Trial Outcomes & Findings for Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis (NCT NCT02224456)
NCT ID: NCT02224456
Last Updated: 2022-02-14
Results Overview
The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules \>2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules \>1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
197 participants
Primary outcome timeframe
Week 240
Results posted on
2022-02-14
Participant Flow
This study was conducted to evaluate the efficacy and safety of 300 milligram (mg) Tenofovir Disoproxil Fumarate (TDF) therapy in Chinese chronic hepatitis B (CHB) participants with advanced fibrosis and compensated cirrhosis
A total of 266 participants were screened, of which 197 entered the study.
Participant milestones
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Overall Study
STARTED
|
197
|
|
Overall Study
COMPLETED
|
161
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Lost to Follow-up
|
15
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Death
|
2
|
|
Overall Study
Pregnancy
|
4
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Treatment Interruptions of ≥28 days
|
1
|
Baseline Characteristics
Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis
Baseline characteristics by cohort
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=195 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Age, Continuous
|
42.3 Years
STANDARD_DEVIATION 9.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
148 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
195 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 240Population: Modified Intent-to-treat (mITT) Population consisted of all recruited participants who received at least one dose of study medication.
The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules \>2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules \>1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=195 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240
|
6.045 Events per person-year
|
PRIMARY outcome
Timeframe: Week 240Population: mITT Population
Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/esophageal varices; 6) hepatocellular carcinoma; 7)liver-related death.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=195 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Percentage of Participants With Disease Progression at Week 240
|
7.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 48, Week 96, Week 144 and Week 192Population: mITT Population
The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules \>2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules \>1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=195 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192
Week 144
|
4 Participants
|
|
Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192
Week 48
|
0 Participants
|
|
Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192
Week 96
|
0 Participants
|
|
Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192
Week 192
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240Population: mITT Population
The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules \>2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules \>1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).The cumulative percentage of participants with newly diagnosed Hepatocellular Carcinoma has been presented along with 95% confidence interval (CI) (Wald method).
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=195 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 48
|
0 Percentage of participants
NA indicates that 95% CI could not be calculated due to insufficient participants with events
|
|
Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 96
|
0 Percentage of participants
NA indicates that 95% CI could not be calculated due to insufficient participants with events
|
|
Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 144
|
2.1 Percentage of participants
Interval 0.0 to 4.3
|
|
Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 192
|
4.6 Percentage of participants
Interval 1.4 to 7.8
|
|
Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 240
|
5.6 Percentage of participants
Interval 2.1 to 9.1
|
SECONDARY outcome
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240Population: mITT Population
Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/oesophageal varices; 6) hepatocellular carcinoma; 7) liver-related death. The cumulative percentage of participants with disease progression has been presented along with 95% CI (Wald method).
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=195 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 48
|
2.1 Percentage of participants
Interval 0.0 to 4.3
|
|
Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 96
|
2.6 Percentage of participants
Interval 0.1 to 5.0
|
|
Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 144
|
4.1 Percentage of participants
Interval 1.1 to 7.1
|
|
Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 192
|
7.2 Percentage of participants
Interval 3.3 to 11.1
|
|
Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 240
|
7.2 Percentage of participants
Interval 3.3 to 11.1
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Week 48, Week 96, Week 144, Week 192 and Week 240Population: mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.
Liver stiffness measure was obtained by a non-invasive transient elastography using FibroScan. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline is defined as post-dose visit value minus Baseline value
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=182 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 48, n=182
|
-3.3 Kilopascals
Standard Deviation 4.84
|
|
Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 96, n= 176
|
-4.7 Kilopascals
Standard Deviation 5.60
|
|
Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 144, n= 175
|
-5.1 Kilopascals
Standard Deviation 5.85
|
|
Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 192, n=167
|
-5.1 Kilopascals
Standard Deviation 7.82
|
|
Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 240, n= 131
|
-6.2 Kilopascals
Standard Deviation 5.55
|
SECONDARY outcome
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240Population: mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.
Serum samples were collected for the analysis of HBV DNA levels using Roche Cobas Taqman HBV test. Confidence interval was calculated by normal approximation and continuity correction method.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=191 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240
Week 48, n=191
|
81.2 Percentage of participants
Interval 75.3 to 87.0
|
|
Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240
Week 96, n=188
|
88.8 Percentage of participants
Interval 84.1 to 93.6
|
|
Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240
Week 144, n=185
|
94.1 Percentage of participants
Interval 90.4 to 97.7
|
|
Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240
Week 192, n=174
|
97.7 Percentage of participants
Interval 95.2 to 100.0
|
|
Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240
Week 240, n=160
|
99.4 Percentage of participants
Interval 97.8 to 100.0
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Week 48, Week 96, Week 144, Week 192 and Week 240Population: mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.
Serum samples were collected for the analysis of HBV DNA levels. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=191 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA
Week 48, n=191
|
-4.2 Log 10 (IU/mL)
Standard Deviation 1.40
|
|
Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA
Week 96, n=188
|
-4.3 Log 10 (IU/mL)
Standard Deviation 1.44
|
|
Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA
Week 144, n=185
|
-4.3 Log 10 (IU/mL)
Standard Deviation 1.48
|
|
Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA
Week 192, n=174
|
-4.2 Log 10 (IU/mL)
Standard Deviation 1.50
|
|
Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA
Week 240, n=160
|
-4.3 Log 10 (IU/mL)
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240Population: mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.
Blood samples were collected for evaluation of ALT at indicated time points. ALT normalization is defined as ALT outside the normal range at Baseline and within the normal range at Week 48, Week 96, Week 144, Week 192 and Week 240. Normal range of ALT is 7 to 56 International Units per liter. Percentage of participants with ALT normalization at Weeks 48, 96, 144, 192 and 240 in participants who had abnormal ALT at Baseline (Day 0) have been presented. Confidence interval was calculated using normal approximation and continuity correction method.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=97 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline
Week 48, n=97
|
63.9 Percentage of participants
Interval 53.8 to 74.0
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline
Week 96, n= 97
|
66.0 Percentage of participants
Interval 56.0 to 75.9
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline
Week 144, n=96
|
70.8 Percentage of participants
Interval 61.2 to 80.4
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline
Week 192, n=93
|
82.8 Percentage of participants
Interval 74.6 to 91.0
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline
Week 240, n=87
|
82.8 Percentage of participants
Interval 74.2 to 91.3
|
SECONDARY outcome
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240Population: mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.)
Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with Positive HBeAg at Baseline (Day 0). It was presented as HBeAg Loss and HBeAg Seroconversion. HBeAg Loss was defined as HBeAg changed to be negative. HBeAg seroconversion was defined as HBeAg changed to negative and HBeAb was positive. Confidence interval was calculated using normal approximation and continuity correction method.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=94 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.
Week 48, HBeAg Loss, n=94
|
18.1 Percentage of participants
Interval 9.8 to 26.4
|
|
Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.
Week 48, HBeAg Seroconversion, n=94
|
9.6 Percentage of participants
Interval 3.1 to 16.1
|
|
Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.
Week 96, HBeAg , n=94
|
33.0 Percentage of participants
Interval 22.9 to 43.0
|
|
Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.
Week 96, HBeAg Seroconversion, n=94
|
14.9 Percentage of participants
Interval 7.2 to 22.6
|
|
Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.
Week 144, HBeAg Loss, n=90
|
35.6 Percentage of participants
Interval 24.5 to 45.1
|
|
Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.
Week 144, HBeAg Seroconversion, n=90
|
14.4 Percentage of participants
Interval 6.5 to 21.8
|
|
Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.
Week 192, HBeAg Loss, n=90
|
47.8 Percentage of participants
Interval 36.4 to 58.1
|
|
Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.
Week 192, HBeAg Seroconversion, n=90
|
16.7 Percentage of participants
Interval 8.3 to 24.7
|
|
Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.
Week 240, HBeAg Loss, n=82
|
51.2 Percentage of participants
Interval 38.7 to 61.3
|
|
Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.
Week 240, HBeAg Seroconversion, n=82
|
23.2 Percentage of participants
Interval 13.1 to 32.2
|
SECONDARY outcome
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240Population: mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.)
Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with negative HBeAg at Baseline (Day 0). HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=97 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 48, HBsAg Loss, n=97
|
1.0 Percentage of Participants
Interval 0.0 to 3.6
|
|
Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 48, HBsAg Seroconversion, n=97
|
1.0 Percentage of Participants
Interval 0.0 to 3.6
|
|
Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 96, HBsAg , n=93
|
0 Percentage of Participants
Interval 0.0 to 0.5
|
|
Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 96, HBsAg Seroconversion, n=93
|
0 Percentage of Participants
Interval 0.0 to 0.5
|
|
Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 144, HBsAg Loss, n=93
|
3.2 Percentage of Participants
Interval 0.0 to 7.4
|
|
Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 144, HBsAg Seroconversion, n=93
|
0 Percentage of Participants
Interval 0.0 to 0.5
|
|
Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 192, HBsAg Loss, n=89
|
4.5 Percentage of Participants
Interval 0.0 to 9.4
|
|
Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 192, HBsAg Seroconversion, n=89
|
2.2 Percentage of Participants
Interval 0.0 to 5.9
|
|
Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 240, HBsAg Loss, n=77
|
5.2 Percentage of Participants
Interval 0.0 to 10.8
|
|
Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240
Week 240, HBsAg Seroconversion, n=77
|
1.3 Percentage of Participants
Interval 0.0 to 4.5
|
SECONDARY outcome
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240Population: mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.)
Viral breakthrough was defined as \>=1 log10 increase in HBV DNA from nadir determined by two sequential HBV DNA measurements. Percentage of Participants who experienced viral breakthrough at Week 48, Week 96, Week 144, Week 192 and Week 240 is presented.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=195 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Percentage of Participants Who Experienced Viral Breakthrough
Week 192, n=180
|
1.1 Percentage of Participants
Interval 0.0 to 2.9
|
|
Percentage of Participants Who Experienced Viral Breakthrough
Week 48, n=195
|
0 Percentage of Participants
NA indicates that 95% CI could not be calculated due to insufficient participants with events
|
|
Percentage of Participants Who Experienced Viral Breakthrough
Week 96, n=195
|
0 Percentage of Participants
NA indicates that 95% CI could not be calculated due to insufficient participants with events
|
|
Percentage of Participants Who Experienced Viral Breakthrough
Week 144, n=185
|
0.5 Percentage of Participants
Interval 0.0 to 1.9
|
|
Percentage of Participants Who Experienced Viral Breakthrough
Week 240, n=161
|
0.6 Percentage of Participants
Interval 0.0 to 2.1
|
SECONDARY outcome
Timeframe: Week 216Population: mITT Population. Only those participants with data available at the specified data points were analyzed
The Knodell scoring system, also called the Histologic Activity Index (HAI), classifies liver biopsy specimens according to scores into 4 categories of histologic features: (I) Periportal or periseptal interface hepatitis (piecemeal necrosis) (scores from 0, 1, 2, 3, 4 or 10); (II) Confluent necrosis (scores from 0, 1, 3, 4, 5, 6 or 10); (III) Focal (spotty) lytic necrosis, apoptosis and focal inflammation (scores from 0, 1, 2, 3, 4 or 10); (IV) Portal inflammation (scores from 0, 1, 2, 3, 4 or 10). Histological improvement is considered as a reduction of two or more points in the Knodell necroinflammatory score with no increase in fibrosis.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=31 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Percentage of Participants With Histological Improvement at Week 216
|
45.2 Percentage of participants
Interval 26.0 to 64.3
|
SECONDARY outcome
Timeframe: Week 216Population: mITT Population. Only those participants with data available at the specified data points were analyzed
Cirrhosis reversal was defined as a reduction of one or more points in the Ishak score with no evidence of cirrhosis. The Ishak liver fibrosis score ranges from 0 indicating no fibrosis to 6 indicating cirrhosis.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=31 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Percentage of Participants With Cirrhosis Reversal at Week 216
|
41.9 Percentage of participants
Interval 23.0 to 60.9
|
SECONDARY outcome
Timeframe: Up to Week 240Population: Safety Analysis Population was defined as all participants who received at least one dose of study medication and have at least one post Baseline safety assessment.
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is defined as AE that occurred on or after the first dose date of study drug. SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events possible drug-induced liver injury with hyperbilirubinemia.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=195 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs
Any TEAEs
|
139 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs
Serious TEAE
|
34 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs
Non-serious TEAE
|
129 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240Population: Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, WBC, lymphocytes, monocytes, neutrophils and platelets. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=191 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 48, WBC, n=191
|
0.02 10^9 cells per liter
Standard Deviation 1.264
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 96, WBC, n=188
|
0.09 10^9 cells per liter
Standard Deviation 1.380
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 144, WBC, n=185
|
-0.12 10^9 cells per liter
Standard Deviation 1.378
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 192, WBC, n=179
|
0.12 10^9 cells per liter
Standard Deviation 1.412
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 240, WBC, n=160
|
0.06 10^9 cells per liter
Standard Deviation 1.434
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 48, Neutrophils, n=191
|
0.08 10^9 cells per liter
Standard Deviation 1.051
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 96, Neutrophils, n=188
|
0.21 10^9 cells per liter
Standard Deviation 1.184
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 144, Neutrophils, n=185
|
0.07 10^9 cells per liter
Standard Deviation 1.162
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 192, Neutrophils, n=179
|
0.26 10^9 cells per liter
Standard Deviation 1.197
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 240, Neutrophils, n=160
|
0.28 10^9 cells per liter
Standard Deviation 1.194
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 48, Lymphocytes, n=191
|
0.00 10^9 cells per liter
Standard Deviation 0.438
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 96, Lymphocytes, n=188
|
-0.06 10^9 cells per liter
Standard Deviation 0.511
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 144, Lymphocytes, n=185
|
-0.13 10^9 cells per liter
Standard Deviation 0.422
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 192, Lymphocytes, n=179
|
-0.10 10^9 cells per liter
Standard Deviation 0.442
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 240, Lymphocytes, n=160
|
-0.15 10^9 cells per liter
Standard Deviation 0.483
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 48, Monocytes, n=191
|
-0.032 10^9 cells per liter
Standard Deviation 0.1056
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 96, Monocytes, n=188
|
-0.033 10^9 cells per liter
Standard Deviation 0.1113
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 144, Monocytes, n=185
|
-0.035 10^9 cells per liter
Standard Deviation 0.1244
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 192, Monocytes, n=179
|
-0.025 10^9 cells per liter
Standard Deviation 0.1162
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 240, Monocytes, n=160
|
-0.005 10^9 cells per liter
Standard Deviation 0.1664
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 48, Eosinophils, n=191
|
-0.02 10^9 cells per liter
Standard Deviation 0.114
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 96, Eosinophils, n=188
|
-0.02 10^9 cells per liter
Standard Deviation 0.164
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 144, Eosinophils, n=185
|
-0.04 10^9 cells per liter
Standard Deviation 0.237
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 192, Eosinophils, n=179
|
-0.03 10^9 cells per liter
Standard Deviation 0.248
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 240, Eosinophils, n=160
|
-0.03 10^9 cells per liter
Standard Deviation 0.251
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 48, Basophils, n=191
|
0.00 10^9 cells per liter
Standard Deviation 0.017
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 96, Basophils, n=188
|
0.00 10^9 cells per liter
Standard Deviation 0.019
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 144, Basophils, n=184
|
0.01 10^9 cells per liter
Standard Deviation 0.025
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 192, Basophils, n=179
|
0.01 10^9 cells per liter
Standard Deviation 0.021
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 240, Basophils, n=160
|
0.01 10^9 cells per liter
Standard Deviation 0.033
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 48, Platelets, n=191
|
7.8 10^9 cells per liter
Standard Deviation 31.45
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 96, Platelets, n=188
|
14.1 10^9 cells per liter
Standard Deviation 32.46
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 144, Platelets, n=185
|
20.6 10^9 cells per liter
Standard Deviation 42.02
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 192, Platelets, n=179
|
25.7 10^9 cells per liter
Standard Deviation 42.56
|
|
Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Week 240, Platelets, n=160
|
26.6 10^9 cells per liter
Standard Deviation 38.39
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240Population: Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze Hb values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=191 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Change From Baseline in Hemoglobin (Hb)
Week 48, n=191
|
-0.6 Grams per liter
Standard Deviation 10.12
|
|
Change From Baseline in Hemoglobin (Hb)
Week 96, n=188
|
0.2 Grams per liter
Standard Deviation 11.63
|
|
Change From Baseline in Hemoglobin (Hb)
Week 144, n=185
|
0.9 Grams per liter
Standard Deviation 11.26
|
|
Change From Baseline in Hemoglobin (Hb)
Week 192, n=179
|
-0.3 Grams per liter
Standard Deviation 12.61
|
|
Change From Baseline in Hemoglobin (Hb)
Week 240, n=160
|
1.2 Grams per liter
Standard Deviation 12.71
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240Population: Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze RBC values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=191 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Change From Baseline in Red Blood Cells (RBC)
Week 48, n=191
|
0.11 Trillion cells per liter
Standard Deviation 0.306
|
|
Change From Baseline in Red Blood Cells (RBC)
Week 96, n=188
|
0.13 Trillion cells per liter
Standard Deviation 0.344
|
|
Change From Baseline in Red Blood Cells (RBC)
Week 144, n=185
|
0.15 Trillion cells per liter
Standard Deviation 0.340
|
|
Change From Baseline in Red Blood Cells (RBC)
Week 192, n=179
|
0.10 Trillion cells per liter
Standard Deviation 0.363
|
|
Change From Baseline in Red Blood Cells (RBC)
Week 240, n=160
|
0.12 Trillion cells per liter
Standard Deviation 0.341
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240Population: Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, CK, LDH. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=191 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 48, ALT, n=190
|
-23.98 Units per liter
Standard Deviation 59.452
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 96, ALT, n=187
|
-28.99 Units per liter
Standard Deviation 56.983
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 144, ALT, n=185
|
-28.99 Units per liter
Standard Deviation 56.983
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 192, ALT, n=178
|
-31.79 Units per liter
Standard Deviation 57.955
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 240, ALT, n=158
|
-32.02 Units per liter
Standard Deviation 63.157
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 48, AST, n=191
|
-14.69 Units per liter
Standard Deviation 36.674
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 96, AST, n=188
|
-17.97 Units per liter
Standard Deviation 36.057
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 144, AST, n=184
|
-18.10 Units per liter
Standard Deviation 36.809
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 192, AST, n=178
|
-19.82 Units per liter
Standard Deviation 36.312
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 240, AST, n=158
|
-20.24 Units per liter
Standard Deviation 43.908
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 48, ALP, n=190
|
10.18 Units per liter
Standard Deviation 20.288
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 96, ALP, n=188
|
2.60 Units per liter
Standard Deviation 28.233
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 144, ALP, n=185
|
-2.20 Units per liter
Standard Deviation 26.555
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 192, ALP, n=177
|
-0.94 Units per liter
Standard Deviation 31.604
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 240, ALP, n=158
|
-4.68 Units per liter
Standard Deviation 27.596
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 48, GGT, n=190
|
-17.88 Units per liter
Standard Deviation 32.753
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 96, GGT, n=188
|
-22.20 Units per liter
Standard Deviation 34.866
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 144, GGT, n=185
|
-24.69 Units per liter
Standard Deviation 39.764
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 192, GGT, n=175
|
-24.07 Units per liter
Standard Deviation 38.609
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 240, GGT, n=152
|
-27.26 Units per liter
Standard Deviation 42.932
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 48 CK, n=188
|
10.51 Units per liter
Standard Deviation 103.515
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 96, CK, n=185
|
16.77 Units per liter
Standard Deviation 141.961
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 144, CK, n=182
|
5.96 Units per liter
Standard Deviation 101.897
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 192, CK, n=173
|
13.72 Units per liter
Standard Deviation 106.986
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 240, CK, n=156
|
2.79 Units per liter
Standard Deviation 105.349
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 48, LDH, n=187
|
-10.62 Units per liter
Standard Deviation 52.851
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 96, LDH, n=185
|
-10.21 Units per liter
Standard Deviation 48.112
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 144, LDH, n=180
|
3.34 Units per liter
Standard Deviation 73.047
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 192, LDH, n=172
|
-18.45 Units per liter
Standard Deviation 87.931
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Week 240, LDH, n=155
|
25.79 Units per liter
Standard Deviation 87.464
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240Population: Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the chemistry parameters: total billirubin,direct bilirubin and serum creatinine. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=191 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine
Week 48, total bilirubin, n=191
|
-1.485 Micromoles per liter
Standard Deviation 7.1347
|
|
Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine
Week 96, total bilirubin, n=188
|
-1.823 Micromoles per liter
Standard Deviation 6.7167
|
|
Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine
Week 144, total bilirubin, n=185
|
-2.665 Micromoles per liter
Standard Deviation 7.1281
|
|
Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine
Week 192, total bilirubin, n=177
|
-2.791 Micromoles per liter
Standard Deviation 6.9230
|
|
Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine
Week 240, total bilirubin, n=158
|
-1.772 Micromoles per liter
Standard Deviation 6.9786
|
|
Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine
Week 48, direct bilirubin, n=191
|
-0.296 Micromoles per liter
Standard Deviation 3.1229
|
|
Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine
Week 96, direct bilirubin, n=188
|
-0.462 Micromoles per liter
Standard Deviation 3.1875
|
|
Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine
Week 144, direct bilirubin, n=185
|
-0.713 Micromoles per liter
Standard Deviation 3.4898
|
|
Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine
Week 192, direct bilirubin, n=178
|
-0.780 Micromoles per liter
Standard Deviation 3.5942
|
|
Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine
Week 240, direct bilirubin, n=157
|
-0.599 Micromoles per liter
Standard Deviation 3.5608
|
|
Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine
Week 48, serum creatinine, n=191
|
1.03 Micromoles per liter
Standard Deviation 7.020
|
|
Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine
Week 96, serum creatinine, n=188
|
1.10 Micromoles per liter
Standard Deviation 7.597
|
|
Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine
Week 144, serum creatinine, n=184
|
0.76 Micromoles per liter
Standard Deviation 9.122
|
|
Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine
Week 192, serum creatinine, n=178
|
1.37 Micromoles per liter
Standard Deviation 8.591
|
|
Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine
Week 240, serum creatinine, n=159
|
1.35 Micromoles per liter
Standard Deviation 9.879
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240Population: Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=191 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Change From Baseline in Chemistry Parameters: Albumin and Total Protein
Week 48, albumin, n=191
|
1.06 Grams per liter
Standard Deviation 3.063
|
|
Change From Baseline in Chemistry Parameters: Albumin and Total Protein
Week 96, albumin, n=188
|
1.23 Grams per liter
Standard Deviation 3.313
|
|
Change From Baseline in Chemistry Parameters: Albumin and Total Protein
Week 144, albumin, n=185
|
1.86 Grams per liter
Standard Deviation 3.675
|
|
Change From Baseline in Chemistry Parameters: Albumin and Total Protein
Week 192, albumin, n=175
|
1.65 Grams per liter
Standard Deviation 3.780
|
|
Change From Baseline in Chemistry Parameters: Albumin and Total Protein
Week 240, albumin, n=158
|
1.81 Grams per liter
Standard Deviation 3.790
|
|
Change From Baseline in Chemistry Parameters: Albumin and Total Protein
Week 48, total protein, n=191
|
-1.01 Grams per liter
Standard Deviation 5.273
|
|
Change From Baseline in Chemistry Parameters: Albumin and Total Protein
Week 96, total protein, n=188
|
-0.21 Grams per liter
Standard Deviation 5.397
|
|
Change From Baseline in Chemistry Parameters: Albumin and Total Protein
Week 144, total protein, n=185
|
0.27 Grams per liter
Standard Deviation 5.065
|
|
Change From Baseline in Chemistry Parameters: Albumin and Total Protein
Week 192, total protein, n=175
|
-0.94 Grams per liter
Standard Deviation 5.175
|
|
Change From Baseline in Chemistry Parameters: Albumin and Total Protein
Week 240, total protein, n=158
|
-1.61 Grams per liter
Standard Deviation 5.829
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240Population: Safety analysis population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the chemistry parameters: BUN, potassium, sodium, chloridion, phosphorus,calcium and fasting blood glucose. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=191 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 48, BUN, n=191
|
-0.046 Millimoles per liter
Standard Deviation 1.1067
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 96, BUN, n=188
|
0.000 Millimoles per liter
Standard Deviation 1.1875
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 144, BUN, n=184
|
0.037 Millimoles per liter
Standard Deviation 1.0892
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 192, BUN, n=178
|
0.143 Millimoles per liter
Standard Deviation 1.1234
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 240, BUN, n=155
|
0.131 Millimoles per liter
Standard Deviation 1.1358
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 48, Potassium, n=191
|
-0.001 Millimoles per liter
Standard Deviation 0.3703
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 96, Potassium, n=186
|
0.002 Millimoles per liter
Standard Deviation 0.3230
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 144, Potassium, n=184
|
-0.039 Millimoles per liter
Standard Deviation 0.3871
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 192, Potassium, n=178
|
0.015 Millimoles per liter
Standard Deviation 0.4223
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 240, Potassium, n=158
|
-0.013 Millimoles per liter
Standard Deviation 0.3946
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 48, Sodium, n=191
|
0.21 Millimoles per liter
Standard Deviation 3.495
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 96, Sodium, n=186
|
-0.02 Millimoles per liter
Standard Deviation 3.121
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 144, Sodium, n=184
|
0.35 Millimoles per liter
Standard Deviation 2.730
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 192, Sodium, n=178
|
0.38 Millimoles per liter
Standard Deviation 2.998
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 240, Sodium, n=158
|
-0.13 Millimoles per liter
Standard Deviation 2.707
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 48, Chloridion, n=191
|
-0.13 Millimoles per liter
Standard Deviation 3.600
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 96, Chloridion, n=186
|
0.40 Millimoles per liter
Standard Deviation 3.535
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 144, Chloridion, n=183
|
0.35 Millimoles per liter
Standard Deviation 3.492
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 192, Chloridion, n=178
|
0.77 Millimoles per liter
Standard Deviation 3.142
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 240, Chloridion, n=158
|
0.49 Millimoles per liter
Standard Deviation 3.364
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 48, Phosphorus, n=190
|
-0.044 Millimoles per liter
Standard Deviation 0.1724
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 96, Phosphorus, n=187
|
-0.038 Millimoles per liter
Standard Deviation 0.1632
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 144, Phosphorus, n=184
|
-0.037 Millimoles per liter
Standard Deviation 0.1955
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 192, Phosphorus, n=175
|
-0.059 Millimoles per liter
Standard Deviation 0.1876
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 240, Phosphorus, n=159
|
-0.042 Millimoles per liter
Standard Deviation 0.2009
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 48, Calcium, n=190
|
-0.023 Millimoles per liter
Standard Deviation 0.1513
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 96, Calcium, n=187
|
-0.006 Millimoles per liter
Standard Deviation 0.1652
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 144, Calcium, n=184
|
-0.022 Millimoles per liter
Standard Deviation 0.1605
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 192, Calcium, n=178
|
-0.004 Millimoles per liter
Standard Deviation 0.1470
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 240, Calcium, n=158
|
-0.006 Millimoles per liter
Standard Deviation 0.1558
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 48, Fasting Blood Glucose, n=191
|
-0.162 Millimoles per liter
Standard Deviation 0.7154
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 96, Fasting Blood Glucose, n=188
|
-0.109 Millimoles per liter
Standard Deviation 0.7139
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 144, Fasting Blood Glucose, n=185
|
-0.094 Millimoles per liter
Standard Deviation 0.8979
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 192, Fasting Blood Glucose, n=177
|
-0.052 Millimoles per liter
Standard Deviation 0.7548
|
|
Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Week 240, Fasting Blood Glucose, n=158
|
0.052 Millimoles per liter
Standard Deviation 1.2197
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240Population: Safety analysis population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the chemistry parameters: creatinine clearance rate. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=190 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate
Week 48, n=190
|
-3.064 Milliliter per minute (mL/min)
Standard Deviation 11.5995
|
|
Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate
Week 96, n=188
|
-4.214 Milliliter per minute (mL/min)
Standard Deviation 12.7883
|
|
Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate
Week 144, n=184
|
-4.324 Milliliter per minute (mL/min)
Standard Deviation 15.3937
|
|
Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate
Week 192, n=177
|
-6.599 Milliliter per minute (mL/min)
Standard Deviation 13.8858
|
|
Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate
Week 240, n=155
|
-6.658 Milliliter per minute (mL/min)
Standard Deviation 16.5351
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240Population: Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the chemistry parameters: eGFR. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=191 Participants
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)
Week 48, n=191
|
-0.86 mL/minute per 1.73 square meter
Standard Deviation 6.581
|
|
Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)
Week 96, n=188
|
-0.87 mL/minute per 1.73 square meter
Standard Deviation 7.078
|
|
Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)
Week 144, n=185
|
-0.68 mL/minute per 1.73 square meter
Standard Deviation 8.368
|
|
Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)
Week 192, n=180
|
-1.06 mL/minute per 1.73 square meter
Standard Deviation 8.442
|
|
Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)
Week 240, n=161
|
-1.42 mL/minute per 1.73 square meter
Standard Deviation 9.609
|
Adverse Events
Tenofovir Disoproxil Fumarate 300 mg
Serious events: 34 serious events
Other events: 129 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=195 participants at risk
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
6.7%
13/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Bile duct stone
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Cholecystitis
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Pneumonia
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Upper respiratory tract infection
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Rheumatic fever
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis hypertrophic
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Reproductive system and breast disorders
Uterine adhesions
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Blood and lymphatic system disorders
Hypersplenism
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Cardiac disorders
Rheumatic heart disease
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Chest X-ray abnormal
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
Other adverse events
| Measure |
Tenofovir Disoproxil Fumarate 300 mg
n=195 participants at risk
Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
18.5%
36/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Urinary tract infection
|
5.6%
11/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
3/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Pharyngitis
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Pneumonia
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Pulmonary tuberculosis
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Urethritis
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Rhinitis
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Myringitis
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Herpes virus infection
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Tonsillitis bacterial
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Infections and infestations
Vaginal infection
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Ascites
|
3.1%
6/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Toothache
|
2.6%
5/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
4/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
3/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
3/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Gastritis
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Abdominal distension
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Flatulence
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Chronic gastritis
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Nausea
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Abdominal mass
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Dysbacteriosis
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Duodenitis
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Dental caries
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Constipation
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Colitis
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Vomiting
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Blood creatine phosphokinase increased
|
4.6%
9/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Protein urine present
|
2.1%
4/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Blood phosphorus decreased
|
1.5%
3/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Alpha 1 foetoprotein increased
|
1.5%
3/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Blood urine present
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Weight decreased
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Blood uric acid increased
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Blood glucose increased
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
White blood cell count decreased
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Red blood cells urine positive
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Platelet count decreased
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Neutrophil count decreased
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Hepatitis B DNA increased
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Glomerular filtration rate decreased
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Creatinine renal clearance decreased
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Blood urine
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Aspartate aminotransferase increased
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Alanine aminotransferase increased
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.7%
15/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.6%
7/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Blood and lymphatic system disorders
Anaemia
|
4.6%
9/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.6%
5/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Hepatic pain
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Liver injury
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Cholecystitis
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.5%
3/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Renal and urinary disorders
Renal impairment
|
1.5%
3/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Renal and urinary disorders
Proteinuria
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Renal and urinary disorders
Haematuria
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Renal and urinary disorders
Renal injury
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Renal and urinary disorders
Renal cyst
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
4/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Animal bite
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.5%
3/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
3/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Skin and subcutaneous tissue disorders
Leukoderma
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Nervous system disorders
Dizziness
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Nervous system disorders
Migraine
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Nervous system disorders
Headache
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Nervous system disorders
Hypoaesthesia
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Reproductive system and breast disorders
Menstruation irregular
|
1.0%
2/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Reproductive system and breast disorders
Uterine enlargement
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Reproductive system and breast disorders
Breast hyperplasia
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Vascular disorders
Hypertension
|
2.6%
5/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
General disorders
Pyrexia
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
General disorders
Fatigue
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
General disorders
Chest pain
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Psychiatric disorders
Sleep disorder
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Psychiatric disorders
Depression
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Psychiatric disorders
Insomnia
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Eye disorders
Vitreous floaters
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Eye disorders
Retinal vein occlusion
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Ear and labyrinth disorders
Tinnitus
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Cardiac disorders
Bradycardia
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Immune system disorders
Hypersensitivity
|
0.51%
1/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Investigations
Transaminases increased
|
1.5%
3/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.5%
3/195 • All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.
Safety analysis population was used to collect the adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER