United States
Colorado Neurological Institute
Englewood
Colorado
80113
United States
Yale University School of Medicine
New Haven
Connecticut
06510
United States
Yale University School of Medicine
New Haven
Connecticut
06519
United States
New England Institute for Clinical Research
Stamford
Connecticut
06905
United States
Mayo Clinic-Jacksonville
Jacksonville
Florida
32224
United States
Tampa General Hospital
Tampa
Florida
33606
United States
Michigan Head, Pain and Neurological Institute
Ann Arbor
Michigan
48104
United States
Thomas Jefferson University
Philadelphia
Pennsylvania
19107
United States
Southwestern Medical Center - Dallas
Dallas
Texas
75390
United States
Northwest Clinical Research Center
Bellevue
Washington
98007-4209
United States
West Virginia University Hospital
Morgantown
West Virginia
26506
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Ghent
9000
Belgium
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Liège
4000
Belgium
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Montreal
H2L 4M1
Canada
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.
Montreal
H2W 1V1
Canada
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Toronto
M4S 1Y2
Canada
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.
Glostrup Municipality
2600
Denmark
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Glostrup Municipality
2600
Denmark
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Helsinki
00930
Finland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Turku
20100
Finland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Lille
59037
France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Marseille
13385
France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Nice
06003
France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Paris
75010
France
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.
Paris
75475
France
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.
Saint-Etienne
42055
France
Praxis Dr. Stude
Bochum
44787
Germany
Universtitätsklinikum Essen AöR
Essen
45147
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Hamburg
20246
Germany
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Jena
07747
Germany
Migräne- und Kopfschmerzklinik GmbH & Co. KG
Königstein
61462
Germany
Klinikum der Universität München Campus Großhadern
München
81377
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Athens
11525
Greece
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Athens
11528
Greece
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Florence
50134
Italy
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Milan
20133
Italy
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Pavia
27100
Italy
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Amsterdam
1078w
Netherlands
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Nijmegen
6532 SZ
Netherlands
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Barcelona
08035
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Valencia
46010
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Hull
HU3 2JZ
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Liverpool
L9 7LJ
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
London
SE5 9RS
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Stoke-on-Trent
ST4 6QG
United Kingdom
Derived
Dodick DW, Goadsby PJ, Lucas C, Jensen R, Bardos JN, Martinez JM, Zhou C, Aurora SK, Yang JY, Conley RR, Oakes T. Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: Results from 3-month double-blind treatment. Cephalalgia. 2020 Aug;40(9):935-948. doi: 10.1177/0333102420905321. Epub 2020 Feb 12.
FG001
GMB 300 mg/GMB 300 mg
Double-Blind Treatment Phase: Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Open-Label Treatment Phase: Participants from galcanezumab group received 300 mg of galcanezumab by subcutaneous injection every 30 days, for up to a total of 12 administrations.
Post-Treatment Phase: Post-Treatment Phase: Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.
FG002
Placebo (Post-Treatment Phase)
Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.
FG003
Galcanezumab 300 mg (Post-Treatment Phase)
Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.
FG000123 subjects
FG001117 subjects
FG0020 subjects
FG0030 subjects
Received at Least 1 Dose of Study Drug
FG000120 subjects
FG001117 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG000117 subjects
FG001113 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0006 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Protocol Violation
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
Screen Failure
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Open-Label Treatment Phase
Type
Comment
Milestone Data
STARTED
FG000116 subjectsThis period is optional phase, one participant chose not to enter the open-label phase.
FG001113 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG00072 subjects
FG00180 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG00044 subjects
FG00133 subjects
FG0020 subjects
FG0030 subjects
Type
Comment
Reasons
Adverse Event
FG00011 subjects
FG0016 subjects
FG0020 subjects
FG003
Post-Treatment Phase
Type
Comment
Milestone Data
STARTED
FG00093 subjectsParticipants who discontinued Open-Label Treatment also had the option to enter Post-Treatment Phase
FG00193 subjectsParticipants who discontinued Open-Label Treatment also had the option to enter Post-Treatment Phase
FG0022 subjectsParticipants entered from Double-Blind Treatment Phase.
FG0034 subjectsParticipants entered from Double-Blind Treatment Phase.
COMPLETED
FG00084 subjects
FG00192 subjects
FG0022 subjects
FG0034 subjects
NOT COMPLETED
FG0009 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG003
All randomized participants who received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
BG001
Galcanezumab 300 mg
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000120
BG001117
BG002237
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
ParticipantsBG000120
ParticipantsBG001117
ParticipantsBG002237
Title
Measurements
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG000120
ParticipantsBG001117
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG000120
ParticipantsBG001117
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG000120
ParticipantsBG001117
ParticipantsBG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Greece
ParticipantsBG000120
ParticipantsBG001117
ParticipantsBG002
Weekly Cluster Headache Attacks
Mean
Standard Deviation
cluster headache attacks per week
Title
Denominators
Categories
ParticipantsBG000120
ParticipantsBG001117
ParticipantsBG002
Lifetime Suicidal Ideation Prior to Screening
Suicidal ideation was defined as a "yes" answer to any 1 of 5 suicidal ideation questions, which included = Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (No Plan); Active Suicidal Ideation with Some Intent to Act, without a Specific Plan; Active Suicidal Ideation with Intent to Act.
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG000120
ParticipantsBG001117
ParticipantsBG002
Lifetime Suicidal Behavior Prior to Screening
Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), and completed suicide.
All randomized participants who received at least 1 dose of study drug and had a baseline value for Lifetime Suicidal Behavior.
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG000119
ParticipantsBG001117
Participants
Verapamil Use at Baseline
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG000120
ParticipantsBG001117
ParticipantsBG002
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
Overall Mean Change From Baseline in Weekly Cluster Headache Attack Frequency
Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary, Baseline and 12 weeks of daily data during double-blind treatment phase will be converted into 14-calendar day intervals: the baseline 14-day interval, Weeks 1/2, 3/4, 5/6, 7/8, 9/10, and 11/12. Next, the biweekly interval results were adjusted to 7-day (weekly) interval in order to report the outcome as weekly frequency. Overall mean change from baseline is derived from mixed model repeated measures (MMRM) analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, verapamil use, pooled investigative site, week, baseline, and treatment by week as fixed effects.
All randomized participants who received at least 1 dose of study drug, and had baseline and at least one post baseline value.
Posted
Least Squares Mean
Standard Error
cluster headache attacks per week
Baseline, Week 1 through Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
OG001
Galcanezumab 300 mg
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Units
Counts
Participants
OG000120
OG001117
Title
Denominators
Categories
Title
Measurements
OG000-4.59± 0.79
OG001-5.38± 0.81
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
Mixed Models Analysis
0.334
Cui, Hung, Wang (CHW) procedure applied
LSMean Difference
-0.80
2-Sided
95
-2.77
1.17
Superiority
Secondary
Percentage of Participants With a 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks
A 50% responder is any participant who has a ≥50% reduction from baseline in the weekly number of cluster headache attacks in a 14-day interval: Weeks 1/2, Weeks 3/4, Weeks 5/6, Weeks 7/8, Weeks 9/10, and Weeks 11/12. Mean percentage of participants is derived from the average of weeks 1/2 to weeks 11/12 from generalized linear mixed model repeated measures method with treatment, sex, verapamil use, week, treatment by week, and baseline as fixed effects.
All randomized participants who received at least 1 dose of study drug, and had baseline and at least 1 post baseline value.
Posted
Mean
Standard Error
percentage of participants
Baseline, Week 1 through Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
OG001
Galcanezumab 300 mg
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Units
Counts
Participants
Secondary
Percentage of Participants With a Sustained Response of 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks
Sustained Response is defined as a 50% or greater reduction in the weekly cluster attack frequency from baseline to Weeks 3/4 and maintained at Weeks 5/6, Weeks 7/8, Weeks 9/10, and Weeks 11/12. Percentage of participants with a sustained response was analyzed using Koch's nonparametric randomization-based analysis of covariance method. This method adjusted for pooled investigative site by including it as a stratification variable. It also adjusted for sex, verapamil use and baseline value.
All randomized participants who received at least 1 dose of study drug, had a baseline, and at least one post baseline value.
Posted
Number
percentage of participants
Baseline, Week 3 through Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
OG001
Galcanezumab 300 mg
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Units
Counts
Participants
Secondary
Percentage of Participants With a 30% Reduction in the Weekly Number of Cluster Headache Attacks
A 30% responder is any participant who has a ≥30% reduction from baseline in the weekly number of cluster headache attacks in a 14-day interval. Weeks 1/2, 3/4, 5/6, 7/8, 9/10, and 11/12. Mean percentage of participants is derived from the average of weeks 1/2 to weeks 11/12 from generalized linear mixed model repeated measures method with treatment, sex, verapamil use, week, treatment by week, and baseline as fixed effects. .
All randomized participants who received at least 1 dose of study drug, and had baseline and at least 1 post baseline value.
