Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome (NCT NCT03806127)
NCT ID: NCT03806127
Last Updated: 2021-08-02
Results Overview
An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 30% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
222 participants
Primary outcome timeframe
Baseline; Week 12
Results posted on
2021-08-02
Participant Flow
Of 806 participants screened for this study, 222 were randomized (after a 2-week, single-blind placebo Run-in Period), and 222 received 1 dose of double-blind study drug in the Treatment Period (Safety Set: placebo, N = 111; vibegron, N = 111).
Participant milestones
| Measure |
Placebo
Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea \[IBS-D\] versus IBS with mixed episodes of diarrhea and constipation \[IBS-M\]).
|
Vibegron 75 mg
Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
111
|
|
Overall Study
COMPLETED
|
90
|
99
|
|
Overall Study
NOT COMPLETED
|
21
|
12
|
Reasons for withdrawal
| Measure |
Placebo
Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea \[IBS-D\] versus IBS with mixed episodes of diarrhea and constipation \[IBS-M\]).
|
Vibegron 75 mg
Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Protocol Violation
|
3
|
1
|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Unable to Complete Procedures
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Could Not Come Due to Covid
|
1
|
0
|
|
Overall Study
Prescribed Exclusionary Medication (Med)
|
1
|
0
|
|
Overall Study
Ran Out of Study Meds (Covid Quarantine)
|
1
|
0
|
|
Overall Study
Covid 19 Restrictions
|
2
|
0
|
|
Overall Study
Withdrawn Due to Work/School Schedule
|
0
|
1
|
|
Overall Study
Covid 19 Concern; Possible Site Closure
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
Baseline characteristics by cohort
| Measure |
Placebo
n=108 Participants
Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea \[IBS-D\] versus IBS with mixed episodes of diarrhea and constipation \[IBS-M\]).
|
Vibegron 75 mg
n=111 Participants
Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.6 years
STANDARD_DEVIATION 13.10 • n=93 Participants
|
40.5 years
STANDARD_DEVIATION 13.88 • n=4 Participants
|
40.1 years
STANDARD_DEVIATION 13.48 • n=27 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=93 Participants
|
111 Participants
n=4 Participants
|
219 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
82 Participants
n=93 Participants
|
80 Participants
n=4 Participants
|
162 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
24 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Captured as Other
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Abdominal Pain Intensity Score (Stratified Strata)
< 6
|
77 Participants
n=93 Participants
|
78 Participants
n=4 Participants
|
155 Participants
n=27 Participants
|
|
Abdominal Pain Intensity Score (Stratified Strata)
≥ 6
|
31 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
|
IBS Subtype (Stratified Strata)
IBS-D
|
63 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
129 Participants
n=27 Participants
|
|
IBS Subtype (Stratified Strata)
IBS-M
|
45 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
90 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 12Population: Full Analysis Set for IBS-D participants: all randomized participants with IBS-D who who took at least one dose of double-blind study medication and had at least one evaluable post-randomization weekly API score (i.e., where evaluable was considered a minimum of 5 diary entries in a week)
An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 30% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea \[IBS-D\] versus IBS with mixed episodes of diarrhea and constipation \[IBS-M\]).
|
Vibegron 75 mg
n=66 Participants
Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).
|
|---|---|---|
|
Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12
|
27 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set: all randomized participants who took at least one dose of double-blind study medication and had at least one evaluable post-randomization weekly API score (i.e., where evaluable was considered a minimum of 5 diary entries in a week)
Global improvement assessment asks participants to evaluate their current IBS status by asking the following question: How would you rate your IBS signs or symptoms overall over the past 7 days?: (1) significantly relieved; (2) moderately relieved; (3) slightly relieved; (4) unchanged; (5) slightly worse; (6) moderately worse; (7) significantly worse. A responder was defined as a participant who answered that their symptoms were either moderately relieved or significantly relieved. A participant with a missing GIS response was considered to be a non-responder.
Outcome measures
| Measure |
Placebo
n=108 Participants
Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea \[IBS-D\] versus IBS with mixed episodes of diarrhea and constipation \[IBS-M\]).
|
Vibegron 75 mg
n=111 Participants
Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).
|
|---|---|---|
|
Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants
IBS-D Participants
|
21 Participants
|
28 Participants
|
|
Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants
IBS-M Participants
|
16 Participants
|
16 Participants
|
|
Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants
All Participants
|
37 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: Baseline; 12 weeksPopulation: Full Analysis Set for IBS-D participants
An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 40% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea \[IBS-D\] versus IBS with mixed episodes of diarrhea and constipation \[IBS-M\]).
|
Vibegron 75 mg
n=66 Participants
Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).
|
|---|---|---|
|
Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks
|
20 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline; 12 weeksPopulation: Full Analysis Set for IBS-D participants
An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 50% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea \[IBS-D\] versus IBS with mixed episodes of diarrhea and constipation \[IBS-M\]).
|
Vibegron 75 mg
n=66 Participants
Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).
|
|---|---|---|
|
Number of IBS-D Participants Who Were API Weekly Responders With ≥ 50% Improvement Over 12 Weeks
|
13 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Day 113 or Early Withdrawal plus 28 days)Population: Safety Analysis Set: all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
TEAEs are defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment.
Outcome measures
| Measure |
Placebo
n=111 Participants
Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea \[IBS-D\] versus IBS with mixed episodes of diarrhea and constipation \[IBS-M\]).
|
Vibegron 75 mg
n=111 Participants
Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).
|
|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
|
37 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Safety Analysis Set
The investigator determined whether a change was clinically meaningful.
Outcome measures
| Measure |
Placebo
n=111 Participants
Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea \[IBS-D\] versus IBS with mixed episodes of diarrhea and constipation \[IBS-M\]).
|
Vibegron 75 mg
n=111 Participants
Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).
|
|---|---|---|
|
Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values at Week 12
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Safety Analysis Set
Clinical relevance was determined by the investigator.
Outcome measures
| Measure |
Placebo
n=111 Participants
Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea \[IBS-D\] versus IBS with mixed episodes of diarrhea and constipation \[IBS-M\]).
|
Vibegron 75 mg
n=111 Participants
Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).
|
|---|---|---|
|
Number of Participants With Clinically Relevant Changes From Baseline in Vital Sign Values at Week 12
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Vibegron 75 mg
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=111 participants at risk
Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea \[IBS-D\] versus IBS with mixed episodes of diarrhea and constipation \[IBS-M\]).
|
Vibegron 75 mg
n=111 participants at risk
Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).
|
|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.90%
1/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.90%
1/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.90%
1/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
Other adverse events
| Measure |
Placebo
n=111 participants at risk
Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea \[IBS-D\] versus IBS with mixed episodes of diarrhea and constipation \[IBS-M\]).
|
Vibegron 75 mg
n=111 participants at risk
Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (\< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.7%
3/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.90%
1/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
2.7%
3/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
2.7%
3/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Infections and infestations
Bacteriuria
|
4.5%
5/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
2.7%
3/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
2.7%
3/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Infections and infestations
Nasopharyngitis
|
2.7%
3/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.5%
5/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.90%
1/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Nervous system disorders
Headache
|
2.7%
3/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
2.7%
3/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
|
Renal and urinary disorders
Leukocyturia
|
2.7%
3/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
0.00%
0/111 • from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor does not object to publication by Institution or Principal Investigator (PI) of results of the Trial based on information collected or generated by the Institution or PI. However, the Institution and PI are required to provide the Sponsor with an opportunity to review any proposed publication or other type of disclosure before it is submitted or otherwise disclosed to ensure against any inadvertent disclosure of Sponsor Confidential Information or unprotected Sponsor Inventions.
- Publication restrictions are in place
Restriction type: OTHER