Trial Outcomes & Findings for Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation (NCT NCT00402363)
NCT ID: NCT00402363
Last Updated: 2017-01-30
Results Overview
A documented episode of symptomatic AF /Flutter was defined as AF/Flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. The occurrence of symptomatic atrial flutter was treated as an occurrence of symptomatic AF for this outcome measure. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF or flutter.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
663 participants
Primary outcome timeframe
From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)
Results posted on
2017-01-30
Participant Flow
Participant milestones
| Measure |
Paroxysmal AF, P-OM3
Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 grams (g) per day for the first 7 days; 4 g per day thereafter through Week 24. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF in the participant's medical record.
|
Paroxysmal AF, Placebo
Participants with paroxysmal AF receiving matching placebo. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
|
Persistent AF, P-OM3
Participants with persistent AF receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
|
Persistent AF, Placebo
Participants with persistent AF receiving matching placebo. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
266
|
276
|
66
|
55
|
|
Overall Study
COMPLETED
|
233
|
246
|
60
|
45
|
|
Overall Study
NOT COMPLETED
|
33
|
30
|
6
|
10
|
Reasons for withdrawal
| Measure |
Paroxysmal AF, P-OM3
Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 grams (g) per day for the first 7 days; 4 g per day thereafter through Week 24. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF in the participant's medical record.
|
Paroxysmal AF, Placebo
Participants with paroxysmal AF receiving matching placebo. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
|
Persistent AF, P-OM3
Participants with persistent AF receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
|
Persistent AF, Placebo
Participants with persistent AF receiving matching placebo. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
9
|
14
|
2
|
2
|
|
Overall Study
Withdrew Consent
|
10
|
5
|
2
|
1
|
|
Overall Study
Protocol Violation
|
3
|
5
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
0
|
2
|
|
Overall Study
Captured as "Other"
|
6
|
2
|
2
|
2
|
Baseline Characteristics
Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Paroxysmal AF, P-OM3
n=266 Participants
Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 grams (g) per day for the first 7 days; 4 g per day thereafter through Week 24. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF in the participant's medical record.
|
Paroxysmal AF, Placebo
n=276 Participants
Participants with paroxysmal AF receiving matching placebo. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
|
Persistent AF, P-OM3
n=66 Participants
Participants with persistent AF receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
|
Persistent AF, Placebo
n=55 Participants
Participants with persistent AF receiving matching placebo. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
|
Total
n=663 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.0 Years
STANDARD_DEVIATION 13.56 • n=93 Participants
|
61.9 Years
STANDARD_DEVIATION 11.57 • n=4 Participants
|
58.7 Years
STANDARD_DEVIATION 12.65 • n=27 Participants
|
57.6 Years
STANDARD_DEVIATION 14.85 • n=483 Participants
|
60.5 Years
STANDARD_DEVIATION 12.84 • n=36 Participants
|
|
Gender
Female
|
119 Participants
n=93 Participants
|
138 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
290 Participants
n=36 Participants
|
|
Gender
Male
|
147 Participants
n=93 Participants
|
138 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
373 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
246 participants
n=93 Participants
|
253 participants
n=4 Participants
|
63 participants
n=27 Participants
|
45 participants
n=483 Participants
|
607 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
African American
|
10 participants
n=93 Participants
|
10 participants
n=4 Participants
|
2 participants
n=27 Participants
|
6 participants
n=483 Participants
|
28 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
9 participants
n=93 Participants
|
9 participants
n=4 Participants
|
1 participants
n=27 Participants
|
3 participants
n=483 Participants
|
22 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
1 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
1 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 participants
n=93 Participants
|
2 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
4 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)Population: Modified Intent-to-Treat (MITT) Population: all randomized participants who provided at least one post-randomization TTM ECG data transfer or equivalent
A documented episode of symptomatic AF /Flutter was defined as AF/Flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. The occurrence of symptomatic atrial flutter was treated as an occurrence of symptomatic AF for this outcome measure. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF or flutter.
Outcome measures
| Measure |
Paroxysmal AF, Placebo
n=269 Participants
Participants with paroxysmal AF receiving matching placebo
|
Paroxysmal AF, P-OM3
n=258 Participants
Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
Participants with both paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
Participants with paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
|---|---|---|---|---|---|---|
|
Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter
Participants with event
|
129 participants
|
135 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter
Censored participants
|
140 participants
|
123 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)Population: MITT Population
A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. The occurrence of symptomatic atrial flutter was treated as an occurrence of symptomatic AF for this outcome measure. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF or flutter.
Outcome measures
| Measure |
Paroxysmal AF, Placebo
n=54 Participants
Participants with paroxysmal AF receiving matching placebo
|
Paroxysmal AF, P-OM3
n=64 Participants
Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
n=323 Participants
Participants with both paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
n=322 Participants
Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
Participants with paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
|---|---|---|---|---|---|---|
|
Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter
Participants with event
|
18 participants
|
32 participants
|
147 participants
|
167 participants
|
—
|
—
|
|
Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter
Censored participants
|
36 participants
|
32 participants
|
176 participants
|
155 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)Population: MITT Population
A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF.
Outcome measures
| Measure |
Paroxysmal AF, Placebo
n=269 Participants
Participants with paroxysmal AF receiving matching placebo
|
Paroxysmal AF, P-OM3
n=258 Participants
Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
n=54 Participants
Participants with both paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
n=64 Participants
Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
Participants with paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
|---|---|---|---|---|---|---|
|
Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)
Participants with event
|
126 participants
|
133 participants
|
18 participants
|
30 participants
|
—
|
—
|
|
Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)
Censored participants
|
143 participants
|
125 participants
|
36 participants
|
34 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)Population: MITT Population
A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF.
Outcome measures
| Measure |
Paroxysmal AF, Placebo
n=323 Participants
Participants with paroxysmal AF receiving matching placebo
|
Paroxysmal AF, P-OM3
n=322 Participants
Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
Participants with both paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
Participants with paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
|---|---|---|---|---|---|---|
|
Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)
Participants with event
|
144 participants
|
163 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)
Censored participants
|
179 participants
|
159 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)Population: MITT Population
A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.
Outcome measures
| Measure |
Paroxysmal AF, Placebo
n=269 Participants
Participants with paroxysmal AF receiving matching placebo
|
Paroxysmal AF, P-OM3
n=258 Participants
Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
n=54 Participants
Participants with both paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
n=64 Participants
Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
Participants with paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
|---|---|---|---|---|---|---|
|
Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter
Participants with event
|
149 participants
|
153 participants
|
27 participants
|
40 participants
|
—
|
—
|
|
Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter
Censored participants
|
120 participants
|
105 participants
|
27 participants
|
24 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)Population: MITT Population
A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.
Outcome measures
| Measure |
Paroxysmal AF, Placebo
n=323 Participants
Participants with paroxysmal AF receiving matching placebo
|
Paroxysmal AF, P-OM3
n=322 Participants
Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
Participants with both paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
Participants with paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
|---|---|---|---|---|---|---|
|
Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF/Flutter
Participants with event
|
176 participants
|
193 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF/Flutter
Censored participants
|
147 participants
|
129 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)Population: MITT Population
A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.
Outcome measures
| Measure |
Paroxysmal AF, Placebo
n=269 Participants
Participants with paroxysmal AF receiving matching placebo
|
Paroxysmal AF, P-OM3
n=258 Participants
Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
n=54 Participants
Participants with both paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
n=64 Participants
Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
Participants with paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
|---|---|---|---|---|---|---|
|
Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)
Participants with event
|
146 participants
|
151 participants
|
27 participants
|
38 participants
|
—
|
—
|
|
Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)
Censored participants
|
123 participants
|
107 participants
|
27 participants
|
26 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)Population: MITT Population
A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.
Outcome measures
| Measure |
Paroxysmal AF, Placebo
n=323 Participants
Participants with paroxysmal AF receiving matching placebo
|
Paroxysmal AF, P-OM3
n=322 Participants
Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
Participants with both paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
Participants with paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
|---|---|---|---|---|---|---|
|
Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)
Participants with event
|
173 participants
|
189 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)
Censored participants
|
150 participants
|
133 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)Population: MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.
A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter.
Outcome measures
| Measure |
Paroxysmal AF, Placebo
n=224 Participants
Participants with paroxysmal AF receiving matching placebo
|
Paroxysmal AF, P-OM3
n=205 Participants
Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
n=49 Participants
Participants with both paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
n=57 Participants
Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
Participants with paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
|---|---|---|---|---|---|---|
|
Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter
Participants with event
|
88 participants
|
87 participants
|
15 participants
|
27 participants
|
—
|
—
|
|
Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter
Censored participants
|
136 participants
|
118 participants
|
34 participants
|
30 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)Population: MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.
A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter.
Outcome measures
| Measure |
Paroxysmal AF, Placebo
n=273 Participants
Participants with paroxysmal AF receiving matching placebo
|
Paroxysmal AF, P-OM3
n=262 Participants
Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
Participants with both paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
Participants with paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
|---|---|---|---|---|---|---|
|
Number of Participants in the Combined AF Subgroups With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter
Participants with event
|
103 participants
|
114 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in the Combined AF Subgroups With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter
Censored participants
|
170 participants
|
148 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)Population: MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.
A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF.
Outcome measures
| Measure |
Paroxysmal AF, Placebo
n=225 Participants
Participants with paroxysmal AF receiving matching placebo
|
Paroxysmal AF, P-OM3
n=206 Participants
Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
n=49 Participants
Participants with both paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
n=57 Participants
Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
Participants with paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
|---|---|---|---|---|---|---|
|
Number of Participants With Paroxysmal or Persistent AF With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)
Participants with event
|
86 participants
|
86 participants
|
15 participants
|
25 participants
|
—
|
—
|
|
Number of Participants With Paroxysmal or Persistent AF With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)
Censored participants
|
139 participants
|
120 participants
|
34 participants
|
32 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)Population: MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.
A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. "Censored" in the table below refers to participants who did not have a documented episode of symptomatic AF.
Outcome measures
| Measure |
Paroxysmal AF, Placebo
n=274 Participants
Participants with paroxysmal AF receiving matching placebo
|
Paroxysmal AF, P-OM3
n=263 Participants
Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
Participants with both paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
Participants with paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
|---|---|---|---|---|---|---|
|
Number of Participants in the Combined AF Subgroups With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)
Participants with event
|
101 participants
|
111 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants in the Combined AF Subgroups With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)
Censored participants
|
173 participants
|
152 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)Population: MITT Population. The number analyzed represents those participants who had a rescue episode.
Rescue was defined as any pharmacological/electrical/surgical intervention for the termination/prevention of AF/flutter with a maximum of one rescue episode counted per day. Note: all annualized values were calculated by counting the number of rescue episodes, dividing by the number of days on treatment, then multiplying that number by 365.25.
Outcome measures
| Measure |
Paroxysmal AF, Placebo
n=34 Participants
Participants with paroxysmal AF receiving matching placebo
|
Paroxysmal AF, P-OM3
n=37 Participants
Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
n=8 Participants
Participants with both paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
n=21 Participants
Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
n=42 Participants
Participants with paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
n=58 Participants
Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
|---|---|---|---|---|---|---|
|
Annualized Number of AF/Flutter Rescue Episodes During the Treatment Period
|
2.44 rescue episodes
Interval 2.15 to 4.4
|
4.17 rescue episodes
Interval 2.16 to 6.52
|
2.17 rescue episodes
Interval 2.12 to 3.16
|
2.24 rescue episodes
Interval 2.15 to 4.25
|
2.19 rescue episodes
Interval 2.12 to 4.35
|
4.01 rescue episodes
Interval 2.15 to 4.37
|
SECONDARY outcome
Timeframe: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)Population: MITT Population. The number analyzed represents those participants with an event.
Values were annualized by counting the number of episodes of symptomatic AF/flutter recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25.
