Trial Outcomes & Findings for Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B (NCT NCT01369199)
NCT ID: NCT01369199
Last Updated: 2022-05-26
Results Overview
Lack of data was considered to be treatment failure.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
28 participants
Primary outcome timeframe
End of follow-up (up to 96 weeks)
Results posted on
2022-05-26
Participant Flow
Twenty-eight (28) adults were enrolled at 11 clinical sites in the United States and Canada between 12/18/12 and 04/29/15.
Participant milestones
| Measure |
Peginterferon and Entecavir
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up for 48 weeks.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
End of Treatment (EOT)
|
26
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Peginterferon and Entecavir
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up for 48 weeks.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B
Baseline characteristics by cohort
| Measure |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Age, Continuous
|
37.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
|
Hepatitis B Virus (HBV) DNA
|
8.2 log10 IU/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: End of follow-up (up to 96 weeks)Lack of data was considered to be treatment failure.
Outcome measures
| Measure |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With HBeAg Loss (Lack of Detectable HBeAg) AND HBV DNA ≤1,000 IU/mL
|
0 Proportion of participants
Interval 0.0 to 0.123
|
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 |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously 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 of Observation
End of follow-up (Up to 96) weeks
|
0.86 Events per person-year of observation
Interval 0.64 to 1.17
|
|
Incidence of Adverse Events (AEs) Per Person-Year of Observation
End of treatment (Up to 48 weeks)
|
1.60 Events per person-year of observation
Interval 1.17 to 2.19
|
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 |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously 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)
|
.021 SAEs per person-year of observation
Interval 0.003 to 0.146
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks)Outcome measures
| Measure |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With HBeAg Loss
|
.036 Proportion of participants
Interval 0.001 to 0.183
|
SECONDARY outcome
Timeframe: End of follow-up (up to 96 weeks)Outcome measures
| Measure |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With HBeAg Loss
|
.036 Proportion of participants
Interval 0.001 to 0.183
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks)Outcome measures
| Measure |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With HBeAg Seroconversion
|
.036 Proportion of participants
Interval 0.001 to 0.183
|
SECONDARY outcome
Timeframe: End of follow-up (up to 96 weeks)Outcome measures
| Measure |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With HBeAg Seroconversion
|
.036 Proportion of participants
Interval 0.001 to 0.183
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks)Outcome measures
| Measure |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With HBsAg Loss
|
0 Proportion of participants
Interval 0.0 to 0.123
|
SECONDARY outcome
Timeframe: End of follow-up (up to 96 weeks)Outcome measures
| Measure |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With HBsAg Loss
|
0 Proportion of participants
Interval 0.0 to 0.123
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks)Outcome measures
| Measure |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With HBsAg Seroconversion
|
0 Proportion of participants
Interval 0.0 to 0.123
|
SECONDARY outcome
Timeframe: End of follow-up (up to 96 weeks)Outcome measures
| Measure |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With HBsAg Seroconversion
|
0 Proportion of participants
Interval 0.0 to 0.123
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks)Outcome measures
| Measure |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With Alanine Aminotransferase (ALT) <45 U/L for Men, <30 U/L for Women
|
.571 Proportion of participants
Interval 0.245 to 0.628
|
SECONDARY outcome
Timeframe: End of follow-up (up to 96 weeks)Outcome measures
| Measure |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With ALT <45 U/L for Men, <30 U/L for Women
|
.750 Proportion of participants
Interval 0.551 to 0.893
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks)Outcome measures
| Measure |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With ALT Normalization (Men <30 U/L, Women <20 U/L)
|
.393 Proportion of participants
Interval 0.215 to 0.594
|
SECONDARY outcome
Timeframe: End of follow-up (up to 96 weeks)Outcome measures
| Measure |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Proportion of Participants With ALT Normalization (Men <30 U/L, Women <20 U/L)
|
.464 Proportion of participants
Interval 0.275 to 0.661
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks)Outcome measures
| Measure |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously 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
|
.929 Proportion of participants
Interval 0.765 to 0.991
|
SECONDARY outcome
Timeframe: End of follow-up (up to 96 weeks)Outcome measures
| Measure |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously 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
|
0 Proportion of participants
Interval 0.0 to 0.123
|
SECONDARY outcome
Timeframe: End of treatment (up to 48 weeks)Outcome measures
| Measure |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously 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
|
.179 Proportion of participants
Interval 0.061 to 0.369
|
SECONDARY outcome
Timeframe: End of follow-up (up to 96 weeks)Outcome measures
| Measure |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously 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
|
0 Proportion of participants
Interval 0.0 to 0.123
|
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 |
Peginterferon and Entecavir
n=28 Participants
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.
|
|---|---|
|
Absence of Detectable Antiviral Drug-resistance HBV Mutations
|
.893 Proportion of participants
Interval 0.718 to 0.977
|
Adverse Events
Peginterferon and Entecavir
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peginterferon and Entecavir
n=28 participants at risk
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously (sq) weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment will be for 48 weeks.
|
|---|---|
|
Infections and infestations
Malaria
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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 |
Peginterferon and Entecavir
n=28 participants at risk
Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon alfa-2a 180 μg subcutaneously (sq) weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment will be for 48 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Low white blood cells, platelets, and absolute neutrophil count
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Altered thyroid function
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Graves disease
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Blurred vision
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Heartburn
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Heartburn and diarrhea
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Poor appetite
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Decrease in appetite
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Fatigue
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Fever
|
7.1%
2/28 • Number of events 2 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Head cold
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Swollen lips
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Upper respiratory infection
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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 in right forefinger
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Intermittent finger joint pain
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Myalgia
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Headache
|
7.1%
2/28 • Number of events 2 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Shingles
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Vertigo
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Depressive disorder
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Foul urine smell
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Frequent urination - prophylaxis
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Penile yeast infection
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Urinary tract infection
|
7.1%
2/28 • Number of events 4 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumococcal pneumonia
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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 (Hair loss)
|
10.7%
3/28 • Number of events 4 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Bruising on legs
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Hives
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Itchiness at injection site (intermittent)
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Rash and itchiness on lower jaw
|
3.6%
1/28 • Number of events 1 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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
Redness at injection site
|
7.1%
2/28 • Number of events 2 • Study entry (consent) to the end of follow-up (up to 96 weeks after treatment initiation).
Asked at each visit. Expected symptoms/signs or common side effects of meds not reported (these are termed Adverse Effects). Below is 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