Trial Outcomes & Findings for A Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Participants With Hepatitis C (NCT NCT01659567)
NCT ID: NCT01659567
Last Updated: 2017-10-03
Results Overview
SVR was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) level undetectable (less than \[\<\] 15 international units per milliliter \[IU/mL\]) 24 weeks after completion of the actual treatment period (measured using the COBAS AmpliPrep \[CAP\]/ COBAS TaqMan \[CTM\] test). Percentage of participants achieving SVR was reported.
COMPLETED
516 participants
At 24 weeks after end of treatment (EOT) (up to 96 weeks), where EOT = up to 72 weeks
2017-10-03
Participant Flow
Participant milestones
| Measure |
Pegylated Interferon Alfa-2a and Ribavirin
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
|
|---|---|
|
Overall Study
STARTED
|
516
|
|
Overall Study
COMPLETED
|
393
|
|
Overall Study
NOT COMPLETED
|
123
|
Reasons for withdrawal
| Measure |
Pegylated Interferon Alfa-2a and Ribavirin
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
22
|
|
Overall Study
Switched to Pegferon
|
6
|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Good result at early stage of treatment
|
5
|
|
Overall Study
Withdrawal by Subject
|
64
|
|
Overall Study
Progression of the main disease
|
1
|
|
Overall Study
Other
|
13
|
Baseline Characteristics
A Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Participants With Hepatitis C
Baseline characteristics by cohort
| Measure |
Pegylated Interferon Alfa-2a and Ribavirin
n=516 Participants
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
|
|---|---|
|
Age, Continuous
|
42.12 years
STANDARD_DEVIATION 10.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
454 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 24 weeks after end of treatment (EOT) (up to 96 weeks), where EOT = up to 72 weeksPopulation: Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure.
SVR was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) level undetectable (less than \[\<\] 15 international units per milliliter \[IU/mL\]) 24 weeks after completion of the actual treatment period (measured using the COBAS AmpliPrep \[CAP\]/ COBAS TaqMan \[CTM\] test). Percentage of participants achieving SVR was reported.
Outcome measures
| Measure |
Pegylated Interferon Alfa-2a and Ribavirin
n=225 Participants
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
|
|---|---|
|
Percentage of Participants Achieving Sustained Virological Response (SVR)
|
79.1 percentage of participants
|
PRIMARY outcome
Timeframe: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeksPopulation: Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure.
RVR was defined as HCV RNA less than or equal to (\<=) 25 IU/mL at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops RVR would achieve SVR was termed as PPV of RVR on SVR. SVR was defined as HCV RNA level undetectable (\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Outcome measures
| Measure |
Pegylated Interferon Alfa-2a and Ribavirin
n=185 Participants
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
|
|---|---|
|
Positive Predictive Value (PPV) of Rapid Viral Response (RVR) on SVR
|
93.1 percentage of participants
Interval 89.3 to 96.7
|
PRIMARY outcome
Timeframe: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeksPopulation: Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure.
cEVR was defined as HCV RNA \<=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops cEVR would achieve SVR was termed as PPV of cEVR on SVR. SVR was defined as HCV RNA level undetectable (\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Outcome measures
| Measure |
Pegylated Interferon Alfa-2a and Ribavirin
n=64 Participants
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
|
|---|---|
|
PPV of Complete Early Viral Response (cEVR) on SVR
|
60.3 percentage of participants
Interval 48.3 to 72.3
|
SECONDARY outcome
Timeframe: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)Population: Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure.
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of age (greater than \[\>\] 42 years versus \<=42 years) on SVR. SVR was defined as HCV RNA level undetectable (\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Outcome measures
| Measure |
Pegylated Interferon Alfa-2a and Ribavirin
n=225 Participants
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
|
|---|---|
|
Odds Ratio (OR) for Impact of Age on SVR
|
0.21 odds ratio
Interval 0.1 to 0.47
|
SECONDARY outcome
Timeframe: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)Population: Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure.
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of gender (male versus female) on SVR. SVR was defined as HCV RNA level undetectable (\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Outcome measures
| Measure |
Pegylated Interferon Alfa-2a and Ribavirin
n=225 Participants
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
|
|---|---|
|
OR for Impact of Gender on SVR
|
0.48 odds ratio
Interval 0.13 to 1.69
|
SECONDARY outcome
Timeframe: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)Population: Analysis population included all treated participants.
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of body weight on SVR. SVR was defined as HCV RNA level undetectable (\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Outcome measures
| Measure |
Pegylated Interferon Alfa-2a and Ribavirin
n=516 Participants
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
|
|---|---|
|
OR for Impact of Body Weight on SVR
|
1.01 odds ratio
Interval 0.99 to 1.02
|
SECONDARY outcome
Timeframe: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)Population: Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure.
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline level of fibrosis on SVR. Level of fibrosis was measured in terms of kilopascals (kPa) using elastography. kPa score was categorized in 4 groups: 0 to 6.0; 6.1 to 9.9; 10.0 to 14.5; and 14.6 and above. SVR was defined as HCV RNA level undetectable (\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Outcome measures
| Measure |
Pegylated Interferon Alfa-2a and Ribavirin
n=186 Participants
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
|
|---|---|
|
OR for Impact of Baseline Level of Fibrosis (kPa) on SVR
|
0.53 odds ratio
Interval 0.38 to 0.74
|
SECONDARY outcome
Timeframe: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)Population: Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure.
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline ALT level (\>40 international units per liter \[IU/L\] versus \<=40 IU/L) on SVR. SVR was defined as HCV RNA level undetectable (\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Outcome measures
| Measure |
Pegylated Interferon Alfa-2a and Ribavirin
n=215 Participants
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
|
|---|---|
|
OR for Impact of Baseline Alanine Transaminase (ALT) Level on SVR
|
0.12 odds ratio
Interval 0.02 to 0.92
|
SECONDARY outcome
Timeframe: Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)Population: Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure.
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline viral load count (\>800000 IU/mL versus \<=800000 IU/mL) on SVR. SVR was defined as HCV RNA level undetectable (\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Outcome measures
| Measure |
Pegylated Interferon Alfa-2a and Ribavirin
n=219 Participants
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
|
|---|---|
|
OR for Impact of Baseline Viral Load Count on SVR
|
1.07 odds ratio
Interval 0.56 to 2.03
|
SECONDARY outcome
Timeframe: Baseline up to 96 weeks (assessed at Baseline, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)Population: Analysis population included all treated participants.
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of overall duration of treatment on SVR. SVR was defined as HCV RNA level undetectable (\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Outcome measures
| Measure |
Pegylated Interferon Alfa-2a and Ribavirin
n=516 Participants
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
|
|---|---|
|
OR for Impact of Overall Duration of Treatment on SVR
|
1.05 odds ratio
Interval 0.59 to 1.86
|
SECONDARY outcome
Timeframe: Baseline up to 96 weeks (assessed at Baseline, Week 4, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)Population: Analysis population included all treated participants.
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving RVR (\>18 weeks versus \<=18 weeks) on SVR. RVR was defined as HCV RNA \<=25 IU/mL at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Outcome measures
| Measure |
Pegylated Interferon Alfa-2a and Ribavirin
n=516 Participants
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
|
|---|---|
|
OR for Impact of Duration of Treatment After Achieving RVR on SVR
|
1.04 odds ratio
Interval 0.92 to 1.18
|
SECONDARY outcome
Timeframe: Baseline up to 96 weeks (assessed at Baseline, Weeks 4, 12, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)Population: Analysis population included all treated participants.
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving cEVR (\>11 weeks versus \<=11 weeks) on SVR. cEVR was defined as HCV RNA \<=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Outcome measures
| Measure |
Pegylated Interferon Alfa-2a and Ribavirin
n=516 Participants
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
|
|---|---|
|
OR for Impact of Duration of Treatment After Achieving cEVR on SVR
|
2.77 odds ratio
Interval 1.14 to 6.72
|
SECONDARY outcome
Timeframe: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeksPopulation: Analysis population included all treated participants.
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of pegylated interferon alfa-2a on SVR. SVR was defined as HCV RNA level undetectable (\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Outcome measures
| Measure |
Pegylated Interferon Alfa-2a and Ribavirin
n=516 Participants
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
|
|---|---|
|
OR for Impact of Cumulative Doses of Pegylated Interferon Alfa-2a on SVR
|
0.99 odds ratio
Interval 0.99 to 1.0
|
SECONDARY outcome
Timeframe: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeksPopulation: Analysis population included all treated participants.
The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of ribavirin on SVR. SVR was defined as HCV RNA level undetectable (\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Outcome measures
| Measure |
Pegylated Interferon Alfa-2a and Ribavirin
n=516 Participants
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
|
|---|---|
|
OR for Impact of Cumulative Doses of Ribavirin on SVR
|
0.99 odds ratio
Interval 0.99 to 1.0
|
Adverse Events
Pegylated Interferon Alfa-2a and Ribavirin
Serious adverse events
| Measure |
Pegylated Interferon Alfa-2a and Ribavirin
n=516 participants at risk
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Blood and lymphatic system disorders
Anemia fourth degree
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.39%
2/516 • Baseline up to 96 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia fourth degree
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Blood and lymphatic system disorders
Neutropenia fourth degree
|
1.2%
6/516 • Baseline up to 96 weeks
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Infections and infestations
Pneumonia
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Gastrointestinal disorders
Rectal bleeding
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Gastrointestinal disorders
Lingual bleeding
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Cardiac disorders
Tachyarrhythmia
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Nervous system disorders
Agitation
|
0.19%
1/516 • Baseline up to 96 weeks
|
Other adverse events
| Measure |
Pegylated Interferon Alfa-2a and Ribavirin
n=516 participants at risk
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.9%
10/516 • Baseline up to 96 weeks
|
|
Blood and lymphatic system disorders
Bilirubinemia
|
0.39%
2/516 • Baseline up to 96 weeks
|
|
Blood and lymphatic system disorders
Thyrotoxicosis second degree
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
16/516 • Baseline up to 96 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia second degree
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia third degree
|
0.97%
5/516 • Baseline up to 96 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.97%
5/516 • Baseline up to 96 weeks
|
|
Blood and lymphatic system disorders
Leukopenia second degree
|
0.78%
4/516 • Baseline up to 96 weeks
|
|
Blood and lymphatic system disorders
Leukopenia third degree
|
0.78%
4/516 • Baseline up to 96 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.7%
14/516 • Baseline up to 96 weeks
|
|
Blood and lymphatic system disorders
Neutropenia second degree
|
0.58%
3/516 • Baseline up to 96 weeks
|
|
Blood and lymphatic system disorders
Neutropenia third degree
|
4.5%
23/516 • Baseline up to 96 weeks
|
|
Blood and lymphatic system disorders
Liver enzymes incresed (ALT, AST other)
|
1.2%
6/516 • Baseline up to 96 weeks
|
|
Cardiac disorders
ST elevation
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Cardiac disorders
Hypertension
|
0.58%
3/516 • Baseline up to 96 weeks
|
|
Cardiac disorders
Hypotension
|
0.39%
2/516 • Baseline up to 96 weeks
|
|
Cardiac disorders
Tachycardia
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Cardiac disorders
Paresthesia (numbness in hands)
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Cardiac disorders
Hemorrhoid varicose veins
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Cardiac disorders
Hyperemia
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Cardiac disorders
Flushing
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia/hair loss
|
0.97%
5/516 • Baseline up to 96 weeks
|
|
Skin and subcutaneous tissue disorders
Itching/pruritus
|
1.7%
9/516 • Baseline up to 96 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.2%
6/516 • Baseline up to 96 weeks
|
|
Skin and subcutaneous tissue disorders
Anal itching
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.78%
4/516 • Baseline up to 96 weeks
|
|
Skin and subcutaneous tissue disorders
Herpes rash
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Skin and subcutaneous tissue disorders
Left nostril furuncle
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Skin and subcutaneous tissue disorders
Sweating - general
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Skin and subcutaneous tissue disorders
Dry mouth
|
0.58%
3/516 • Baseline up to 96 weeks
|
|
Skin and subcutaneous tissue disorders
Toxidermia
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Skin and subcutaneous tissue disorders
Sty
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.6%
65/516 • Baseline up to 96 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.5%
18/516 • Baseline up to 96 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.39%
2/516 • Baseline up to 96 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness in legs
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Immune system disorders
Allergic reactions
|
1.6%
8/516 • Baseline up to 96 weeks
|
|
Immune system disorders
Autoimmune thyroiditis
|
0.39%
2/516 • Baseline up to 96 weeks
|
|
Nervous system disorders
Headache
|
6.0%
31/516 • Baseline up to 96 weeks
|
|
Nervous system disorders
Irritability
|
1.6%
8/516 • Baseline up to 96 weeks
|
|
Nervous system disorders
Migraine
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Nervous system disorders
Dizziness
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Nervous system disorders
Sexual potency impairment
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
9/516 • Baseline up to 96 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Flue-like syndrome
|
2.9%
15/516 • Baseline up to 96 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sour throat
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.97%
5/516 • Baseline up to 96 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.39%
2/516 • Baseline up to 96 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.39%
2/516 • Baseline up to 96 weeks
|
|
Gastrointestinal disorders
Heartburn
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper/epigastric pain
|
0.58%
3/516 • Baseline up to 96 weeks
|
|
Gastrointestinal disorders
Meteorism (flatulence)
|
0.39%
2/516 • Baseline up to 96 weeks
|
|
Gastrointestinal disorders
Ascites
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
General disorders
Fatigue
|
0.58%
3/516 • Baseline up to 96 weeks
|
|
General disorders
Pyrexia
|
24.8%
128/516 • Baseline up to 96 weeks
|
|
General disorders
Adynamy
|
1.9%
10/516 • Baseline up to 96 weeks
|
|
General disorders
General weakness
|
14.5%
75/516 • Baseline up to 96 weeks
|
|
General disorders
Rigors
|
0.39%
2/516 • Baseline up to 96 weeks
|
|
General disorders
Sweating - general
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Eye disorders
Blurred vision
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Ear and labyrinth disorders
Earache
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
0.39%
2/516 • Baseline up to 96 weeks
|
|
Renal and urinary disorders
Scalding during urination/urine scald
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Renal and urinary disorders
Sexual potency impairment
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Metabolism and nutrition disorders
Weight decrease
|
0.19%
1/516 • Baseline up to 96 weeks
|
|
Metabolism and nutrition disorders
Hyperthyroidism
|
0.78%
4/516 • Baseline up to 96 weeks
|
|
Metabolism and nutrition disorders
Hypothyroidism
|
0.39%
2/516 • Baseline up to 96 weeks
|
|
Metabolism and nutrition disorders
Loss of appetite
|
1.6%
8/516 • Baseline up to 96 weeks
|
|
Psychiatric disorders
Anxiety
|
1.9%
10/516 • Baseline up to 96 weeks
|
|
Psychiatric disorders
Depression
|
1.9%
10/516 • Baseline up to 96 weeks
|
|
Psychiatric disorders
Insomnia
|
2.1%
11/516 • Baseline up to 96 weeks
|
|
Psychiatric disorders
Emotional liability
|
0.58%
3/516 • Baseline up to 96 weeks
|
Additional Information
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