Trial Outcomes & Findings for Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment (NCT NCT01183169)
NCT ID: NCT01183169
Last Updated: 2016-08-25
Results Overview
cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (\< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
459 participants
Primary outcome timeframe
after 12 weeks of treatment
Results posted on
2016-08-25
Participant Flow
Participant milestones
| Measure |
Treatment A
Alisporivir (ALV; DEB025) 600 mg once daily (QD) with peginterferon alfa-2a (PEG) and ribavirin (RBV) for up to 48 weeks.
|
Treatment B
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment C1
Treatment C subset C1: ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR: hepatitis C virus (HCV) ribonucleic acid (RNA) \<LOQ after 12 weeks of treatment) could switch to active ALV 600 mg QD with PEG and RBV.
|
Treatment C2
Treatment C subset C2: ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
|
Treatment D
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
|
Treatment C1A
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
|
Treatment C2A
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
|
|---|---|---|---|---|---|---|---|
|
Main Phase
STARTED
|
121
|
115
|
59
|
55
|
109
|
0
|
0
|
|
Main Phase
Completed Treatment
|
72
|
78
|
17
|
17
|
77
|
0
|
0
|
|
Main Phase
Switched to ALV
|
0
|
0
|
35
|
30
|
0
|
0
|
0
|
|
Main Phase
COMPLETED
|
94
|
93
|
18
|
18
|
83
|
0
|
0
|
|
Main Phase
NOT COMPLETED
|
27
|
22
|
41
|
37
|
26
|
0
|
0
|
|
Post-switch Phase
STARTED
|
0
|
0
|
0
|
0
|
0
|
35
|
30
|
|
Post-switch Phase
Completed Treatment
|
0
|
0
|
0
|
0
|
0
|
12
|
13
|
|
Post-switch Phase
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
21
|
21
|
|
Post-switch Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
14
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment
Baseline characteristics by cohort
| Measure |
Treatment A
n=121 Participants
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment B
n=115 Participants
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment C
n=114 Participants
Treatment C1 + Treatment C2. ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
|
Treatment D
n=109 Participants
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
|
Total
n=459 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50.2 years
STANDARD_DEVIATION 9.24 • n=5 Participants
|
50.9 years
STANDARD_DEVIATION 10.11 • n=7 Participants
|
50.5 years
STANDARD_DEVIATION 10.50 • n=5 Participants
|
51.0 years
STANDARD_DEVIATION 9.68 • n=4 Participants
|
50.6 years
STANDARD_DEVIATION 9.86 • n=21 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
181 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
278 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: after 12 weeks of treatmentPopulation: Full Analysis Set (FAS) For Efficacy, defined as all randomized participants who were randomized after the 2nd protocol amendment
cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (\< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Outcome measures
| Measure |
Treatment A
n=110 Participants
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment B
n=108 Participants
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment C
n=110 Participants
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
|
Treatment D
n=109 Participants
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
|
Treatment C1A
n=33 Participants
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
|
Treatment C2A
n=30 Participants
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)
|
48.2 percentage of participants
|
61.1 percentage of participants
|
35.5 percentage of participants
|
74.3 percentage of participants
|
45.5 percentage of participants
|
80.0 percentage of participants
|
SECONDARY outcome
Timeframe: after 12 weeks of treatmentPopulation: FAS For Efficacy
cEVR-LOD was defined as serum HCV RNA below the limit of detection (\< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Outcome measures
| Measure |
Treatment A
n=110 Participants
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment B
n=108 Participants
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment C
n=110 Participants
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
|
Treatment D
n=109 Participants
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
|
Treatment C1A
n=33 Participants
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
|
Treatment C2A
n=30 Participants
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)
|
39.1 percentage of participants
|
41.7 percentage of participants
|
20.9 percentage of participants
|
58.7 percentage of participants
|
39.4 percentage of participants
|
73.3 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks after treatmentPopulation: FAS For Efficacy
SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD 12 weeks after treatment, respectively.
Outcome measures
| Measure |
Treatment A
n=110 Participants
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment B
n=108 Participants
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment C
n=110 Participants
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
|
Treatment D
n=109 Participants
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
|
Treatment C1A
n=33 Participants
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
|
Treatment C2A
n=30 Participants
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD
SVR12-LOQ
|
42.7 percentage of participants
|
51.9 percentage of participants
|
14.5 percentage of participants
|
65.1 percentage of participants
|
18.2 percentage of participants
|
53.3 percentage of participants
|
|
Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD
SVR12-LOD
|
40.9 percentage of participants
|
50.9 percentage of participants
|
14.5 percentage of participants
|
63.3 percentage of participants
|
18.2 percentage of participants
|
53.3 percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeks after treatmentPopulation: FAS For Efficacy
SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD 24 weeks after treatment, respectively.
Outcome measures
| Measure |
Treatment A
n=110 Participants
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment B
n=108 Participants
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment C
n=110 Participants
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
|
Treatment D
n=109 Participants
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
|
Treatment C1A
n=33 Participants
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
|
Treatment C2A
n=30 Participants
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD
SVR24-LOQ
|
41.8 percentage of participants
|
51.9 percentage of participants
|
14.5 percentage of participants
|
65.1 percentage of participants
|
18.2 percentage of participants
|
53.3 percentage of participants
|
|
Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD
SVR24-LOD
|
40.0 percentage of participants
|
50.0 percentage of participants
|
14.5 percentage of participants
|
63.3 percentage of participants
|
18.2 percentage of participants
|
53.3 percentage of participants
|
SECONDARY outcome
Timeframe: after 4 weeks of treatmentPopulation: FAS For Efficacy
RVR-LOQ and RVR-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch.
Outcome measures
| Measure |
Treatment A
n=110 Participants
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment B
n=108 Participants
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment C
n=110 Participants
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
|
Treatment D
n=109 Participants
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
|
Treatment C1A
n=33 Participants
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
|
Treatment C2A
n=30 Participants
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD
RVR-LOQ
|
20.9 percentage of participants
|
25.0 percentage of participants
|
7.3 percentage of participants
|
41.3 percentage of participants
|
39.4 percentage of participants
|
56.7 percentage of participants
|
|
Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD
RVR-LOD
|
9.1 percentage of participants
|
8.3 percentage of participants
|
2.7 percentage of participants
|
22.9 percentage of participants
|
18.2 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: after 12 weeks of treatmentPopulation: FAS For Efficacy
pEVR-LOQ and pEVR-LOD were defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ and ≥ LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Outcome measures
| Measure |
Treatment A
n=110 Participants
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment B
n=108 Participants
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment C
n=110 Participants
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
|
Treatment D
n=109 Participants
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
|
Treatment C1A
n=33 Participants
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
|
Treatment C2A
n=30 Participants
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD
pEVR-LOQ
|
38.2 percentage of participants
|
28.7 percentage of participants
|
31.8 percentage of participants
|
11.9 percentage of participants
|
3.0 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD
pEVR-LOD
|
47.3 percentage of participants
|
48.1 percentage of participants
|
46.4 percentage of participants
|
27.5 percentage of participants
|
9.1 percentage of participants
|
13.3 percentage of participants
|
SECONDARY outcome
Timeframe: within 48 weeksPopulation: FAS For Efficacy
ETR-LOQ and ETR-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD at treatment end (completed or prematurely discontinued), respectively.
Outcome measures
| Measure |
Treatment A
n=110 Participants
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment B
n=108 Participants
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment C
n=110 Participants
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
|
Treatment D
n=109 Participants
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
|
Treatment C1A
n=33 Participants
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
|
Treatment C2A
n=30 Participants
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD
ETR-LOQ
|
68.2 percentage of participants
|
74.1 percentage of participants
|
33.6 percentage of participants
|
82.6 percentage of participants
|
51.5 percentage of participants
|
73.3 percentage of participants
|
|
Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD
ETR-LOD
|
61.8 percentage of participants
|
70.4 percentage of participants
|
31.8 percentage of participants
|
78.9 percentage of participants
|
36.4 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: Participants in the FAS For Efficacy with abnormal ALT at baseline and available data at the respective time point
Outcome measures
| Measure |
Treatment A
n=53 Participants
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment B
n=49 Participants
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment C
n=61 Participants
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
|
Treatment D
n=53 Participants
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
|
Treatment C1A
n=14 Participants
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
|
Treatment C2A
n=7 Participants
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
End of Treatment (n = 53,49,60,53,14,7)
|
77.4 percentage of participants
|
77.6 percentage of participants
|
59.0 percentage of participants
|
83.0 percentage of participants
|
35.7 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
End of Study (n = 49,42,18,46,13,6)
|
54.7 percentage of participants
|
61.2 percentage of participants
|
18.0 percentage of participants
|
67.9 percentage of participants
|
21.4 percentage of participants
|
28.6 percentage of participants
|
SECONDARY outcome
Timeframe: within 48 weeksPopulation: FAS For Efficacy
On-treatment viral breakthrough was defined as either: * Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or * HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (\< LOQ) during treatment
Outcome measures
| Measure |
Treatment A
n=110 Participants
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment B
n=108 Participants
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment C
n=110 Participants
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
|
Treatment D
n=109 Participants
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
|
Treatment C1A
n=33 Participants
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
|
Treatment C2A
n=30 Participants
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With On-treatment Viral Breakthrough
|
12.7 percentage of participants
|
9.3 percentage of participants
|
5.5 percentage of participants
|
2.8 percentage of participants
|
6.1 percentage of participants
|
10.0 percentage of participants
|
SECONDARY outcome
Timeframe: within 24 weeks after treatmentPopulation: FAS For Efficacy
Viral relapse was defined as reappearance of detectable HCV RNA after previously being undetectable (\< LOQ) during treatment.
Outcome measures
| Measure |
Treatment A
n=110 Participants
ALV 600 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment B
n=108 Participants
ALV 800 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment C
n=110 Participants
ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
|
Treatment D
n=109 Participants
ALV 400 mg BID with PEG and RBV for up to 48 weeks.
|
Treatment C1A
n=33 Participants
ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
|
Treatment C2A
n=30 Participants
ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Viral Relapse
|
19.1 percentage of participants
|
18.5 percentage of participants
|
17.3 percentage of participants
|
12.8 percentage of participants
|
30.3 percentage of participants
|
13.3 percentage of participants
|
Adverse Events
Treatment A: On-treatment AEs
Serious events: 7 serious events
Other events: 116 other events
Deaths: 0 deaths
Treatment B: On-treatment AEs
Serious events: 11 serious events
Other events: 108 other events
Deaths: 0 deaths
Treatment C1: On-treatment AEs
Serious events: 5 serious events
Other events: 58 other events
Deaths: 0 deaths
Treatment C2: On-treatment AEs
Serious events: 1 serious events
Other events: 54 other events
Deaths: 0 deaths
Treatment D: On-treatment AEs
Serious events: 18 serious events
Other events: 106 other events
Deaths: 0 deaths
Treatment A: Post-treatment AEs
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Treatment B: Post-treatment AEs
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
Treatment C1: Post-treatment AEs
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Treatment C2: Post-treatment AEs
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Treatment D: Post-treatment AEs
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment A: On-treatment AEs
n=120 participants at risk
Adverse events (AEs) occurring while on treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment B: On-treatment AEs
n=115 participants at risk
AEs occurring while on treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment C1: On-treatment AEs
n=59 participants at risk
AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks.
|
Treatment C2: On-treatment AEs
n=55 participants at risk
AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks.
|
Treatment D: On-treatment AEs
n=108 participants at risk
AEs occurring while on treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks.
|
Treatment A: Post-treatment AEs
n=120 participants at risk
AEs occurring after end of treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment B: Post-treatment AEs
n=115 participants at risk
AEs occurring after end of treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment C1: Post-treatment AEs
n=59 participants at risk
AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks.
|
Treatment C2: Post-treatment AEs
n=55 participants at risk
AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks.
|
Treatment D: Post-treatment AEs
n=108 participants at risk
AEs occurring after end of treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/120
|
1.7%
2/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Infections and infestations
Appendicitis
|
0.00%
0/120
|
1.7%
2/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Infections and infestations
Arthritis viral
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
General disorders
Chest discomfort
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
General disorders
Chest pain
|
0.83%
1/120
|
0.00%
0/115
|
1.7%
1/59
|
0.00%
0/55
|
1.9%
2/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Infections and infestations
Cystitis
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Nervous system disorders
Dizziness
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
General disorders
Drug interaction
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Infections and infestations
Ear infection
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
General disorders
Fatigue
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Nervous system disorders
Headache
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Infections and infestations
Hepatitis C
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Vascular disorders
Hypertension
|
0.83%
1/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
1.9%
2/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/120
|
0.00%
0/115
|
1.7%
1/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
1.9%
2/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/120
|
0.00%
0/115
|
1.7%
1/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
General disorders
Multi-organ failure
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/120
|
0.87%
1/115
|
1.7%
1/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage I
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Infections and infestations
Orchitis
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Infections and infestations
Osteomyelitis
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Infections and infestations
Peritonitis
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Infections and infestations
Pneumonia
|
0.00%
0/120
|
0.00%
0/115
|
1.7%
1/59
|
0.00%
0/55
|
2.8%
3/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
General disorders
Pyrexia
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/120
|
0.00%
0/115
|
1.7%
1/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Infections and infestations
Salpingitis
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Infections and infestations
Septic shock
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Nervous system disorders
Syncope
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Infections and infestations
Urinary tract infection
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
1.8%
1/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
Other adverse events
| Measure |
Treatment A: On-treatment AEs
n=120 participants at risk
Adverse events (AEs) occurring while on treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment B: On-treatment AEs
n=115 participants at risk
AEs occurring while on treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment C1: On-treatment AEs
n=59 participants at risk
AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks.
|
Treatment C2: On-treatment AEs
n=55 participants at risk
AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks.
|
Treatment D: On-treatment AEs
n=108 participants at risk
AEs occurring while on treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks.
|
Treatment A: Post-treatment AEs
n=120 participants at risk
AEs occurring after end of treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment B: Post-treatment AEs
n=115 participants at risk
AEs occurring after end of treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks.
|
Treatment C1: Post-treatment AEs
n=59 participants at risk
AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks.
|
Treatment C2: Post-treatment AEs
n=55 participants at risk
AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks.
|
Treatment D: Post-treatment AEs
n=108 participants at risk
AEs occurring after end of treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
40.8%
49/120
|
35.7%
41/115
|
40.7%
24/59
|
38.2%
21/55
|
47.2%
51/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
1.8%
1/55
|
0.00%
0/108
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.2%
17/120
|
11.3%
13/115
|
13.6%
8/59
|
10.9%
6/55
|
18.5%
20/108
|
0.00%
0/120
|
0.00%
0/115
|
5.1%
3/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.2%
5/120
|
1.7%
2/115
|
6.8%
4/59
|
0.00%
0/55
|
7.4%
8/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
|
Blood and lymphatic system disorders
Neutropenia
|
40.8%
49/120
|
34.8%
40/115
|
37.3%
22/59
|
29.1%
16/55
|
42.6%
46/108
|
0.00%
0/120
|
0.00%
0/115
|
3.4%
2/59
|
1.8%
1/55
|
0.00%
0/108
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
24/120
|
16.5%
19/115
|
6.8%
4/59
|
10.9%
6/55
|
25.9%
28/108
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
1.8%
1/55
|
0.93%
1/108
|
|
Cardiac disorders
Palpitations
|
9.2%
11/120
|
6.1%
7/115
|
5.1%
3/59
|
3.6%
2/55
|
1.9%
2/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Cardiac disorders
Tachycardia
|
1.7%
2/120
|
0.87%
1/115
|
3.4%
2/59
|
5.5%
3/55
|
4.6%
5/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Ear and labyrinth disorders
Tinnitus
|
3.3%
4/120
|
3.5%
4/115
|
5.1%
3/59
|
5.5%
3/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Endocrine disorders
Hypothyroidism
|
5.8%
7/120
|
5.2%
6/115
|
3.4%
2/59
|
12.7%
7/55
|
13.0%
14/108
|
1.7%
2/120
|
0.00%
0/115
|
1.7%
1/59
|
1.8%
1/55
|
0.93%
1/108
|
|
Eye disorders
Dry eye
|
5.8%
7/120
|
6.1%
7/115
|
5.1%
3/59
|
1.8%
1/55
|
2.8%
3/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Eye disorders
Ocular icterus
|
4.2%
5/120
|
7.0%
8/115
|
1.7%
1/59
|
5.5%
3/55
|
13.0%
14/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
1.8%
1/55
|
0.00%
0/108
|
|
Eye disorders
Vision blurred
|
3.3%
4/120
|
7.0%
8/115
|
5.1%
3/59
|
1.8%
1/55
|
2.8%
3/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Gastrointestinal disorders
Abdominal distension
|
1.7%
2/120
|
4.3%
5/115
|
3.4%
2/59
|
3.6%
2/55
|
6.5%
7/108
|
0.83%
1/120
|
0.00%
0/115
|
1.7%
1/59
|
0.00%
0/55
|
1.9%
2/108
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
9/120
|
6.1%
7/115
|
11.9%
7/59
|
10.9%
6/55
|
5.6%
6/108
|
0.00%
0/120
|
0.00%
0/115
|
1.7%
1/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
15/120
|
7.0%
8/115
|
8.5%
5/59
|
9.1%
5/55
|
12.0%
13/108
|
0.00%
0/120
|
0.87%
1/115
|
3.4%
2/59
|
1.8%
1/55
|
0.00%
0/108
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
5.0%
6/120
|
2.6%
3/115
|
5.1%
3/59
|
3.6%
2/55
|
5.6%
6/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Gastrointestinal disorders
Cheilitis
|
0.83%
1/120
|
5.2%
6/115
|
3.4%
2/59
|
1.8%
1/55
|
2.8%
3/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Gastrointestinal disorders
Constipation
|
8.3%
10/120
|
6.1%
7/115
|
3.4%
2/59
|
9.1%
5/55
|
13.9%
15/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Gastrointestinal disorders
Diarrhoea
|
15.8%
19/120
|
15.7%
18/115
|
18.6%
11/59
|
16.4%
9/55
|
9.3%
10/108
|
0.00%
0/120
|
0.00%
0/115
|
3.4%
2/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
15/120
|
8.7%
10/115
|
8.5%
5/59
|
14.5%
