Study NCT03617367
Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS) (ASPEN-OLS)
Submitted Date:  June 2, 2023 (v10)
Quality Control Review Has Not Concluded

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This submission includes brief standardized QC review comments added by the National Library of Medicine (NLM). These comments indicate the location of apparent errors, deficiencies, or inconsistencies. For more information, see the Final Rule (42 CFR Part 11) Information page.


Open or close this module Study Identification
Unique Protocol ID: 1720304
Brief Title: Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS) (ASPEN-OLS)
Official Title: A Phase 3, Open-Label, Multi-Center Trial to Evaluate the Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS)
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2023
Overall Status: Completed
Study Start: September 5, 2018
Primary Completion: May 25, 2021 [Actual]
Study Completion: May 25, 2021 [Actual]
First Submitted: July 12, 2018
First Submitted that
Met QC Criteria:
July 31, 2018
First Posted: August 6, 2018 [Actual]
Results First Submitted: June 2, 2023
Results First Submitted that
Met QC Criteria:
Results First Posted: June 29, 2023 [Actual]
Certification/Extension
First Submitted:
January 20, 2022
Certification/Extension
First Submitted that
Met QC Criteria:
January 20, 2022
Certification/Extension
First Posted:
January 24, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
Last Update Posted: June 29, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Revance Therapeutics, Inc.
Responsible Party: Sponsor
Collaborators: Syneos Health
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Phase 3, open-label, multi-center trial to evaluate the long-term safety, efficacy, and immunogenicity of up to four continuous treatment cycles of daxibotulinumtoxinA (DAXI) for injection.
Detailed Description: Approximately 350 adult subjects will be recruited from approximately 80 study centers in the United States, Canada, and Europe who were enrolled in the ASPEN-1 Study Protocol 1720302 and de novo subjects (not previously enrolled in ASPEN-1 Study Protocol 1720302) will be treated with up to 4 different doses of daxibotulinumtoxinA for injection.
Open or close this module Conditions
Conditions: Cervical Dystonia
Keywords: DAXI
Cervical Dystonia
TWSTRS
Toxin
multiple treatment
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Single Group Assignment
This is a Phase 3, open-label, multi-center trial to evaluate the long-term safety, efficacy, and immunogenicity of up to four continuous treatment cycles of daxibotulinumtoxinA (DAXI) for injection with up to four different doses in adults with isolated cervical dystonia (CD).
Number of Arms: 4
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 357 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Cycle 1: 125 U or 250 U
DAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults
Biological: daxibotulinumtoxinA for injection
DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.
Experimental: Cycle 2: 125 U, 200 U, 250 U or 300 U
DAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults
Biological: daxibotulinumtoxinA for injection
DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.
Experimental: Cycle 3: 125 U, 200 U, 250 U or 300 U
DAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults
Biological: daxibotulinumtoxinA for injection
DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.
Experimental: Cycle 4: 125 U, 200 U, 250 U or 300 U
DAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults
Biological: daxibotulinumtoxinA for injection
DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. The Dose and Cycle-specific Incidence of Drug-related AEs
[ Time Frame: Up to 52 Weeks ]

The dose and cycle-specific incidence of drug-related AEs
Secondary Outcome Measures:
1. The Dose and Cycle-specific Incidence of Study Drug Discontinuation Due to Drug Related AEs
[ Time Frame: up to 52 weeks ]

The dose and cycle-specific incidence of study drug discontinuation due to drug related AEs
2. The Dose and Cycle-specific Average of the Change in the TWSTRS-total Score at Weeks 4 and 6 of Each Treatment Cycle
[ Time Frame: Weeks 4 and 6 of each treatment cycle ]

The TWSTRS is an assessment scale used to measure the impact of CD on subjects. TWSTRS-total score has a minimum score of 0 and a maximum score of 85, where higher scores represent worse outcomes. It is made up of the summation of 3 subscales: the Torticollis Severity Scale (minimum score of 0, maximum score of 35), the Disability Scale (minimum score of 0, maximum score of 30), and the Pain Scale (minimum score of 0, maximum score of 20).

Quality Control Review Comment provided by the National Library of Medicine:

  1. The Time Frame, or information elsewhere, appears to contain more than one time point. It is unclear which time points are reported or how they were combined.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Meets diagnostic criteria for isolated CD (idiopathic; dystonic symptoms localized to the head, neck, shoulder areas) with at least moderate severity at Baseline (Day 1), defined as a TWSTRS-total score of at least 20, with at least 15 on the TWSTRS-Severity subscale, at least 3 on the TWSTRS-Disability subscale, and at least 1 on the TWSTRS-Pain subscale (minimum TWSTRS subscale criteria applicable only to subjects not previously enrolled in Study Protocol 1720302)
  • Subjects who were previously enrolled in Study Protocol 1720302, and completed the study, including:
    • Those with no reduction or have an increase from baseline in the average TWSTRS-total score at Weeks 4 and 6 (i.e., no improvement or worsened disease status), and the investigator agreed that there was a need for retreatment based on the subject's symptoms and neurologic exam findings
    • Those who benefited from study treatment and completed follow-up study visits up to the time point of when their TWSTRS - total score reached/exceeded their target TWSTRS score
    • Those who benefited from study treatment but subsequently experienced significant recurrence of CD symptoms (e.g. pain) during the study before their TWSTRS-total score reached their target TWSTRS score and requested retreatment, which the investigator determined was warranted based on the subject's symptoms and neurologic exam findings
    • Those who completed study visits up to Week 36 and their TWSTRS-total score never reached their target TWSTRS score and they never requested another treatment. The investigator determined that these subjects can be followed in the OLS until their TWSTRS-total score is the same or higher than their target TWSTRS score or until they request retreatment, which the investigator determined is clinically indicated
  • De novo subjects (not previously enrolled in Study Protocol 1720302):
    • Naïve to BoNT treatment
    • BoNT treatment-experienced; if previously treated with BoNTA, the subject must have demonstrated a clinically meaningful response to the last BoNTA treatment based on the clinical judgment of the investigator

Exclusion Criteria:

  • Cervical dystonia attributable to an underlying etiology, (e.g., traumatic torticollis or tardive torticollis)
  • Predominant retrocollis or anterocollis CD
  • Significant dystonia in other body areas, or is currently being treated with botulinum toxin (BoNT) for dystonia in areas other than those associated with isolated CD
  • Severe dysphagia (Grade 3 or 4 on the Dysphagia Severity Scale) at Screening or Baseline (prior to study treatment)
  • Any neuromuscular neurological conditions that may place the subject at increased risk of morbidity with exposure to BoNT, including peripheral motor neuropathic diseases (e.g., amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis)
  • Previous treatment with any BoNT product for any condition within the 14 weeks prior to Screening (applicable only to de novo subjects)
  • Botulinum neurotoxin treatment-experienced subjects who had suboptimal or no treatment response to the most recent BoNTA injection for CD, as determined by the investigator; or history of primary or secondary non-response to BoNTA injections, known to have neutralizing antibodies to BoNTA; or have a history of botulinum toxin type B (rimabotulinumtoxinA [Myobloc/Neurobloc]) injection for CD due to non-response or suboptimal response to BoNTA (applicable only to de novo subjects)
Open or close this module Contacts/Locations
Locations: United States, Arizona
HOPE Research Institute
Phoenix, Arizona, United States, 85018
Movement Disorders Center of Arizona
Scottsdale, Arizona, United States, 85258
United States, California
The Parkinsons and Movement Disorder Institute
Fountain Valley, California, United States, 92708
Loma Linda University
Loma Linda, California, United States, 92354
USC Keck School of Medicine
Los Angeles, California, United States, 90033
Care Access Research LLC
Pasadena, California, United States, 91101
United States, Colorado
Rocky Mountain Movement Disorders Center
Englewood, Colorado, United States, 80113
United States, Connecticut
Ki Health Partners LLC DBA New England Institute for Clinical Research
Stamford, Connecticut, United States, 06905
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States, 32609
Infinity Clinical research
Hollywood, Florida, United States, 33024
University of Miami
Miami, Florida, United States, 33136
Suncoast Neuroscience Associates
Saint Petersburg, Florida, United States, 33713
USF Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States, 33613
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Kansas
Kansas Institute of Research
Overland Park, Kansas, United States, 66211-1358
United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
QUEST Research Institute
Farmington, Michigan, United States, 48334
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States, 48322
United States, Missouri
St Louis University
Saint Louis, Missouri, United States, 63104
Washington University
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68105
United States, New York
Mount Sinai Movement Disorders Center
New York, New York, United States, 10029
University of Rochester
Rochester, New York, United States, 14618
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Coastal Neurology
Port Royal, South Carolina, United States, 29935
United States, Tennessee
Intrafusion Research Network - Wesley Neurology Clinic
Cordova, Tennessee, United States, 38018
Veracity Neuroscience LLC
Memphis, Tennessee, United States, 38157
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Neurology. P.A.
Dallas, Texas, United States, 75214
Baylor College of Medicine
Houston, Texas, United States, 77030
Houston Methodist Neurological Institute
Houston, Texas, United States, 77030
Central Texas Neurology Consultants
Round Rock, Texas, United States, 78681
United States, Vermont
The University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Austria
Neurologisches Studienzentrum Universitätsklinik für Neurologie Innsbruck
Innsbruck, Austria, 30539
Canada, Ontario
University Health Network, Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Czechia
Fakultní nemocnice Ostrava
Ostrava-Poruba, Czechia, 70852
Nemocnice Pardubickeho kraje, a.s.; Pardubicka nemocnice
Pardubice, Czechia, 53203
Neurologicka klinika 1. LF UK a VFN v Praze
Praha, Czechia, 12821
Vestra Clinics s.r.o.
Rychnov nad Kneznou, Czechia, 51601
France
Hôpital Neurologique Pierre Wertheimer
Bron, France, 69500
CHU de Grenoble
Grenoble cedex 9, France, 38043
Hôpital Roger Salengro
Lille Cedex, France, 59037
CHU Caremeau
Nîmes, France, 30029
Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, Germany, 40225
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Klinikum rechts der Isar der TUM
Muenchen, Germany, 81675
GFO Kliniken Troisdorf, Betriebsstätte St. Johannes Sieglar
Troisdorf, Germany, 53844
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Poland
Szpital sw. Wojciecha Podmiot Leczniczy Copernicus Sp. Z o.o.
Gdansk, Poland, 80462
Marta Dagmara BANACH Marta Banach Specjalistyczny Gabinet Neurologiczny
Kraków, Poland, 30539
Krakowska Akademia Neurologii Sp. z o.o.
Kraków, Poland, 31505
Wojewodzki Szpital Specjalistyczny w Olsztynie
Olsztyn, Poland, 10561
Centrum Medyczne Pratia Warszawa
Warsaw, Poland, 01868
Mazovian Brodno Hospital
Warsaw, Poland, 03242
Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Hospital Universitario Burgos
Burgos, Spain, 09006
Hospital Universitario de La Princesa
Madrid, Spain, 28006
United Kingdom
Royal Devon and Exeter Foundation Trust Hospital
Exeter, United Kingdom, EX2 5DW
The Walton Centre NHS Foundation Trust, Neuroscience Research Centre
Liverpool, United Kingdom, L97LJ
Salford Royal NHS Foundation Trust
Salford, United Kingdom, M55AP
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:
Open or close this module Document Section
Study Protocol
Document Date: July 10, 2019
Uploaded: 06/01/2023 16:22
File Name: Prot_000.pdf
Statistical Analysis Plan
Document Date: March 31, 2021
Uploaded: 06/01/2023 20:51
File Name: SAP_001.pdf
Study Results
Open or close this module Participant Flow
Recruitment Details
Pre-assignment Details The first cycle total will be the treated study population. Participants can receive up to four cycles.
 
Arm/Group Title DAXI 125 U, 200 U, 250 U or 300 U
Arm/Group Description DAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults.

Quality Control Review Comment provided by the National Library of Medicine:

  1. The participant flow appears to include insufficient information to understand the arms/groups to which participants were assigned, the intervention strategy used in each arm/group, or how participants progressed in the study.
Period Title: Overall Study
Started 357
Completed 297
Not Completed 60
Open or close this module Baseline Characteristics
Arm/Group TitleDAXI
Arm/Group DescriptionDAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults.
Overall Number of Baseline Participants 357
Baseline Analysis Population Description
Age, Continuous
Mean (Full Range)
Unit of measure: years
Number Analyzed357 Participants
57.6(19 to 80)
Age, Customized
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed357 Participants
18 to < 65
240
67.23%
65 to < 75
96
26.89%
>= 75 years
21
5.88%
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed357 Participants
Female
238
66.67%
Male
119
33.33%
Race/Ethnicity, Customized
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed357 Participants
White
342
95.8%
Black
6
1.68%
Asian
4
1.12%
American Indian or Alaska Native
1
0.28%
Native Hawaiian or Other Pacific Islander
1
0.28%
Other
3
0.84%
Open or close this module Outcome Measures
1. Primary Outcome:
Title The Dose and Cycle-specific Incidence of Drug-related AEs
Description The dose and cycle-specific incidence of drug-related AEs
Time Frame Up to 52 Weeks
Outcome Measure Data
Analysis Population Description
Safety Population
 
Arm/Group TitleCycle 1: 125 U or 250 UCycle 2: 125 U, 200 U, 250 U or 300 UCycle 3: 125 U, 200 U, 250 U or 300 UCycle 4: 125 U, 200 U, 250 U or 300 U
Arm/Group DescriptionDAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults.DAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults.DAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults.DAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults.
Overall Number of Participants Analyzed357 329 234 65
Measure Type: Count of Participants
Unit of Measure: Participants
75
21%
56
17%
46
19.7%
9
13.8%

Quality Control Review Comment provided by the National Library of Medicine:

  1. The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided.
2. Secondary Outcome:
Title The Dose and Cycle-specific Incidence of Study Drug Discontinuation Due to Drug Related AEs
Description The dose and cycle-specific incidence of study drug discontinuation due to drug related AEs
Time Frame up to 52 weeks
Outcome Measure Data
Analysis Population Description
Safety population
 
Arm/Group TitleCycle 1: 125 U or 250 UCycle 2: 125 U, 200 U, 250 U or 300 UCycle 3: 125 U, 200 U, 250 U or 300 UCycle 4: 125 U, 200 U, 250 U or 300 U
Arm/Group DescriptionDAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults.DAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults.DAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults.DAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults.
Overall Number of Participants Analyzed357 329 234 65
Measure Type: Count of Participants
Unit of Measure: Participants
Injection site erythema
0
0%
0
0%
1
0.4%
0
0%
Hematoma
1
0.3%
0
0%
0
0%
0
0%

Quality Control Review Comment provided by the National Library of Medicine:

  1. The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided.
3. Secondary Outcome:
Title The Dose and Cycle-specific Average of the Change in the TWSTRS-total Score at Weeks 4 and 6 of Each Treatment Cycle
Description The TWSTRS is an assessment scale used to measure the impact of CD on subjects. TWSTRS-total score has a minimum score of 0 and a maximum score of 85, where higher scores represent worse outcomes. It is made up of the summation of 3 subscales: the Torticollis Severity Scale (minimum score of 0, maximum score of 35), the Disability Scale (minimum score of 0, maximum score of 30), and the Pain Scale (minimum score of 0, maximum score of 20).
Time Frame Weeks 4 and 6 of each treatment cycle

Quality Control Review Comment provided by the National Library of Medicine:

  1. The Time Frame, or information elsewhere, appears to contain more than one time point. It is unclear which time points are reported or how they were combined.
Outcome Measure Data
Analysis Population Description
Safety population
 
Arm/Group TitleCycle 1 - 125 U or 250 UCycle 2 - 125 U, 200 U, 250 U or 300 UCycle 3 - 125 U, 200 U, 250 U or 300 UCycle 4 - 125 U, 200 U, 250 U or 300 U
Arm/Group DescriptionDAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults.DAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults.DAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults.DAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults.
Overall Number of Participants Analyzed357 329 234 65
Mean (Standard Deviation)
Unit of Measure: score on a scale
-15.4(10.30) -17.7(11.35) -17.9(11.31) -19.9(13.56)

Quality Control Review Comment provided by the National Library of Medicine:

  1. The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided.
Open or close this module Adverse Events
 
Time Frame The adverse events were collected throughout the entire study, up to 52 weeks.
Adverse Event Reporting Description The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
 
Arm/Group Title Cycle 1 - 125 U or 250 U Cycle 2 - 125 U, 200 U, 250 U or 300 U Cycle 3 - 125 U, 200 U, 250 U or 300 U Cycle 4 - 125 U, 200 U, 250 U or 300 U
Arm/Group Description DAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults. DAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults. DAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults. DAXI for injection for the treatment of Isolated Cervical Dystonia (CD) in adults.

Quality Control Review Comment provided by the National Library of Medicine:

  1. The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided.
All-Cause Mortality
  Cycle 1 - 125 U or 250 UCycle 2 - 125 U, 200 U, 250 U or 300 UCycle 3 - 125 U, 200 U, 250 U or 300 UCycle 4 - 125 U, 200 U, 250 U or 300 U
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 0 / 357 (0%)1 / 329 (0.3%)0 / 234 (0%)0 / 65 (0%)
Serious Adverse Events
  Cycle 1 - 125 U or 250 UCycle 2 - 125 U, 200 U, 250 U or 300 UCycle 3 - 125 U, 200 U, 250 U or 300 UCycle 4 - 125 U, 200 U, 250 U or 300 U
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 2 / 357 (0.56%)6 / 329 (1.82%)8 / 234 (3.42%)1 / 65 (1.54%)
Blood and lymphatic system disorders
Blood loss anemia 0 / 357 (0%)01 / 329 (0.3%)10 / 234 (0%)00 / 65 (0%)0
Gastrointestinal disorders
Hiatus hernia 0 / 357 (0%)00 / 329 (0%)01 / 234 (0.43%)10 / 65 (0%)0
General disorders
Non-cardiac chest pain 1 / 357 (0.28%)10 / 329 (0%)00 / 234 (0%)00 / 65 (0%)0
Infections and infestations
COVID-19 0 / 357 (0%)00 / 329 (0%)02 / 234 (0.85%)20 / 65 (0%)0
Clostridium difficile colitis 0 / 357 (0%)00 / 329 (0%)01 / 234 (0.43%)20 / 65 (0%)0
Diverticulitis 0 / 357 (0%)01 / 329 (0.3%)11 / 234 (0.43%)10 / 65 (0%)0
Injury, poisoning and procedural complications
Accidental overdose 0 / 357 (0%)00 / 329 (0%)00 / 234 (0%)01 / 65 (1.54%)1
Fall 0 / 357 (0%)01 / 329 (0.3%)10 / 234 (0%)00 / 65 (0%)0
Head injury 0 / 357 (0%)00 / 329 (0%)01 / 234 (0.43%)10 / 65 (0%)0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer 0 / 357 (0%)00 / 329 (0%)01 / 234 (0.43%)10 / 65 (0%)0
Intraductal proliferative breast lesion 0 / 357 (0%)01 / 329 (0.3%)10 / 234 (0%)00 / 65 (0%)0
Squamous cell carcinoma of lung 0 / 357 (0%)00 / 329 (0%)01 / 234 (0.43%)10 / 65 (0%)0
Nervous system disorders
Intracranial aneurysm 1 / 357 (0.28%)10 / 329 (0%)00 / 234 (0%)00 / 65 (0%)0
Renal and urinary disorders
Acute kidney injury 0 / 357 (0%)01 / 329 (0.3%)10 / 234 (0%)00 / 65 (0%)0
Chronic kidney disease 0 / 357 (0%)01 / 329 (0.3%)10 / 234 (0%)00 / 65 (0%)0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism 0 / 357 (0%)00 / 329 (0%)01 / 234 (0.43%)10 / 65 (0%)0
Indicates events were collected by systematic assessment.
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
  Cycle 1 - 125 U or 250 UCycle 2 - 125 U, 200 U, 250 U or 300 UCycle 3 - 125 U, 200 U, 250 U or 300 UCycle 4 - 125 U, 200 U, 250 U or 300 U
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 63 / 357 (17.65%)48 / 329 (14.59%)40 / 234 (17.09%)10 / 65 (15.38%)
Gastrointestinal disorders
Dysphagia 15 / 357 (4.2%)1514 / 329 (4.26%)1412 / 234 (5.13%)122 / 65 (3.08%)2
General disorders
Injection site erythema 9 / 357 (2.52%)96 / 329 (1.82%)67 / 234 (2.99%)71 / 65 (1.54%)1
Injection site pain 19 / 357 (5.32%)199 / 329 (2.74%)105 / 234 (2.14%)62 / 65 (3.08%)2
Injury, poisoning and procedural complications
Fall 5 / 357 (1.4%)52 / 329 (0.61%)23 / 234 (1.28%)32 / 65 (3.08%)2
Musculoskeletal and connective tissue disorders
Arthralgia 4 / 357 (1.12%)41 / 329 (0.3%)10 / 234 (0%)02 / 65 (3.08%)2
Muscular weakness 16 / 357 (4.48%)1617 / 329 (5.17%)1815 / 234 (6.41%)152 / 65 (3.08%)2
Nervous system disorders
Headache 11 / 357 (3.08%)119 / 329 (2.74%)93 / 234 (1.28%)41 / 65 (1.54%)1
Indicates events were collected by systematic assessment.
Open or close this module Limitations and Caveats
[Not specified]
Open or close this module More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The Study Center and/or Investigator shall submit to Revance a copy of the proposed publication at least sixty (60) days prior to the submission thereof for publication or disclosure to a third party: (i)to provide Revance with the opportunity to review and comment on the contents thereof, (ii)to identify any Confidential Information to be deleted from the proposed publication or disclosure, and (iii)or delay the publication or disclosure 90 days to allow Revance to pursue patent protections.
Results Point of Contact:
Name/Official Title:
Todd Gross, PhD, VP, Clinical Development & Data Science
Organization:
Revance Therapeutics, Inc.
Phone:
510-742-3400
Email:
tgross@revance.com

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