Trial Outcomes & Findings for ACCELERATE Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC) Infection. (NCT NCT00077636)
NCT ID: NCT00077636
Last Updated: 2016-02-23
Results Overview
SVR was defined as the percentage of participants with undetectable HCV RNA at 24 weeks after the completion of the study treatment. The negative assessment was required to be the last one collected at or after week 36 (ie, on or after study Day 253) for the 16-week treatment group or at or after week 44 (ie, on or after study Day 309) for the 24-week treatment group.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1469 participants
Primary outcome timeframe
Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)
Results posted on
2016-02-23
Participant Flow
The study was conducted in 8 countries from 20 November 2003 to 13 September 2005.
A total of 1400 participants were planned for the study; 1469 were randomized (736 were assigned to the 16-week treatment group and 733 were assigned to the 24-week treatment group) and 1465 received the study treatment.
Participant milestones
| Measure |
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks
Participants received 180 micrograms (mcg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
|
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks
Participants received 180 mcg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
736
|
733
|
|
Overall Study
COMPLETED
|
692
|
641
|
|
Overall Study
NOT COMPLETED
|
44
|
92
|
Reasons for withdrawal
| Measure |
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks
Participants received 180 micrograms (mcg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
|
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks
Participants received 180 mcg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
|
|---|---|---|
|
Overall Study
Refused Treatment
|
9
|
31
|
|
Overall Study
Admin
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Adverse Event
|
17
|
34
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
10
|
18
|
|
Overall Study
Abnormality Of Laboratory Test
|
3
|
2
|
Baseline Characteristics
ACCELERATE Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC) Infection.
Baseline characteristics by cohort
| Measure |
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks
n=736 Participants
Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
|
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks
n=733 Participants
Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
|
Total
n=1469 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.1 Years
STANDARD_DEVIATION 9.83 • n=99 Participants
|
45.6 Years
STANDARD_DEVIATION 9.98 • n=107 Participants
|
45.8 Years
STANDARD_DEVIATION 9.90 • n=206 Participants
|
|
Sex: Female, Male
Female
|
285 Participants
n=99 Participants
|
271 Participants
n=107 Participants
|
556 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
451 Participants
n=99 Participants
|
462 Participants
n=107 Participants
|
913 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)Population: Standard population: The standard population includes all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations.
SVR was defined as the percentage of participants with undetectable HCV RNA at 24 weeks after the completion of the study treatment. The negative assessment was required to be the last one collected at or after week 36 (ie, on or after study Day 253) for the 16-week treatment group or at or after week 44 (ie, on or after study Day 309) for the 24-week treatment group.
Outcome measures
| Measure |
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks
n=679 Participants
Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
|
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks
n=630 Participants
Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With Sustained Virological Response (SVR)
|
65 percentage of participants
|
76 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group)Population: Standard population: The standard population included all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations.
Virological response was defined as the percentage of participants with undetectable HCV RNA at the completion of the study treatment. The negative assessment was required to be the last one collected in the Week 16 time window for the 16-week treatment group or in the Week 24 time window for the 24-week treatment group.
Outcome measures
| Measure |
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks
n=679 Participants
Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
|
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks
n=630 Participants
Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With Virological Response at The End of Study Treatment
|
94 Percentage of participants
|
92 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group)Population: Standard population: The standard population included all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations.
Virological response 12 weeks post-treatment was defined as the percentage of participants with undetectable HCV RNA 12 weeks after the completion of the study treatment . The negative assessment was required to be the last one collected in the week 28 time window for the 16- week treatment group or in the week 36 time window for the 24-week treatment group.
Outcome measures
| Measure |
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks
n=679 Participants
Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
|
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks
n=630 Participants
Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
|
|---|---|---|
|
Percentage of Participants Virological Response 12 Weeks Post-Treatment
|
59 Percentage of participants
|
69 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 40 and Week 48Population: Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.
An adverse event was defined as any untoward medical occurrence that occurred during he course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
Outcome measures
| Measure |
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks
n=731 Participants
Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
|
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks
n=728 Participants
Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE
|
97 Percentage of participants
|
99 Percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAE
|
5 Percentage of participants
|
6 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 40 and Week 48Population: Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.
Participants with changes in Hematocrit: Fraction 0.36 - 0.60 g/dL, Hemoglobin: 11.0 -20.0 g/dL, WBC 3.0 - 18.0 g/dL, Platelets 100 - 700 g/dL, Basophils 0.00 - 0.30 g/dL, Lymphocytes 1.00 - 6.30 g/dL, Monocytes 0.08 - 2.00 g/dL, Neutrophils 1.50 or more g/dL, Eosinophils 0.00 - 1.50 g/dL , PTT 0 - 50 seconds, Alkaline Phosphatase 0 - 190 and ASAT 0 - 50 U/L, ALAT 0 - 60 U/L, Gamma - GT 0 - 120 U/L, Total Protein 55 - 87 g/L ;Albumin 27.0 or more g/L, Total Bilirubin 0 - 34.2 μmol/L, BUN 0 - 14.3 mmol/L, Creatinine 0 - 154 μmol/L, Free T3, T4 5 - 40 pmol/L, TSH 0.0 - 10.0 mU/L, Cholesterol 0.0 - 8.3 mmol/L; Triglycerides 0.00 - 2.83 mmol/L, Chloride 95 - 115 mmol/L; Potassium 3.0 - 6.0 mmol/L; Sodium 130 - 150 mmol/L, miscellaneous: Calcium 2.00 - 2.90 mmol/L; Phosphate 0.75 - 1.60 mmol/L; Blood Glucose (Random) 2.80 - 11.10 mmol/L, Uric Acid 0 - 600 μmol/L, Proteinuria, Glycosuria, Hematuria (Qualitative 0 to 4+) 0 - 1 were analysed for the laboratory abnormality.
Outcome measures
| Measure |
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks
n=731 Participants
Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
|
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks
n=728 Participants
Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With Marked Laboratory Abnormalities
Hemoglobin (g/dL)- low, n=731,727
|
15 Percentage of participants
|
16 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Neutrophils (10^9/L)- low, n=731,727
|
69 Percentage of participants
|
75 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Total protein (g/L)- high, n=731,728
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Potassium (mmol/L)- low, n=731,728
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Sodium (mmol/L) - high, n=731,728
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Free T4 (pmol/L)- low, n=716,715
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
TSH (mU/L)- high, n=716,715
|
2 Percentage of participants
|
6 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Cholesterol (mmol/L)- high, n=730,728
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Phosphate (mmol/L)- high, n=730,728
|
2 Percentage of participants
|
2 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Phosphate (mmol/L)- low, n=730,728
|
18 Percentage of participants
|
21 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Uric acid (umol/L)- high, n=730,728
|
2 Percentage of participants
|
2 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Hematuria (0 to 4+) high, n= 721,716
|
4 Percentage of participants
|
4 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Proteinuria (0 to 4+) - high, n= 721,716
|
0 Percentage of participants
|
2 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Miscellaneous: calcium (mmol/L)- low, n= 731,728
|
1 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Hematocrit (fraction)- low n=731,728
|
18 Percentage of participants
|
21 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Platelets(10^9/L)- low,n=731,727
|
24 Percentage of participants
|
22 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Basophils(10^9/L)- high, n=731,727
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
WBC (10^9/L)- low, n=731,727
|
64 Percentage of participants
|
71 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
WBC (10^9/L)- high, n=731,727
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Eosinophils (10^9/L )- high, n=731,727
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Lymphocytes (10^9/L)- low, n=731,727
|
49 Percentage of participants
|
57 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Monocytes (10^9/L )- low, n=731,727
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Partial throm.(seconds)- high, n=730,728
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Liver function: ALAT (SGPT) (U/L)- HIGH n=731,728
|
15 Percentage of participants
|
10 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Albumin (g/L)- low, n=730,728
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Alk. Phos.(U/L)- high,n=731,728
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
ASAT (SGOT) (U/L)- high,n= 731,727
|
15 Percentage of participants
|
10 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
GGT (U/L)- high,n=731,728
|
12 Percentage of participants
|
10 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Total bilirubin (umol/L)- high, n=731,728
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Renal function: bun (mmol/L)- high, n=731,728
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Chloride (mmol/L)- high, n=731,728
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Chloride (mmol/L)- low, n=731,728
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Creatinine (umol/L)- high, n=731,728
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Potassium (mmol/L)- high, n=731,728
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Sodium (mmol/L)- low,n=731,728
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Thyroid function: free T4 (pmol/)- high, n=716,715
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Random glucose (mmol/L)- high, n= 731,728
|
2 Percentage of participants
|
1 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Random glucose (mmol/L)- low, n= 731,728
|
2 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Triglycerides (mmol/L)- high, n=730,728
|
31 Percentage of participants
|
33 Percentage of participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities
Urinalysis: glycosuria (0 to 4+)- high, n= 721,71
|
0 Percentage of participants
|
1 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 40 and Week 48Population: Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.
Participants with changes in Systolic and diastolic blood pressure, heart rate were analysed abnormal vital signs.
Outcome measures
| Measure |
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks
n=731 Participants
Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
|
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks
n=728 Participants
Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
|
|---|---|---|
|
Participants With Marked Abnormal Vital Signs
Diastolic BP, High, n=729,726
|
4 participants
|
3 participants
|
|
Participants With Marked Abnormal Vital Signs
Systolic BP, High, n=729,726
|
2 participants
|
2 participants
|
|
Participants With Marked Abnormal Vital Signs
Systolic BP, Low, n=729,726
|
9 participants
|
2 participants
|
|
Participants With Marked Abnormal Vital Signs
Heart Rate, High, n=728,725
|
2 participants
|
3 participants
|
|
Participants With Marked Abnormal Vital Signs
Heart Rate, Low, n=728,725
|
4 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Up to Week 40 and Week 48Population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.
Participants with triglyceride level above normal (i.e. \< 200 mg/dL) were analysed.
Outcome measures
| Measure |
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks
n=731 Participants
Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
|
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks
n=728 Participants
Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With Highest Triglyceride Level
200 - 400 mg/dL
|
280 participants
|
284 participants
|
|
Number of Participants With Highest Triglyceride Level
>400 - 1000 mg/dL
|
117 participants
|
138 participants
|
|
Number of Participants With Highest Triglyceride Level
>1000 mg/dL
|
17 participants
|
14 participants
|
Adverse Events
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks
Serious events: 34 serious events
Other events: 696 other events
Deaths: 0 deaths
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks
Serious events: 47 serious events
Other events: 713 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks
n=731 participants at risk
Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
|
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks
n=728 participants at risk
Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.41%
3/731 • Up to week 48
An adverse event 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.
|
0.41%
3/728 • Up to week 48
An adverse event 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.
|
|
Infections and infestations
Cellulitis
|
0.27%
2/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.27%
2/728 • Up to week 48
An adverse event 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.
|
|
Infections and infestations
Pyelonephritis
|
0.27%
2/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Infections and infestations
Staphylococcal infection
|
0.27%
2/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Infections and infestations
Subcutaneous abscess
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Infections and infestations
Abscess limb
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Infections and infestations
Keratitis herpetic
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Infections and infestations
Lobar pneumonia
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Infections and infestations
Meningitis viral
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Infections and infestations
Osteomyelitis
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Infections and infestations
Septic shock
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.27%
2/728 • Up to week 48
An adverse event 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.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Gastrointestinal disorders
Vomiting
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Gastrointestinal disorders
Dysphagia
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Gastrointestinal disorders
Volvulus of bowel
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.55%
4/728 • Up to week 48
An adverse event 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.
|
|
Psychiatric disorders
Depression
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.27%
2/728 • Up to week 48
An adverse event 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.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Psychiatric disorders
Homicidal ideation
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Psychiatric disorders
Psychotic disorder
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.27%
2/731 • Up to week 48
An adverse event 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.
|
0.27%
2/728 • Up to week 48
An adverse event 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.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Injury, poisoning and procedural complications
Cervical vertebra injury
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.27%
2/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
General disorders
Chest pain
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.27%
2/728 • Up to week 48
An adverse event 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.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
General disorders
Pyrexia
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Nervous system disorders
Syncope
|
0.27%
2/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Nervous system disorders
Mononeuropathy multiplex
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Cardiac disorders
Angina pectoris
|
0.27%
2/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.27%
2/728 • Up to week 48
An adverse event 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.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Eye disorders
Retinal artery thrombosis
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Eye disorders
Retinal exudates
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.27%
2/728 • Up to week 48
An adverse event 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Renal and urinary disorders
Renal failure acute
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Vascular disorders
Deep vein thrombosis
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Vascular disorders
Thrombophlebitis
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/731 • Up to week 48
An adverse event 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.
|
0.14%
1/728 • Up to week 48
An adverse event 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.
|
|
Immune system disorders
Hypersensitivity
|
0.14%
1/731 • Up to week 48
An adverse event 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.
|
0.00%
0/728 • Up to week 48
An adverse event 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.
|
Other adverse events
| Measure |
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks
n=731 participants at risk
Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
|
PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks
n=728 participants at risk
Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
|
|---|---|---|
|
Eye disorders
Vision blurred
|
5.1%
37/731 • Up to week 48
An adverse event 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.
|
5.2%
38/728 • Up to week 48
An adverse event 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.9%
36/731 • Up to week 48
An adverse event 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.
|
6.5%
47/728 • Up to week 48
An adverse event 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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
43/731 • Up to week 48
An adverse event 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.
|
5.5%
40/728 • Up to week 48
An adverse event 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.8%
123/731 • Up to week 48
An adverse event 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.
|
22.7%
165/728 • Up to week 48
An adverse event 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.
|
|
Gastrointestinal disorders
Dry mouth
|
3.7%
27/731 • Up to week 48
An adverse event 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.
|
5.1%
37/728 • Up to week 48
An adverse event 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.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
33/731 • Up to week 48
An adverse event 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.
|
5.8%
42/728 • Up to week 48
An adverse event 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.
|
|
Gastrointestinal disorders
Nausea
|
31.5%
230/731 • Up to week 48
An adverse event 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.
|
33.9%
247/728 • Up to week 48
An adverse event 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.
|
|
Gastrointestinal disorders
Vomiting
|
11.9%
87/731 • Up to week 48
An adverse event 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.
|
10.7%
78/728 • Up to week 48
An adverse event 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.
|
|
General disorders
Asthenia
|
13.0%
95/731 • Up to week 48
An adverse event 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.
|
14.8%
108/728 • Up to week 48
An adverse event 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.
|
|
General disorders
Chills
|
20.5%
150/731 • Up to week 48
An adverse event 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.
|
20.1%
146/728 • Up to week 48
An adverse event 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.
|
|
General disorders
Fatigue
|
48.7%
356/731 • Up to week 48
An adverse event 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.
|
54.0%
393/728 • Up to week 48
An adverse event 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.
|
|
General disorders
Injection site erythema
|
10.8%
79/731 • Up to week 48
An adverse event 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.
|
14.1%
103/728 • Up to week 48
An adverse event 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.
|
|
General disorders
Pain
|
8.3%
61/731 • Up to week 48
An adverse event 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.
|
10.0%
73/728 • Up to week 48
An adverse event 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.
|
|
General disorders
Pyrexia
|
25.6%
187/731 • Up to week 48
An adverse event 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.
|
25.3%
184/728 • Up to week 48
An adverse event 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
26/731 • Up to week 48
An adverse event 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.
|
5.4%
39/728 • Up to week 48
An adverse event 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.
|
|
Metabolism and nutrition disorders
Anorexia
|
10.1%
74/731 • Up to week 48
An adverse event 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.
|
10.2%
74/728 • Up to week 48
An adverse event 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.4%
69/731 • Up to week 48
An adverse event 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.
|
9.8%
71/728 • Up to week 48
An adverse event 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.0%
139/731 • Up to week 48
An adverse event 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.
|
20.9%
152/728 • Up to week 48
An adverse event 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.4%
69/731 • Up to week 48
An adverse event 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.
|
9.3%
68/728 • Up to week 48
An adverse event 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.7%
188/731 • Up to week 48
An adverse event 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.
|
27.3%
199/728 • Up to week 48
An adverse event 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.1%
30/731 • Up to week 48
An adverse event 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.
|
5.4%
39/728 • Up to week 48
An adverse event 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.
|
|
Nervous system disorders
Disturbance in attention
|
5.3%
39/731 • Up to week 48
An adverse event 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.
|
7.4%
54/728 • Up to week 48
An adverse event 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.
|
|
Nervous system disorders
Dizziness
|
10.4%
76/731 • Up to week 48
An adverse event 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.
|
12.5%
91/728 • Up to week 48
An adverse event 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.
|
|
Nervous system disorders
Headache
|
39.0%
285/731 • Up to week 48
An adverse event 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.
|
46.3%
337/728 • Up to week 48
An adverse event 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.
|
|
Psychiatric disorders
Anxiety
|
10.7%
78/731 • Up to week 48
An adverse event 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.
|
11.0%
80/728 • Up to week 48
An adverse event 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.
|
|
Psychiatric disorders
Depression
|
20.2%
148/731 • Up to week 48
An adverse event 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.
|
22.4%
163/728 • Up to week 48
An adverse event 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.
|
|
Psychiatric disorders
Insomnia
|
32.0%
234/731 • Up to week 48
An adverse event 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.
|
37.4%
272/728 • Up to week 48
An adverse event 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.
|
|
Psychiatric disorders
Irritability
|
21.3%
156/731 • Up to week 48
An adverse event 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.
|
25.3%
184/728 • Up to week 48
An adverse event 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.0%
88/731 • Up to week 48
An adverse event 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.
|
12.0%
87/728 • Up to week 48
An adverse event 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.0%
88/731 • Up to week 48
An adverse event 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.
|
12.8%
93/728 • Up to week 48
An adverse event 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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.8%
86/731 • Up to week 48
An adverse event 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.
|
14.0%
102/728 • Up to week 48
An adverse event 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.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.6%
63/731 • Up to week 48
An adverse event 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.
|
11.8%
86/728 • Up to week 48
An adverse event 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.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.1%
37/731 • Up to week 48
An adverse event 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.
|
6.5%
47/728 • Up to week 48
An adverse event 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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.6%
107/731 • Up to week 48
An adverse event 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.
|
19.2%
140/728 • Up to week 48
An adverse event 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.0%
124/731 • Up to week 48
An adverse event 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.
|
16.2%
118/728 • Up to week 48
An adverse event 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.
|
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