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The purpose of this study is to provide entecavir to participants who have completed another entecavir trial without achieving virologic response or who relapsed during postdosing follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entecavir, 1.0 mg, with or without lamivudine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir | Drug | Tablets, Oral, 1.0 mg, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Study: Number of Participants With Death As Outcome, Any Adverse Event (AE), Grade 3-4 AEs, Serious Adverse Events (SAEs), and Discontinuations Due to AEs | An AE is a new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not be causally related to treatment. An SAE is an unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. ALT=alanine transaminase; ULN=upper limit of normal. | Continuously from Day 1 through Week 240 |
| Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240 | Hemoglobin (g/dL): Grade (Gr) 1=9.5-11.0; Gr 2=8.0-<9.5; Gr 3=6.5-<8.0; Gr 4=<6.5 White blood cells (cells/mm^3): Gr 1=2,500-<4,000; Gr 2=1,000-<2,500; Gr 3=800-<1,000; Gr 4=<800. Neutrophils (cells/mm^3): Gr 1=1000-<1500; Gr 2=750-<1000; Gr 3=500-<750; Gr 4=<500. Platelets (cells/mm^3): Gr 1=75,000-99,000; Gr 2=50,000-<75,000; Gr 3=20,000-<50,000; Gr 4=<20,000. Prothrombin time (seconds): Gr 1=1.01-<1.26*ULN; Gr 2=1.26-<1.51 *ULN; Gr 3=1.51-3*ULN; Gr 4=>3*ULN. INR: Gr 1=1.24-1.5; Gr 2=1.5-2; Gr 3=2-3; Gr 4=>3. INR=international normalized ratio; ULN=upper limit of normal. . | Day 1 of treatment through Week 240 |
| Overall Study: Number of Participants With Normal Pancreatic Enzyme and Renal Function Values at Baseline and Abnormalities in Pancreatic Enzyme and Renal Function Laboratory Test Results at End of Dosing | Amylase: Grade 1=1.10-<1.40*ULN; Grade 2=1.40-< 2.10*ULN; Grade 3=2.10-5.00*ULN; Grade 4=>5.00*ULN. Lipase: Grade 1.1-<1.4*ULN; Grade 2=1.4-<2.1*ULN; Grade 3=2.1-5.0*ULN; Grade 4=>5.0*ULN. Creatinine: Grade 1=1.10-< 1.60*ULN; Grade 2=1.60-<3.10*ULN; Grade 3=3.10-6.00*ULN; Grade 4=>6.00*ULN. Blood urea nitrogen (BUN): Grade 1=1.25-<2.60*ULN; Grade 2=2.60-<5.10*ULN; Grade 3=5.10-10*ULN; Grade 4=>10*ULN. ULN=upper limit of normal. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay | Study entry to Week 192 | |
| Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay | Study entry to Week 192 |
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Key inclusion criteria:
Participants who were, based on their response to entecavir:
Virologic nonresponders at Week 48
Partial virologic responders who became nonresponders during the second year of treatment
Partial virologic responders at Week 96
Complete responders who relapsed during postdosing follow-up
Nonresponse to adefovir after at least 24 weeks of treatment
Partial response to adefovir after 96 weeks of treatment
Complete response to adefovir after relapsing during postdosing follow-up
Demonstrated intolerance to adefovir
Key exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22233350 | Derived | Manns MP, Akarca US, Chang TT, Sievert W, Yoon SK, Tsai N, Min A, Pangerl A, Beebe S, Yu M, Wongcharatrawee S. Long-term safety and tolerability of entecavir in patients with chronic hepatitis B in the rollover study ETV-901. Expert Opin Drug Saf. 2012 May;11(3):361-8. doi: 10.1517/14740338.2012.653340. Epub 2012 Jan 11. |
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Of 1053 participants enrolled, 1051 received treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine | Participants originally received 0.5 mg of entecavir once daily (QD) with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine | Participants originally received 0.5 mg of entecavir once daily (QD) with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| 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 | Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Posted | Number | Percentage of participants | Study entry to Week 192 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adefovir, 10 mg | Participants who received adefovir concomitantly at postdosing follow-up |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VESTIBULAR NEURONITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HEPATIC ENCEPHALOPATHY | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| C413685 | entecavir |
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Lamivudine | Drug | Oral, 100 mg, daily |
|
| Day 1 of treatment through Week 240 |
| Overall Study: Number of Participants With Normal Electrolyte and Fasting Glucose Values at Baseline and Abnormalities in Electrolyte and Fasting Glucose Laboratory Test Results at End of Dosing | Hypochloremia: Grade (Gr) 1=90-93; Gr 2=85-<90; Gr 3=80-<85; Gr 4=40-<80. Hyperchloremia: Gr 1=113-<117; Gr 2=117-<121; Gr 3=121-125; Gr 4>125. Hypocarbia: Gr 1=19-21; Gr 2=15-<19; Gr 3=41-45; Gr 4=>45. Hypercarbia: Gr 1=31-36; Gr 2=37-40; Gr 3=41-45; Gr 4=>45. Hyponatremia: Gr 1=130-132; Gr 2=123-<130; Gr 3=116-<123; Gr 4<116. Hypernatremia: Gr 1=148-<151; Gr 2=151-<158; Gr 3=158-165; Gr 4=>165. Hypokalemia: Gr 1=3-3.4; Gr 2=2.5-<3; Gr 3=2-<2.5; Gr 4=<2. Hyperkalemia: Gr 1=5.6-<6.1; G2=6.1-<6.6; Gr 3=6.6-7; Gr 4=>7. Hypoglycemia: Gr 1=55-64; Gr 2=40-<55; Gr 3=30-< 40; G4=-<30. Hyperglycemia: Gr 1=116-<161; Gr 2=161-<251; Gr 3=251-500; Gr 4>500. | Day 1 of treatment through Week 240 |
