Trial Outcomes & Findings for A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B. (NCT NCT01519921)
NCT ID: NCT01519921
Last Updated: 2016-04-21
Results Overview
Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (EOF) period (24 weeks after the end of treatment) were classified as responders.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
150 participants
Primary outcome timeframe
Week 72
Results posted on
2016-04-21
Participant Flow
A total of 150 participants were enrolled in this study conducted from 26 October 2005 to 24 June 2008 at 7 centers in Republic of Korea.
Participant milestones
| Measure |
PEG-IFN Alfa-2a (Treatment naïve)
Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
|
PEG-IFN Alfa-2a (YMDD Mutant)
Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
64
|
|
Overall Study
COMPLETED
|
65
|
49
|
|
Overall Study
NOT COMPLETED
|
21
|
15
|
Reasons for withdrawal
| Measure |
PEG-IFN Alfa-2a (Treatment naïve)
Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
|
PEG-IFN Alfa-2a (YMDD Mutant)
Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
9
|
|
Overall Study
Lack of Efficacy
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Treatment refusal
|
2
|
1
|
|
Overall Study
High alanine aminotransferase (ALT)
|
0
|
1
|
Baseline Characteristics
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.
Baseline characteristics by cohort
| Measure |
PEG-IFN Alfa-2a (Treatment naïve)
n=86 Participants
Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
|
PEG-IFN Alfa-2a (YMDD Mutant)
n=64 Participants
Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.3 Years
STANDARD_DEVIATION 9.20 • n=5 Participants
|
36.8 Years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
35.9 Years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 72Population: Intent-to-treat (ITT) population included all participants who received at least one dose of study drug.
Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (EOF) period (24 weeks after the end of treatment) were classified as responders.
Outcome measures
| Measure |
PEG-IFN Alfa-2a (Treatment naïve)
n=86 Participants
Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
|
PEG-IFN Alfa-2a (YMDD Mutant)
n=64 Participants
Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72
|
20.9 percentage of participants
Interval 12.9 to 31.0
|
21.9 percentage of participants
Interval 12.5 to 34.0
|
PRIMARY outcome
Timeframe: Week 72Population: The ITT population included all participants who received at least one dose of study drug.
Participants with loss of hepatitis B virus e antigen (HBeAg) at the EOF period (24 weeks after the end of treatment) were classified as responders.
Outcome measures
| Measure |
PEG-IFN Alfa-2a (Treatment naïve)
n=86 Participants
Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
|
PEG-IFN Alfa-2a (YMDD Mutant)
n=64 Participants
Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Hepatitis B Virus e Antigen Loss At Week 72
|
20.9 Percentage of participants
Interval 12.9 to 31.0
|
23.4 Percentage of participants
Interval 13.8 to 35.7
|
SECONDARY outcome
Timeframe: Week 48 and Week 72Population: The ITT population included all participants who received at least one dose of study drug.
Participants with ALT less than the upper limit of normal (ULN) at end of treatment (EOT) and EOF period were responders.
Outcome measures
| Measure |
PEG-IFN Alfa-2a (Treatment naïve)
n=86 Participants
Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
|
PEG-IFN Alfa-2a (YMDD Mutant)
n=64 Participants
Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
|
|---|---|---|
|
Percentage of Participants With ALT Normalization At Week 48 and Week 72
Week 48 (EOT)
|
34.9 percentage of participants
Interval 24.9 to 45.9
|
29.7 percentage of participants
Interval 18.9 to 42.4
|
|
Percentage of Participants With ALT Normalization At Week 48 and Week 72
Week 72 (EOF)
|
36.0 percentage of participants
Interval 26.0 to 47.1
|
29.7 percentage of participants
Interval 18.9 to 42.4
|
SECONDARY outcome
Timeframe: Week 48 and Week 72Population: The ITT population included all participants who received at least one dose of study drug.
Participants with HBV-DNA below the limit of detection i.e. \<174 copies/mL at EOT and EOF period were responders.
Outcome measures
| Measure |
PEG-IFN Alfa-2a (Treatment naïve)
n=86 Participants
Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
|
PEG-IFN Alfa-2a (YMDD Mutant)
n=64 Participants
Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Hepatitis B Virus DNA Below the Limit of Detection At Week 48 and Week 72
Week 48 (EOT)
|
10.5 Percentage of participants
Interval 4.9 to 18.9
|
10.9 Percentage of participants
Interval 4.5 to 21.2
|
|
Percentage of Participants With Hepatitis B Virus DNA Below the Limit of Detection At Week 48 and Week 72
Week 72 (EOF)
|
3.5 Percentage of participants
Interval 0.7 to 9.9
|
9.4 Percentage of participants
Interval 3.5 to 19.3
|
SECONDARY outcome
Timeframe: Week 48 and Week 72Population: The ITT population included all participants who received at least one dose of study drug.
A responder with Combined Response was a participant with HBV-DNA\<100,000 copies/mL, HBeAg seroconversion (i.e. loss of HBeAg and presence of anti-HBe) and ALT normalization at EOT and EOF period.
Outcome measures
| Measure |
PEG-IFN Alfa-2a (Treatment naïve)
n=86 Participants
Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
|
PEG-IFN Alfa-2a (YMDD Mutant)
n=64 Participants
Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
|
|---|---|---|
|
Percentage of Participants With a Combined Response At Week 48 and Week 72
Week 48 (EOT)
|
8.1 Percentage of participants
Interval 3.3 to 16.1
|
9.4 Percentage of participants
Interval 3.5 to 19.3
|
|
Percentage of Participants With a Combined Response At Week 48 and Week 72
Week 72 (EOF)
|
9.3 Percentage of participants
Interval 4.1 to 17.5
|
14.1 Percentage of participants
Interval 6.6 to 25.0
|
SECONDARY outcome
Timeframe: Week 48 and Week 72Population: The ITT population included all participants who received at least one dose of study drug.
A responder was a participant with loss of HBeAg and presence of anti-HBe at EOT and EOF period.
Outcome measures
| Measure |
PEG-IFN Alfa-2a (Treatment naïve)
n=86 Participants
Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
|
PEG-IFN Alfa-2a (YMDD Mutant)
n=64 Participants
Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion
Week 48 (EOT)
|
15.1 Percentage of participants
Interval 8.3 to 24.5
|
23.4 Percentage of participants
Interval 13.8 to 35.7
|
|
Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion
Week 72 (EOF)
|
20.9 Percentage of participants
Interval 12.9 to 31.0
|
21.9 Percentage of participants
Interval 12.5 to 34.0
|
SECONDARY outcome
Timeframe: Week 48 and Week 72Population: The ITT population included all participants who received at least one dose of study drug.
A responder was a participant who were analysed with loss of Hepatitis B Surface Antigen (HBsAg) at EOT and EOF period.
Outcome measures
| Measure |
PEG-IFN Alfa-2a (Treatment naïve)
n=86 Participants
Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
|
PEG-IFN Alfa-2a (YMDD Mutant)
n=64 Participants
Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Loss of Hepatitis B Surface Antigen At Week 48 and Week 72
Week 72 (EOF)
|
1.2 Percentage of participants
Interval 0.03 to 6.3
|
1.6 Percentage of participants
Interval 0.04 to 8.4
|
|
Percentage of Participants With Loss of Hepatitis B Surface Antigen At Week 48 and Week 72
Week 48 (EOT)
|
1.2 Percentage of participants
Interval 0.03 to 6.3
|
1.6 Percentage of participants
Interval 0.04 to 8.4
|
SECONDARY outcome
Timeframe: Week 48 and Week 72Population: The ITT population included all participants who received at least one dose of study drug.
A responder was a participant with loss of HBsAg and presence of anti-HBs at EOT and EOF period.
Outcome measures
| Measure |
PEG-IFN Alfa-2a (Treatment naïve)
n=86 Participants
Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
|
PEG-IFN Alfa-2a (YMDD Mutant)
n=64 Participants
Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Hepatitis B Surface Antigen Seroconversion At Week 48 and Week 72
Week 48 (EOT)
|
1.2 Percentage of participants
Interval 0.03 to 6.3
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Hepatitis B Surface Antigen Seroconversion At Week 48 and Week 72
Week 72 (EOF)
|
1.2 Percentage of participants
Interval 0.03 to 6.3
|
1.6 Percentage of participants
Interval 0.04 to 8.4
|
SECONDARY outcome
Timeframe: Up to Week 72Population: Safety population included participants who received at least one dose of study medication and who had at least one post-baseline safety assessment.
An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Participants with any AEs and any SAEs have been presented.
Outcome measures
| Measure |
PEG-IFN Alfa-2a (Treatment naïve)
n=86 Participants
Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
|
PEG-IFN Alfa-2a (YMDD Mutant)
n=64 Participants
Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
|
|---|---|---|
|
Number of Participants With Any Adverse Events and Any Serious Adverse Events
Any AEs
|
75 Participants
|
54 Participants
|
|
Number of Participants With Any Adverse Events and Any Serious Adverse Events
Any SAEs
|
4 Participants
|
5 Participants
|
Adverse Events
PEG-IFN Alfa-2a (Treatment naïve)
Serious events: 4 serious events
Other events: 69 other events
Deaths: 0 deaths
PEG-IFN Alfa-2a (YMDD Mutant)
Serious events: 5 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG-IFN Alfa-2a (Treatment naïve)
n=86 participants at risk
Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
|
PEG-IFN Alfa-2a (YMDD Mutant)
n=64 participants at risk
Group B included tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants who received PEGASYS 180mcg subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.2%
1/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
1.6%
1/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
1.6%
1/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Gastrointestinal disorders
Exomphalos
|
1.2%
1/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.2%
1/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
General disorders
Pyrexia
|
1.2%
1/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
1.6%
1/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
1.6%
1/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
1.6%
1/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
3.1%
2/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumonia
|
1.2%
1/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
0.00%
0/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
Other adverse events
| Measure |
PEG-IFN Alfa-2a (Treatment naïve)
n=86 participants at risk
Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
|
PEG-IFN Alfa-2a (YMDD Mutant)
n=64 participants at risk
Group B included tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants who received PEGASYS 180mcg subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
24.4%
21/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
28.1%
18/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.3%
2/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
6.2%
4/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.1%
7/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
7.8%
5/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.6%
10/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
1.6%
1/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
General disorders
Asthenia
|
8.1%
7/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
7.8%
5/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
General disorders
Fatigue
|
18.6%
16/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
26.6%
17/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
General disorders
Influenza like illness
|
12.8%
11/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
18.8%
12/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
General disorders
Pain
|
15.1%
13/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
9.4%
6/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
General disorders
Pyrexia
|
3.5%
3/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
9.4%
6/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Investigations
Liver function test abnormal
|
11.6%
10/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
10.9%
7/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Investigations
Weight decreased
|
5.8%
5/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
1.6%
1/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.3%
2/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
6.2%
4/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.5%
9/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
9.4%
6/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Nervous system disorders
Dizziness
|
7.0%
6/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
3.1%
2/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Nervous system disorders
Headache
|
18.6%
16/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
23.4%
15/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.8%
5/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
3.1%
2/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
7.0%
6/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
3.1%
2/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
11.6%
10/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
20.3%
13/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
39.5%
34/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
37.5%
24/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.8%
11/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
18.8%
12/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.7%
4/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
6.2%
4/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Gastrointestinal disorders
Nausea
|
3.5%
3/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
6.2%
4/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
|
Psychiatric disorders
Insomnia
|
4.7%
4/86 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
6.2%
4/64 • Up to Week 72
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 616878333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER