A Study to Evaluate the Safety and Efficacy of Ombitasvir... | NCT02292719 | Trialant
NCT02292719
Sponsor
AbbVie
Status
Completed
Last Update Posted
Jul 12, 2021Actual
Enrollment
70Actual
Phase
Phase 2
Conditions
Chronic Hepatitis C Virus Infection
Interventions
OBV/PTV/r
Sofosbuvir
Ribavirin (RBV)
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT02292719
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M14-567
Secondary IDs
ID
Type
Description
Link
2014-003147-35
EudraCT Number
Brief Title
A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection
Official Title
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of the Co-Administration of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Sofosbuvir (SOF) With or Without Ribavirin (RBV) in Subjects With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection or Genotype 3 HCV Infection With or Without Cirrhosis
Acronym
Quartz II/III
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Jul 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 19, 2014Actual
Primary Completion Date
Jul 14, 2017Actual
Completion Date
Jul 14, 2017Actual
First Submitted Date
Nov 13, 2014
First Submission Date that Met QC Criteria
Nov 13, 2014
First Posted Date
Nov 17, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 7, 2018
Results First Submitted that Met QC Criteria
Jun 7, 2018
Results First Posted Date
Jul 6, 2018Actual
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
Jul 8, 2021
Last Update Posted Date
Jul 12, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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 purpose of this study is to evaluate the safety and efficacy of Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) with sofosbuvir (SOF) with or without ribavirin (RBV) in adults with Genotype 2 Chronic Hepatitis C Virus (HCV) infection or Genotype 3 HCV infection with or without Cirrhosis.
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Hepatitis C Virus Infection
Keywords
Hepatitis C Virus
Genotype 2
Chronic Hepatitis C
Genotype 3
Non-cirrhotic
Cirrhotic
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
70Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm A (genotype [GT]3, noncirrhotic)
Experimental
Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
Drug: OBV/PTV/r
Drug: Sofosbuvir
Arm B (GT3, noncirrhotic)
Experimental
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.
Drug: OBV/PTV/r
Drug: Sofosbuvir
Drug: Ribavirin (RBV)
Arm C (GT2, noncirrhotic)
Experimental
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.
Drug: OBV/PTV/r
Drug: Sofosbuvir
Drug: Ribavirin (RBV)
Arm D (GT2, noncirrhotic)
Experimental
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.
Drug: OBV/PTV/r
Drug: Sofosbuvir
Drug: Ribavirin (RBV)
Arm E (GT3, cirrhotic)
Experimental
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
OBV/PTV/r
Drug
Tablet
Arm A (genotype [GT]3, noncirrhotic)
Arm B (GT3, noncirrhotic)
Arm C (GT2, noncirrhotic)
Arm D (GT2, noncirrhotic)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link)
12 weeks after the last actual dose of study drug
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment for 12-week and 8-week treatment or at least 26 days of treatments for 6-week treatment.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Chronic HCV infection prior to study enrollment.
Screening laboratory results from the central clinical laboratory indicating HCV genotype 2 or 3 infection only (no mixed genotype).
Absence OR presence of cirrhosis.
If cirrhotic, need to have compensated cirrhosis and absence of hepatocellular carcinoma (HCC)
Exclusion Criteria:
Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse.
Current enrollment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV therapy (other than interferon, pegIFN, RBV, and or SOF) including previous exposure to telaprevir, boceprevir, ABT-450, or ombitasvir (ABT-267).
Subjects without cirrhosis: Any current or past clinical evidence of cirrhosis.
Abnormal lab tests.
Females who are pregnant or plan to become pregnant or breastfeeding, or males whose partners are pregnant or planning to become pregnant
Shafran SD, Shaw D, Charafeddine M, Agarwal K, Foster GR, Abunimeh M, Pilot-Matias T, Pothacamury RK, Fu B, Cohen E, Cohen DE, Gane E. Efficacy and safety results of patients with HCV genotype 2 or 3 infection treated with ombitasvir/paritaprevir/ritonavir and sofosbuvir with or without ribavirin (QUARTZ II-III). J Viral Hepat. 2018 Feb;25(2):118-125. doi: 10.1111/jvh.12782. Epub 2017 Sep 14.
Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
FG001
Arm B (GT3, Noncirrhotic)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
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
Jul 31, 2014
Jun 7, 2018
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Australia
Canada
New Zealand
United Kingdom
United States
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
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: OBV/PTV/r
Drug: Sofosbuvir
Drug: Ribavirin (RBV)
Arm F (GT3, noncirrhotic)
Experimental
OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
Drug: OBV/PTV/r
Drug: Sofosbuvir
Arm E (GT3, cirrhotic)
Arm F (GT3, noncirrhotic)
ABT-267 also known as ombitasvir
ABT-450 also known as paritaprevir
ritonavir (r) also known as Norvir
VIEKIRAX combination tablets
TECHNIVIE
Sofosbuvir
Drug
Tablet
Arm A (genotype [GT]3, noncirrhotic)
Arm B (GT3, noncirrhotic)
Arm C (GT2, noncirrhotic)
Arm D (GT2, noncirrhotic)
Arm E (GT3, cirrhotic)
Arm F (GT3, noncirrhotic)
Sovaldi
Ribavirin (RBV)
Drug
Tablet
Arm B (GT3, noncirrhotic)
Arm C (GT2, noncirrhotic)
Arm D (GT2, noncirrhotic)
Arm E (GT3, cirrhotic)
Up to Week 12
Percentage of Participants With Post-treatment Relapse
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
Up to 12 weeks after the last actual dose of active study drug
Derived
King JR, Dutta S, Cohen D, Podsadecki TJ, Ding B, Awni WM, Menon RM. Drug-Drug Interactions between Sofosbuvir and Ombitasvir-Paritaprevir-Ritonavir with or without Dasabuvir. Antimicrob Agents Chemother. 2015 Nov 23;60(2):855-61. doi: 10.1128/AAC.01913-15. Print 2016 Feb.
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.
FG002
Arm C (GT2, Noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.
FG003
Arm D (GT2, Noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.
FG004
Arm E (GT3, Cirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.
FG005
Arm F (GT3, Noncirrhotic)
OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
FG0009 subjects
FG00111 subjects
FG00210 subjects
FG0039 subjects
FG00421 subjects
FG00510 subjects
COMPLETED
FG0009 subjects
FG00111 subjects
FG0029 subjects
FG0038 subjects
FG00420 subjects
FG00510 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
Subject enrolled in new study.
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
All subjects who received at least 1 dose of study drug were included in the intent-to-treat (ITT) population; the safety population is the same as the ITT population.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm A (Genotype [GT]3, Noncirrhotic)
Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
BG001
Arm B (GT3, Noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.
BG002
Arm C (GT2, Noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.
BG003
Arm D (GT2, Noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.
BG004
Arm E (GT3, Cirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.
BG005
Arm F (GT3, Noncirrhotic)
OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0009
BG00111
BG00210
BG0039
BG00421
BG00510
BG00670
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00052.1± 9.17
BG00153.5± 8.26
BG00256.6± 6.70
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0014
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG0007
BG00111
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link)
ITT population
Posted
Number
95% Confidence Interval
percentage of participants
12 weeks after the last actual dose of study drug
ID
Title
Description
OG000
Arm A (Genotype [GT]3, Noncirrhotic)
Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
OG001
Arm B (GT3, Noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.
OG002
Arm C (GT2, Noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.
OG003
Arm D (GT2, Noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.
OG004
Arm E (GT3, Cirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.
OG005
Arm F (GT3, Noncirrhotic)
OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
Units
Counts
Participants
OG0009
OG00111
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG000100(70.1 to 100)
OG00190.9(62.3 to 98.4)
OG00290.0(59.6 to 98.2)
OG003
Secondary
Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment for 12-week and 8-week treatment or at least 26 days of treatments for 6-week treatment.
ITT population
Posted
Number
95% Confidence Interval
percentage of participants
Up to Week 12
ID
Title
Description
OG000
Arm A (Genotype [GT]3, Noncirrhotic)
Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
OG001
Arm B (GT3, Noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.
OG002
Arm C (GT2, Noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.
Secondary
Percentage of Participants With Post-treatment Relapse
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
ITT population
Posted
Number
95% Confidence Interval
percentage of participants
Up to 12 weeks after the last actual dose of active study drug
ID
Title
Description
OG000
Arm A (Genotype [GT]3, Noncirrhotic)
Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
OG001
Arm B (GT3, Noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.
OG002
Arm C (GT2, Noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.
OG003
Arm D (GT2, Noncirrhotic)
Time Frame
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
Description
TEAEs and and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
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
Arm A (Genotype [GT]3, Noncirrhotic)
Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD ) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
0
9
0
9
8
9
EG001
Arm B (GT3, Noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.
0
11
0
11
10
11
EG002
Arm C (GT2, Noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.
0
10
1
10
10
10
EG003
Arm D (GT2, Noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.
0
9
0
9
9
9
EG004
Arm E (GT3, Cirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.
0
21
2
21
20
21
EG005
Arm F (GT3, Noncirrhotic)
OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
0
10
0
10
8
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected9 at risk
EG0041 events1 affected21 at risk
EG0050 events0 affected10 at risk
PNEUMONIA
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
RESPIRATORY TRACT INFECTION VIRAL
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0021 events1 affected10 at risk
EG0030 events0 affected9 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected10 at risk
PALPITATIONS
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
HYPOACUSIS
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
DRY EYE
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
ABDOMINAL DISCOMFORT
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0021 events1 affected10 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0023 events3 affected10 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0021 events1 affected10 at risk
EG003
FLATULENCE
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
MOUTH ULCERATION
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0023 events3 affected10 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
CHEST PAIN
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
ENERGY INCREASED
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
FATIGUE
General disorders
MedDRA 20.0
Systematic Assessment
EG0003 events3 affected9 at risk
EG0013 events3 affected11 at risk
EG0024 events3 affected10 at risk
EG003
FEELING ABNORMAL
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
MALAISE
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
PAIN
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
GENITAL HERPES
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
LOWER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
PARONYCHIA
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
RESPIRATORY TRACT INFECTION VIRAL
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0024 events4 affected10 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
BACK INJURY
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
MUSCLE STRAIN
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
HAEMOGLOBIN DECREASED
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
INTERNATIONAL NORMALISED RATIO DECREASED
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
POLYDIPSIA
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
JOINT SWELLING
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
PLANTAR FASCIITIS
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
DISTURBANCE IN ATTENTION
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected9 at risk
EG0011 events1 affected11 at risk
EG0021 events1 affected10 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
HEAD DISCOMFORT
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0012 events2 affected11 at risk
EG0028 events6 affected10 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
INTERCOSTAL NEURALGIA
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
MEMORY IMPAIRMENT
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
POOR QUALITY SLEEP
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
AGITATION
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
DEPRESSED MOOD
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
DISORIENTATION
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
HALLUCINATION
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected11 at risk
EG0022 events2 affected10 at risk
EG003
IRRITABILITY
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
MOOD SWINGS
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
SLEEP DISORDER
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
TEARFULNESS
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
WITHDRAWAL SYNDROME
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
CHROMATURIA
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
MICTURITION URGENCY
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
POLLAKIURIA
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
URINE ODOUR ABNORMAL
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
BENIGN PROSTATIC HYPERPLASIA
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
NIPPLE PAIN
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0013 events3 affected11 at risk
EG0020 events0 affected10 at risk
EG003
DYSPNOEA EXERTIONAL
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0021 events1 affected10 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
RESPIRATORY TRACT CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
UPPER RESPIRATORY TRACT CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0021 events1 affected10 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
INGROWING NAIL
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0022 events2 affected10 at risk
EG003
NIGHT SWEATS
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected9 at risk
EG0013 events2 affected11 at risk
EG0020 events0 affected10 at risk
EG003
PRURITUS ALLERGIC
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
PRURITUS GENERALISED
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
PSORIASIS
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
RASH ERYTHEMATOUS
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
RASH PRURITIC
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected10 at risk
EG003
SKIN ODOUR ABNORMAL
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected10 at risk
EG003
SKIN ULCER
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
PERIPHERAL ARTERY STENOSIS
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected10 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.