8/55
|
9.3%
10/108
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
15/120
|
3.5%
4/115
|
8.5%
5/59
|
3.6%
2/55
|
13.9%
15/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.7%
2/120
|
0.87%
1/115
|
3.4%
2/59
|
5.5%
3/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
1.7%
1/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.8%
7/120
|
8.7%
10/115
|
5.1%
3/59
|
9.1%
5/55
|
2.8%
3/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Gastrointestinal disorders
Nausea
|
38.3%
46/120
|
30.4%
35/115
|
28.8%
17/59
|
30.9%
17/55
|
47.2%
51/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
|
Gastrointestinal disorders
Toothache
|
2.5%
3/120
|
2.6%
3/115
|
5.1%
3/59
|
1.8%
1/55
|
1.9%
2/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
19/120
|
15.7%
18/115
|
11.9%
7/59
|
16.4%
9/55
|
17.6%
19/108
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
General disorders
Asthenia
|
15.8%
19/120
|
26.1%
30/115
|
15.3%
9/59
|
25.5%
14/55
|
15.7%
17/108
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
General disorders
Chest pain
|
2.5%
3/120
|
3.5%
4/115
|
3.4%
2/59
|
10.9%
6/55
|
3.7%
4/108
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
General disorders
Chills
|
11.7%
14/120
|
11.3%
13/115
|
10.2%
6/59
|
9.1%
5/55
|
13.0%
14/108
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
General disorders
Fatigue
|
39.2%
47/120
|
39.1%
45/115
|
42.4%
25/59
|
49.1%
27/55
|
41.7%
45/108
|
0.83%
1/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
|
General disorders
Influenza like illness
|
10.8%
13/120
|
8.7%
10/115
|
25.4%
15/59
|
10.9%
6/55
|
10.2%
11/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
General disorders
Injection site erythema
|
6.7%
8/120
|
9.6%
11/115
|
8.5%
5/59
|
5.5%
3/55
|
2.8%
3/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
General disorders
Injection site rash
|
0.83%
1/120
|
0.87%
1/115
|
6.8%
4/59
|
1.8%
1/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
General disorders
Irritability
|
6.7%
8/120
|
6.1%
7/115
|
5.1%
3/59
|
5.5%
3/55
|
5.6%
6/108
|
0.00%
0/120
|
0.00%
0/115
|
1.7%
1/59
|
0.00%
0/55
|
0.00%
0/108
|
|
General disorders
Malaise
|
7.5%
9/120
|
7.0%
8/115
|
3.4%
2/59
|
3.6%
2/55
|
8.3%
9/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
General disorders
Pyrexia
|
26.7%
32/120
|
29.6%
34/115
|
30.5%
18/59
|
32.7%
18/55
|
25.9%
28/108
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
15.8%
19/120
|
12.2%
14/115
|
6.8%
4/59
|
10.9%
6/55
|
33.3%
36/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Hepatobiliary disorders
Jaundice
|
11.7%
14/120
|
9.6%
11/115
|
8.5%
5/59
|
10.9%
6/55
|
16.7%
18/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
6/120
|
4.3%
5/115
|
1.7%
1/59
|
5.5%
3/55
|
3.7%
4/108
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
2.8%
3/108
|
|
Infections and infestations
Oral herpes
|
3.3%
4/120
|
6.1%
7/115
|
3.4%
2/59
|
0.00%
0/55
|
2.8%
3/108
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Infections and infestations
Pharyngitis
|
3.3%
4/120
|
2.6%
3/115
|
3.4%
2/59
|
3.6%
2/55
|
5.6%
6/108
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
12/120
|
4.3%
5/115
|
5.1%
3/59
|
10.9%
6/55
|
5.6%
6/108
|
0.83%
1/120
|
0.00%
0/115
|
3.4%
2/59
|
1.8%
1/55
|
0.93%
1/108
|
|
Infections and infestations
Urinary tract infection
|
5.8%
7/120
|
1.7%
2/115
|
6.8%
4/59
|
5.5%
3/55
|
8.3%
9/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
6/120
|
0.87%
1/115
|
1.7%
1/59
|
1.8%
1/55
|
2.8%
3/108
|
0.83%
1/120
|
1.7%
2/115
|
0.00%
0/59
|
1.8%
1/55
|
1.9%
2/108
|
|
Investigations
Lipase increased
|
1.7%
2/120
|
0.87%
1/115
|
6.8%
4/59
|
3.6%
2/55
|
4.6%
5/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Investigations
Total bile acids increased
|
4.2%
5/120
|
2.6%
3/115
|
5.1%
3/59
|
1.8%
1/55
|
7.4%
8/108
|
0.00%
0/120
|
0.00%
0/115
|
1.7%
1/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Investigations
Weight decreased
|
7.5%
9/120
|
7.8%
9/115
|
5.1%
3/59
|
7.3%
4/55
|
8.3%
9/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.8%
31/120
|
20.0%
23/115
|
15.3%
9/59
|
21.8%
12/55
|
24.1%
26/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
13.3%
16/120
|
18.3%
21/115
|
6.8%
4/59
|
5.5%
3/55
|
16.7%
18/108
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.8%
19/120
|
16.5%
19/115
|
13.6%
8/59
|
14.5%
8/55
|
8.3%
9/108
|
1.7%
2/120
|
0.87%
1/115
|
1.7%
1/59
|
0.00%
0/55
|
3.7%
4/108
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
20/120
|
4.3%
5/115
|
6.8%
4/59
|
10.9%
6/55
|
9.3%
10/108
|
1.7%
2/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.7%
14/120
|
10.4%
12/115
|
5.1%
3/59
|
9.1%
5/55
|
15.7%
17/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.2%
23/120
|
18.3%
21/115
|
27.1%
16/59
|
23.6%
13/55
|
16.7%
18/108
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.3%
4/120
|
0.87%
1/115
|
5.1%
3/59
|
5.5%
3/55
|
2.8%
3/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
4.2%
5/120
|
5.2%
6/115
|
0.00%
0/59
|
3.6%
2/55
|
5.6%
6/108
|
1.7%
2/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.8%
7/120
|
4.3%
5/115
|
5.1%
3/59
|
1.8%
1/55
|
4.6%
5/108
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
|
Nervous system disorders
Disturbance in attention
|
7.5%
9/120
|
8.7%
10/115
|
5.1%
3/59
|
9.1%
5/55
|
3.7%
4/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
|
Nervous system disorders
Dizziness
|
16.7%
20/120
|
19.1%
22/115
|
18.6%
11/59
|
14.5%
8/55
|
13.9%
15/108
|
0.00%
0/120
|
0.87%
1/115
|
1.7%
1/59
|
3.6%
2/55
|
3.7%
4/108
|
|
Nervous system disorders
Dysgeusia
|
4.2%
5/120
|
6.1%
7/115
|
6.8%
4/59
|
9.1%
5/55
|
8.3%
9/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Nervous system disorders
Headache
|
49.2%
59/120
|
40.9%
47/115
|
40.7%
24/59
|
40.0%
22/55
|
35.2%
38/108
|
1.7%
2/120
|
1.7%
2/115
|
1.7%
1/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Nervous system disorders
Hypoaesthesia
|
5.0%
6/120
|
1.7%
2/115
|
1.7%
1/59
|
1.8%
1/55
|
1.9%
2/108
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
1.8%
1/55
|
0.00%
0/108
|
|
Nervous system disorders
Memory impairment
|
4.2%
5/120
|
3.5%
4/115
|
3.4%
2/59
|
10.9%
6/55
|
2.8%
3/108
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
|
Psychiatric disorders
Anxiety
|
15.8%
19/120
|
7.0%
8/115
|
6.8%
4/59
|
9.1%
5/55
|
10.2%
11/108
|
1.7%
2/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
|
Psychiatric disorders
Depressed mood
|
2.5%
3/120
|
3.5%
4/115
|
5.1%
3/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Psychiatric disorders
Depression
|
18.3%
22/120
|
12.2%
14/115
|
16.9%
10/59
|
12.7%
7/55
|
12.0%
13/108
|
0.00%
0/120
|
1.7%
2/115
|
1.7%
1/59
|
1.8%
1/55
|
0.00%
0/108
|
|
Psychiatric disorders
Insomnia
|
29.2%
35/120
|
20.9%
24/115
|
18.6%
11/59
|
34.5%
19/55
|
15.7%
17/108
|
0.83%
1/120
|
1.7%
2/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
|
Psychiatric disorders
Nervousness
|
0.83%
1/120
|
0.87%
1/115
|
3.4%
2/59
|
7.3%
4/55
|
1.9%
2/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Psychiatric disorders
Restlessness
|
5.8%
7/120
|
3.5%
4/115
|
3.4%
2/59
|
7.3%
4/55
|
0.93%
1/108
|
0.83%
1/120
|
0.00%
0/115
|
1.7%
1/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Psychiatric disorders
Sleep disorder
|
1.7%
2/120
|
3.5%
4/115
|
6.8%
4/59
|
1.8%
1/55
|
1.9%
2/108
|
0.00%
0/120
|
0.00%
0/115
|
3.4%
2/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Psychiatric disorders
Suspiciousness
|
0.83%
1/120
|
3.5%
4/115
|
1.7%
1/59
|
5.5%
3/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.7%
38/120
|
25.2%
29/115
|
30.5%
18/59
|
30.9%
17/55
|
14.8%
16/108
|
1.7%
2/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/120
|
0.87%
1/115
|
5.1%
3/59
|
0.00%
0/55
|
0.93%
1/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.5%
21/120
|
7.0%
8/115
|
10.2%
6/59
|
9.1%
5/55
|
14.8%
16/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.0%
6/120
|
7.8%
9/115
|
5.1%
3/59
|
10.9%
6/55
|
7.4%
8/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
5/120
|
2.6%
3/115
|
6.8%
4/59
|
3.6%
2/55
|
9.3%
10/108
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.5%
9/120
|
7.0%
8/115
|
8.5%
5/59
|
7.3%
4/55
|
7.4%
8/108
|
0.83%
1/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.3%
22/120
|
20.0%
23/115
|
16.9%
10/59
|
16.4%
9/55
|
17.6%
19/108
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.83%
1/120
|
0.00%
0/115
|
5.1%
3/59
|
0.00%
0/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.5%
3/120
|
1.7%
2/115
|
5.1%
3/59
|
3.6%
2/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
15/120
|
13.9%
16/115
|
18.6%
11/59
|
21.8%
12/55
|
14.8%
16/108
|
0.83%
1/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.0%
6/120
|
6.1%
7/115
|
0.00%
0/59
|
0.00%
0/55
|
4.6%
5/108
|
0.00%
0/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.7%
2/120
|
0.87%
1/115
|
8.5%
5/59
|
3.6%
2/55
|
2.8%
3/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
1.8%
1/55
|
0.00%
0/108
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.0%
36/120
|
26.1%
30/115
|
35.6%
21/59
|
30.9%
17/55
|
29.6%
32/108
|
1.7%
2/120
|
1.7%
2/115
|
1.7%
1/59
|
1.8%
1/55
|
0.00%
0/108
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.2%
23/120
|
19.1%
22/115
|
25.4%
15/59
|
16.4%
9/55
|
15.7%
17/108
|
2.5%
3/120
|
1.7%
2/115
|
1.7%
1/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/120
|
1.7%
2/115
|
0.00%
0/59
|
5.5%
3/55
|
0.00%
0/108
|
0.00%
0/120
|
0.00%
0/115
|
0.00%
0/59
|
0.00%
0/55
|
0.00%
0/108
|
|
Vascular disorders
Hypertension
|
17.5%
21/120
|
19.1%
22/115
|
8.5%
5/59
|
20.0%
11/55
|
25.9%
28/108
|
1.7%
2/120
|
0.87%
1/115
|
0.00%
0/59
|
0.00%
0/55
|
0.93%
1/108
|
Additional Information
Vice President Clinical Research & Development
Debiopharm International S.A.
Phone: 4121 321 01 11
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER