Trial Outcomes & Findings for A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection (NCT NCT02673489)
NCT ID: NCT02673489
Last Updated: 2018-05-08
Results Overview
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
106 participants
Primary outcome timeframe
Week 12
Results posted on
2018-05-08
Participant Flow
Of the 106 subjects enrolled, 78 participants entered the treatment period and received study treatment; 28 participants were enrolled but did not enter the treatment period. 26 were due to no longer meeting study criteria; 1 was due to poor/non-compliance (missed Day 1 visit); and 1 was other (missed screening window).
Participant milestones
| Measure |
Treatment Naive
HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
|
Treatment Experienced
HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
|
|---|---|---|
|
Treatment Period
STARTED
|
54
|
24
|
|
Treatment Period
COMPLETED
|
49
|
21
|
|
Treatment Period
NOT COMPLETED
|
5
|
3
|
|
Follow Up Period
STARTED
|
50
|
23
|
|
Follow Up Period
COMPLETED
|
50
|
21
|
|
Follow Up Period
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Treatment Naive
HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
|
Treatment Experienced
HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
|
|---|---|---|
|
Treatment Period
Lost to Follow-up
|
3
|
0
|
|
Treatment Period
Participant request to discontinue
|
1
|
1
|
|
Treatment Period
Participant moved to another province
|
1
|
0
|
|
Treatment Period
Participant was incarcerated
|
0
|
1
|
|
Treatment Period
Adverse Event
|
0
|
1
|
|
Follow Up Period
Unable to return for week 24 follow-up
|
0
|
1
|
|
Follow Up Period
Unable to return for follow-up
|
0
|
1
|
Baseline Characteristics
All Treated Participants
Baseline characteristics by cohort
| Measure |
Treatment Naive
n=54 Participants
HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
|
Treatment Experienced
n=24 Participants
HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 Years
STANDARD_DEVIATION 7.97 • n=5 Participants • All Treated Participants
|
55.3 Years
STANDARD_DEVIATION 4.90 • n=7 Participants • All Treated Participants
|
54.4 Years
STANDARD_DEVIATION 7.16 • n=5 Participants • All Treated Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants • All Treated Participants
|
7 Participants
n=7 Participants • All Treated Participants
|
21 Participants
n=5 Participants • All Treated Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants • All Treated Participants
|
17 Participants
n=7 Participants • All Treated Participants
|
57 Participants
n=5 Participants • All Treated Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
27 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All treated participants
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach.
Outcome measures
| Measure |
HCV Treatment Naive
n=54 Participants
HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
|
HCV Treatment Experienced
n=24 Participants
HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR12)
|
92.6 Percentage of participants
Interval 82.1 to 97.9
|
75.0 Percentage of participants
Interval 53.3 to 90.2
|
SECONDARY outcome
Timeframe: Week 12 (Follow-up period)Population: All treated participants
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach.
Outcome measures
| Measure |
HCV Treatment Naive
n=54 Participants
HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
|
HCV Treatment Experienced
n=24 Participants
HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
|
|---|---|---|
|
Percentage of Participants Who Achieve SVR12 in the Presence and Absence of Baseline NS5A (Non-structural Protein 5A) Resistance-associated Polymorphisms
NS5A-Y93 Polymorphism: YES
|
85.7 Percentage of participants
Interval 42.1 to 99.6
|
0.0 Percentage of participants
Interval 0.0 to 97.5
|
|
Percentage of Participants Who Achieve SVR12 in the Presence and Absence of Baseline NS5A (Non-structural Protein 5A) Resistance-associated Polymorphisms
NS5A-Y93 Polymorphism: NO
|
93.6 Percentage of participants
Interval 82.5 to 98.7
|
78.3 Percentage of participants
Interval 56.3 to 92.5
|
SECONDARY outcome
Timeframe: At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment (24 weeks), Follow Up Week 4 (28 weeks), Follow Up Week 12 (36 weeks), Follow Up Week 24 (48 weeks)Population: All treated participants
HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria. SVR12 is based on Next Value Carried Backwards approach.
Outcome measures
| Measure |
HCV Treatment Naive
n=54 Participants
HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
|
HCV Treatment Experienced
n=24 Participants
HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
|
|---|---|---|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24
Week 20
|
94.4 Percentage
Interval 84.6 to 98.8
|
83.3 Percentage
Interval 62.6 to 95.3
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24
Follow Up Week 4
|
88.9 Percentage
Interval 77.4 to 95.8
|
79.2 Percentage
Interval 57.8 to 92.9
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24
Follow Up Week 24
|
92.6 Percentage
Interval 82.1 to 97.9
|
66.7 Percentage
Interval 44.7 to 84.4
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24
Week 1
|
14.8 Percentage
Interval 6.6 to 27.1
|
12.5 Percentage
Interval 2.7 to 32.4
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24
Week 2
|
50.0 Percentage
Interval 36.1 to 63.9
|
54.2 Percentage
Interval 32.8 to 74.4
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24
Week 4
|
92.6 Percentage
Interval 82.1 to 97.9
|
75.0 Percentage
Interval 53.3 to 90.2
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24
Week 8
|
98.1 Percentage
Interval 90.1 to 100.0
|
91.7 Percentage
Interval 73.0 to 99.0
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24
Week 12
|
92.6 Percentage
Interval 82.1 to 97.9
|
87.5 Percentage
Interval 67.6 to 97.3
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24
Week 16
|
90.7 Percentage
Interval 79.7 to 96.9
|
83.3 Percentage
Interval 62.6 to 95.3
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24
Week 24
|
88.9 Percentage
Interval 77.4 to 95.8
|
87.5 Percentage
Interval 67.6 to 97.3
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24
End of Treatment
|
100.0 Percentage
Interval 93.4 to 100.0
|
91.7 Percentage
Interval 73.0 to 99.0
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24
Follow Up Week 12 (Imputed)
|
92.6 Percentage
Interval 82.1 to 97.9
|
75.0 Percentage
Interval 53.3 to 90.2
|
SECONDARY outcome
Timeframe: At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment, Follow Up Week 4, Follow Up Week 12, Follow Up Week 24Population: All treated participants
HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria.
Outcome measures
| Measure |
HCV Treatment Naive
n=54 Participants
HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
|
HCV Treatment Experienced
n=24 Participants
HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
|
|---|---|---|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24
Week 1
|
1.9 Percentage
Interval 0.0 to 9.9
|
0.0 Percentage
Interval 0.0 to 14.2
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24
Week 2
|
11.1 Percentage
Interval 4.2 to 22.6
|
12.5 Percentage
Interval 2.7 to 32.4
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24
Week 4
|
64.8 Percentage
Interval 50.6 to 77.3
|
62.5 Percentage
Interval 40.6 to 81.2
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24
Week 8
|
94.4 Percentage
Interval 84.6 to 98.8
|
83.3 Percentage
Interval 62.6 to 95.3
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24
Week 12
|
90.7 Percentage
Interval 79.7 to 96.9
|
83.3 Percentage
Interval 62.6 to 95.3
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24
Week 16
|
90.7 Percentage
Interval 79.7 to 96.9
|
79.2 Percentage
Interval 57.8 to 92.9
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24
Week 20
|
94.4 Percentage
Interval 84.6 to 98.8
|
83.3 Percentage
Interval 62.6 to 95.3
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24
Week 24
|
88.9 Percentage
Interval 77.4 to 95.8
|
83.3 Percentage
Interval 62.6 to 95.3
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24
End of Treatment
|
100.0 Percentage
Interval 93.4 to 100.0
|
87.5 Percentage
Interval 67.6 to 97.3
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24
Follow Up Week 4
|
88.9 Percentage
Interval 77.4 to 95.8
|
79.2 Percentage
Interval 57.8 to 92.9
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24
Follow Up Week 12
|
90.7 Percentage
Interval 79.7 to 96.9
|
75.0 Percentage
Interval 53.3 to 90.2
|
|
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24
Follow Up Week 24
|
90.7 Percentage
Interval 79.7 to 96.9
|
66.7 Percentage
Interval 44.7 to 84.4
|
Adverse Events
Overall: Daclatasvir(DCV) + Sofosbuvir(SOF) + Ribavirin(RBV)
Serious events: 8 serious events
Other events: 63 other events
Deaths: 0 deaths
HCV Treatment Naive
Serious events: 4 serious events
Other events: 44 other events
Deaths: 0 deaths
HCV Treatment Experienced
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Overall: Daclatasvir(DCV) + Sofosbuvir(SOF) + Ribavirin(RBV)
n=78 participants at risk
Oral dosing of DCV 60 mg tablet once daily + SOF 400 mg tablet once daily + RBV 1000-1200 mg tablet per day (weight based) for 24 weeks.
|
HCV Treatment Naive
n=54 participants at risk
HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
|
HCV Treatment Experienced
n=24 participants at risk
HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
|
|---|---|---|---|
|
Gastrointestinal disorders
Ascites
|
1.3%
1/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
1.9%
1/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
0.00%
0/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
General disorders
Chest discomfort
|
1.3%
1/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
1.9%
1/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
0.00%
0/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Hepatobiliary disorders
Cholecystitis
|
1.3%
1/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
0.00%
0/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
4.2%
1/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Infections and infestations
Bronchiolitis
|
1.3%
1/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
1.9%
1/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
0.00%
0/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Infections and infestations
Streptococcal bacteraemia
|
1.3%
1/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
0.00%
0/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
4.2%
1/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
2.6%
2/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
1.9%
1/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
4.2%
1/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Injury, poisoning and procedural complications
Overdose
|
1.3%
1/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
1.9%
1/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
0.00%
0/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Psychiatric disorders
Depression
|
1.3%
1/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
0.00%
0/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
4.2%
1/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
Other adverse events
| Measure |
Overall: Daclatasvir(DCV) + Sofosbuvir(SOF) + Ribavirin(RBV)
n=78 participants at risk
Oral dosing of DCV 60 mg tablet once daily + SOF 400 mg tablet once daily + RBV 1000-1200 mg tablet per day (weight based) for 24 weeks.
|
HCV Treatment Naive
n=54 participants at risk
HCV treatment-naive: No previous exposure to any interferon (IFN) formulation (ie, IFN or peg-IFN), RBV, or any HCV DAAs
|
HCV Treatment Experienced
n=24 participants at risk
HCV treatment-experienced: Previous treatment with IFN/RBV, SOF + RBV, and other anti-HCV agents
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.8%
10/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
11.1%
6/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
16.7%
4/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
5.1%
4/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
5.6%
3/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
4.2%
1/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
4/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
5.6%
3/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
4.2%
1/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Gastrointestinal disorders
Nausea
|
24.4%
19/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
24.1%
13/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
25.0%
6/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Gastrointestinal disorders
Toothache
|
6.4%
5/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
5.6%
3/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
8.3%
2/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
4/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
5.6%
3/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
4.2%
1/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
General disorders
Fatigue
|
43.6%
34/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
38.9%
21/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
54.2%
13/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
4/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
7.4%
4/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
0.00%
0/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.4%
5/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
5.6%
3/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
8.3%
2/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Nervous system disorders
Dizziness
|
7.7%
6/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
5.6%
3/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
12.5%
3/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Nervous system disorders
Headache
|
28.2%
22/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
25.9%
14/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
33.3%
8/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Psychiatric disorders
Anxiety
|
6.4%
5/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
5.6%
3/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
8.3%
2/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Psychiatric disorders
Insomnia
|
17.9%
14/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
20.4%
11/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
12.5%
3/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Psychiatric disorders
Irritability
|
9.0%
7/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
11.1%
6/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
4.2%
1/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.1%
4/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
3.7%
2/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
8.3%
2/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.1%
4/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
3.7%
2/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
8.3%
2/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
General disorders
Pyrexia
|
2.6%
2/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
0.00%
0/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
8.3%
2/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Gastrointestinal disorders
Constipation
|
3.8%
3/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
5.6%
3/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
0.00%
0/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
3.8%
3/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
1.9%
1/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
8.3%
2/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Infections and infestations
Oral Herpes
|
2.6%
2/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
0.00%
0/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
8.3%
2/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.6%
2/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
0.00%
0/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
8.3%
2/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
|
Skin and subcutaneous tissue disorders
Pruritis Generalised
|
3.8%
3/78 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
5.6%
3/54 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
0.00%
0/24 • From first dose until last dose plus 7 days (assessed up to May 2017, approximately 14 months).
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER