Trial Outcomes & Findings for Treatment of Persistent Viremia (Virus in Blood) in Chronic Hepatitis B Subjects Already Receiving Adefovir Dipivoxil (NCT NCT00307489)
NCT ID: NCT00307489
Last Updated: 2011-11-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
106 participants
Primary outcome timeframe
48 weeks
Results posted on
2011-11-01
Participant Flow
A total of 106 subjects were randomized (105 of which were subsequently treated) across 28 study centers in the US, Germany, France and Spain between 24 April 2006 and 07 March 2007.
Participant milestones
| Measure |
Tenofovir DF
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Baseline Through Week 48
STARTED
|
53
|
52
|
|
Baseline Through Week 48
COMPLETED
|
52
|
50
|
|
Baseline Through Week 48
NOT COMPLETED
|
1
|
2
|
|
Week 48 Through Week 168
STARTED
|
52
|
50
|
|
Week 48 Through Week 168
COMPLETED
|
46
|
44
|
|
Week 48 Through Week 168
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Tenofovir DF
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Baseline Through Week 48
Lost to Follow-up
|
0
|
1
|
|
Baseline Through Week 48
Physician Decision
|
1
|
0
|
|
Baseline Through Week 48
Withdrawal by Subject
|
0
|
1
|
|
Week 48 Through Week 168
Adverse Event
|
1
|
0
|
|
Week 48 Through Week 168
Physician Decision
|
1
|
0
|
|
Week 48 Through Week 168
Withdrawal by Subject
|
1
|
2
|
|
Week 48 Through Week 168
Lack of Efficacy
|
2
|
2
|
|
Week 48 Through Week 168
Death
|
0
|
1
|
|
Week 48 Through Week 168
Lost to Follow-up
|
0
|
1
|
|
Week 48 Through Week 168
Seroconversion
|
1
|
0
|
Baseline Characteristics
Treatment of Persistent Viremia (Virus in Blood) in Chronic Hepatitis B Subjects Already Receiving Adefovir Dipivoxil
Baseline characteristics by cohort
| Measure |
Tenofovir DF
n=53 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=52 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
40 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
39 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
39 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
26 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Previous Lamivudine Experience
Yes
|
30 participants
n=5 Participants
|
31 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Previous Lamivudine Experience
No
|
23 participants
n=5 Participants
|
21 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Baseline HBV DNA
|
6.06 log10 copies/mL
STANDARD_DEVIATION 1.430 • n=5 Participants
|
5.87 log10 copies/mL
STANDARD_DEVIATION 1.779 • n=7 Participants
|
5.97 log10 copies/mL
STANDARD_DEVIATION 1.607 • n=5 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Randomized and Treated (RAT) subjects at Week 48 - Non-Completers=Failure (ie, includes subjects who switched to open-label FTC/TDF at or after Week 24)
Outcome measures
| Measure |
Tenofovir DF
n=53 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=52 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 48
|
75.5 percentage of participants
|
69.2 percentage of participants
|
PRIMARY outcome
Timeframe: 48 WeeksPopulation: RAT Analysis Set Non-Completers=Failure
Outcome measures
| Measure |
Tenofovir DF
n=53 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=52 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48
|
81.1 percentage of participants
|
80.8 percentage of participants
|
SECONDARY outcome
Timeframe: 48 WeeksPopulation: RAT Analysis Set
Outcome measures
| Measure |
Tenofovir DF
n=52 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=50 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Change From Baseline in log10 Plasma HBV DNA Levels at Week 48
|
-3.58 log10 copies/mL
Standard Deviation 1.290
|
-3.34 log10 copies/mL
Standard Deviation 1.753
|
SECONDARY outcome
Timeframe: 48 WeeksPopulation: RAT Analysis Set
Outcome measures
| Measure |
Tenofovir DF
n=50 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=50 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 48
|
-21.6 U/mL
Standard Deviation 54.53
|
-41.4 U/mL
Standard Deviation 151.67
|
SECONDARY outcome
Timeframe: 48 WeeksPopulation: RAT Analysis Set Non-Completers=Failure
ULN for males = 43 U/L; 34 U/L for females
Outcome measures
| Measure |
Tenofovir DF
n=51 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=52 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Percentage of Participants With Normal ALT at Week 48
|
66.7 percentage of participants
|
73.1 percentage of participants
|
SECONDARY outcome
Timeframe: 48 WeeksPopulation: RAT Analysis Set - subjects with ALT above ULN at baseline. Non-Completers=Failure
Subjects with elevated ALT at baseline that return to normal by Week 48.
Outcome measures
| Measure |
Tenofovir DF
n=27 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=26 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Percentage of Participants With Normalized ALT at Week 48
|
40.7 percentage of participants
|
61.5 percentage of participants
|
SECONDARY outcome
Timeframe: 48 WeeksPopulation: RAT Analysis Set with Positive HBeAg at Baseline. Non-Completers=Failure
Defined as having negative serum HBeAg for subjects with positive HBeAg at baseline.
Outcome measures
| Measure |
Tenofovir DF
n=38 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=39 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Hepatitis B Early Antigen (HBeAg) Loss at Week 48
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 48 WeeksPopulation: RAT Analysis Set with Positive Baseline HBeAg. Non-Completers=Failure
Defined as having negative serum HBeAg and positive serum antibody to HBeAg \[anti-HBe\] for subjects with positive serum HBeAg at baseline.
Outcome measures
| Measure |
Tenofovir DF
n=38 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=39 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
HBeAg Seroconversion at Week 48
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 48 WeeksPopulation: RAT Analysis Set Non-Completers=Failure
Defined as having negative serum HBsAg for subjects with positive HBsAg at baseline.
Outcome measures
| Measure |
Tenofovir DF
n=53 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=51 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
HBsAg Loss at Week 48
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 48 WeeksPopulation: RAT Analysis Set Non-Completers=Failure
Defined as having negative serum HBsAg and positive serum antibody to HBsAg \[anti-HBs\] for subject with positive serum HBsAg at baseline.
Outcome measures
| Measure |
Tenofovir DF
n=53 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=51 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 48
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 168 weeksPopulation: Non-completers = failure analysis
Outcome measures
| Measure |
Tenofovir DF
n=53 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=52 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Change From Baseline in log10 Plasma HBV DNA Levels at Week 168
|
-3.79 log10 copies/mL
Standard Deviation 1.305
|
-3.48 log10 copies/mL
Standard Deviation 1.629
|
SECONDARY outcome
Timeframe: 168 weeksPopulation: Non-completers = failure analysis
Outcome measures
| Measure |
Tenofovir DF
n=53 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=52 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 168
|
-26.8 U/mL
Standard Deviation 60.23
|
-54.5 U/mL
Standard Deviation 141.63
|
SECONDARY outcome
Timeframe: 168 weeksPopulation: Non-completers = failure analysis
Outcome measures
| Measure |
Tenofovir DF
n=53 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=52 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168
|
82.4 Percent of Participants
|
84.0 Percent of Participants
|
SECONDARY outcome
Timeframe: 168 weeksPopulation: Non-completers = failure analysis
ULN for males = 43 U/L; ULN for females = 34 U/L
Outcome measures
| Measure |
Tenofovir DF
n=50 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=50 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Percentage of Participants With Normal ALT at Week 168
|
74.0 Percent of Participants
|
74.0 Percent of Participants
|
SECONDARY outcome
Timeframe: 168 weeksSubjects with elevated ALT at baseline that return to normal by Week 48.
Outcome measures
| Measure |
Tenofovir DF
n=25 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=24 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Percentage of Participants With Normalized ALT at Week 168
|
68.0 Percent of Participants
|
70.8 Percent of Participants
|
SECONDARY outcome
Timeframe: 168 weeksPopulation: Non-completer = Failure Analysis
Defined as having negative serum HBeAg for subjecst with positive HBeAg at baseline.
Outcome measures
| Measure |
Tenofovir DF
n=37 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=37 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Hepatitis B Early Antigen (HBeAg) Loss at Week 168
|
21.6 Percent of Participants
|
24.3 Percent of Participants
|
SECONDARY outcome
Timeframe: 168 weeksPopulation: Non-completer = Failure Analysis
Defined as having negative serum BHsAg and positive serum antibody to HBsAg (anti-HBs) for subject with positive serum BHsAg at baseline.
Outcome measures
| Measure |
Tenofovir DF
n=51 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=51 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 168
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 168 weeksDefined as having negative serum HBsAg for subjects with positive HBsAg at baseline.
Outcome measures
| Measure |
Tenofovir DF
n=51 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=51 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
HBsAg Loss at Week 168
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 168 weeksPopulation: Non-completers = failure analysis
P-values were from a Cochran-Mantel-Haenszel test, controlling for baseline HBeAg status and prior lamivudine use.
Outcome measures
| Measure |
Tenofovir DF
n=51 Participants
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
n=50 Participants
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 168
|
80.4 Percent of Participants
|
78.0 Percent of Participants
|
Adverse Events
Tenofovir DF
Serious events: 6 serious events
Other events: 49 other events
Deaths: 0 deaths
Emtricitibine/Tenofovir DF
Serious events: 10 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tenofovir DF
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/53 • 168 weeks
|
3.8%
2/52 • 168 weeks
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
1/53 • 168 weeks
|
0.00%
0/52 • 168 weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
Reproductive system and breast disorders
Bartholinitis
|
0.00%
0/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
Nervous system disorders
Carotid Arteriosclerosis
|
1.9%
1/53 • 168 weeks
|
0.00%
0/52 • 168 weeks
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
General disorders
Chest Pain
|
1.9%
1/53 • 168 weeks
|
0.00%
0/52 • 168 weeks
|
|
Infections and infestations
Chronic Sinusitis
|
0.00%
0/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.9%
1/53 • 168 weeks
|
0.00%
0/52 • 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
1/53 • 168 weeks
|
0.00%
0/52 • 168 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of Breast
|
0.00%
0/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
Infections and infestations
Gastroenteritis
|
1.9%
1/53 • 168 weeks
|
0.00%
0/52 • 168 weeks
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
General disorders
Oedema Peripheral
|
1.9%
1/53 • 168 weeks
|
0.00%
0/52 • 168 weeks
|
|
Nervous system disorders
Pain
|
0.00%
0/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Waldenstrom's Macroglobulinaemia
|
1.9%
1/53 • 168 weeks
|
0.00%
0/52 • 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
Other adverse events
| Measure |
Tenofovir DF
tenofovir DF 300 mg QD
|
Emtricitibine/Tenofovir DF
emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
9.4%
5/53 • 168 weeks
|
9.6%
5/52 • 168 weeks
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
15.1%
8/53 • 168 weeks
|
17.3%
9/52 • 168 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.7%
3/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
5.7%
3/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
2/53 • 168 weeks
|
9.6%
5/52 • 168 weeks
|
|
General disorders
Asthenia
|
13.2%
7/53 • 168 weeks
|
3.8%
2/52 • 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
17.0%
9/53 • 168 weeks
|
11.5%
6/52 • 168 weeks
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/53 • 168 weeks
|
7.7%
4/52 • 168 weeks
|
|
Infections and infestations
Bronchitis
|
5.7%
3/53 • 168 weeks
|
13.5%
7/52 • 168 weeks
|
|
Gastrointestinal disorders
Constipation
|
3.8%
2/53 • 168 weeks
|
5.8%
3/52 • 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
3/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.7%
3/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
Psychiatric disorders
Depression
|
1.9%
1/53 • 168 weeks
|
5.8%
3/52 • 168 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
9.4%
5/53 • 168 weeks
|
5.8%
3/52 • 168 weeks
|
|
Nervous system disorders
Dizziness
|
7.5%
4/53 • 168 weeks
|
7.7%
4/52 • 168 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
7.5%
4/53 • 168 weeks
|
3.8%
2/52 • 168 weeks
|
|
General disorders
Fatigue
|
17.0%
9/53 • 168 weeks
|
17.3%
9/52 • 168 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.7%
3/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
Nervous system disorders
Headache
|
28.3%
15/53 • 168 weeks
|
19.2%
10/52 • 168 weeks
|
|
Infections and infestations
Influenza
|
5.7%
3/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
Psychiatric disorders
Insomnia
|
1.9%
1/53 • 168 weeks
|
5.8%
3/52 • 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.7%
3/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
|
Infections and infestations
Nasopharyngitis
|
30.2%
16/53 • 168 weeks
|
23.1%
12/52 • 168 weeks
|
|
Gastrointestinal disorders
Nausea
|
9.4%
5/53 • 168 weeks
|
3.8%
2/52 • 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
3.8%
2/53 • 168 weeks
|
7.7%
4/52 • 168 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/53 • 168 weeks
|
5.8%
3/52 • 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
15.1%
8/53 • 168 weeks
|
5.8%
3/52 • 168 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.7%
3/53 • 168 weeks
|
3.8%
2/52 • 168 weeks
|
|
Immune system disorders
Seasonal allergy
|
3.8%
2/53 • 168 weeks
|
5.8%
3/52 • 168 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
1/53 • 168 weeks
|
5.8%
3/52 • 168 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
9.4%
5/53 • 168 weeks
|
7.7%
4/52 • 168 weeks
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/53 • 168 weeks
|
5.8%
3/52 • 168 weeks
|
|
Gastrointestinal disorders
Gastroenteritis
|
5.7%
3/53 • 168 weeks
|
1.9%
1/52 • 168 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place