Telbivudine in Adults Previously Treated in Idenix-Sponso... | NCT00142298 | Trialant
NCT00142298
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Aug 21, 2020Actual
Enrollment
1,869Actual
Phase
Phase 3
Conditions
Chronic Hepatitis B
Interventions
Telbivudine (LdT)
Countries
United States
Australia
Canada
China
Czechia
France
Germany
Hong Kong
India
Israel
Italy
New Zealand
Poland
Puerto Rico
Singapore
South Korea
Spain
Taiwan
Thailand
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00142298
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CLDT600A2303
Secondary IDs
ID
Type
Description
Link
NV-02B-022
Other Identifier
Idenix
Brief Title
Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies
Official Title
An Open Label Trial of Telbivudine (LdT) in Adults With Chronic Hepatitis B Previously Treated in Idenix-Sponsored Telbivudine Studies
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Aug 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
Mar 2005
Primary Completion Date
Nov 2009Actual
Completion Date
Nov 2009Actual
First Submitted Date
Aug 31, 2005
First Submission Date that Met QC Criteria
Aug 31, 2005
First Posted Date
Sep 2, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 12, 2011
Results First Submitted that Met QC Criteria
Jun 24, 2011
Results First Posted Date
Jul 25, 2011Estimated
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 9, 2020
Last Update Posted Date
Aug 21, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Name
Class
Merck Sharp & Dohme LLC
INDUSTRY
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This trial is being conducted as an open-label, extended-term study for patients with chronic hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.
Detailed Description
Patients from 6 feeder trials could be eligible to enter current study CLDT600A2303 ( NCT00142298) if they met inclusion/exclusion criteria. The feeder studies were as follows:
CLDT600A2302 (NV-02B-007)(NCT00057265), the GLOBE study, was a Phase III, randomized, doubleblind,multi-center, 104-week, pivotal study of telbivudine vs. lamivudine in treatment of naïve patients with compensated chronic hepatitis B. CLDT600A2302/NV-02B-007 (NCT00057265) is hereafter referred to as study 2302.
NV-02B-015 (NCT00131742) was a Phase III, randomized, double-blind, 104-week study comparing the efficacy and safety of telbivudine (600 mg/day) to lamivudine (100 mg/day) in treatment of naïve Chinese patients with compensated chronic hepatitis B. NV-02B-015 (NCT00131742) is hereafter referred to as study 015.
CLDT600A2301 (NV-02B-011)(NCT00076336) was a Phase III, randomized double-blind, multi-center, 104-week, pivotal study of telbivudine (600 mg/day) vs. lamivudine (100 mg/day) in treatment-naïve adults with decompensated chronic hepatitis B. CLDT600A2301/NV-02B-011 (NCT00076336) is hereafter referred to as study 2301.
NV-02B-010 (NCT00124241) was a Phase IIb, 104-week extension study of telbivudine, lamivudine or the combination of both agents in patients with chronic hepatitis B who had completed the core study NV-02B-003 (NCT00124241). NV-02B-010 (NCT00124241) is hereafter referred to as study 010.
NV-02B-003 (NCT00124241) was a Phase IIa, 52-week study of telbivudine, lamivudine or the combination of both agents in patients with HBeAg-positive chronic hepatitis B.
CLDT600A2401 (NV-02B-018) (NCT00115245) was a Phase IIIb, randomized, open-label, multi-center,52-week study of telbivudine vs. adefovir dipivoxil for 24 weeks then a switch to telbivudine for another 28 weeks in treatment-naïve patients with compensated chronic hepatitis B. CLDT600A2401/NV-02B-018 (NCT00115245) is hereafter referred to as study 2401.
CLDT600A2402 (NV-02B-019) (NCT00132652) was a Phase IIIb, randomized, open-label, multi-center, 52-week study of switching lamivudine to telbivudine vs. continued on lamivudine treatment in adults with compensated chronic hepatitis B who were previously treated with lamivudine for 3-12 months. CLDT600A2402/NV-02-019 (NCT00132652) is hereafter referred to as study 2402.
PATIENT GROUPS:
GROUP A: Patients with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B who did not discontinue treatment in their previous study due to an efficacy response and required further treatment or who had met the criteria for discontinuation of treatment in their previous study due to efficacy, but were being maintained on study drug by the principal investigator. For patients treated with telbivudine who enrolled into Group A from studies 2302 and 015, the total telbivudine treatment time (starting from feeder study baseline to the end of the on-treatment period in study 2303) was 208 weeks. For patients treated with lamivudine in studies 2302/015 and enrolled into group A and for all patients in group A from studies 2401/2402/010, the total telbivudine treatment time was 104 weeks.
GROUP B: Patients with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B who did not discontinue treatment in their previous study due to an efficacy response and required further treatment. Patients treated with telbivudine in study 2301 were enrolled to group B and the total telbivudine treatment time (starting from feeder study baseline to the end of the on-treatment period in study 2303) was 208 weeks. For patients treated with lamivudine in study 2301 and enrolled into group B, the total telbivudine treatment time was 104 weeks.
GROUP C: Patients with either compensated or decompensated chronic hepatitis B, who had discontinued study drug treatment in their previous Idenix-sponsored study due to an efficacy response as recommended by protocol. Patients who were eligible for treatment discontinuation in their previous study but who were, at the principal investigators discretion, continued on study therapy, were eligible to enter this study in Group C provided their treatment was discontinued at their last visit of the previous study. The feeder studies for group C of current study were study 2302/015, 2401, 2402, and 010. For patients who enrolled into group C, total telbivudine treatment time was 104 weeks starting from the baseline of the feeder studies to their last visit of the feeder studies. Patients were enrolled to current study (study 2303) for off-treatment follow-up after the treatment discontinuation due to efficacy. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
Conditions Module
Conditions
Chronic Hepatitis B
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
1,869Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
telbivudine
Experimental
telbivudine 600 mg p.o. daily for 104 weeks.
Drug: Telbivudine (LdT)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Telbivudine (LdT)
Drug
Telbivudine was to be supplied as white to off-white, oval, bi-convex tablets for the 200 mg tablets and white to off-white ovaloid, slightly curved, beveled edges, film coated tablets for the 600 mg tablets. Study drug (600 mg) was to be self-administered by patients orally (p.o.) in a once daily regimen for 104 weeks; for study consistency, the daily dose had to be taken at the same time each day, with or without food.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015]
The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
156 weeks, 208 weeks (from feeder study baseline)
Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015]
The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
52 weeks, 104 weeks
Percentage of Participants Who Maintained Therapeutic Response [Group A: Feeder Studies 2401/2402/010]
The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
52 weeks, 104 weeks
Percentage of Participants With Maintained Clinical Response [Group B: LdT 2301]
Secondary Outcomes
Measure
Description
Time Frame
To Longitudinally Assess the Longer-term Antiviral Efficacy Achieved With Telbivudine Treatment
52 weeks, 104 weeks, 156 weeks, 208 weeks
To Longitudinally Assess the Clinical Efficacy of Longer-term Treatment With Telbivudine
52 weeks, 104 weeks, 156 weeks, 208 weeks
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patient completed a previous qualifying Idenix-Sponsored trial with telbivudine
Patient was not discontinued from previous Idenix-Sponsored study
Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
Patient is pregnant or breastfeeding
Patient is co-infected with hepatitis C, hepatitis D or HIV
Other protocol-defined exclusion criteria may apply
Hsu CW, Chao YC, Lee CM, Chang TT, Chen YC. Efficacy of telbivudine in Taiwanese chronic hepatitis B patients compared with GLOBE extension study and predicting treatment outcome by HBV DNA kinetics at week 24. BMC Gastroenterol. 2012 Dec 13;12:178. doi: 10.1186/1471-230X-12-178.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Undecided
Description
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
An open-label trial of telbivudine in adults with chronic hepatitis B previously treated in Idenix-sponsored telbivudine studies. Study start March 2005 and completed November 2009.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group A : LdT Pool 2302/015
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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
No data available
No data is available for this block.
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
N/A
Intervention Model
Single Group 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
telbivudine
Sebivo®/Tyzeka®
LdT600
Maintained clinical response is defined as achievement of serum HBV DNA < 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient's baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.
156 weeks, 208 weeks (from feeder study baseline)
Percentage of Participants With Maintained Clinical Response [Group B: LAM 2301]
Maintained clinical response is defined as achievement of serum HBV DNA < 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient's baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.
52 weeks,104 weeks
Percentage of Participants With Sustained Therapeutic Response [Group C: LdT Pool and LAM Pool (2302/015)]
The primary efficacy endpoint for Group C patients was the percentage of patients with sustained therapeutic response (defined as HBV DNA < 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
52 weeks,104 weeks
Percentage of Participants With Sustained Therapeutic Response [Group C: Other Feeder Studies]
The primary efficacy endpoint for Group C (other feeder studies) was the percentage of patients with sustained therapeutic response (defined as HBV DNA < 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up.
Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive study drug except in case of patients who relapsed and reinitiated treatment. No statistical summary was performed , only patient listing was generated.
52 weeks,104 weeks
To Longitudinally Assess the Durability of HBeAg Responses Achieved With Telbivudine Treatment and Other Previous Treatments in Patients
52 weeks, 104 weeks, 156 weeks, 208 weeks
To Determine the Longitudinal Frequency of Virologic Breakthrough and Characterize the Associated Mutations in the HBV Polymerase Gene in HBV DNA Amplified From Sera of Patients With Virologic Breakthrough
52 weeks, 104 weeks, 156 weeks, 208 weeks
Los Angeles
California
90001
United States
Novartis Investigational Site
Los Angeles
California
90073
United States
Novartis Investigational Site
Pasadena
California
91103
United States
Novartis Investigational Site
Sacramento
California
United States
Novartis Investigational Site
San Diego
California
91945
United States
Novartis Investigational Site
San Francisco
California
94115
United States
Novartis Investigational Site
Sarasota
Florida
United States
Novartis Investigational Site
Atlanta
Georgia
United States
Novartis Investigational Site
Honolulu
Hawaii
96812
United States
Novartis Investigational Site
Chicago
Illinois
60176
United States
Novartis Investigational Site
Boston
Massachusetts
02215
United States
Novartis Investigational Site
Ann Arbor
Michigan
48104
United States
Novartis Investigational Site
St Louis
Missouri
63143
United States
Novartis Investigational Site
New York
New York
10029
United States
Novartis Investigational Site
Chapel Hill
North Carolina
27599-7211
United States
Novartis Investigational Site
Philadelphia
Pennsylvania
19103
United States
Novartis Investigational Site
Houston
Texas
77007
United States
Novartis Investigational Site
Richmond
Virginia
23220
United States
Novartis Investigational Site
Heidelberg
Victoria
3084
Australia
Novartis Investigational Site
Toronto
Ontario
Canada
Novartis Investigational Site
Beijing
Beijing Municipality
China
Novartis Investigational Site
Prague
Czechia
Novartis Investigational Site
Paris
75270
France
Novartis Investigational Site
Hanover
30159
Germany
Novartis Investigational Site
Hong Kong
999077
Hong Kong
Novartis Investigational Site
New Delhi
India
Novartis Investigational Site
Nazareth
1613101
Israel
Novartis Investigational Site
Torino
Italy
Novartis Investigational Site
Hamilton
New Zealand
Novartis Investigational Site
Krakow
Poland
Novartis Investigational Site
Santurce
Puerto Rico
Novartis Investigational Site
Singapore
Singapore
Novartis Investigational Site
Seoul
South Korea
Novartis Investigational Site
Valencia
Spain
Novartis Investigational Site
Tainan
Taiwan
Novartis Investigational Site
Bangkok
Thailand
Novartis Investigational Site
Istanbul
TR-34353
Turkey (Türkiye)
Novartis Investigational Site
London
United Kingdom
FG001
Group A : LAM Pool 2302/015
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
FG002
Group A: Feeder Study 2401
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
FG003
Group A: Feeder Study 2402
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
FG004
Group A: Feeder Study 010
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
FG005
Group B: LdT 2301
Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
FG006
Group B: LAM 2301
Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
FG007
Group C: LdT Pool 2302/015
Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
FG008
Group C: LAM Pool 2302/015
Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
FG009
Group C: Other Feeder Studies
Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
FG000667 subjects
FG001632 subjects
FG002123 subjects
FG003206 subjects
FG00456 subjects
FG00526 subjects
FG00623 subjects
FG00766 subjects
FG00857 subjects
FG00913 subjects
Safety Population
FG000655 subjects
FG001626 subjects
FG002122 subjects
FG003206 subjects
FG00450 subjects
FG00526 subjects
FG00623 subjects
FG00766 subjects
FG00857 subjects
FG00913 subjects
Per Protocol Population
FG000635 subjects
FG001606 subjects
FG002120 subjects
FG003202 subjects
FG00450 subjects
FG00525 subjects
FG00619 subjects
FG00764 subjects
FG00856 subjects
FG00913 subjects
COMPLETED
FG000507 subjectsCompleted week 104/week 208.
FG001456 subjects
FG00290 subjects
FG003121 subjects
FG00446 subjects
FG00510 subjects
FG00615 subjects
FG00758 subjects
FG00852 subjects
FG00913 subjects
NOT COMPLETED
FG000160 subjects
FG001176 subjects
FG00233 subjects
FG00385 subjects
FG00410 subjects
FG00516 subjects
FG0068 subjects
FG0078 subjects
FG0085 subjects
FG0090 subjects
Type
Comment
Reasons
Adverse Event
FG00010 subjects
FG00110 subjects
FG0021 subjects
FG0035 subjects
FG0042 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Clinical disease progression
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG00044 subjects
FG00162 subjects
FG0029 subjects
FG00312 subjects
FG004
Non-compliance
FG00015 subjects
FG00113 subjects
FG0020 subjects
FG0036 subjects
FG004
Patient, Investigator,or Sponsor request
FG00066 subjects
FG00160 subjects
FG00211 subjects
FG00351 subjects
Pregnancy
FG0004 subjects
FG0014 subjects
FG0022 subjects
FG0033 subjects
FG004
Virologic breakthrough
FG00019 subjects
FG00123 subjects
FG0029 subjects
FG0037 subjects
FG004
Other- not specified
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Treatment Failure
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group A : LdT Pool 2302/015
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
BG001
Group A : LAM Pool 2302/015
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
BG002
Group A: Feeder Study 2401
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
BG003
Group A: Feeder Study 2402
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
BG004
Group A: Feeder Study 010
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
BG005
Group B: LdT 2301
Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
BG006
Group B: LAM 2301
Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
BG007
Group C: LdT Pool 2302/015
Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
BG008
Group C: LAM Pool 2302/015
Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
BG009
Group C: Other Feeder Studies
Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000667
BG001632
BG002123
BG003206
BG00456
BG00526
BG00623
BG00766
BG00857
BG00913
BG0101869
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Participants
Title
Denominators
Categories
< 30 years
Title
Measurements
BG000276
BG001207
BG00251
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000147
BG001142
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
Secondary
To Longitudinally Assess the Longer-term Antiviral Efficacy Achieved With Telbivudine Treatment
Not Posted
52 weeks, 104 weeks, 156 weeks, 208 weeks
Participants
Secondary
To Longitudinally Assess the Clinical Efficacy of Longer-term Treatment With Telbivudine
Not Posted
52 weeks, 104 weeks, 156 weeks, 208 weeks
Participants
Secondary
To Longitudinally Assess the Durability of HBeAg Responses Achieved With Telbivudine Treatment and Other Previous Treatments in Patients
Not Posted
52 weeks, 104 weeks, 156 weeks, 208 weeks
Participants
Secondary
To Determine the Longitudinal Frequency of Virologic Breakthrough and Characterize the Associated Mutations in the HBV Polymerase Gene in HBV DNA Amplified From Sera of Patients With Virologic Breakthrough
Not Posted
52 weeks, 104 weeks, 156 weeks, 208 weeks
Participants
Primary
Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015]
The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
Per protocol (PP) population. The PP analysis was done on separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response.
Posted
Number
95% Confidence Interval
Percentage of participants
156 weeks, 208 weeks (from feeder study baseline)
ID
Title
Description
OG000
Group A : LdT Pool 2302/015
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
Units
Primary
Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015]
The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
Per protocol (PP) population. The PP analysis was done separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response.
Posted
Number
95% Confidence Interval
Percentage of Participants
52 weeks, 104 weeks
ID
Title
Description
OG000
Group A : LAM Pool 2302/015
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
Units
Counts
Participants
Primary
Percentage of Participants Who Maintained Therapeutic Response [Group A: Feeder Studies 2401/2402/010]
The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
Per protocol (PP) population. The PP analysis was done on the PP population, separately for the HBeAg-positive and HBeAg-negative subpopulation (status as feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response.
Posted
Number
95% Confidence Interval
Percentage of Participants
52 weeks, 104 weeks
ID
Title
Description
OG000
Group A: Feeder Study 2401
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
OG001
Group A: Feeder Study 2402
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
Primary
Percentage of Participants With Maintained Clinical Response [Group B: LdT 2301]
Maintained clinical response is defined as achievement of serum HBV DNA < 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient's baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.
Per protocol (PP) population. The PP analysis was done on the overall PP population and separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of patients who were eligible for maintained clinical response.
Posted
Number
95% Confidence Interval
Percentage of Participants
156 weeks, 208 weeks (from feeder study baseline)
ID
Title
Description
OG000
Group B : LdT 2301
Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
Units
Primary
Percentage of Participants With Maintained Clinical Response [Group B: LAM 2301]
Maintained clinical response is defined as achievement of serum HBV DNA < 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient's baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.
Per protocol (PP) population. The PP analysis was done on the overall PP population and separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of patients who were eligible for maintained clinical response.
Posted
Number
95% Confidence Interval
Percentage of Participants
52 weeks,104 weeks
ID
Title
Description
OG000
Group B : LAM 2301
Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
Units
Counts
Participants
Primary
Percentage of Participants With Sustained Therapeutic Response [Group C: LdT Pool and LAM Pool (2302/015)]
The primary efficacy endpoint for Group C patients was the percentage of patients with sustained therapeutic response (defined as HBV DNA < 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
The per protocol population. n= is the number of HBeAg-positive/HBeAg-negative patients from per protocol population who achieved maintained response at the end of treatment and had off-treatment assessment to determine the sustained response at that time point or lost sustained response before the off-treatment timepoint.
Posted
Number
95% Confidence Interval
Percentage of Participants
52 weeks,104 weeks
ID
Title
Description
OG000
Group C : LdT Pool 2302/015
Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
OG001
Primary
Percentage of Participants With Sustained Therapeutic Response [Group C: Other Feeder Studies]
The primary efficacy endpoint for Group C (other feeder studies) was the percentage of patients with sustained therapeutic response (defined as HBV DNA < 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up.
Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive study drug except in case of patients who relapsed and reinitiated treatment. No statistical summary was performed , only patient listing was generated.
In "Group C: other feeder study" reporting group, there were only 13 patients; hence, no summary statistics were performed. Only listings were generated.
Posted
52 weeks,104 weeks
ID
Title
Description
OG000
Group C : Other Feeder Studies
Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
Units
Counts
Participants
Time Frame
Not provided
Description
All safety analyses were performed on the safety populations defined for each reporting group.
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
Group A : LdT Pool 2302/015
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
45
655
318
655
EG001
Group A : LAM Pool 2302/015
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
21
626
309
626
EG002
Group A: Feeder Study 010
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
3
50
24
50
EG003
Group A: Feeder 2401
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10
122
74
122
EG004
Group A: Feeder 2402
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
14
206
88
206
EG005
Group B: LdT 2301
Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
16
26
21
26
EG006
Group B: Lam 2301
Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
10
23
19
23
EG007
Group C : LdT Pool 2302/015
Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
1
66
40
66
EG008
Group C: Lam Pool 2302/015
Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
2
57
33
57
EG009
Group C : Other Feeder Studies
Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
2
13
13
13
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
APLASIA PURE RED CELL
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG0030 affected122 at risk
EG0040 affected206 at risk
EG0050 affected26 at risk
EG0060 affected23 at risk
EG0070 affected66 at risk
EG0080 affected57 at risk
EG0090 affected13 at risk
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
ANGINA PECTORIS
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
ARRHYTHMIA
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
CORONARY ARTERY DISEASE
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
MYOCARDIAL ISCHAEMIA
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
VESTIBULAR NEURONITIS
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
ASCITES
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
ENTERITIS
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
HAEMORRHOIDAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
INGUINAL HERNIA
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
LARGE INTESTINE PERFORATION
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0021 affected50 at risk
EG003
MELAENA
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
OESOPHAGEAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
OESOPHAGEAL VARICES HAEMORRHAGE
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
PANCREATITIS ACUTE
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
PERITONEAL ADHESIONS
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
VARICES OESOPHAGEAL
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
APLASIA
General disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
CONCOMITANT DISEASE PROGRESSION
General disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
DEATH
General disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
CHOLANGITIS ACUTE
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
CHRONIC HEPATITIS
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
HEPATITIS
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0002 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
HEPATOMEGALY
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
APPENDICITIS
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
DENGUE FEVER
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
DENTAL CARIES
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
EPIGLOTTITIS
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
HEPATITIS B
Infections and infestations
MedDRA
Systematic Assessment
EG0003 affected655 at risk
EG0015 affected626 at risk
EG0021 affected50 at risk
EG003
LEPTOSPIROSIS
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
PERITONITIS BACTERIAL
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
POSTOPERATIVE INFECTION
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
SEPTIC SHOCK
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
UROSEPSIS
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
EXCORIATION
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
FACIAL BONES FRACTURE
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
FIBULA FRACTURE
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
HEAD INJURY
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
JOINT DISLOCATION
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
JOINT LIGAMENT RUPTURE
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
JOINT SPRAIN
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
LIMB INJURY
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
LOWER LIMB FRACTURE
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
OVERDOSE
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
RIB FRACTURE
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
ROAD TRAFFIC ACCIDENT
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0002 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
SKIN LACERATION
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
TOOTH INJURY
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
WRIST FRACTURE
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA
Systematic Assessment
EG0004 affected655 at risk
EG0012 affected626 at risk
EG0020 affected50 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
DIABETES MELLITUS INADEQUATE CONTROL
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
DIABETIC HYPEROSMOLAR NON-KETOACIDOSIS
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
FLUID OVERLOAD
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
HYPERKALAEMIA
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
MUSCLE ATROPHY
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
MYOPATHY
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
MYOSITIS
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0021 affected50 at risk
EG003
POLYMYOSITIS
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
ROTATOR CUFF SYNDROME
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
ACOUSTIC NEUROMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
BILE DUCT CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
BREAST CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
COLON CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0021 affected50 at risk
EG003
DIFFUSE LARGE B-CELL LYMPHOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
GASTRIC CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
HEPATIC NEOPLASM
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
HEPATIC NEOPLASM MALIGNANT
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0005 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
LYMPHOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
NASAL NEOPLASM BENIGN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
POLYP
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
PROLACTINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
RENAL CELL CARCINOMA STAGE UNSPECIFIED
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
THYROID GLAND CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
CEREBRAL HAEMORRHAGE
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
CEREBRAL ISCHAEMIA
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
CEREBROVASCULAR ACCIDENT
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
DIABETIC HYPEROSMOLAR COMA
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
HEPATIC ENCEPHALOPATHY
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
ABORTION
Pregnancy, puerperium and perinatal conditions
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
ABORTION MISSED
Pregnancy, puerperium and perinatal conditions
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
ABORTION SPONTANEOUS
Pregnancy, puerperium and perinatal conditions
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
ADJUSTMENT DISORDER
Psychiatric disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA
Systematic Assessment
EG0002 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
HYPOMANIA
Psychiatric disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
SUICIDE ATTEMPT
Psychiatric disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
CALCULUS URETERIC
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
CALCULUS URINARY
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
GLOMERULONEPHRITIS PROLIFERATIVE
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
OBSTRUCTIVE UROPATHY
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
PROTEINURIA
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
RENAL FAILURE ACUTE
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
URINARY RETENTION
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
METRORRHAGIA
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
PROSTATIC HYPERTROPHY
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
VULVAL ANGIOKERATOMA
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
ACUTE RESPIRATORY DISTRESS SYNDROME
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
CATARRH
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
NASAL MUCOSAL DISORDER
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
NASAL SEPTUM DEVIATION
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
NASAL TURBINATE ABNORMALITY
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
ABORTION INDUCED
Surgical and medical procedures
MedDRA
Systematic Assessment
EG0004 affected655 at risk
EG0012 affected626 at risk
EG0020 affected50 at risk
EG003
FRACTURE TREATMENT
Surgical and medical procedures
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
BLEEDING VARICOSE VEIN
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
THROMBOCYTHAEMIA
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG0030 affected122 at risk
EG0040 affected206 at risk
EG0050 affected26 at risk
EG0060 affected23 at risk
EG0070 affected66 at risk
EG0080 affected57 at risk
EG0091 affected13 at risk
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG00010 affected655 at risk
EG00113 affected626 at risk
EG0021 affected50 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0008 affected655 at risk
EG00110 affected626 at risk
EG0021 affected50 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG00026 affected655 at risk
EG00115 affected626 at risk
EG0023 affected50 at risk
EG003
ABDOMINAL SYMPTOM
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
ASCITES
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG00011 affected655 at risk
EG0018 affected626 at risk
EG0023 affected50 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG00021 affected655 at risk
EG00121 affected626 at risk
EG0022 affected50 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG00012 affected655 at risk
EG00112 affected626 at risk
EG0021 affected50 at risk
EG003
GINGIVAL BLEEDING
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
HAEMORRHOIDAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG00010 affected655 at risk
EG00118 affected626 at risk
EG0022 affected50 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0006 affected655 at risk
EG0019 affected626 at risk
EG0022 affected50 at risk
EG003
ASTHENIA
General disorders
MedDRA
Systematic Assessment
EG0009 affected655 at risk
EG0016 affected626 at risk
EG0020 affected50 at risk
EG003
FATIGUE
General disorders
MedDRA
Systematic Assessment
EG00029 affected655 at risk
EG00133 affected626 at risk
EG0022 affected50 at risk
EG003
MALAISE
General disorders
MedDRA
Systematic Assessment
EG0002 affected655 at risk
EG0012 affected626 at risk
EG0020 affected50 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA
Systematic Assessment
EG0004 affected655 at risk
EG0014 affected626 at risk
EG0020 affected50 at risk
EG003
PITTING OEDEMA
General disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
PYREXIA
General disorders
MedDRA
Systematic Assessment
EG00011 affected655 at risk
EG00111 affected626 at risk
EG0021 affected50 at risk
EG003
HEPATIC LESION
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0002 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
HEPATIC STEATOSIS
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0017 affected626 at risk
EG0020 affected50 at risk
EG003
HYPERSENSITIVITY
Immune system disorders
MedDRA
Systematic Assessment
EG0002 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
BODY TINEA
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA
Systematic Assessment
EG0005 affected655 at risk
EG0015 affected626 at risk
EG0021 affected50 at risk
EG003
HEPATITIS B
Infections and infestations
MedDRA
Systematic Assessment
EG00016 affected655 at risk
EG0017 affected626 at risk
EG0023 affected50 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA
Systematic Assessment
EG00025 affected655 at risk
EG00122 affected626 at risk
EG00211 affected50 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA
Systematic Assessment
EG00069 affected655 at risk
EG00173 affected626 at risk
EG0021 affected50 at risk
EG003
TINEA VERSICOLOUR
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
TONSILLITIS
Infections and infestations
MedDRA
Systematic Assessment
EG0004 affected655 at risk
EG0012 affected626 at risk
EG0020 affected50 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA
Systematic Assessment
EG00050 affected655 at risk
EG00160 affected626 at risk
EG0022 affected50 at risk
EG003
VIRAL INFECTION
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0002 affected655 at risk
EG0013 affected626 at risk
EG0020 affected50 at risk
EG003
JOINT SPRAIN
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0004 affected655 at risk
EG0014 affected626 at risk
EG0020 affected50 at risk
EG003
POST PROCEDURAL PAIN
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0004 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
THERMAL BURN
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA
Systematic Assessment
EG00018 affected655 at risk
EG00112 affected626 at risk
EG0021 affected50 at risk
EG003
BLOOD CREATINE PHOSPHOKINASE INCREASED
Investigations
MedDRA
Systematic Assessment
EG00056 affected655 at risk
EG00147 affected626 at risk
EG0022 affected50 at risk
EG003
HBV DNA INCREASED
Investigations
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA
Systematic Assessment
EG0003 affected655 at risk
EG0014 affected626 at risk
EG0020 affected50 at risk
EG003
WEIGHT INCREASED
Investigations
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
DIABETES MELLITUS NON-INSULIN-DEPENDENT
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0021 affected50 at risk
EG003
HYPERCHOLESTEROLAEMIA
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG00018 affected655 at risk
EG00115 affected626 at risk
EG0021 affected50 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG00016 affected655 at risk
EG00116 affected626 at risk
EG0021 affected50 at risk
EG003
MUSCLE CRAMP
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0003 affected655 at risk
EG0010 affected626 at risk
EG0023 affected50 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0002 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0005 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0008 affected655 at risk
EG00110 affected626 at risk
EG0020 affected50 at risk
EG003
HEPATIC NEOPLASM
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA
Systematic Assessment
EG0007 affected655 at risk
EG0017 affected626 at risk
EG0021 affected50 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA
Systematic Assessment
EG00028 affected655 at risk
EG00128 affected626 at risk
EG0022 affected50 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA
Systematic Assessment
EG0005 affected655 at risk
EG0014 affected626 at risk
EG0020 affected50 at risk
EG003
GLOMERULONEPHRITIS PROLIFERATIVE
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG00027 affected655 at risk
EG00122 affected626 at risk
EG0021 affected50 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0003 affected655 at risk
EG0012 affected626 at risk
EG0020 affected50 at risk
EG003
PHARYNGOLARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG00017 affected655 at risk
EG00111 affected626 at risk
EG0021 affected50 at risk
EG003
RHINITIS ALLERGIC
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0005 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
ACNE
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected655 at risk
EG0013 affected626 at risk
EG0021 affected50 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0003 affected655 at risk
EG0013 affected626 at risk
EG0021 affected50 at risk
EG003
PALMAR ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0011 affected626 at risk
EG0020 affected50 at risk
EG003
PSORIASIS
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0023 affected50 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG00012 affected655 at risk
EG0016 affected626 at risk
EG0020 affected50 at risk
EG003
SPIDER NAEVUS
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0002 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
EYE OPERATION
Surgical and medical procedures
MedDRA
Systematic Assessment
EG0000 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA
Systematic Assessment
EG00011 affected655 at risk
EG00115 affected626 at risk
EG0020 affected50 at risk
EG003
VARICOSE VEIN
Vascular disorders
MedDRA
Systematic Assessment
EG0002 affected655 at risk
EG0010 affected626 at risk
EG0020 affected50 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
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial; or the publication of the trial results in their entirety.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis Pharmaceuticals
862-778-8300
ID
Term
D019694
Hepatitis B, Chronic
Ancestor Terms
ID
Term
D006509
Hepatitis B
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D018347
Hepadnaviridae Infections
D004266
DNA Virus Infections
D014777
Virus Diseases
D006525
Hepatitis, Viral, Human
D006521
Hepatitis, Chronic
D006505
Hepatitis
D008107
Liver Diseases
D004066
Digestive System Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000077712
Telbivudine
Ancestor Terms
ID
Term
D013936
Thymidine
D011741
Pyrimidine Nucleosides
D011743
Pyrimidines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D003853
Deoxyribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0056 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0073 subjects
FG0083 subjects
FG0090 subjects
FG004
4 subjects
FG0053 subjects
FG0061 subjects
FG0074 subjects
FG0081 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
2 subjects
FG0053 subjects
FG0063 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0052 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
54
BG0049
BG0051
BG0060
BG00730
BG00827
BG0098
BG010663
30-50 years
Title
Measurements
BG000320
BG001325
BG00266
BG003122
BG00440
BG00510
BG0065
BG00731
BG00824
BG0095
BG010948
> 50 years
Title
Measurements
BG00071
BG001100
BG0026
BG00330
BG0047
BG00515
BG00618
BG0075
BG0086
BG0090
BG010258
30
BG00353
BG0049
BG0059
BG0066
BG00720
BG00814
BG0093
BG010433
Male
BG000520
BG001490
BG00293
BG003153
BG00447
BG00517
BG00617
BG00746
BG00843
BG00910
BG0101436
Counts
Participants
OG000635
Title
Denominators
Categories
HBeAg Positive: week 156 (n=338)
Title
Measurements
OG00067.2(61.9 to 72.1)
HBeAg Positive: week 208 (n=252)
Title
Measurements
OG00073.8(67.9 to 79.1)
HBeAg Negative: week 156 (n=197)
Title
Measurements
OG00081.7(75.6 to 86.9)
HBeAg Negative: week 208 (n=168)
Title
Measurements
OG00086.3(80.2 to 91.1)
OG000606
Title
Denominators
Categories
HBeAg Positive: week 52 (n=338)
Title
Measurements
OG00060.1(54.6 to 65.3)
HBeAg Positive: week 104 (n=101)
Title
Measurements
OG00065.3(55.2 to 74.5)
HBeAg Negative: week 52 (n=182)
Title
Measurements
OG00080.8(74.3 to 86.2)
HBeAg Negative: week 104 (n=79)
Title
Measurements
OG00081.0(70.6 to 89.0)
OG002
Group A: Feeder Study 010
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
Units
Counts
Participants
OG000120
OG001131
OG00250
Title
Denominators
Categories
HBeAg Positive: 52 week (n = 103, 79, 43)
Title
Measurements
OG00077.7(68.4 to 85.3)
OG00135.4(25.0 to 47.0)
OG00269.8(53.9 to 82.8)
HBeAg Positive: 104 week (n = 66, 15, 30)
Title
Measurements
OG00081.8(70.4 to 90.2)
OG00146.7(21.3 to 73.4)
OG00276.7(57.7 to 90.1)
HBeAg Negative: 52 week (n = 0, 37, 0)
Title
Measurements
OG000NA(NA to NA)In per protocol population, all participants from feeder study 2401 are HBeAg-positive. So, no analysis was done at week 52.
OG00154.1(36.9 to 70.5)
OG002NA(NA to NA)In per protocol population, all participants from feeder study 010 are HBeAg-positive. So, no analysis was done at week 52.
HBeAg Negative: 104 week (n = 0, 10, 0)
Title
Measurements
OG000NA(NA to NA)In per protocol population, all participants from feeder study 2401 are HBeAg-positive. So, no analysis was done at week 104.
OG00160.0(26.2 to 87.8)
OG002NA(NA to NA)In per protocol population, all participants from feeder study 010 are HBeAg-positive. So, no analysis was done at week 104.
Counts
Participants
OG00025
Title
Denominators
Categories
HBeAg Positive: week 156 (n= 4)
Title
Measurements
OG000100(39.8 to 100)
HBeAg Positive: week 208 (n= 1)
Title
Measurements
OG000100(2.5 to 100)
HBeAg Negative: week 156 (n= 11)
Title
Measurements
OG00072.7(39.0 to 94.0)
HBeAg Negative: week 208 (n= 7)
Title
Measurements
OG00071.4(29.0 to 96.3)
Overall: Week 156 (n= 15)
Title
Measurements
OG00080.0(51.9 to 95.7)
Overall: Week 208 (n= 8)
Title
Measurements
OG00075.0(34.9 to 96.8)
OG00019
Title
Denominators
Categories
HBeAg Positive: week 52 (n=4)
Title
Measurements
OG000100(39.8 to 100)
HBeAg Positive: week 104 (n=1)
Title
Measurements
OG000100(2.5 to 100)
HBeAg Negative: week 52 (n=11)
Title
Measurements
OG00072.7(39.9 to 94)
HBeAg Negative: week 104 (n=5)
Title
Measurements
OG000100(47.8 to 100)
Overall: week 52 (n= 15)
Title
Measurements
OG00080.0(51.9 to 95.7)
Overall: week 104 (n= 6)
Title
Measurements
OG000100(54.1 to 100)
Group C: LAM Pool 2302/015
Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.