Posted
Mean
Standard Error
percentage of participants
Baseline, Week 1 through Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
OG001
Galcanezumab 300 mg
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Units
Counts
Participants
Secondary
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects.
All randomized participants who received at least one dose of study drug and had PGI-I measurement at Week 4.
Posted
Number
percentage of participants
Week 4
ID
Title
Description
OG000
Placebo
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
OG001
Galcanezumab 300 mg
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Units
Counts
Secondary
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects.
All randomized participants who received at least one dose of study drug and had PGI-I measurement at Week 8.
Posted
Number
percentage of participants
Week 8
ID
Title
Description
OG000
Placebo
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
OG001
Galcanezumab 300 mg
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Units
Counts
Secondary
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects.
All randomized participants who received at least one dose of study drug and had PGI-I measurement at week 12.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
OG001
Galcanezumab 300 mg
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Units
Counts
Secondary
Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal ideation: a "yes" answer to any of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent.
All randomized participants who received at least one dose of study drug and had at least one post baseline C-SSRS assessment.
Posted
Number
percentage of participants
Week 1 through Week 12
ID
Title
Description
OG000
Placebo
Placebo administered by SQ injection every 30 Days for 12 weeks.
OG001
Galcanezumab 300 mg
300 mg galcanezumab (LY2951742) administered by subcutaneous (SQ) injection every 30 days for 12 weeks.
Secondary
Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
All randomized participants who received at least one dose of study drug and had at least one post baseline C-SSRS assessment.
Posted
Number
percentage of participants
Week 1 through Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
OG001
Galcanezumab 300 mg
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Units
Counts
Secondary
Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab (LY2951742)
Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject has at least one post-baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post-baseline result of ADA present with titer >= 1: 20.
All randomized participants who received at least one dose of study drug and had non-missing baseline ADA result, and at least one non-missing post baseline ADA result.
Posted
Number
percentage of participants
Baseline, Week 1 through Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
OG001
Galcanezumab 300 mg
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Units
Counts
Participants
Secondary
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 2.
Posted
Mean
Standard Deviation
nanogram per milliliter
Week 2
ID
Title
Description
OG000
Galcanezumab 300 mg
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Units
Counts
Participants
OG00090
Secondary
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 4.
Posted
Mean
Standard Deviation
nanogram per milliliter
Week 4
ID
Title
Description
OG000
Galcanezumab 300 mg
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Units
Counts
Participants
OG00096
Secondary
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 8.
Posted
Mean
Standard Deviation
nanogram per milliliter
Week 8
ID
Title
Description
OG000
Galcanezumab 300 mg
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Units
Counts
Participants
OG00094
Secondary
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 12.
Posted
Mean
Standard Deviation
nanogram per milliliter
Week 12
ID
Title
Description
OG000
Galcanezumab 300 mg
Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Units
Counts
Participants
OG00096
Time Frame
Up to 1 Year 7 Months
Description
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
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
Placebo (Double-Blind Treatment Phase)
Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
Participants from galcanezumab of double-blind group received 300 mg of galcanezumab by subcutaneous injection every 30 days, for up to a total of 12 administrations.
0
113
10
113
72
113
EG004
Placebo (Post-Treatment Phase)
Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.
0
2
0
2
1
2
EG005
Galcanezumab 300 mg (Post-Treatment Phase)
Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.
0
4
0
4
2
4
EG006
Placebo/GMB 300 mg (Post-Treatment Phase)
Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.
0
93
0
93
18
93
EG007
GMB 300 mg/GMB 300 Mg-Post-Treatment Phase
Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.
0
93
5
93
16
93
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0011 events1 affected117 at risk
EG0020 events0 affected116 at risk
EG0030 events0 affected113 at risk
EG0040 events0 affected2 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected93 at risk
EG0070 events0 affected93 at risk
Palpitations
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected116 at risk
EG003
Amaurosis
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected116 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0011 events1 affected117 at risk
EG0020 events0 affected116 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected120 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected116 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected116 at risk
EG003
Chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected116 at risk
EG003
Injection site urticaria
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected116 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected120 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected116 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected116 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected116 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected116 at risk
EG003
Helicobacter gastritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected116 at risk
EG003
Rectal abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected116 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected116 at risk
EG003
Extradural haematoma
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected116 at risk
EG003
Kidney rupture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected116 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected116 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected116 at risk
EG003
Breast cancer stage iii
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected116 at risk
EG003
Colon neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected116 at risk
EG003
Metastasis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected120 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected116 at risk
EG003
Pituitary tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)