Outcome measures
| Measure |
Paroxysmal AF, Placebo
n=129 Participants
Participants with paroxysmal AF receiving matching placebo
|
Paroxysmal AF, P-OM3
n=140 Participants
Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
n=19 Participants
Participants with both paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
n=34 Participants
Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
n=148 Participants
Participants with paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
n=174 Participants
Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
|---|---|---|---|---|---|---|
|
Annualized Cumulative Frequency of Symptomatic AF/Flutter Recurrences During the Treatment Period
|
6.81 recurrences
Interval 3.89 to 13.12
|
8.32 recurrences
Interval 4.17 to 16.8
|
4.22 recurrences
Interval 2.08 to 6.37
|
4.35 recurrences
Interval 2.19 to 10.62
|
6.48 recurrences
Interval 2.23 to 12.89
|
6.52 recurrences
Interval 3.93 to 15.22
|
SECONDARY outcome
Timeframe: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)Population: MITT Population. The number analyzed represents those participants with an event.
Values were annualized by counting the number of episodes of symptomatic AF recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25.
Outcome measures
| Measure |
Paroxysmal AF, Placebo
n=126 Participants
Participants with paroxysmal AF receiving matching placebo
|
Paroxysmal AF, P-OM3
n=139 Participants
Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
n=19 Participants
Participants with both paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
n=32 Participants
Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
Combined, Placebo
n=145 Participants
Participants with paroxysmal and persistent AF receiving matching placebo
|
Combined, P-OM3
n=171 Participants
Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
|---|---|---|---|---|---|---|
|
Annualized Cumulative Frequency of Symptomatic AF Recurrences During the Treatment Period
|
6.91 recurrences
Interval 2.23 to 13.12
|
8.30 recurrences
Interval 4.01 to 16.6
|
4.22 recurrences
Interval 2.08 to 6.37
|
4.35 recurrences
Interval 2.18 to 11.02
|
6.48 recurrences
Interval 2.17 to 12.89
|
6.52 recurrences
Interval 3.02 to 15.13
|
Adverse Events
Placebo
Serious events: 20 serious events
Other events: 66 other events
Deaths: 0 deaths
Prescription Omega-3 Acid Ethyl Esters
Serious events: 25 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=331 participants at risk
Participants receiving matching placebo
|
Prescription Omega-3 Acid Ethyl Esters
n=332 participants at risk
Participants receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.60%
2/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.60%
2/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.60%
2/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Cardiac disorders
Angina pectoris
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.00%
0/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.00%
0/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Cardiac disorders
Cardiac discomfort
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Cardiac disorders
Myocardial infarction
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.00%
0/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.00%
0/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.00%
0/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Retroperitoneal hematoma
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Nervous system disorders
Presyncope
|
0.60%
2/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.00%
0/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Nervous system disorders
Syncope
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.00%
0/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Nervous system disorders
Transient ischemic attack
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.00%
0/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Renal and urinary disorders
Hematuria
|
0.60%
2/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.00%
0/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Renal and urinary disorders
Renal failure acute
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.60%
2/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Infections and infestations
Septic shock
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.00%
0/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.60%
2/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.00%
0/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.00%
0/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Vascular disorders
Arterial thrombosis limb
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Vascular disorders
Hypotension
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.00%
0/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Vascular disorders
Vasculitis
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.00%
0/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
General disorders
Chest pain
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
General disorders
Non-cardiac chest pain
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.00%
0/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Investigations
False positive tuberculosis test
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Investigations
International normalized ratio increased
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.00%
0/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.00%
0/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.00%
0/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Reproductive system and breast disorders
Polycystic ovaries
|
0.30%
1/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.00%
0/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Psychiatric disorders
Suicide
|
0.00%
0/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
0.30%
1/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
Other adverse events
| Measure |
Placebo
n=331 participants at risk
Participants receiving matching placebo
|
Prescription Omega-3 Acid Ethyl Esters
n=332 participants at risk
Participants receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
3.6%
12/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
3.6%
12/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Infections and infestations
Sinusitis
|
3.6%
12/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
3.0%
10/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
8/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
3.0%
10/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Nausea
|
3.9%
13/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
4.8%
16/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
10/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
3.3%
11/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Nervous system disorders
Dizziness
|
3.3%
11/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
3.9%
13/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
General disorders
Fatigue
|
2.7%
9/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
3.0%
10/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
General disorders
Edema peripheral
|
1.5%
5/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
4.2%
14/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.1%
7/331 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
3.0%
10/332 • Day 1 through Week 24
Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all participants who received and took at least one dose of study medication. Events reported are "treatment emergent," defined as an event of new onset or one that worsened during the on-treatment period.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER