Trial Outcomes & Findings for Safety and Antiviral Activity of Entecavir in Participants With Chronic Hepatitis B Following Monotherapy in Other Entecavir Trials (NCT NCT01438424)
NCT ID: NCT01438424
Last Updated: 2012-08-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1053 participants
Primary outcome timeframe
Continuously from Day 1 through Week 240
Results posted on
2012-08-23
Participant Flow
Of 1053 participants enrolled, 1051 received treatment.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
1051
|
|
Overall Study
COMPLETED
|
634
|
|
Overall Study
NOT COMPLETED
|
417
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Continuing treatment
|
29
|
|
Overall Study
Minimal virologic response
|
95
|
|
Overall Study
Not identified
|
55
|
|
Overall Study
Withdrawal by Subject
|
104
|
|
Overall Study
Progression of chronic hepatitis B
|
22
|
|
Overall Study
Death
|
22
|
|
Overall Study
Adverse Event
|
17
|
|
Overall Study
Lost to Follow-up
|
17
|
|
Overall Study
Abnormal laboratory test result
|
14
|
|
Overall Study
Need for drug prohibited by protocol
|
14
|
|
Overall Study
Pregnancy
|
7
|
|
Overall Study
No longer met inclusion criteria
|
1
|
|
Overall Study
Participant noncompliance
|
20
|
Baseline Characteristics
Safety and Antiviral Activity of Entecavir in Participants With Chronic Hepatitis B Following Monotherapy in Other Entecavir Trials
Baseline characteristics by cohort
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=1051 Participants
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.
|
|---|---|
|
Age, Customized
|
41 Years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
241 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
810 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
544 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
481 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Filipino
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
1 Participants
n=5 Participants
|
|
Region: Continent
Asia
|
451 Participants
n=5 Participants
|
|
Region: Continent
Europe
|
334 Participants
n=5 Participants
|
|
Region: Continent
North America
|
141 Participants
n=5 Participants
|
|
Region: Continent
South America
|
125 Participants
n=5 Participants
|
|
Age
|
41 Years
n=5 Participants
|
PRIMARY outcome
Timeframe: Continuously from Day 1 through Week 240Population: All participants who received at least 1 dose of study drug in the current study.
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.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=1051 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
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
Deaths on treatment
|
18 Participants
|
|
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
Deaths off treatment
|
9 Participants
|
|
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
SAEs on treatment
|
169 Participants
|
|
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
Discontinuations due to AEs on treatment
|
14 Participants
|
|
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
Any AE on treatment
|
900 Participants
|
|
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
Grade 3 and 4 AEs on treatment
|
203 Participants
|
|
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
Malignancies on and off treatment
|
35 Participants
|
|
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
ALT flares (ALT>2*entry and >10*ULN) on treatment
|
32 Participants
|
|
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
Hepatic disease progression on and off treatment
|
33 Participants
|
PRIMARY outcome
Timeframe: Day 1 of treatment through Week 240Population: Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)
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. .
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=1051 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240
Hemoglobin (All grades) (n=1007)
|
49 Participants
|
|
Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240
White blood cells (All grades) (n=950)
|
226 Participants
|
|
Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240
Neutrophils (All grades) (n=1002)
|
109 Participants
|
|
Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240
Platelets (All grades) (n=979)
|
51 Participants
|
|
Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240
Protrombin time (All grades) (n=746)
|
226 Participants
|
|
Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240
INR (All grades)(n=746)
|
214 Participants
|
|
Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240
Hemoglobin (Grades 3-4) (n=1007)
|
2 Participants
|
|
Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240
White blood cells (Grades 3-4) (n=950)
|
1 Participants
|
|
Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240
Neutrophils (Grades 3-4) (n=1002)
|
21 Participants
|
|
Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240
Platelets (Grades 3-4) (n=979)
|
1 Participants
|
|
Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240
Prothrombin time (Grades 3-4) (n=746)
|
21 Participants
|
|
Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240
INR (Grades 3-4) (n=746)
|
12 Participants
|
PRIMARY outcome
Timeframe: Day 1 of treatment through Week 240Population: Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)
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.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=1051 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
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 (All grades) (n=875)
|
179 Participants
|
|
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
Lipase (All grades) (n=390)
|
126 Participants
|
|
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 (Grades 3-4) (n=875)
|
13 Participants
|
|
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
Lipase (Grades 3-4) (n=390)
|
38 Participants
|
|
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
BUN/Urea (All grades) (n=998)
|
57 Participants
|
|
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
Creatinine (All grades) (n=1000)
|
61 Participants
|
|
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
BUN/Urea (Grades 3-4) (n=998)
|
0 Participants
|
|
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
Creatinine (Grades 3-4) (n=1000)
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1 of treatment through Week 240Population: Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)
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.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=1051 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
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 (mEq/L) (All grades) (n=982)
|
44 Participants
|
|
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
Hyperchloremia (mEq/L) (All grades) (n=982)
|
76 Participants
|
|
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
