Trial Outcomes & Findings for Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B (NCT NCT01369212)
NCT ID: NCT01369212
Last Updated: 2023-04-28
Results Overview
Estimated percent of participants who became HBsAg negative by week 240 from randomization
COMPLETED
PHASE3
201 participants
Week 240
2023-04-28
Participant Flow
Participant milestones
| Measure |
Tenofovir
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
99
|
|
Overall Study
COMPLETED
|
95
|
92
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Height data was missing for one participant
Baseline characteristics by cohort
| Measure |
Tenofovir
n=102 Participants
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=99 Participants
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41 years
n=102 Participants
|
41 years
n=99 Participants
|
41 years
n=201 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=102 Participants
|
40 Participants
n=99 Participants
|
71 Participants
n=201 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=102 Participants
|
59 Participants
n=99 Participants
|
130 Participants
n=201 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=102 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=201 Participants
|
|
Race (NIH/OMB)
Asian
|
80 Participants
n=102 Participants
|
85 Participants
n=99 Participants
|
165 Participants
n=201 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=102 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=201 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=102 Participants
|
7 Participants
n=99 Participants
|
16 Participants
n=201 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=102 Participants
|
7 Participants
n=99 Participants
|
16 Participants
n=201 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=102 Participants
|
0 Participants
n=99 Participants
|
2 Participants
n=201 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=102 Participants
|
0 Participants
n=99 Participants
|
2 Participants
n=201 Participants
|
|
Region of Enrollment
Canada
|
21 Participants
n=102 Participants
|
22 Participants
n=99 Participants
|
43 Participants
n=201 Participants
|
|
Region of Enrollment
United States
|
81 Participants
n=102 Participants
|
77 Participants
n=99 Participants
|
158 Participants
n=201 Participants
|
|
Body Mass Index
|
25 kg/m^2
n=101 Participants • Height data was missing for one participant
|
24 kg/m^2
n=99 Participants • Height data was missing for one participant
|
24 kg/m^2
n=200 Participants • Height data was missing for one participant
|
|
HBeAg Positive
|
54 Participants
n=102 Participants
|
50 Participants
n=99 Participants
|
104 Participants
n=201 Participants
|
|
Quantitative HBeAg (qHBeAg) level
|
3.0 log10 IU/mL
n=54 Participants • qHBeAg is measured only among HBeAg positive participants. One person in the Tenofovir group did not have this data
|
2.6 log10 IU/mL
n=49 Participants • qHBeAg is measured only among HBeAg positive participants. One person in the Tenofovir group did not have this data
|
2.9 log10 IU/mL
n=103 Participants • qHBeAg is measured only among HBeAg positive participants. One person in the Tenofovir group did not have this data
|
|
Hepatitis B Virus (HBV) Genotype
A1
|
8 Participants
n=102 Participants
|
4 Participants
n=99 Participants
|
12 Participants
n=201 Participants
|
|
Hepatitis B Virus (HBV) Genotype
A2
|
7 Participants
n=102 Participants
|
5 Participants
n=99 Participants
|
12 Participants
n=201 Participants
|
|
Hepatitis B Virus (HBV) Genotype
B
|
37 Participants
n=102 Participants
|
50 Participants
n=99 Participants
|
87 Participants
n=201 Participants
|
|
Hepatitis B Virus (HBV) Genotype
C
|
32 Participants
n=102 Participants
|
36 Participants
n=99 Participants
|
68 Participants
n=201 Participants
|
|
Hepatitis B Virus (HBV) Genotype
D
|
12 Participants
n=102 Participants
|
1 Participants
n=99 Participants
|
13 Participants
n=201 Participants
|
|
Hepatitis B Virus (HBV) Genotype
E
|
5 Participants
n=102 Participants
|
3 Participants
n=99 Participants
|
8 Participants
n=201 Participants
|
|
Hepatitis B Virus (HBV) Genotype
F
|
1 Participants
n=102 Participants
|
0 Participants
n=99 Participants
|
1 Participants
n=201 Participants
|
|
HBV DNA
|
6.7 log10 IU/mL
n=102 Participants
|
6.3 log10 IU/mL
n=99 Participants
|
6.5 log10 IU/mL
n=201 Participants
|
|
Quantitative HBsAg level
|
3.9 log10 IU/mL
n=102 Participants
|
3.6 log10 IU/mL
n=99 Participants
|
3.8 log10 IU/mL
n=201 Participants
|
|
ALT
|
81 U/L
n=102 Participants
|
71 U/L
n=99 Participants
|
75 U/L
n=201 Participants
|
|
Platelet Count
|
192 cells X 10^3/mm^3
n=102 Participants
|
196 cells X 10^3/mm^3
n=99 Participants
|
193 cells X 10^3/mm^3
n=201 Participants
|
|
Total Bilirubin
|
0.6 mg/dL
n=102 Participants
|
0.7 mg/dL
n=99 Participants
|
0.6 mg/dL
n=201 Participants
|
|
White Cell Count
|
5.6 cells X 10^3/mm^3
n=102 Participants
|
5.2 cells X 10^3/mm^3
n=99 Participants
|
5.3 cells X 10^3/mm^3
n=201 Participants
|
|
Hemoglobin
|
14.8 g/dL
n=102 Participants
|
14.5 g/dL
n=99 Participants
|
14.6 g/dL
n=201 Participants
|
|
Creatinine clearance
|
106 mL/min/1.73m2
n=102 Participants
|
96 mL/min/1.73m2
n=99 Participants
|
101 mL/min/1.73m2
n=201 Participants
|
|
Albumin
|
4.2 g/dL
n=101 Participants • One participant missing albumin levels
|
4.3 g/dL
n=99 Participants • One participant missing albumin levels
|
4.3 g/dL
n=200 Participants • One participant missing albumin levels
|
|
Necroinflammatory Activity (HAI>= 3)
|
97 Participants
n=102 Participants
|
96 Participants
n=99 Participants
|
193 Participants
n=201 Participants
|
|
Bridiging Fibrosis or Cirrhosis (Ishak score 5-6)
|
7 Participants
n=102 Participants
|
7 Participants
n=99 Participants
|
14 Participants
n=201 Participants
|
PRIMARY outcome
Timeframe: Week 240Population: This outcome is analyzed as a survival outcome with proportion estimated at week 240 using Kaplan-Meier Method
Estimated percent of participants who became HBsAg negative by week 240 from randomization
Outcome measures
| Measure |
Tenofovir
n=102 Participants
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=99 Participants
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Percent of Participants With Hepatitis B Surface Antigen (HBsAg) Loss by Week 240
|
4.1 Percentage of participants
|
5.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 192Cumulative percentage of participants with HBsAg loss at week 192 estimated using Kaplan-Meier method
Outcome measures
| Measure |
Tenofovir
n=102 Participants
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=99 Participants
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Cumulative Percent of Participants With HBsAg Loss at Week 192
|
1.0 Cumulative percentage of participants
|
5.2 Cumulative percentage of participants
|
SECONDARY outcome
Timeframe: Up to 240 weeksPopulation: All randomized participants
Number of participants with at least one serious adverse event between randomization and week 240
Outcome measures
| Measure |
Tenofovir
n=102 Participants
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=99 Participants
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Number of Participants With Serious Adverse Events
|
11 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: up to 240 weeksPopulation: All randomized participants
Number of participants with at least one adverse event between randomization and week 240
Outcome measures
| Measure |
Tenofovir
n=102 Participants
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=99 Participants
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Number of Participants With Adverse Events
|
50 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: week 192Population: Among HBeAg positive participants at baseline who had HBeAg data available at week 192
Number of participants who became Hepatitis B e antigen (HBeAg) negative at week 192 among HBeAg positive participants at randomization (baseline)
Outcome measures
| Measure |
Tenofovir
n=51 Participants
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=47 Participants
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 192
|
14 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: week 240Population: Participants who were HBeAg positive at baseline and who had data for HBeAg at week 240 visit
Number of participants who became HBeAg negative at week 240 among HBeAg positive participants at baseline
Outcome measures
| Measure |
Tenofovir
n=49 Participants
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=45 Participants
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Number of Participants With HBeAg Loss at Week 240
|
19 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: week 192Population: Participants with data on HBsAg and anti-HBs at week 192
Number of participants who became with HBsAg negative and developed anti-HBs at week 192
Outcome measures
| Measure |
Tenofovir
n=96 Participants
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=92 Participants
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Number of Participants With HBsAg Seroconversion at Week 192
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: week 240Population: HBsAg and antiHBs data at week 240
Number of participants who became HBsAg negative and developed anti-HBs at week 240
Outcome measures
| Measure |
Tenofovir
n=91 Participants
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=89 Participants
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Number of Participants With HBsAg Seroconversion at Week 240
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: week 192Population: HBeAg positives at baseline with HBeAg and anti-HBe data available at week 192
Number of participants who became HBeAg negative and developed anti-HBe at week 192 among HBeAg positive participants at baseline
Outcome measures
| Measure |
Tenofovir
n=51 Participants
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=47 Participants
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Number of Participants With HBeAg Seroconversion at Week 192
|
8 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: week 240Population: HBeAg positive participants at baseline with HBeAg and anti-HBe data at week 240
Number of participants who became HBeAg negative and developed anti-HBe at week 240 among HBeAg positive participants at baseline
Outcome measures
| Measure |
Tenofovir
n=49 Participants
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=45 Participants
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Number of Participants With HBeAg Seroconversion at Week 240
|
14 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: week 192Population: Participants with ALT data at week 192
Number of participants with normal alanine transaminase (ALT) levels at week 192 (Normal ALT for males ≤30 U/L, for females ≤20 U/L)
Outcome measures
| Measure |
Tenofovir
n=96 Participants
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=91 Participants
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Number of Participants With Normal Alanine Transaminase (ALT) Levels at Week 192
|
37 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: week 240Population: Participants with ALT data at week 240
Number of participants with normal alanine transaminase (ALT) levels \[males ≤30 U/L, for females ≤20 U/L\] at week 240
Outcome measures
| Measure |
Tenofovir
n=92 Participants
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=89 Participants
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Number of Participants With Normal Alanine Transaminase (ALT) Levels at Week 240
|
38 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: week 192Population: Participants with HBV DNA data at week 192
Number of participants with HBV DNA \<1000 IU/mL at week 192
Outcome measures
| Measure |
Tenofovir
n=96 Participants
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=91 Participants
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Number of Participants With HBV DNA<1000 IU/mL at Week 192
|
95 Participants
|
90 Participants
|
SECONDARY outcome
Timeframe: week 240Population: Participants with HBV DNA data available at week 240
Number of participants with HBV DNA \<1000 IU/mL at week 240
Outcome measures
| Measure |
Tenofovir
n=92 Participants
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=89 Participants
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Number of Participants With HBV DNA<1000 IU/mL at Week 240
|
66 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: week 192Population: Participants with HBV DNA data at week 192
Number of participants with HBV DNA\<20 IU/mL at week 192
Outcome measures
| Measure |
Tenofovir
n=96 Participants
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=91 Participants
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Number of Participants With HBV DNA<20 IU/mL at Week 192
|
82 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: week 240Population: Participants with HBV DNA data at week 240
Number of participants with HBV DNA\<20 IU/mL at week 240
Outcome measures
| Measure |
Tenofovir
n=92 Participants
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=89 Participants
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Number of Participants With HBV DNA<20 IU/mL at Week 240
|
46 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: week 192Population: The anti-viral drug resistance test was not done
Absence of detectable antiviral drug-resistant HBV mutations at Week 192
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 240Cumulative percent of participants with HBsAg loss at week 240 estimated using Kaplan-Meier method
Outcome measures
| Measure |
Tenofovir
n=102 Participants
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=99 Participants
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Cumulative Percent of Participants With HBsAg Loss at Week 240
|
4.1 percentage of participants
|
5.2 percentage of participants
|
SECONDARY outcome
Timeframe: week 192Population: Participants with ALT data at week 192
Number of participants with alanine transaminase(ALT) levels \<= 38 U/L for males and \<=25 for females at week 192. The cut-offs 38 and 25 are approximately 1.25 times the upper limit of normal (30 U/L for males and 20 U/L for females) respectively.
Outcome measures
| Measure |
Tenofovir
n=96 Participants
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=91 Participants
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Number of Participants With Alanine Transaminase(ALT) Levels <= 38 U/L for Males and <=25 for Females at Week 192
|
58 Participants
|
72 Participants
|
Adverse Events
Tenofovir
Peginterferon-alfa 2a and Tenofovir
Serious adverse events
| Measure |
Tenofovir
n=102 participants at risk
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=99 participants at risk
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
General disorders
BENIGN PAROXYSMAL POSITIONAL VERTIGO
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.98%
1/102 • Number of events 2 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Cardiac disorders
CHEST PAIN
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Cardiac disorders
CHEST TIGHTNESS, LEFT SIDED WEAKNESS
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Hepatobiliary disorders
CLINICAL DECOMPENSATION
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Hepatobiliary disorders
ELEVATED ALT
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
FRACTURE, RIGHT ANKLE
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Gastrointestinal disorders
GASTRECTOMY
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Gastrointestinal disorders
GERD
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Nervous system disorders
HEARING LOSS
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 2 • 240 weeks
|
|
Pregnancy, puerperium and perinatal conditions
PREGNANCY
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
2.0%
2/99 • Number of events 2 • 240 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Surgical and medical procedures
RECONSTRUCTION OF BREAST
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Reproductive system and breast disorders
UTERINE FIBROIDS, OVARIAN CYST
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Infections and infestations
WOUND INFECTION
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
Other adverse events
| Measure |
Tenofovir
n=102 participants at risk
Tenofovir 192 weeks
Tenofovir: 300 mg daily for 192 weeks (4 years)
|
Peginterferon-alfa 2a and Tenofovir
n=99 participants at risk
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
|
|---|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
3.0%
3/99 • Number of events 3 • 240 weeks
|
|
Blood and lymphatic system disorders
BETA-THALESSEMIA, ANEMIA
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Blood and lymphatic system disorders
HYPOPHOSPHATEMIA
|
0.00%
0/102 • 240 weeks
|
2.0%
2/99 • Number of events 3 • 240 weeks
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY DEVELOPED WITHOUT ANEMIA
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Blood and lymphatic system disorders
LOW ANC
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Blood and lymphatic system disorders
LOW PLATELETS
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Blood and lymphatic system disorders
LOW-NORMAL POTASSIUM LEVEL AND RUQ MUSCLE CRAMPS
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Blood and lymphatic system disorders
LYMPHOCYTE COUNT DECREASED
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Blood and lymphatic system disorders
MICROCYTIC ANEMIA
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/102 • 240 weeks
|
2.0%
2/99 • Number of events 2 • 240 weeks
|
|
Blood and lymphatic system disorders
PLATELET COUNT DECREASED
|
0.00%
0/102 • 240 weeks
|
2.0%
2/99 • Number of events 2 • 240 weeks
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/102 • 240 weeks
|
3.0%
3/99 • Number of events 3 • 240 weeks
|
|
Blood and lymphatic system disorders
WHITE BLOOD CELL DECREASED
|
0.00%
0/102 • 240 weeks
|
2.0%
2/99 • Number of events 3 • 240 weeks
|
|
Blood and lymphatic system disorders
WHITE BLOOD CELL, PLATELET COUNT, AND NEUTROPHIL
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Cardiac disorders
CHEST DISCOMFORT
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Cardiac disorders
CHEST PAIN
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Cardiac disorders
CHEST PRESSURE
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Cardiac disorders
HIGH CHOLESTEROL
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Cardiac disorders
HYPERTENSION
|
2.0%
2/102 • Number of events 2 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Cardiac disorders
HYPERTENSION, DIZZINESS
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Cardiac disorders
HYPERTRIGLYCERIDEMIA
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Cardiac disorders
RAPID HEART RATE
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Endocrine disorders
HEMOGLOBIN A1C ELEVATED
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Endocrine disorders
LOW TSH EPISODE
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Endocrine disorders
PARATHYROID ADENOMECTOMY
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Endocrine disorders
VITAMIN D DEFICIENCY
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Eye disorders
DRY EYES
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Eye disorders
PERIORBITAL EDEMA
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.0%
2/102 • Number of events 2 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Gastrointestinal disorders
ABDOMINAL PAIN, NAUSEA, GASTRIC REFLUX
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Gastrointestinal disorders
ACTIVE DUODENITIS WITH ULCER
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Gastrointestinal disorders
ACUTE APPENDICITIS
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Gastrointestinal disorders
CAMPYLOBACTER INFECTION
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Gastrointestinal disorders
CONSTIPATION
|
2.0%
2/102 • Number of events 2 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Gastrointestinal disorders
CONSTIPATION, HEMORRHOIDS
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Gastrointestinal disorders
DAILY NAUSEA AND DIZZINESS
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Gastrointestinal disorders
DIARRHEA
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Gastrointestinal disorders
DRY COUGH ASSOCIATED WITH EATING/REFLUX
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Gastrointestinal disorders
ENDOSCOPIC ULTRASOUND SUGGESTED A SUBMUCOSAL GI TUMOR (GIST)
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Gastrointestinal disorders
EPIGASRIC PAIN AND BLACK DIARRHEA
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Gastrointestinal disorders
GAS AND DIARRHEA
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Gastrointestinal disorders
H.PYLORI ANTIBODY POSITIVE
|
2.0%
2/102 • Number of events 2 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Gastrointestinal disorders
HELICOBACTER PYLORI
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME WITH DIARRHEA
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Gastrointestinal disorders
NAUSEA, MILD ABDOMINAL PAIN, WEAKNESS, DIZZINESS,SHORTNESS OF BREATH
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Gastrointestinal disorders
OPEN HERNIA UMBILICAL REPAIR
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Gastrointestinal disorders
UPPER ABDOMINAL PAIN
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Gastrointestinal disorders
UPSET STOMACH
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
General disorders
APHTHOUS ORAL ULCERS
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
General disorders
CHILLS
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
General disorders
COUGH
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
General disorders
DENTAL PROCEDURE
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
General disorders
EAR ACHE POTENTIAL EAR INFECTION
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
General disorders
EAR INFECTION/FUNGUS
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
General disorders
EAR PAIN
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
General disorders
FATIGUE
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
General disorders
FEVER
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
General disorders
FLU-LIKE SYMPTOMS
|
2.0%
2/102 • Number of events 3 • 240 weeks
|
2.0%
2/99 • Number of events 3 • 240 weeks
|
|
General disorders
HERPESVIRAL GINGIVOSTOMATITIS AND PHARYNGOTONSILLITIS
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
General disorders
HYPOKALEMIA
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
General disorders
INFECTION OF TOOTH
|
2.0%
2/102 • Number of events 2 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
General disorders
IRRITABILITY
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
General disorders
MALAISE
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
General disorders
MUCUS IN THROAT
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
General disorders
NASAL CONGESTION AND POST NASAL DRIP
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
General disorders
OTITIS EXTERNA
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
General disorders
PREP
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
General disorders
SINUSITIS
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
General disorders
SURGICAL DENTAL EXTRACTION
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
General disorders
TOOTH EXTRACTION
|
0.00%
0/102 • 240 weeks
|
2.0%
2/99 • Number of events 2 • 240 weeks
|
|
General disorders
TOOTHACHE
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Hepatobiliary disorders
ALT AND AST INCREASED
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Hepatobiliary disorders
ALT FLARE
|
2.9%
3/102 • Number of events 3 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Hepatobiliary disorders
ELEVATED ALT
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
3.0%
3/99 • Number of events 3 • 240 weeks
|
|
Hepatobiliary disorders
ENLARGING GALLBLADDER POLYP
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Hepatobiliary disorders
HCC
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Hepatobiliary disorders
SEVERE FLARE DEVELOPED INTO CLINICAL DECOMPENSATION
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Hepatobiliary disorders
SPASM LIKE PAIN IN RUQ
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Immune system disorders
CHEST PAIN
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Immune system disorders
RED ITCHY BUMPS/LESIONS ACROSS BODY
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Immune system disorders
SHINGLES
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Immune system disorders
SINUSITIS
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Immune system disorders
URTICARIA
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Infections and infestations
ACCIDENTAL OCCUPATIONAL BLOOD EXPOSURE TO HIV
|
0.98%
1/102 • Number of events 2 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Infections and infestations
CELLULITIS
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Infections and infestations
SCRATCH BY CAT INFECTION AND PAIN
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Infections and infestations
SHINGLES
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Infections and infestations
SYPHILIS
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Infections and infestations
TUBERCULOSIS
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Metabolism and nutrition disorders
WEIGHT LOSS
|
0.00%
0/102 • 240 weeks
|
5.1%
5/99 • Number of events 5 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
ACHES AND PAINS
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
ACUTE SCIATICA AND BACK PAIN
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
ANKLE FRACTURE
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
5.9%
6/102 • Number of events 8 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
CERVICAL RADICULOPATHY
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
MOTORCYCLE ACCIDENT WITH MULTIPLE INJURIES
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
ELBOW PAIN AND EFFUSION
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
FOOT SPRAIN
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
GASTROCNEMIUS MUSCLE TEAR
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
INCREASED JOINT AND MUSCLE PAIN
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
JOINT ACHES
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
KNEE PAIN, LOWER BACK PAIN
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
KNEE PAIN
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
LEFT KNEE EFFUSION
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
MUSCLE PAIN
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
MYOSITIS
|
0.00%
0/102 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
OSTEOPENIA
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
PINCHED NERVE , NECK BACK PAIN
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
PROXIMAL HUMERUS FRACTURE
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
RIGHT SHOULDER STIFFNESS
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
RIGHT TRIGGER AND MIDDLE FINGERS INCREASINGLY STIFF
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
SHOULDER PAIN
|
2.0%
2/102 • Number of events 2 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
THUMB PAIN
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
TRIGGER MIDDLE FINGER
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Nervous system disorders
BELL'S PALSY
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Nervous system disorders
DIZZINESS
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Nervous system disorders
EPISODE OF SYNCOPE
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Nervous system disorders
HEADACHE
|
2.0%
2/102 • Number of events 2 • 240 weeks
|
2.0%
2/99 • Number of events 2 • 240 weeks
|
|
Nervous system disorders
INSOMNIA
|
0.00%
0/102 • 240 weeks
|
2.0%
2/99 • Number of events 2 • 240 weeks
|
|
Nervous system disorders
MIGRAINE
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Nervous system disorders
NUMBNESS
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Psychiatric disorders
ACUTE ANXIETY
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Psychiatric disorders
DECREASED LIBIDO
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/102 • 240 weeks
|
6.1%
6/99 • Number of events 7 • 240 weeks
|
|
Psychiatric disorders
HALLUCINATIONS
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Psychiatric disorders
INTERMITTENT CONFUSION
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Psychiatric disorders
IRRITABILITY
|
0.00%
0/102 • 240 weeks
|
2.0%
2/99 • Number of events 2 • 240 weeks
|
|
Psychiatric disorders
MOOD DISORDER
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Psychiatric disorders
MOOD SWING
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Psychiatric disorders
POLYNEUROPATHY
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Psychiatric disorders
SUICIDAL THOUGHT
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Psychiatric disorders
SYMPTOMS OF FEELING SAD, IRRITABLE, TROUBLE SLEEP
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Renal and urinary disorders
BLOOD IN URINE
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Renal and urinary disorders
BPH WITH OBSTRUCTION/LOWER URINARY TRACT SYMPTOMS
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Renal and urinary disorders
DYSURIA, URINARY FREQUENCY
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Renal and urinary disorders
E COLI INFECTION IN URINE
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Renal and urinary disorders
ERECTILE DYSFUNCTION
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Renal and urinary disorders
KIDNEY STONE
|
2.0%
2/102 • Number of events 2 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Renal and urinary disorders
LOW PHOSPHATE LEVELS
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Renal and urinary disorders
URETERIC STONE RECURRENCE
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
2.9%
3/102 • Number of events 3 • 240 weeks
|
3.0%
3/99 • Number of events 3 • 240 weeks
|
|
Reproductive system and breast disorders
MENSES CEASED
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Reproductive system and breast disorders
POOR LIBIDO AND RECURRENT UTI
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Reproductive system and breast disorders
TUBAL REVERSAL
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Reproductive system and breast disorders
POST TUBAL REVERSION PROCEDURE WOUND INFECTION
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFECTION
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Respiratory, thoracic and mediastinal disorders
MILD CHEST TIGHTNESS
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Respiratory, thoracic and mediastinal disorders
NON-PRODUCTIVE COUGH AND SHORTNESS OF BREATH
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Respiratory, thoracic and mediastinal disorders
REACTIVE AIRWAY DISEASE
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY INFECTION
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
2.0%
2/99 • Number of events 2 • 240 weeks
|
|
Skin and subcutaneous tissue disorders
CELLULITIS
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Skin and subcutaneous tissue disorders
DERMATITIS HERPETIFORMIS
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Skin and subcutaneous tissue disorders
DRY SKIN AND HYPOPIGMENTATION
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Skin and subcutaneous tissue disorders
EYE LID AND FACIAL SWELLING
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS
|
0.00%
0/102 • 240 weeks
|
2.0%
2/99 • Number of events 2 • 240 weeks
|
|
Skin and subcutaneous tissue disorders
HIVES
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Skin and subcutaneous tissue disorders
ITCHING
|
0.00%
0/102 • 240 weeks
|
2.0%
2/99 • Number of events 2 • 240 weeks
|
|
Skin and subcutaneous tissue disorders
POISON IVY RASH
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
3.0%
3/99 • Number of events 4 • 240 weeks
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Skin and subcutaneous tissue disorders
RASH
|
2.9%
3/102 • Number of events 3 • 240 weeks
|
7.1%
7/99 • Number of events 7 • 240 weeks
|
|
Skin and subcutaneous tissue disorders
RASH AT INJECTION SITE
|
0.00%
0/102 • 240 weeks
|
2.0%
2/99 • Number of events 2 • 240 weeks
|
|
Skin and subcutaneous tissue disorders
RASH, SKIN IRRITATION, ERYTHEMA AT INJECTION SITE
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Skin and subcutaneous tissue disorders
REDNESS AND ITCHINESS AT INJECTION SITE
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Skin and subcutaneous tissue disorders
RING WORM
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Skin and subcutaneous tissue disorders
ROSACEA
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
|
Skin and subcutaneous tissue disorders
TICK BITE
|
0.98%
1/102 • Number of events 1 • 240 weeks
|
0.00%
0/99 • 240 weeks
|
|
Musculoskeletal and connective tissue disorders
BACK SPRAIN
|
0.00%
0/102 • 240 weeks
|
1.0%
1/99 • Number of events 1 • 240 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee From the Publications and Presentations policy "Disagreements between the HBRN Steering Committee and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) on the merits of journal submission of a specific manuscript will be mediated through discussion on Steering Committee conference calls, ad hoc conference calls or during face to face Steering Committee meetings. The decision of the NIDDK is final and cannot be appealed."
- Publication restrictions are in place
Restriction type: OTHER