| Week 144: Number of Participants With Death As Outcome, Any AE, Grade 3-4 AEs, SAEs, Discontinuations Due to AEs, and Abnormalities in Selected Laboratory Test Results | An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. AST=aspartate aminotransferase; ULN=upper limit of normal. | Continuously from Day 1 through Week 144 |
| Week 192: Number of Participants With Death As Outcome, Any AE, Grade 3-4 AEs, SAEs, Discontinuations Due to AEs, and Abnormalities in Selected Laboratory Test Results | An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. CTC Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. ALT=alanine aminotransferase; ULN=upper limit of normal. | Continuously from Day 1 through Week 192 |
| Off-treatment Follow-up: Percentage of Participants With Sustained Hepatitis B Virus (HBV) DNA <10,000 Copies by Polymerase Chain Reaction (PCR) Assay (Amendment 11 Cohort) | The Amendment 11 Cohort consisted of participants who were hepatitis B e antigen (HBeAg) negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing.ALT=alanine aminotransferase; ULN=upper limit of normal. | End of dosing to Week 48 off-treatment follow-up |
| Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay | Observed values. | Baseline to Week 192 |
| Overall Study: Mean HBV DNA Level by PCR Assay | Study entry to Week 216 |
| Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg) | Observed values. | Study entry to Week 216 |
| Overall Study: Percentage of Participants With HBeAg Seroconversion | Observed values. Seroconversion=negative HBeAg with detectable anti-HBe antibody. | Study entry to Week 216 |
| Overall Study: Mean Alanine Transaminase (ALT) Levels | Observed values. | Study entry to Week 216 |
| Overall Study: Percentage of Participants Who Achieved ALT Normalization | ULN=upper limit of normal. ALT normalization=ALT levels ≤1.0*ULN. | Study entry to Week 216 |
| Week 192: Percentage of Participants With Histologic Improvement (Efficacy Evaluable Cohort) | The Knodell Histologic Activity Index scores stage of necrosis and grade of inflammation in liver biopsies. Components are necrosis near the portal vein, intralobular degeneration and focal necrosis, portal inflammation, and fibrosis. The 4 components are scored from 1 to 4 and 1 to 10 (necrosis near the portal vein) and combined for a total score, with 22 being the highest possible score. Higher the score for each component=greater liver damage. Histologic improvement=a ≥2-point reduction in total Knodell score and no worsening in fibrosis. Cohort participants had to have adequate baseline and long-term biopsy samples and baseline Knodell necroinflammatory scores ≥2. | Baseline to Week 192 |
| Week 192: Percentage of Participants With Improvement in Fibrosis (Efficacy Evaluable Cohort) | The Ishak Modification for Hepatic Activity Index (HAI) scores necroinflammatory activity in chronic hepatitis. 0=no fibrosis, 1=fibrosis expansion of some portal areas, 2=fibrosis expansion of most portal areas, 3=fibrosis expansion of most portal areas with occasional bridging, 4=fibrosis expansion of portal areas with marked bridging, 5=incomplete cirrhosis, 6=probable or definite cirrhosis. Higher score=more severe necrosis. Improvement in fibrosis=≥1-point reduction in HAI score. Cohort participants had to have adequate baseline and long-term biopsy samples and baseline Knodell scores ≥2. | Baseline to Week 192 |
| Overall Study: Percentage of Participants With a Confirmed ≥1 log10 Increase From Nadir in HBV DNA by PCR Assay | Baseline to Week 144 |
| Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay, Loss of HBeAG, Seroconversion, and ALT ≤1.0*Upper Limit of Normal (ULN) (Entecavir Continuous Treatment Cohort) | The Entecavir Continuous Treatment Cohort consisted of participants from study AI463-022 (NCT00035633) who were nucleoside-naive HBeAg-positive and enrolled in the current study with ≤35 days off treatment between the last dose in AI463-022 and the first dose in the current. This cohort is considered to be on continuous entecavir treatment and permitted assessment of continuous administration of entecavir in AI463-022 and the current study. | Baseline to Weeks 48, 96, 144, 192, and 240 |
| Percentage of Participants Who Achieved HBV DNA <300 and <10^4 Copies/mL by PCR Assay and ALT ≤1.0*Upper Limit of Normal (ULN) (Entecavir Retreatment Cohort) | The Entecavir Retreatment Cohort consisted of participants who were nucleoside-naive, HBeAg-negative and enrolled from BMS study AI463-027 with >60 days off treatment between the last dose in AI463-027 and the first dose in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as retreatment in the current study. | Baseline to Weeks 48, 96, and 144 |
| Week 96: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay, Loss of HBeAg, HBeAg Seroconversion, and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort) | The Lamivudine Continuous Switch Cohort consisted of participants who were nucleoside-naive, HBeAg-positive and received lamivudine in BMS study AI463-022 (NCT00035633) and enrolled in the current study with ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study. | Baseline to Week 96 |
| Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort) | The Lamivudine Continuous Switch Cohort consisted of participants who were nucleoside-naive, HBeAg-positive and received lamivudine in BMS study AI463-022 (NCT00035633) and enrolled in the current study with ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study. | Baseline to Week 144 |
| Week 96: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort) | The Lamivudine Retreatment Switch Cohort consisted of participants who were nucleoside-naive HBeAg negative and enrolled from BMS study AI463-027 (NCT00035789) with >60 days between end of dosing in AI463-027 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study. | Baseline to Week 96 |
| Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort) | The Lamivudine Retreatment Switch Cohort consisted of participants who were nucleoside-naive HBeAg negative and enrolled from BMS study AI463-027 (NCT00035789) with >60 days between end of dosing in AI463-027 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study. | Baseline to Week 144 |
| Off-treatment Follow-up: Percentage of Participants With Sustained HBV DNA <1,000, <300, and <10,000 Copies/mL by PCR Assay and With ALT ≤1*ULN (Amendment 11 Cohort) | The Amendment 11 Cohort consisted of participants who were HBeAg negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR Assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing. ULN=upper limit of normal. | End of dosing to Weeks 48 and 96 off-treatment follow-up |
| Off-treatment Follow-up: Mean Change in HBV DNA (Amendment 11 Cohort) | The Amendment 11 Cohort consisted of participants who were HBeAg negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing. | End of dosing to Weeks 48 and 96 off-treatment follow-up |
| Withdrawal by Subject |
|
| Progression of chronic hepatitis B |
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| Death |
|
| Adverse Event |
|
| Lost to Follow-up |
|
| Abnormal laboratory test result |
|
| Need for drug prohibited by protocol |
|
| Pregnancy |
|
| No longer met inclusion criteria |
|
| Participant noncompliance |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region: Continent | Number | Participants |
|
| Age | Mean | Full Range | Years |
|
|
| Secondary | Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Posted | Number | Percentage of participants | Study entry to Week 192 |
|
|
|
| Secondary | Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay | Observed values. | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Posted | Number | Percentage of participants | Baseline to Week 192 |
|
|
|
| Primary | Overall Study: Number of Participants With Death As Outcome, Any Adverse Event (AE), Grade 3-4 AEs, Serious Adverse Events (SAEs), and Discontinuations Due to AEs | An AE is a new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not be causally related to treatment. An SAE is an unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. ALT=alanine transaminase; ULN=upper limit of normal. | All participants who received at least 1 dose of study drug in the current study. | Posted | Number | Participants | Continuously from Day 1 through Week 240 |
|
|
|
| Secondary | Overall Study: Mean HBV DNA Level by PCR Assay | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Posted | Mean | Standard Deviation | log10 copies/mL | Study entry to Week 216 |
|
|
|
| Secondary | Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg) | Observed values. | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Posted | Number | Percentage of participants | Study entry to Week 216 |
|
|
|
| Secondary | Overall Study: Percentage of Participants With HBeAg Seroconversion | Observed values. Seroconversion=negative HBeAg with detectable anti-HBe antibody. | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Posted | Number | Percentage of participants | Study entry to Week 216 |
|
|
|
| Secondary | Overall Study: Mean Alanine Transaminase (ALT) Levels | Observed values. | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Posted | Mean | Standard Deviation | U/L | Study entry to Week 216 |
|
|
|
| Secondary | Overall Study: Percentage of Participants Who Achieved ALT Normalization | ULN=upper limit of normal. ALT normalization=ALT levels ≤1.0*ULN. | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Posted | Number | Percentage of participants | Study entry to Week 216 |
|
|
|
| Secondary | Week 192: Percentage of Participants With Histologic Improvement (Efficacy Evaluable Cohort) | The Knodell Histologic Activity Index scores stage of necrosis and grade of inflammation in liver biopsies. Components are necrosis near the portal vein, intralobular degeneration and focal necrosis, portal inflammation, and fibrosis. The 4 components are scored from 1 to 4 and 1 to 10 (necrosis near the portal vein) and combined for a total score, with 22 being the highest possible score. Higher the score for each component=greater liver damage. Histologic improvement=a ≥2-point reduction in total Knodell score and no worsening in fibrosis. Cohort participants had to have adequate baseline and long-term biopsy samples and baseline Knodell necroinflammatory scores ≥2. | Subset of participants who who had evaluable paired liver biopsy results at Phase 3 study baseline and on their last observed biopsies performed in the current study. (n=number of evaluable participants) | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to Week 192 |
|
|
|
| Secondary | Week 192: Percentage of Participants With Improvement in Fibrosis (Efficacy Evaluable Cohort) | The Ishak Modification for Hepatic Activity Index (HAI) scores necroinflammatory activity in chronic hepatitis. 0=no fibrosis, 1=fibrosis expansion of some portal areas, 2=fibrosis expansion of most portal areas, 3=fibrosis expansion of most portal areas with occasional bridging, 4=fibrosis expansion of portal areas with marked bridging, 5=incomplete cirrhosis, 6=probable or definite cirrhosis. Higher score=more severe necrosis. Improvement in fibrosis=≥1-point reduction in HAI score. Cohort participants had to have adequate baseline and long-term biopsy samples and baseline Knodell scores ≥2. | Subset of participants who who had evaluable paired liver biopsy results at Phase 3 study baseline and on their last observed biopsies performed in the current study. (n=number of evaluable participants) | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to Week 192 |
|
|
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| Primary | Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240 | Hemoglobin (g/dL): Grade (Gr) 1=9.5-11.0; Gr 2=8.0-<9.5; Gr 3=6.5-<8.0; Gr 4=<6.5 White blood cells (cells/mm^3): Gr 1=2,500-<4,000; Gr 2=1,000-<2,500; Gr 3=800-<1,000; Gr 4=<800. Neutrophils (cells/mm^3): Gr 1=1000-<1500; Gr 2=750-<1000; Gr 3=500-<750; Gr 4=<500. Platelets (cells/mm^3): Gr 1=75,000-99,000; Gr 2=50,000-<75,000; Gr 3=20,000-<50,000; Gr 4=<20,000. Prothrombin time (seconds): Gr 1=1.01-<1.26*ULN; Gr 2=1.26-<1.51 *ULN; Gr 3=1.51-3*ULN; Gr 4=>3*ULN. INR: Gr 1=1.24-1.5; Gr 2=1.5-2; Gr 3=2-3; Gr 4=>3. INR=international normalized ratio; ULN=upper limit of normal. . | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Posted | Number | Participants | Day 1 of treatment through Week 240 |
|
|
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| Primary | Overall Study: Number of Participants With Normal Pancreatic Enzyme and Renal Function Values at Baseline and Abnormalities in Pancreatic Enzyme and Renal Function Laboratory Test Results at End of Dosing | Amylase: Grade 1=1.10-<1.40*ULN; Grade 2=1.40-< 2.10*ULN; Grade 3=2.10-5.00*ULN; Grade 4=>5.00*ULN. Lipase: Grade 1.1-<1.4*ULN; Grade 2=1.4-<2.1*ULN; Grade 3=2.1-5.0*ULN; Grade 4=>5.0*ULN. Creatinine: Grade 1=1.10-< 1.60*ULN; Grade 2=1.60-<3.10*ULN; Grade 3=3.10-6.00*ULN; Grade 4=>6.00*ULN. Blood urea nitrogen (BUN): Grade 1=1.25-<2.60*ULN; Grade 2=2.60-<5.10*ULN; Grade 3=5.10-10*ULN; Grade 4=>10*ULN. ULN=upper limit of normal. | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Posted | Number | Participants | Day 1 of treatment through Week 240 |
|
|
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| Primary | Overall Study: Number of Participants With Normal Electrolyte and Fasting Glucose Values at Baseline and Abnormalities in Electrolyte and Fasting Glucose Laboratory Test Results at End of Dosing | Hypochloremia: Grade (Gr) 1=90-93; Gr 2=85-<90; Gr 3=80-<85; Gr 4=40-<80. Hyperchloremia: Gr 1=113-<117; Gr 2=117-<121; Gr 3=121-125; Gr 4>125. Hypocarbia: Gr 1=19-21; Gr 2=15-<19; Gr 3=41-45; Gr 4=>45. Hypercarbia: Gr 1=31-36; Gr 2=37-40; Gr 3=41-45; Gr 4=>45. Hyponatremia: Gr 1=130-132; Gr 2=123-<130; Gr 3=116-<123; Gr 4<116. Hypernatremia: Gr 1=148-<151; Gr 2=151-<158; Gr 3=158-165; Gr 4=>165. Hypokalemia: Gr 1=3-3.4; Gr 2=2.5-<3; Gr 3=2-<2.5; Gr 4=<2. Hyperkalemia: Gr 1=5.6-<6.1; G2=6.1-<6.6; Gr 3=6.6-7; Gr 4=>7. Hypoglycemia: Gr 1=55-64; Gr 2=40-<55; Gr 3=30-< 40; G4=-<30. Hyperglycemia: Gr 1=116-<161; Gr 2=161-<251; Gr 3=251-500; Gr 4>500. | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Posted | Number | Participants | Day 1 of treatment through Week 240 |
|
|
|
| Secondary | Overall Study: Percentage of Participants With a Confirmed ≥1 log10 Increase From Nadir in HBV DNA by PCR Assay | Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Posted | Number | Percentage of participants | Baseline to Week 144 |
|
|
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| Primary | Week 144: Number of Participants With Death As Outcome, Any AE, Grade 3-4 AEs, SAEs, Discontinuations Due to AEs, and Abnormalities in Selected Laboratory Test Results | An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. AST=aspartate aminotransferase; ULN=upper limit of normal. | Participants enrolled up to Week 144 who received at least 1 dose of study drug in the current study. (n=number of evaluable participants) | Posted | Number | Participants | Continuously from Day 1 through Week 144 |
|
|
|
| Secondary | Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay, Loss of HBeAG, Seroconversion, and ALT ≤1.0*Upper Limit of Normal (ULN) (Entecavir Continuous Treatment Cohort) | The Entecavir Continuous Treatment Cohort consisted of participants from study AI463-022 (NCT00035633) who were nucleoside-naive HBeAg-positive and enrolled in the current study with ≤35 days off treatment between the last dose in AI463-022 and the first dose in the current. This cohort is considered to be on continuous entecavir treatment and permitted assessment of continuous administration of entecavir in AI463-022 and the current study. | Participants enrolled from study AI463-022 who were nucleoside-naive, HBeAg-positive and enrolled in the current study with ≤35 days off treatment between the last dose in AI463-022 and the first dose in the current study and were evaluable. (n=number of evaluable participants) | Posted | Number | Percentage of participants | Baseline to Weeks 48, 96, 144, 192, and 240 |
|
|
|
| Secondary | Percentage of Participants Who Achieved HBV DNA <300 and <10^4 Copies/mL by PCR Assay and ALT ≤1.0*Upper Limit of Normal (ULN) (Entecavir Retreatment Cohort) | The Entecavir Retreatment Cohort consisted of participants who were nucleoside-naive, HBeAg-negative and enrolled from BMS study AI463-027 with >60 days off treatment between the last dose in AI463-027 and the first dose in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as retreatment in the current study. | Participants enrolled from study AI463-027 who were nucleoside-naive, HBeAg-negative and had >60 days off treatment between the last dose in AI463-027 and the first dose in the current study. (n=number of evaluable participants) | Posted | Number | Percentage of participants | Baseline to Weeks 48, 96, and 144 |
|
|
|
| Secondary | Week 96: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay, Loss of HBeAg, HBeAg Seroconversion, and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort) | The Lamivudine Continuous Switch Cohort consisted of participants who were nucleoside-naive, HBeAg-positive and received lamivudine in BMS study AI463-022 (NCT00035633) and enrolled in the current study with ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study. | Participants enrolled from AI463-022 who received lamivudine, were nucleoside-naive HBeAg-positive, and had ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. (n=number of evaluable participants) | Posted | Number | Percentage of participants | Baseline to Week 96 |
|
|
|
| Secondary | Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort) | The Lamivudine Continuous Switch Cohort consisted of participants who were nucleoside-naive, HBeAg-positive and received lamivudine in BMS study AI463-022 (NCT00035633) and enrolled in the current study with ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study. | Participants enrolled from AI463-022 who received lamivudine, were nucleoside-naive HBeAg-positive, and had ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. (n=number of evaluable participants) | Posted | Number | Percentage of participants | Baseline to Week 144 |
|
|
|
| Primary | Week 192: Number of Participants With Death As Outcome, Any AE, Grade 3-4 AEs, SAEs, Discontinuations Due to AEs, and Abnormalities in Selected Laboratory Test Results | An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. CTC Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. ALT=alanine aminotransferase; ULN=upper limit of normal. | Participants who enrolled from Phase 3 studies of nucleoside-naive HBeAg-positive (AI463-022) and HBeAg-negative (AI463-027) participants and received at least 1 dose of study drug in the current study up to Week 192. (n=number of evaluable participants) | Posted | Number | Participants | Continuously from Day 1 through Week 192 |
|
|
|
| Secondary | Week 96: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort) | The Lamivudine Retreatment Switch Cohort consisted of participants who were nucleoside-naive HBeAg negative and enrolled from BMS study AI463-027 (NCT00035789) with >60 days between end of dosing in AI463-027 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study. | Participants enrolled from AI463-027 who were nucleoside-naive HBeAg-negative, received lamivudine, and had >60 days between end of dosing in AI463-027 and the switch to entecavir in the current study. (n=number of evaluable participants) | Posted | Number | Percentage of participants | Baseline to Week 96 |
|
|
|
| Secondary | Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort) | The Lamivudine Retreatment Switch Cohort consisted of participants who were nucleoside-naive HBeAg negative and enrolled from BMS study AI463-027 (NCT00035789) with >60 days between end of dosing in AI463-027 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study. | Participants enrolled from study AI463-027 who were nucleoside-naive HBeAg-negative and had >60 days off treatment between the last dose in AI463-027 and the first dose in the current study. (n=number of evaluable participants) | Posted | Number | Percentage of participants | Baseline to Week 144 |
|
|
|
| Primary | Off-treatment Follow-up: Percentage of Participants With Sustained Hepatitis B Virus (HBV) DNA <10,000 Copies by Polymerase Chain Reaction (PCR) Assay (Amendment 11 Cohort) | The Amendment 11 Cohort consisted of participants who were hepatitis B e antigen (HBeAg) negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing.ALT=alanine aminotransferase; ULN=upper limit of normal. | Participants who were HBeAg negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing. | Posted | Number | Percentage of participants | End of dosing to Week 48 off-treatment follow-up |
|
|
|
| Secondary | Off-treatment Follow-up: Percentage of Participants With Sustained HBV DNA <1,000, <300, and <10,000 Copies/mL by PCR Assay and With ALT ≤1*ULN (Amendment 11 Cohort) | The Amendment 11 Cohort consisted of participants who were HBeAg negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR Assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing. ULN=upper limit of normal. | Participants who were HBeAg negative and who had liver disease, a minimum of 192 weeks of entecavir treatment, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks before end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing. (n=number of evaluable participants) | Posted | Number | Percentage of participants | End of dosing to Weeks 48 and 96 off-treatment follow-up |
|
|
|
| Secondary | Off-treatment Follow-up: Mean Change in HBV DNA (Amendment 11 Cohort) | The Amendment 11 Cohort consisted of participants who were HBeAg negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing. | Participants who were HBeAg negative and who had liver disease, a minimum of 192 weeks of entecavir treatment, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks before end of dosing, and had serum ALT levels ≤1.0*ULN at the end of study drug dosing. (n=number of evaluable participants) | Posted | Mean | Standard Error | Log10 copies/mL | End of dosing to Weeks 48 and 96 off-treatment follow-up |
|
|
|
| 7 |
| 35 |
| 27 |
| 35 |
| EG001 | Entecavir, 0.02588 mg | Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine. | 0 | 1 | 0 | 1 |
| EG002 | Entecavir, 0.1 mg | Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine. | 3 | 29 | 25 | 29 |
| EG003 | Entecavir, 0.5 mg | Participants received entecavir QD with lamovidine | 57 | 336 | 274 | 336 |
| EG004 | Entecavir, 1.0 mg | Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine. | 15 | 123 | 94 | 123 |
| EG005 | Lamovidine, 100 mg | Participants originally received lamovidine with entecavir | 87 | 523 | 439 | 523 |
| EG006 | Missing | Category missing | 0 | 2 | 2 | 2 |
| EG007 | Placebo | Participants originally assigned to placebo before protocol change to study drug. | 0 | 2 | 1 | 2 |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| ASCITES | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| NASAL SEPTUM DEVIATION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| LUNG NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| HEPATIC ENCEPHALOPATHY | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| VASCULAR ENCEPHALOPATHY | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| OBSTRUCTIVE UROPATHY | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| HAEMORRHAGIC FEVER | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| MALFORMATION VENOUS | Congenital, familial and genetic disorders | MedDRA 13.1 | Systematic Assessment |
|
| VERTIGO POSITIONAL | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| HEPATIC HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| PERITONITIS | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| MYOLIPOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| PANCREATIC CARCINOMA METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| SPINAL COLUMN INJURY | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| CHRONIC HEPATITIS | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| HEPATIC NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| TRANSAMINASES INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| TUBERCULIN TEST POSITIVE | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| BENIGN BREAST NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| AMOEBIASIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| BILIARY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| HEPATITIS B | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| SLEEP APNOEA SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| OSTEOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| THYROID ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| MEDICATION ERROR | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| SIALOADENITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| STREPTOCOCCAL SEPSIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| BURN OESOPHAGEAL | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| RESTLESS LEGS SYNDROME | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| MANIA | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| HEPATITIS INFECTIOUS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| PYELONEPHRITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| VENTRICULAR EXTRASYSTOLES | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| MACULAR OEDEMA | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| OVARIAN CYST | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| EYE PENETRATION | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| SPINAL CORD INJURY CERVICAL | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| HEPATIC NEOPLASM MALIGNANT RECURRENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| BLOOD AMYLASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| LIPASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| SJOGREN'S SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| ARRHYTHMIA | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| POLYNEUROPATHY | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| KLEBSIELLA SEPSIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| CARDIAC FAILURE | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| URETHRAL DISORDER | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| MENORRHAGIA | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| ELECTRICAL BURN | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| OESOPHAGEAL VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| INFLAMMATION | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| MULTIPLE MYELOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| LIVER DISORDER | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| CEREBRAL HAEMATOMA | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| UTERINE POLYP | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| ANAL FISTULA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| FOOD POISONING | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| GASTRIC VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| LYMPHOPROLIFERATIVE DISORDER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| SPINAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| OBESITY | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| CHONDROPATHY | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| EPILEPSY | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| INTRACRANIAL HAEMATOMA | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| ANAL ABSCESS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| CHRONIC SINUSITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| DENGUE FEVER | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| AUTOIMMUNE THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| COMPLETED SUICIDE | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| CALCULUS URETERIC | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| ADRENAL MASS | Endocrine disorders | MedDRA 13.1 | Systematic Assessment |
|
| PULMONARY MASS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| TONSILLAR DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| ELECTIVE SURGERY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
|
| HAEMATOMA | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| GENITAL INJURY | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| TRANSITIONAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| JAUNDICE | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| HAEMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| SOFT TISSUE INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| TYPHOID FEVER | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| HEPATIC NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| LYMPHOMA CUTIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| MALIGNANT PERITONEAL NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| METASTASES TO BONE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| LABORATORY TEST ABNORMAL | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| ADENOMA BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| BILE DUCT CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| CEREBRAL HAEMANGIOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| DIPLOPIA | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| OESOPHAGEAL ULCER | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| GASTRIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| INVESTIGATION | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| IIIRD NERVE PARESIS | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| LIVER ABSCESS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| PERITONITIS BACTERIAL | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| PERITONSILLAR ABSCESS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| CORONARY ARTERY STENOSIS | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| SKIN NEOPLASM EXCISION | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
|
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| HAND FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| SQUAMOUS CELL CARCINOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| PAIN | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| HEPATITIS | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| VIRAL INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| INTERVERTEBRAL DISC DEGENERATION | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| DIARRHOEA INFECTIOUS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| EAR INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| NEPHROPATHY | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| HERPES ZOSTER | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| OVARIAN CYST RUPTURED | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| VARICES OESOPHAGEAL | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| VARICOSE VEIN | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| ABSCESS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| UTERINE LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| ASCITES | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| DUODENAL ULCER | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| GALLBLADDER POLYP | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| HEPATIC STEATOSIS | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| LIPODYSTROPHY ACQUIRED | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| RESTLESS LEGS SYNDROME | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| HAEMATURIA | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| SCIATICA | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| TACHYCARDIA | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| TOOTHACHE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| LACERATION | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| PALPITATIONS | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| FOOD POISONING | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| PROSTATITIS | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| CONJUNCTIVITIS | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| MALAISE | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| MUSCLE RUPTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| GROIN PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| PAIN | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| SEASONAL ALLERGY | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| RHINITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| TONSILLITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPERSENSITIVITY | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
|
| HERPES ZOSTER | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| Title | Measurements |
|---|
|
| Week 144 (n=597) |
|
| Week 192 (n=485) |
|
| Title | Measurements |
|---|---|
|
| Baseline: 1.0E4 - <1.0E5 copies/mL (n=1051) |
|
| Baseline: 1.0E5 - <1.0E6 copies/mL (n=1051) |
|
| Baseline: 1.0E6 - <1.0E7 copies/mL (n=1051) |
|
| Baseline: 1.0E7 - <1.0E8 copies/mL (n=1051) |
|
| Baseline: 1.0E8 - <1.0E9 copies/mL (n=1051) |
|
| Baseline: 1.0E9 - <1.0E10 copies/mL (n=1051) |
|
| Baseline: >= 1.0E10 copies/mL (n=1051) |
|
| Week 192: < 300 copies/mL (n=485) |
|
| Week 192: 300 - <1.0E3 copies/mL (n=485) |
|
| Week 192: 1.0E3 - <1.0E4 copies/mL (n=485) |
|
| Week 192: 1.0E4 - <1.0E5 copies/mL (n=485) |
|
| Week 192: 1.0E5 - <1.0E6 copies/mL (n=485) |
|
| Week 192: 1.0E6 - <1.0E7 copies/mL (n=485) |
|
| Week 192: 1.0E7 - <1.0E8 copies/mL (n=485) |
|
| Week 192: 1.0E8 - <1.0E9 copies/mL (n=485) |
|
| Week 192: 1.0E9 - <1.0E10 copies/mL (n=485) |
|
| Week 192: >= 1.0E10 copies/mL (n=485) |
|
| Title | Measurements |
|---|---|
|
| Discontinuations due to AEs on treatment |
|
| Any AE on treatment |
|
| Grade 3 and 4 AEs on treatment |
|
| Malignancies on and off treatment |
|
| ALT flares (ALT>2*entry and >10*ULN) on treatment |
|
| Hepatic disease progression on and off treatment |
|
| Title | Measurements |
|---|
|
| Week 48 (n=905) |
|
| Week 72 (n=769) |
|
| Week 96 (n=691) |
|
| Week 120 (n=629) |
|
| Week 144 (n=597) |
|
| Week 168 (n=514) |
|
| Week 192 (n=485) |
|
| Week 216 (n=455) |
|
| Title | Measurements |
|---|
|
| Week 48 (n=864) |
|
| Week 72 (n=752) |
|
| Week 96 (n=679) |
|
| Week 120 (n=609) |
|
| Week 144 (n=587) |
|
| Week 168 (n=518) |
|
| Week 192 (n=491) |
|
| Week 216 (n=436) |
|
| Title | Measurements |
|---|
|
| Week 48 (n=862) |
|
| Week 72 (n=755) |
|
| Week 96 (n=678) |
|
| Week 120 (n=607) |
|
| Week 144 (n=587) |
|
| Week 168 (n=517) |
|
| Week 192 (n=491) |
|
| Week 216 (n=434) |
|
| Title | Measurements |
|---|
|
| Week 48 (n=942) |
|
| Week 72 (n=835) |
|
| Week 96 (n=740) |
|
| Week 120 (n=675) |
|
| Week 144 (n=627) |
|
| Week 168 (n=563) |
|
| Week 192 (n=528) |
|
| Week 216 (n=482) |
|
| Title | Measurements |
|---|---|
|
| Week 216 (n=482) |
|
| Title | Measurements |
|---|---|
|
| Platelets (All grades) (n=979) |
|
| Protrombin time (All grades) (n=746) |
|
| INR (All grades)(n=746) |
|
| Hemoglobin (Grades 3-4) (n=1007) |
|
| White blood cells (Grades 3-4) (n=950) |
|
| Neutrophils (Grades 3-4) (n=1002) |
|
| Platelets (Grades 3-4) (n=979) |
|
| Prothrombin time (Grades 3-4) (n=746) |
|
| INR (Grades 3-4) (n=746) |
|
| Title | Measurements |
|---|---|
|
| Lipase (Grades 3-4) (n=390) |
|
| BUN/Urea (All grades) (n=998) |
|
| Creatinine (All grades) (n=1000) |
|
| BUN/Urea (Grades 3-4) (n=998) |
|
| Creatinine (Grades 3-4) (n=1000) |
|
| Title | Measurements |
|---|---|
|
| Hypercarbia (mEq/L) (All grades) (n=831) |
|
| Hyponatremia (mEq/L) (All grades) (n=1003) |
|
| Hypernatremia (mEq/L) (All grades) (n=1003) |
|
| Hypokalemia (mEq/L) (All grades) (n=993) |
|
| Hyperkalemia (mEq/L) (All grades (n=993) |
|
| Hypochloremia (mEq/L) (Grades 3-4) (n=982) |
|
| Hyperchloremia (mEq/L) (Grades 3-4) (n=982) |
|
| Hypocarbia (mEq/L) (Grades 3-4) (n=831) |
|
| Hypercarbia (mEq/L) (Grades 3-4) (n=831) |
|
| Hyponatremia (mEq/L)(Grades 3-4) (n=1003) |
|
| Hypernatremia (mEq/L) (Grades 3-4) (n=1003) |
|
| Hypokalemia (mEq/L) (Grades 3-4) (n=993) |
|
| Hyperkalemia (mEq/L) (Grades 3-4) (n=993) |
|
| Hypoglycemia (mg/dL) (All grades) (n=521) |
|
| Hyperglycemia (mg/dL) (All grades) (n=521) |
|
| Hypoglycemia (mg/dL) (Grades 3-4) (n=521) |
|
| Hyperglycemia (mg/dL) (Grades 3-4) (n=521) |
|
| Title | Measurements |
|---|---|
|
| Discontinuations due to AEs |
|
| Any AE |
|
| Grade 3 and 4 AEs |
|
| ALT flares (ALT>2*entry and >10*ULN) |
|
| ALT >5.0*ULN |
|
| AST >5.0*ULN |
|
| Total bilirubin >2.5*ULN |
|
| Lipase >2.0*ULN |
|
| Creatinine ≥0.5 mg/dL from baseline |
|
| Hypocarbia |
|
| Title | Measurements |
|---|---|
|
| Week 192: HBV DNA < 10^4 copies/mL (n=108) |
|
| Week 240: HBV DNA <300 copies/mL (n=94) |
|
| Week 48: Loss of HBeAg (n=146) |
|
| Week 96: Loss of HBeAg (n=140) |
|
| Week 144: Loss of HBeAg (n=132) |
|
| Week 192: Loss of HBeAg (n=111) |
|
| Week 240: Loss of HBeAg (n=95) |
|
| Week 48: Seroconversion (n=146) |
|
| Week 96: Seroconversion (n=140) |
|
| Week 144: Seroconversion (n=133) |
|
| Week 192: Seroconversion (n=111) |
|
| Week 240: Seroconversion (n=95) |
|
| Week 48: ALT ≤1.0*ULN (n=146) |
|
| Week 96: ALT ≤1.0*ULN (n=140) |
|
| Week 144: ALT ≤1.0*ULN (n=134) |
|
| Week 192: ALT ≤1.0*ULN (n=112) |
|
| Week 240: ALT ≤1.0*ULN (n=98) |
|
| Title | Measurements |
|---|---|
|
| Week 96: HBV DNA <300 copies/mL (n=74) |
|
| Week: 96: ALT ≤1.0*ULN (n=76) |
|
| Week 144: HBV DNA <300 copies/mL (n=57) |
|
| Week 144: ALT ≤1.0*ULN (n=66) |
|
| Title | Measurements |
|---|---|
|
| Achieved ALT ≤1.0*ULN (n=154) |
|
| Title | Measurements |
|---|---|
|
| Discontinuations due to AEs |
|
| Any AE |
|
| Grade 3 and 4 AEs |
|
| ALT flares (ALT>2*entry and >10*ULN) |
|
| ALT >5.0*ULN |
|
| Total bilirubin >2.5*ULN |
|
| Lipase >2.0*ULN |
|
| Creatinine ≥0.3 mg/dL from baseline |
|
| Hypocarbia Grades 3-4 |
|
| Title | Measurements |
|---|---|
|
| Off-treatment Week 96 <300 copies/mL |
|
| Off treatment Week 96 <10,000 copies/mL |
|
| Off treatment Week 48: ALT ≤1*ULN |
|
| Off treatment Week 96: ALT ≤1*ULN |
|