Trial Outcomes & Findings for Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection (NCT NCT01368497)
NCT ID: NCT01368497
Last Updated: 2022-05-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
End of follow-up (up to 96 weeks)
Results posted on
2022-05-26
Participant Flow
Sixty children were enrolled at 7 pediatric clinical sites in the United States and Canada between 9/20/2012 and 12/30/2014.
Participant milestones
| Measure |
Entecavir and Peginterferon
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
End of Treatment
|
60
|
|
Overall Study
COMPLETED
|
58
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Entecavir and Peginterferon
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection
Baseline characteristics by cohort
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Age, Continuous
|
10.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 Participants
n=5 Participants
|
|
HBV DNA
|
8.2 log10 IU/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: End of follow-up (up to 96 weeks)Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss & Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels ≤1,000 International Units (IU) Per Milliliter (mL)
|
.033 Proportion of participants
Interval 0.004 to 0.115
|
PRIMARY outcome
Timeframe: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)The number of AEs includes both AEs and Serious Adverse Events (SAEs). The incidence is calculated as the number of AEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.
Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Incidence of Adverse Events (AEs) Per Person-Year
End of treatment (Up to 48 weeks)
|
1.13 AEs per person-year of observation
Interval 0.88 to 1.46
|
|
Incidence of Adverse Events (AEs) Per Person-Year
End of follow-up (Up to 96 weeks)
|
0.70 AEs per person-year of observation
Interval 0.56 to 0.87
|
PRIMARY outcome
Timeframe: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)The incidence is calculated as the number of SAEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.
Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Incidence of Serious Adverse Events (SAEs) Per Person-Year
End of treatment (Up to 48 weeks)
|
0 SAEs per person-year of observation
95% Confidence Interval (CI) around 0 not calculated
|
|
Incidence of Serious Adverse Events (SAEs) Per Person-Year
End of follow-up (Up to 96 weeks)
|
0.01 SAEs per person-year of observation
Interval 0.0 to 0.07
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks)Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss
|
.050 Proportion of participants
Interval 0.01 to 0.139
|
SECONDARY outcome
Timeframe: End of follow-up (up to 96 weeks)Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss
|
.033 Proportion of participants
Interval 0.004 to 0.115
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks)Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss
|
.033 Proportion of participants
Interval 0.004 to 0.115
|
SECONDARY outcome
Timeframe: End of follow-up (up to 96 weeks)Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss
|
.033 Proportion of participants
Interval 0.004 to 0.115
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks)Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With HBeAg Seroconversion
|
.033 Proportion of participants
Interval 0.004 to 0.115
|
SECONDARY outcome
Timeframe: End of follow-up (up to 96 weeks)Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With HBeAg Seroconversion
|
.033 Proportion of participants
Interval 0.004 to 0.115
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks)Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With HBsAg Seroconversion
|
.033 Proportion of participants
Interval 0.004 to 0.115
|
SECONDARY outcome
Timeframe: End of follow-up (up to 96 weeks)Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With HBsAg Seroconversion
|
.033 Proportion of participants
Interval 0.004 to 0.115
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks)Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With Alanine Aminotransferase (ALT) ≤ 40 Units (U) Per Liter (L) for Males, ≤ 35 U/L for Females
|
.350 Proportion of participants
Interval 0.231 to 0.484
|
SECONDARY outcome
Timeframe: End of follow-up (up to 96 weeks)Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With ALT ≤ 40 U/L for Males, ≤ 35 U/L for Females
|
.650 Proportion of participants
Interval 0.516 to 0.769
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks)Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With HBV DNA ≤1000 IU/mL
|
.750 Proportion of participants
Interval 0.621 to 0.853
|
SECONDARY outcome
Timeframe: End of follow-up (up to 96 weeks)Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With HBV DNA ≤1000 IU/mL
|
.033 Proportion of participants
Interval 0.004 to 0.115
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks)Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With HBV DNA < 20 IU/mL
|
.233 Proportion of participants
Interval 0.134 to 0.36
|
SECONDARY outcome
Timeframe: End of follow-up (up to 96 weeks)Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With HBV DNA < 20 IU/mL
|
.033 Proportion of participants
Interval 0.004 to 0.115
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks)HBV drug resistance variant testing was performed at the CDC laboratory. The sequences of the HBV polymerase spanning nucleotide positions 311-1021 were determined by Sanger sequencing. Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.
Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion Without Detectable Antiviral Drug-resistance HBV Mutations
|
.733 Proportion of participants
Interval 0.603 to 0.839
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks)A child's Z-score is the number of standard deviations that the child is from the average of children of the same sex and age from a reference population. The reference population is provided in the 2000 Centers for Disease Control and Prevention (CDC) growth charts. Positive Z scores mean the growth measure (weight, height, or body mass index) is above the average, negative Z scores mean the growth measure is below the average.
Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Growth Measures: Z-scores Weight, Height, and Body Mass Index
Z-score weight
|
-0.48 Z-score
Interval -0.94 to -0.1
|
|
Growth Measures: Z-scores Weight, Height, and Body Mass Index
Z-score height
|
-0.41 Z-score
Interval -0.78 to -0.04
|
|
Growth Measures: Z-scores Weight, Height, and Body Mass Index
Z-score BMI
|
-0.37 Z-score
Interval -0.82 to 0.01
|
SECONDARY outcome
Timeframe: End of follow-up (up to 96 weeks)A child's Z-score is the number of standard deviations that the child is from the average of children of the same sex and age from a reference population. The reference population is provided in the 2000 Centers for Disease Control and Prevention (CDC) growth charts. Positive Z scores mean the growth measure (weight, height, or body mass index) is above the average, negative Z scores mean the growth measure is below the average.
Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Growth Measures: Z-scores Weight, Height, and Body Mass Index
Z-score weight
|
-0.34 Z-score
Interval -0.81 to 0.02
|
|
Growth Measures: Z-scores Weight, Height, and Body Mass Index
Z-score height
|
-0.45 Z-score
Interval -0.88 to -0.04
|
|
Growth Measures: Z-scores Weight, Height, and Body Mass Index
Z-score BMI
|
-0.14 Z-score
Interval -0.54 to 0.21
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks)The Tanner Stage questionnaire is only completed by participants 8 years of age and older. The copyrighted form includes pictures and descriptions. Girls selected the picture closest to their self-perceived breast growth from among 5 stages of breast growth and boys did the same for testes, scrotum, and penis growth. Boys: I-prepubertal; II-enlargement of scrotum and testes; III-enlargement of the penis and further growth of testes; IV- increased size of penis with growth in breadth and development of glans, testes, and scrotum larger, scrotum skin darker; V- adult genitalia. Girls: I-prepubertal; II-breast bud stage with the elevation of breast and papilla and enlargement of the areola; III-further enlargement of breast and areola, no separation of their contour; IV-areola and papilla form a secondary mound above the level of the breast; V: mature adult stage. There is no "better" or "worse" outcome. They are self-assessed descriptive measures of physical growth.
Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Tanner Stages of Physical Growth
I
|
12 Participants
|
|
Tanner Stages of Physical Growth
II
|
3 Participants
|
|
Tanner Stages of Physical Growth
III
|
12 Participants
|
|
Tanner Stages of Physical Growth
IV
|
8 Participants
|
|
Tanner Stages of Physical Growth
V
|
7 Participants
|
|
Tanner Stages of Physical Growth
Missing
|
18 Participants
|
SECONDARY outcome
Timeframe: End of follow-up (up to 96 weeks)The Tanner Stage questionnaire is only completed by participants 8 years of age and older. The copyrighted form includes pictures and descriptions. Girls selected the picture closest to their self-perceived breast growth from among 5 stages of breast growth and boys did the same for testes, scrotum, and penis growth. Boys: I-prepubertal; II-enlargement of scrotum and testes; III-enlargement of the penis and further growth of testes; IV- increased size of penis with growth in breadth and development of glans, testes, and scrotum larger, scrotum skin darker; V- adult genitalia. Girls: I-prepubertal; II-breast bud stage with the elevation of breast and papilla and enlargement of the areola; III-further enlargement of breast and areola, no separation of their contour; IV-areola and papilla form a secondary mound above the level of the breast; V: mature adult stage. There is no "better" or "worse" outcome. They are self-assessed descriptive measures of physical growth.
Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Tanner Stages of Physical Growth
I
|
14 Participants
|
|
Tanner Stages of Physical Growth
II
|
5 Participants
|
|
Tanner Stages of Physical Growth
III
|
9 Participants
|
|
Tanner Stages of Physical Growth
IV
|
8 Participants
|
|
Tanner Stages of Physical Growth
V
|
12 Participants
|
|
Tanner Stages of Physical Growth
Missing
|
12 Participants
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks)The Tanner Stage questionnaire is only completed by participants 8 years of age and older. The copyrighted form includes pictures and descriptions. Participants selected the picture closest to their self-perceived pubic hair growth. Boys and girls: I-prepubertal (no pubic hair at all); II-sparse growth of long, slightly pigmented hair, straight or curled, at base of penis or along labia; III: darker, coarser and more curled hair, spreading sparsely over junction of pubes; IV- hair adult in type, but covering smaller area than in adult; V-adult in type and quantity. There is no "better" or "worse" outcome. They are self-assessed descriptive measures of physical growth.
Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Tanner Stages of Pubic Hair Growth
I
|
15 Participants
|
|
Tanner Stages of Pubic Hair Growth
II
|
4 Participants
|
|
Tanner Stages of Pubic Hair Growth
III
|
4 Participants
|
|
Tanner Stages of Pubic Hair Growth
IV
|
12 Participants
|
|
Tanner Stages of Pubic Hair Growth
V
|
7 Participants
|
|
Tanner Stages of Pubic Hair Growth
Missing
|
18 Participants
|
SECONDARY outcome
Timeframe: End of follow-up (up to 96 weeks)The Tanner Stage questionnaire is only completed by participants 8 years of age and older. The copyrighted form includes pictures and descriptions. Participants selected the picture closest to their self-perceived pubic hair growth. Boys and girls: I-prepubertal (no pubic hair at all); II-sparse growth of long, slightly pigmented hair, straight or curled, at base of penis or along labia; III: darker, coarser and more curled hair, spreading sparsely over junction of pubes; IV- hair adult in type, but covering smaller area than in adult; V-adult in type and quantity. There is no "better" or "worse" outcome. They are self-assessed descriptive measures of physical growth.
Outcome measures
| Measure |
Entecavir and Peginterferon
n=60 Participants
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Tanner Stages of Pubic Hair Growth
I
|
16 Participants
|
|
Tanner Stages of Pubic Hair Growth
II
|
6 Participants
|
|
Tanner Stages of Pubic Hair Growth
III
|
5 Participants
|
|
Tanner Stages of Pubic Hair Growth
IV
|
9 Participants
|
|
Tanner Stages of Pubic Hair Growth
V
|
12 Participants
|
|
Tanner Stages of Pubic Hair Growth
Missing
|
12 Participants
|
Adverse Events
Entecavir and Peginterferon
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Entecavir and Peginterferon
n=60 participants at risk
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Nervous system disorders
Myasthenia gravis
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
Other adverse events
| Measure |
Entecavir and Peginterferon
n=60 participants at risk
Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m\^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Small splenic mass
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Blood and lymphatic system disorders
Low absolute neutrophil count
|
16.7%
10/60 • Number of events 13 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Blood and lymphatic system disorders
Low absolute neutrophil count and platelets
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.3%
2/60 • Number of events 2 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Cardiac disorders
Syncope Episode
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Ear and labyrinth disorders
Fluid in left ear
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Endocrine disorders
Thyroid-stimulating hormone (TSH) elevation
|
3.3%
2/60 • Number of events 2 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Endocrine disorders
Hyperthyroidism
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Endocrine disorders
Hypothyroidism
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Eye disorders
Bilateral conjunctivitis
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Eye disorders
Blurry vision
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Eye disorders
Decreased visual acuity
|
1.7%
1/60 • Number of events 2 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Gastrointestinal disorders
Upset stomach
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
General disorders
Elective extraction of four primary teeth
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
General disorders
Nauseous and achy
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
General disorders
Mild nose bleed
|
1.7%
1/60 • Number of events 2 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
General disorders
Sore throat
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Hepatobiliary disorders
ALT or AST elevation
|
10.0%
6/60 • Number of events 6 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Hepatobiliary disorders
Total bilirubin elevation
|
1.7%
1/60 • Number of events 2 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Immune system disorders
Bilateral periocular dermatitis
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Immune system disorders
Bilateral rash and swelling of feet
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Immune system disorders
Hives
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Infections and infestations
Strep throat
|
6.7%
4/60 • Number of events 4 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Infections and infestations
Ear infection
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Infections and infestations
Infection from tooth extraction
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Infections and infestations
Keratitis and uveitis
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Infections and infestations
Pneumonia
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Infections and infestations
Sinus infection
|
6.7%
4/60 • Number of events 5 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Infections and infestations
Sore throat and fever
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Infections and infestations
Upper respiratory infection
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Metabolism and nutrition disorders
Creatinine elevation
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Musculoskeletal and connective tissue disorders
Creatine kinase elevation
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Nervous system disorders
Ptosis
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Nervous system disorders
Febrile seizure
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Psychiatric disorders
Short temper or slight agitation
|
1.7%
1/60 • Number of events 2 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Renal and urinary disorders
Occult blood in urine
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Reproductive system and breast disorders
Menstrual cramping
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.3%
2/60 • Number of events 2 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.3%
2/60 • Number of events 2 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
3.3%
2/60 • Number of events 2 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Skin and subcutaneous tissue disorders
Skin lesions
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
|
Skin and subcutaneous tissue disorders
Abscess gum from tooth extraction
|
1.7%
1/60 • Number of events 1 • Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator. 1. Symptom or event requiring discontinuation of study medication. 2. New symptom or event requiring a written prescription for treatment. 3. New symptom or event resulting in a referral to another provider. 4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
|
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 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