Hypocarbia (mEq/L) (All grades) (n=831)
|
285 Participants
|
|
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
Hypercarbia (mEq/L) (All grades) (n=831)
|
148 Participants
|
|
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
Hyponatremia (mEq/L) (All grades) (n=1003)
|
68 Participants
|
|
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
Hypernatremia (mEq/L) (All grades) (n=1003)
|
106 Participants
|
|
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
Hypokalemia (mEq/L) (All grades) (n=993)
|
135 Participants
|
|
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
Hyperkalemia (mEq/L) (All grades (n=993)
|
42 Participants
|
|
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 (mEq/L) (Grades 3-4) (n=982)
|
3 Participants
|
|
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
Hyperchloremia (mEq/L) (Grades 3-4) (n=982)
|
7 Participants
|
|
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
Hypocarbia (mEq/L) (Grades 3-4) (n=831)
|
14 Participants
|
|
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
Hypercarbia (mEq/L) (Grades 3-4) (n=831)
|
2 Participants
|
|
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
Hyponatremia (mEq/L)(Grades 3-4) (n=1003)
|
2 Participants
|
|
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
Hypernatremia (mEq/L) (Grades 3-4) (n=1003)
|
5 Participants
|
|
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
Hypokalemia (mEq/L) (Grades 3-4) (n=993)
|
1 Participants
|
|
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
Hyperkalemia (mEq/L) (Grades 3-4) (n=993)
|
6 Participants
|
|
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
Hypoglycemia (mg/dL) (All grades) (n=521)
|
47 Participants
|
|
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
Hyperglycemia (mg/dL) (All grades) (n=521)
|
150 Participants
|
|
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
Hypoglycemia (mg/dL) (Grades 3-4) (n=521)
|
3 Participants
|
|
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
Hyperglycemia (mg/dL) (Grades 3-4) (n=521)
|
4 Participants
|
PRIMARY outcome
Timeframe: Continuously from Day 1 through Week 144Population: Participants enrolled up to Week 144 who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)
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.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=996 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
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
Deaths on study
|
13 Participants
|
|
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
Malignant neoplasms
|
17 Participants
|
|
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
SAEs
|
107 Participants
|
|
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
Discontinuations due to AEs
|
13 Participants
|
|
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
Any AE
|
842 Participants
|
|
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
Grade 3 and 4 AEs
|
156 Participants
|
|
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
ALT flares (ALT>2*entry and >10*ULN)
|
29 Participants
|
|
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
ALT >5.0*ULN
|
93 Participants
|
|
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
AST >5.0*ULN
|
53 Participants
|
|
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
Total bilirubin >2.5*ULN
|
22 Participants
|
|
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
Lipase >2.0*ULN
|
71 Participants
|
|
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
Creatinine ≥0.5 mg/dL from baseline
|
6 Participants
|
|
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
Hypocarbia
|
4 Participants
|
PRIMARY outcome
Timeframe: Continuously from Day 1 through Week 192Population: 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)
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.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=1006 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
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
ALT flares (ALT>2*entry and >10*ULN)
|
30 Participants
|
|
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
ALT >5.0*ULN
|
175 Participants
|
|
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
Deaths on study
|
18 Participants
|
|
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
Malignant neoplasms
|
27 Participants
|
|
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
SAEs
|
135 Participants
|
|
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
Discontinuations due to AEs
|
11 Participants
|
|
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
Any AE
|
862 Participants
|
|
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
Grade 3 and 4 AEs
|
174 Participants
|
|
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
Total bilirubin >2.5*ULN
|
32 Participants
|
|
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
Lipase >2.0*ULN
|
81 Participants
|
|
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
Creatinine ≥0.3 mg/dL from baseline
|
80 Participants
|
|
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
Hypocarbia Grades 3-4
|
5 Participants
|
PRIMARY outcome
Timeframe: End of dosing to Week 48 off-treatment follow-upPopulation: 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.
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.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=29 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
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)
End of dosing current study
|
100 Percentage of participants
|
|
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)
Off-treatment Week 48
|
21 Percentage of participants
|
SECONDARY outcome
Timeframe: Study entry to Week 192Population: Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=1051 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay
At study entry (n=1051)
|
17 Percentage of participants
|
|
Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay
Week 48 (n=905)
|
63 Percentage of participants
|
|
Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay
Week 96 (n=691)
|
67 Percentage of participants
|
|
Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay
Week 144 (n=597)
|
73 Percentage of participants
|
|
Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay
Week 192 (n=485)
|
78 Percentage of participants
|
SECONDARY outcome
Timeframe: Study entry to Week 192Population: Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=1051 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay
At study entry (n=1051)
|
28 Percentage of participants
|
|
Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay
Week 48 (n=905)
|
76 Percentage of participants
|
|
Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay
Week 96 (n=691)
|
77 Percentage of participants
|
|
Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay
Week 144 (n=597)
|
81 Percentage of participants
|
|
Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay
Week 192 (n=485)
|
85 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 192Population: Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)
Observed values.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=1051 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Baseline: <300 copies/mL (n=1051)
|
17 Percentage of participants
4
|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Baseline: 300 - <1.0E3 copies/mL (n=1051)
|
4 Percentage of participants
8
|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Baseline: 1.0E3 - <1.0E4 copies/mL (n=1051)
|
8 Percentage of participants
13
|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Baseline: 1.0E4 - <1.0E5 copies/mL (n=1051)
|
8 Percentage of participants
11
|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Baseline: 1.0E5 - <1.0E6 copies/mL (n=1051)
|
12 Percentage of participants
|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Baseline: 1.0E6 - <1.0E7 copies/mL (n=1051)
|
13 Percentage of participants
|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Baseline: 1.0E7 - <1.0E8 copies/mL (n=1051)
|
8 Percentage of participants
|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Baseline: 1.0E8 - <1.0E9 copies/mL (n=1051)
|
11 Percentage of participants
|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Baseline: 1.0E9 - <1.0E10 copies/mL (n=1051)
|
13 Percentage of participants
|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Baseline: >= 1.0E10 copies/mL (n=1051)
|
6 Percentage of participants
|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Week 192: < 300 copies/mL (n=485)
|
78 Percentage of participants
|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Week 192: 300 - <1.0E3 copies/mL (n=485)
|
3 Percentage of participants
|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Week 192: 1.0E3 - <1.0E4 copies/mL (n=485)
|
3 Percentage of participants
|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Week 192: 1.0E4 - <1.0E5 copies/mL (n=485)
|
4 Percentage of participants
|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Week 192: 1.0E5 - <1.0E6 copies/mL (n=485)
|
2 Percentage of participants
|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Week 192: 1.0E6 - <1.0E7 copies/mL (n=485)
|
2 Percentage of participants
|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Week 192: 1.0E7 - <1.0E8 copies/mL (n=485)
|
1 Percentage of participants
|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Week 192: 1.0E8 - <1.0E9 copies/mL (n=485)
|
5 Percentage of participants
|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Week 192: 1.0E9 - <1.0E10 copies/mL (n=485)
|
2 Percentage of participants
|
|
Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay
Week 192: >= 1.0E10 copies/mL (n=485)
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Study entry to Week 216Population: Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=1051 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
Overall Study: Mean HBV DNA Level by PCR Assay
At study entry (n=1051)
|
6.14 log10 copies/mL
Standard Deviation 2.667
|
|
Overall Study: Mean HBV DNA Level by PCR Assay
Week 12 (n=1017)
|
3.87 log10 copies/mL
Standard Deviation 1.749
|
|
Overall Study: Mean HBV DNA Level by PCR Assay
Week 24 (n=1010)
|
3.62 log10 copies/mL
Standard Deviation 1.684
|
|
Overall Study: Mean HBV DNA Level by PCR Assay
Week 48 (n=905)
|
3.37 log10 copies/mL
Standard Deviation 1.543
|
|
Overall Study: Mean HBV DNA Level by PCR Assay
Week 72 (n=769)
|
3.31 log10 copies/mL
Standard Deviation 1.549
|
|
Overall Study: Mean HBV DNA Level by PCR Assay
Week 96 (n=691)
|
3.34 log10 copies/mL
Standard Deviation 1.592
|
|
Overall Study: Mean HBV DNA Level by PCR Assay
Week 120 (n=629)
|
3.32 log10 copies/mL
Standard Deviation 1.665
|
|
Overall Study: Mean HBV DNA Level by PCR Assay
Week 144 (n=597)
|
3.34 log10 copies/mL
Standard Deviation 1.826
|
|
Overall Study: Mean HBV DNA Level by PCR Assay
Week 168 (n=514)
|
3.18 log10 copies/mL
Standard Deviation 1.663
|
|
Overall Study: Mean HBV DNA Level by PCR Assay
Week 192 (n=485)
|
3.19 log10 copies/mL
Standard Deviation 1.757
|
|
Overall Study: Mean HBV DNA Level by PCR Assay
Week 216 (n=455)
|
3.20 log10 copies/mL
Standard Deviation 1.789
|
SECONDARY outcome
Timeframe: Study entry to Week 216Population: Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)
Observed values.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=1051 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg)
At study entry (n=1051)
|
34 Percentage of participants
|
|
Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg)
Week 12 (n=935)
|
40 Percentage of participants
|
|
Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg)
Week 24 (n=939)
|
42 Percentage of participants
|
|
Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg)
Week 48 (n=864)
|
46 Percentage of participants
|
|
Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg)
Week 72 (n=752)
|
45 Percentage of participants
|
|
Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg)
Week 96 (n=679)
|
50 Percentage of participants
|
|
Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg)
Week 120 (n=609)
|
51 Percentage of participants
|
|
Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg)
Week 144 (n=587)
|
53 Percentage of participants
|
|
Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg)
Week 168 (n=518)
|
58 Percentage of participants
|
|
Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg)
Week 192 (n=491)
|
60 Percentage of participants
|
|
Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg)
Week 216 (n=436)
|
59 Percentage of participants
|
SECONDARY outcome
Timeframe: Study entry to Week 216Population: Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)
Observed values. Seroconversion=negative HBeAg with detectable anti-HBe antibody.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=1051 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
Overall Study: Percentage of Participants With HBeAg Seroconversion
At study entry (n=1051)
|
30 Percentage of participants
|
|
Overall Study: Percentage of Participants With HBeAg Seroconversion
Week 12 (n=931)
|
33 Percentage of participants
|
|
Overall Study: Percentage of Participants With HBeAg Seroconversion
Week 24 (n=934)
|
34 Percentage of participants
|
|
Overall Study: Percentage of Participants With HBeAg Seroconversion
Week 48 (n=862)
|
36 Percentage of participants
|
|
Overall Study: Percentage of Participants With HBeAg Seroconversion
Week 72 (n=755)
|
32 Percentage of participants
|
|
Overall Study: Percentage of Participants With HBeAg Seroconversion
Week 96 (n=678)
|
34 Percentage of participants
|
|
Overall Study: Percentage of Participants With HBeAg Seroconversion
Week 120 (n=607)
|
36 Percentage of participants
|
|
Overall Study: Percentage of Participants With HBeAg Seroconversion
Week 144 (n=587)
|
37 Percentage of participants
|
|
Overall Study: Percentage of Participants With HBeAg Seroconversion
Week 168 (n=517)
|
39 Percentage of participants
|
|
Overall Study: Percentage of Participants With HBeAg Seroconversion
Week 192 (n=491)
|
42 Percentage of participants
|
|
Overall Study: Percentage of Participants With HBeAg Seroconversion
Week 216 (n=434)
|
40 Percentage of participants
|
SECONDARY outcome
Timeframe: Study entry to Week 216Population: Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)
Observed values.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=1051 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
Overall Study: Mean Alanine Transaminase (ALT) Levels
At study entry (n=1051)
|
109.4 U/L
Standard Deviation 170.5
|
|
Overall Study: Mean Alanine Transaminase (ALT) Levels
Week 12 (n=1049)
|
48.77 U/L
Standard Deviation 48.68
|
|
Overall Study: Mean Alanine Transaminase (ALT) Levels
Week 24 (n=1029)
|
42.10 U/L
Standard Deviation 36.83
|
|
Overall Study: Mean Alanine Transaminase (ALT) Levels
Week 48 (n=942)
|
37.06 U/L
Standard Deviation 34.20
|
|
Overall Study: Mean Alanine Transaminase (ALT) Levels
Week 72 (n=835)
|
38.10 U/L
Standard Deviation 41.90
|
|
Overall Study: Mean Alanine Transaminase (ALT) Levels
Week 96 (n=740)
|
39.30 U/L
Standard Deviation 46.35
|
|
Overall Study: Mean Alanine Transaminase (ALT) Levels
Week 120 (n=675)
|
37.43 U/L
Standard Deviation 28.97
|
|
Overall Study: Mean Alanine Transaminase (ALT) Levels
Week 144 (n=627)
|
38.51 U/L
Standard Deviation 38.95
|
|
Overall Study: Mean Alanine Transaminase (ALT) Levels
Week 168 (n=563)
|
36.80 U/L
Standard Deviation 29.06
|
|
Overall Study: Mean Alanine Transaminase (ALT) Levels
Week 192 (n=528)
|
37.36 U/L
Standard Deviation 30.44
|
|
Overall Study: Mean Alanine Transaminase (ALT) Levels
Week 216 (n=482)
|
38.43 U/L
Standard Deviation 55.09
|
SECONDARY outcome
Timeframe: Study entry to Week 216Population: Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)
ULN=upper limit of normal. ALT normalization=ALT levels ≤1.0\*ULN.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=1051 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
Overall Study: Percentage of Participants Who Achieved ALT Normalization
Week 144 (n=627)
|
74 Percentage of participants
|
|
Overall Study: Percentage of Participants Who Achieved ALT Normalization
Week 216 (n=482)
|
78 Percentage of participants
|
|
Overall Study: Percentage of Participants Who Achieved ALT Normalization
At study entry (n=1019)
|
40 Percentage of participants
|
|
Overall Study: Percentage of Participants Who Achieved ALT Normalization
Week 48 (n=942)
|
75 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 192Population: 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)
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.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=57 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
Week 192: Percentage of Participants With Histologic Improvement (Efficacy Evaluable Cohort)
Histologic improvement (n=56) (Week 48)
|
73 Percentage of participants
Interval 60.0 to 84.0
|
|
Week 192: Percentage of Participants With Histologic Improvement (Efficacy Evaluable Cohort)
Histologic improvement (n=57) (Long-term biopsy)
|
96 Percentage of participants
Interval 88.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline to Week 192Population: 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)
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.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=57 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
Week 192: Percentage of Participants With Improvement in Fibrosis (Efficacy Evaluable Cohort)
Improvement in fibrosis (n=56) (Week 48)
|
32 Percentage of participants
Interval 20.0 to 46.0
|
|
Week 192: Percentage of Participants With Improvement in Fibrosis (Efficacy Evaluable Cohort)
Improvement in fibrosis (n=57) (Long-term biopsy)
|
88 Percentage of participants
Interval 76.0 to 95.0
|
SECONDARY outcome
Timeframe: Baseline to Week 144Population: Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=1051 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
Overall Study: Percentage of Participants With a Confirmed ≥1 log10 Increase From Nadir in HBV DNA by PCR Assay
|
18 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 48, 96, 144, 192, and 240Population: 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)
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.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=146 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
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)
Week 96: Seroconversion (n=140)
|
3 Percentage of participants
|
|
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)
Week 144: Seroconversion (n=133)
|
17 Percentage of participants
|
|
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)
Week 192: Seroconversion (n=111)
|
16 Percentage of participants
|
|
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)
Week 240: Seroconversion (n=95)
|
17 Percentage of participants
|
|
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)
Week 48: ALT ≤1.0*ULN (n=146)
|
65 Percentage of participants
|
|
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)
Week 96: ALT ≤1.0*ULN (n=140)
|
78 Percentage of participants
|
|
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)
Week 144: ALT ≤1.0*ULN (n=134)
|
77 Percentage of participants
|
|
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)
Week 192: ALT ≤1.0*ULN (n=112)
|
86 Percentage of participants
|
|
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)
Week 240: ALT ≤1.0*ULN (n=98)
|
80 Percentage of participants
|
|
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)
Week 48: HBV DNA <300 copies/mL (n=146)
|
55 Percentage of participants
|
|
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)
Week 96: HBV DNA <300 copies/mL (n=140)
|
83 Percentage of participants
|
|
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)
Week 144: HBV DNA <10^4 copies/mL (n=131)
|
89 Percentage of participants
|
|
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)
Week 192: HBV DNA < 10^4 copies/mL (n=108)
|
91 Percentage of participants
|
|
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)
Week 240: HBV DNA <300 copies/mL (n=94)
|
94 Percentage of participants
|
|
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)
Week 48: Loss of HBeAg (n=146)
|
1 Percentage of participants
|
|
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)
Week 96: Loss of HBeAg (n=140)
|
4 Percentage of participants
|
|
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)
Week 144: Loss of HBeAg (n=132)
|
30 Percentage of participants
|
|
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)
Week 192: Loss of HBeAg (n=111)
|
39 Percentage of participants
|
|
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)
Week 240: Loss of HBeAg (n=95)
|
41 Percentage of participants
|
|
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)
Week 48: Seroconversion (n=146)
|
1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 48, 96, and 144Population: 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)
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.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=99 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
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)
Week 48: HBV DNA <300 copies/mL (n=119)
|
88 Percentage of participants
|
|
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)
Week 48: HBV DNA <10^4 copies/mL (n=88)
|
87 Percentage of participants
|
|
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)
Week: 48: ALT ≤1.0*ULN (n=95)
|
83 Percentage of participants
|
|
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)
Week 96: HBV DNA <300 copies/mL (n=74)
|
91 Percentage of participants
|
|
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)
Week: 96: ALT ≤1.0*ULN (n=76)
|
79 Percentage of participants
|
|
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)
Week 144: HBV DNA <300 copies/mL (n=57)
|
95 Percentage of participants
|
|
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)
Week 144: ALT ≤1.0*ULN (n=66)
|
86 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 96Population: 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)
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.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=183 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
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)
HBV DNA <300 copies/mL (n=147)
|
58 Percentage of participants
|
|
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)
Achieved loss of HbeAg (n=129)
|
25 Percentage of participants
|
|
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)
Achieved HBeAg seroconversion (n=129)
|
8 Percentage of participants
|
|
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)
Achieved ALT ≤1.0*ULN (n=154)
|
76 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 144Population: 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)
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.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=183 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort)
HBV DNA <300 copies/mL (n=130)
|
65 Percentage of participants
|
|
Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort)
Achieved ALT ≤1.0*ULN (n=135)
|
68 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 96Population: 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)
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.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=123 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
Week 96: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort)
HBV DNA <300 copies/mL (n=69)
|
97 Percentage of participants
|
|
Week 96: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort)
ALT ≤1.0*ULN (n=81)
|
81 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 144Population: 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)
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.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=123 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort)
HBV DNA <300 copies/mL (n=67)
|
99 Percentage of participants
|
|
Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort)
Achieved ALT ≤1.0*ULN (n=73)
|
85 Percentage of participants
|
SECONDARY outcome
Timeframe: End of dosing to Weeks 48 and 96 off-treatment follow-upPopulation: 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)
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.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=29 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
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)
Off-treatment Week 48 <1000 copies/mL
|
10 Percentage of participants
|
|
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)
Off-treatment Week 96 <1000 copies/mL
|
10 Percentage of participants
|
|
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)
Off-treatment Week 48 <300 copies/mL
|
7 Percentage of participants
|
|
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)
Off-treatment Week 96 <300 copies/mL
|
3 Percentage of participants
|
|
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)
Off treatment Week 96 <10,000 copies/mL
|
14 Percentage of participants
|
|
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)
Off treatment Week 48: ALT ≤1*ULN
|
31 Percentage of participants
|
|
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)
Off treatment Week 96: ALT ≤1*ULN
|
24 Percentage of participants
|
SECONDARY outcome
Timeframe: End of dosing to Weeks 48 and 96 off-treatment follow-upPopulation: 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)
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.
Outcome measures
| Measure |
Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine
n=29 Participants
Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
|---|---|
|
Off-treatment Follow-up: Mean Change in HBV DNA (Amendment 11 Cohort)
Off-treatment Week 48
|
1.54 Log10 copies/mL
Standard Error 0.336
|
|
Off-treatment Follow-up: Mean Change in HBV DNA (Amendment 11 Cohort)
Off-treatment Week 96
|
1.18 Log10 copies/mL
Standard Error 0.326
|
Adverse Events
Adefovir, 10 mg
Serious events: 7 serious events
Other events: 27 other events
Deaths: 0 deaths
Entecavir, 0.02588 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Entecavir, 0.1 mg
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Entecavir, 0.5 mg
Serious events: 57 serious events
Other events: 274 other events
Deaths: 0 deaths
Entecavir, 1.0 mg
Serious events: 15 serious events
Other events: 94 other events
Deaths: 0 deaths
Lamovidine, 100 mg
Serious events: 87 serious events
Other events: 439 other events
Deaths: 0 deaths
Missing
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adefovir, 10 mg
n=35 participants at risk
Participants who received adefovir concomitantly at postdosing follow-up
|
Entecavir, 0.02588 mg
n=1 participants at risk
Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
Entecavir, 0.1 mg
n=29 participants at risk
Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
Entecavir, 0.5 mg
n=336 participants at risk
Participants received entecavir QD with lamovidine
|
Entecavir, 1.0 mg
n=123 participants at risk
Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
Lamovidine, 100 mg
n=523 participants at risk
Participants originally received lamovidine with entecavir
|
Missing
n=2 participants at risk
Category missing
|
Placebo
n=2 participants at risk
Participants originally assigned to placebo before protocol change to study drug.
|
|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
SPINAL CORD INJURY CERVICAL
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
1.8%
6/336
|
2.4%
3/123
|
3.1%
16/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.81%
1/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
TUBERCULIN TEST POSITIVE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN BREAST NEOPLASM
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
AMOEBIASIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.81%
1/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
BILIARY TRACT INFECTION
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
HEPATITIS B
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
SEPSIS
|
2.9%
1/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OSTEOMA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID ADENOMA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
MEDICATION ERROR
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
SIALOADENITIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
STREPTOCOCCAL SEPSIS
|
2.9%
1/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
BURN OESOPHAGEAL
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
1.1%
6/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.38%
2/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.81%
1/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.38%
2/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT RECURRENT
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
BLOOD AMYLASE INCREASED
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
LIPASE INCREASED
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.9%
1/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
SJOGREN'S SYNDROME
|
0.00%
0/35
|
0.00%
0/1
|
3.4%
1/29
|
0.00%
0/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
GASTROENTERITIS
|
2.9%
1/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.81%
1/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Cardiac disorders
ARRHYTHMIA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
POLYNEUROPATHY
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
KLEBSIELLA SEPSIS
|
2.9%
1/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Renal and urinary disorders
URETHRAL DISORDER
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.57%
3/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
HAEMOLYTIC ANAEMIA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Psychiatric disorders
MANIA
|
2.9%
1/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
HEPATITIS INFECTIOUS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Cardiac disorders
VENTRICULAR EXTRASYSTOLES
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.81%
1/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Eye disorders
MACULAR OEDEMA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.38%
2/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
EYE PENETRATION
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
VESTIBULAR NEURONITIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
CONSTIPATION
|
2.9%
1/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
NASAL SEPTUM DEVIATION
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
HEPATIC ENCEPHALOPATHY
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
CELLULITIS
|
2.9%
1/35
|
0.00%
0/1
|
0.00%
0/29
|
0.60%
2/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
2.9%
1/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
VASCULAR ENCEPHALOPATHY
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Renal and urinary disorders
OBSTRUCTIVE UROPATHY
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
HAEMORRHAGIC FEVER
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Congenital, familial and genetic disorders
MALFORMATION VENOUS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Ear and labyrinth disorders
VERTIGO POSITIONAL
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.81%
1/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.60%
2/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
HEPATIC HAEMATOMA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
PERITONITIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYOLIPOMA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA METASTATIC
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.81%
1/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
SPINAL COLUMN INJURY
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Hepatobiliary disorders
CHRONIC HEPATITIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
ELECTRICAL BURN
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
|
2.9%
1/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
INFLAMMATION
|
0.00%
0/35
|
0.00%
0/1
|
3.4%
1/29
|
0.00%
0/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MULTIPLE MYELOMA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Hepatobiliary disorders
LIVER DISORDER
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
CEREBRAL HAEMATOMA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Reproductive system and breast disorders
UTERINE POLYP
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.81%
1/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
FOOD POISONING
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
GASTRIC VARICES HAEMORRHAGE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOPROLIFERATIVE DISORDER
|
0.00%
0/35
|
0.00%
0/1
|
3.4%
1/29
|
0.00%
0/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
OBESITY
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
CHONDROPATHY
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.60%
2/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
INTRACRANIAL HAEMATOMA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
ANAL ABSCESS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.57%
3/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
CHRONIC SINUSITIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
DENGUE FEVER
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
AUTOIMMUNE THROMBOCYTOPENIA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.81%
1/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Endocrine disorders
ADRENAL MASS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.81%
1/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY MASS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
TONSILLAR DISORDER
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Surgical and medical procedures
ELECTIVE SURGERY
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
GENITAL INJURY
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TRANSITIONAL CELL CARCINOMA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.81%
1/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
PYREXIA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Hepatobiliary disorders
JAUNDICE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.60%
2/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOTHORAX
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
SOFT TISSUE INFECTION
|
2.9%
1/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
TYPHOID FEVER
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
2.9%
1/35
|
0.00%
0/1
|
0.00%
0/29
|
1.2%
4/336
|
0.00%
0/123
|
1.5%
8/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA CUTIS
|
0.00%
0/35
|
0.00%
0/1
|
3.4%
1/29
|
0.00%
0/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT PERITONEAL NEOPLASM
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO BONE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
2.9%
1/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
LABORATORY TEST ABNORMAL
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOMA BENIGN
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BILE DUCT CANCER
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CEREBRAL HAEMANGIOMA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.81%
1/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Eye disorders
DIPLOPIA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.81%
1/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
OESOPHAGEAL ULCER
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.38%
2/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
INVESTIGATION
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
IIIRD NERVE PARESIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
LIVER ABSCESS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.60%
2/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
PERITONITIS BACTERIAL
|
2.9%
1/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
PERITONSILLAR ABSCESS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
PNEUMONIA
|
5.7%
2/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.81%
1/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Surgical and medical procedures
SKIN NEOPLASM EXCISION
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
PAIN
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.38%
2/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.60%
2/336
|
0.81%
1/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Hepatobiliary disorders
HEPATITIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.60%
2/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.38%
2/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DEGENERATION
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.60%
2/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
DIARRHOEA INFECTIOUS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Renal and urinary disorders
NEPHROPATHY
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.81%
1/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Reproductive system and breast disorders
OVARIAN CYST RUPTURED
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.81%
1/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
VARICES OESOPHAGEAL
|
0.00%
0/35
|
0.00%
0/1
|
3.4%
1/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
CHEST PAIN
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Vascular disorders
VARICOSE VEIN
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
ABSCESS
|
2.9%
1/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
Other adverse events
| Measure |
Adefovir, 10 mg
n=35 participants at risk
Participants who received adefovir concomitantly at postdosing follow-up
|
Entecavir, 0.02588 mg
n=1 participants at risk
Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
Entecavir, 0.1 mg
n=29 participants at risk
Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
Entecavir, 0.5 mg
n=336 participants at risk
Participants received entecavir QD with lamovidine
|
Entecavir, 1.0 mg
n=123 participants at risk
Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
|
Lamovidine, 100 mg
n=523 participants at risk
Participants originally received lamovidine with entecavir
|
Missing
n=2 participants at risk
Category missing
|
Placebo
n=2 participants at risk
Participants originally assigned to placebo before protocol change to study drug.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
MALAISE
|
5.7%
2/35
|
0.00%
0/1
|
6.9%
2/29
|
1.5%
5/336
|
0.81%
1/123
|
3.8%
20/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
MUSCLE RUPTURE
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.81%
1/123
|
0.00%
0/523
|
0.00%
0/2
|
50.0%
1/2
|
|
Skin and subcutaneous tissue disorders
RASH
|
5.7%
2/35
|
0.00%
0/1
|
6.9%
2/29
|
3.3%
11/336
|
5.7%
7/123
|
2.7%
14/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
DIARRHOEA
|
14.3%
5/35
|
0.00%
0/1
|
3.4%
1/29
|
13.1%
44/336
|
9.8%
12/123
|
13.2%
69/523
|
50.0%
1/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.60%
2/336
|
0.81%
1/123
|
0.76%
4/523
|
50.0%
1/2
|
0.00%
0/2
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
2.9%
1/35
|
0.00%
0/1
|
20.7%
6/29
|
9.8%
33/336
|
8.9%
11/123
|
16.4%
86/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/35
|
0.00%
0/1
|
6.9%
2/29
|
0.89%
3/336
|
0.81%
1/123
|
2.7%
14/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
NASOPHARYNGITIS
|
22.9%
8/35
|
0.00%
0/1
|
17.2%
5/29
|
17.9%
60/336
|
14.6%
18/123
|
15.9%
83/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/35
|
0.00%
0/1
|
17.2%
5/29
|
6.5%
22/336
|
7.3%
9/123
|
8.4%
44/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.9%
1/35
|
0.00%
0/1
|
17.2%
5/29
|
13.7%
46/336
|
9.8%
12/123
|
16.1%
84/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/35
|
0.00%
0/1
|
6.9%
2/29
|
0.60%
2/336
|
0.00%
0/123
|
0.57%
3/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/35
|
0.00%
0/1
|
6.9%
2/29
|
2.1%
7/336
|
1.6%
2/123
|
1.3%
7/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.89%
3/336
|
0.00%
0/123
|
0.57%
3/523
|
50.0%
1/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
2.9%
1/35
|
0.00%
0/1
|
24.1%
7/29
|
12.5%
42/336
|
5.7%
7/123
|
12.8%
67/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.00%
0/35
|
0.00%
0/1
|
6.9%
2/29
|
0.89%
3/336
|
0.81%
1/123
|
0.57%
3/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
TOOTHACHE
|
5.7%
2/35
|
0.00%
0/1
|
3.4%
1/29
|
4.8%
16/336
|
3.3%
4/123
|
7.3%
38/523
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/35
|
0.00%
0/1
|
3.4%
1/29
|
3.0%
10/336
|
2.4%
3/123
|
3.4%
18/523
|
50.0%
1/2
|
0.00%
0/2
|
|
General disorders
OEDEMA PERIPHERAL
|
5.7%
2/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.81%
1/123
|
2.5%
13/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
URINARY TRACT INFECTION
|
8.6%
3/35
|
0.00%
0/1
|
0.00%
0/29
|
5.4%
18/336
|
2.4%
3/123
|
5.5%
29/523
|
50.0%
1/2
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
LACERATION
|
5.7%
2/35
|
0.00%
0/1
|
0.00%
0/29
|
1.2%
4/336
|
2.4%
3/123
|
1.3%
7/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Psychiatric disorders
INSOMNIA
|
5.7%
2/35
|
0.00%
0/1
|
13.8%
4/29
|
7.7%
26/336
|
4.9%
6/123
|
9.4%
49/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY TRACT CONGESTION
|
5.7%
2/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.19%
1/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/35
|
0.00%
0/1
|
6.9%
2/29
|
2.7%
9/336
|
0.00%
0/123
|
2.3%
12/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
DYSPEPSIA
|
8.6%
3/35
|
0.00%
0/1
|
27.6%
8/29
|
7.4%
25/336
|
8.1%
10/123
|
8.4%
44/523
|
50.0%
1/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
FOOD POISONING
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.38%
2/523
|
50.0%
1/2
|
0.00%
0/2
|
|
General disorders
PYREXIA
|
20.0%
7/35
|
0.00%
0/1
|
24.1%
7/29
|
11.3%
38/336
|
8.1%
10/123
|
8.2%
43/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Reproductive system and breast disorders
PROSTATITIS
|
0.00%
0/35
|
0.00%
0/1
|
6.9%
2/29
|
0.30%
1/336
|
0.00%
0/123
|
0.57%
3/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
14.3%
5/35
|
0.00%
0/1
|
13.8%
4/29
|
14.3%
48/336
|
12.2%
15/123
|
14.7%
77/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/35
|
0.00%
0/1
|
6.9%
2/29
|
1.5%
5/336
|
1.6%
2/123
|
1.3%
7/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Eye disorders
CONJUNCTIVITIS
|
2.9%
1/35
|
0.00%
0/1
|
0.00%
0/29
|
2.4%
8/336
|
0.81%
1/123
|
0.96%
5/523
|
50.0%
1/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
5.7%
2/35
|
0.00%
0/1
|
17.2%
5/29
|
10.4%
35/336
|
4.1%
5/123
|
11.3%
59/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
LIPODYSTROPHY ACQUIRED
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.81%
1/123
|
0.00%
0/523
|
0.00%
0/2
|
50.0%
1/2
|
|
Vascular disorders
HYPERTENSION
|
2.9%
1/35
|
0.00%
0/1
|
13.8%
4/29
|
13.1%
44/336
|
10.6%
13/123
|
12.0%
63/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
5.7%
2/35
|
0.00%
0/1
|
10.3%
3/29
|
3.9%
13/336
|
5.7%
7/123
|
6.9%
36/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.00%
0/523
|
50.0%
1/2
|
0.00%
0/2
|
|
Renal and urinary disorders
HAEMATURIA
|
2.9%
1/35
|
0.00%
0/1
|
3.4%
1/29
|
6.2%
21/336
|
3.3%
4/123
|
5.5%
29/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
HEPATIC ENCEPHALOPATHY
|
5.7%
2/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.00%
0/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.9%
1/35
|
0.00%
0/1
|
0.00%
0/29
|
6.8%
23/336
|
4.1%
5/123
|
9.9%
52/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
ASCITES
|
5.7%
2/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
0.38%
2/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
DUODENAL ULCER
|
8.6%
3/35
|
0.00%
0/1
|
0.00%
0/29
|
1.8%
6/336
|
0.00%
0/123
|
0.96%
5/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
5.7%
2/35
|
0.00%
0/1
|
0.00%
0/29
|
4.8%
16/336
|
1.6%
2/123
|
2.7%
14/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/35
|
0.00%
0/1
|
3.4%
1/29
|
4.5%
15/336
|
3.3%
4/123
|
5.9%
31/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
5.7%
2/35
|
0.00%
0/1
|
0.00%
0/29
|
1.5%
5/336
|
1.6%
2/123
|
1.1%
6/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
NAUSEA
|
5.7%
2/35
|
0.00%
0/1
|
13.8%
4/29
|
3.6%
12/336
|
1.6%
2/123
|
7.1%
37/523
|
50.0%
1/2
|
0.00%
0/2
|
|
General disorders
ASTHENIA
|
5.7%
2/35
|
0.00%
0/1
|
3.4%
1/29
|
3.9%
13/336
|
3.3%
4/123
|
4.8%
25/523
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
FATIGUE
|
5.7%
2/35
|
0.00%
0/1
|
24.1%
7/29
|
10.7%
36/336
|
10.6%
13/123
|
12.0%
63/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Hepatobiliary disorders
GALLBLADDER POLYP
|
5.7%
2/35
|
0.00%
0/1
|
3.4%
1/29
|
2.7%
9/336
|
0.81%
1/123
|
2.5%
13/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.00%
0/35
|
0.00%
0/1
|
6.9%
2/29
|
4.2%
14/336
|
6.5%
8/123
|
4.0%
21/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
25.7%
9/35
|
0.00%
0/1
|
17.2%
5/29
|
26.5%
89/336
|
22.0%
27/123
|
29.4%
154/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
0.00%
0/336
|
0.00%
0/123
|
0.19%
1/523
|
50.0%
1/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/35
|
0.00%
0/1
|
17.2%
5/29
|
3.6%
12/336
|
1.6%
2/123
|
5.0%
26/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/35
|
0.00%
0/1
|
6.9%
2/29
|
2.1%
7/336
|
1.6%
2/123
|
3.8%
20/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
HEADACHE
|
8.6%
3/35
|
0.00%
0/1
|
44.8%
13/29
|
20.5%
69/336
|
13.0%
16/123
|
25.0%
131/523
|
50.0%
1/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
2.9%
1/35
|
0.00%
0/1
|
3.4%
1/29
|
8.3%
28/336
|
5.7%
7/123
|
7.1%
37/523
|
50.0%
1/2
|
0.00%
0/2
|
|
General disorders
PAIN
|
0.00%
0/35
|
0.00%
0/1
|
6.9%
2/29
|
0.60%
2/336
|
0.81%
1/123
|
2.1%
11/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.00%
0/35
|
0.00%
0/1
|
3.4%
1/29
|
2.1%
7/336
|
2.4%
3/123
|
3.6%
19/523
|
50.0%
1/2
|
0.00%
0/2
|
|
Infections and infestations
BRONCHITIS
|
2.9%
1/35
|
0.00%
0/1
|
6.9%
2/29
|
5.1%
17/336
|
3.3%
4/123
|
3.8%
20/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
INFLUENZA
|
11.4%
4/35
|
0.00%
0/1
|
13.8%
4/29
|
13.4%
45/336
|
10.6%
13/123
|
10.1%
53/523
|
50.0%
1/2
|
0.00%
0/2
|
|
Infections and infestations
RHINITIS
|
0.00%
0/35
|
0.00%
0/1
|
0.00%
0/29
|
3.3%
11/336
|
2.4%
3/123
|
2.9%
15/523
|
50.0%
1/2
|
0.00%
0/2
|
|
Infections and infestations
TONSILLITIS
|
5.7%
2/35
|
0.00%
0/1
|
3.4%
1/29
|
3.3%
11/336
|
0.81%
1/123
|
2.1%
11/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
2.9%
1/35
|
0.00%
0/1
|
13.8%
4/29
|
2.4%
8/336
|
2.4%
3/123
|
2.1%
11/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/35
|
0.00%
0/1
|
13.8%
4/29
|
4.8%
16/336
|
4.1%
5/123
|
2.5%
13/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
DIZZINESS
|
5.7%
2/35
|
0.00%
0/1
|
6.9%
2/29
|
7.1%
24/336
|
4.1%
5/123
|
8.4%
44/523
|
50.0%
1/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
8.6%
3/35
|
0.00%
0/1
|
0.00%
0/29
|
1.8%
6/336
|
1.6%
2/123
|
2.7%
14/523
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
CHEST PAIN
|
5.7%
2/35
|
0.00%
0/1
|
10.3%
3/29
|
2.4%
8/336
|
4.9%
6/123
|
3.8%
20/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Immune system disorders
HYPERSENSITIVITY
|
5.7%
2/35
|
0.00%
0/1
|
0.00%
0/29
|
0.30%
1/336
|
0.00%
0/123
|
2.1%
11/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/35
|
0.00%
0/1
|
6.9%
2/29
|
0.30%
1/336
|
0.00%
0/123
|
1.3%
7/523
|
0.00%
0/2
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
5.7%
2/35
|
0.00%
0/1
|
10.3%
3/29
|
4.8%
16/336
|
3.3%
4/123
|
5.9%
31/523
|
0.00%
0/2
|
0.00%
0/2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER