Trial Outcomes & Findings for Vortioxetine for Binge Eating Disorder (NCT NCT02528409)

Last Updated: 2020-11-23

Results Overview

Subjects will report the number of binge eating episodes in the week preceding the final visit (Week 12 of treatment), both to the investigator and via daily eating journals at all 9 visits. The outcome measure was the change in number of episodes from Week 0 (baseline) to the final visit (Week 12).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

12 weeks

Results posted on

2020-11-23

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo 10 milligrams per day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Placebo	Vortioxetine 10 milligrams per day day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Vortioxetine: Medication currently approved for major depression.
Overall Study STARTED	40	40
Overall Study COMPLETED	18	24
Overall Study NOT COMPLETED	22	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vortioxetine for Binge Eating Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=40 Participants 10 milligrams per day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Placebo	Vortioxetine n=40 Participants 10 milligrams per day day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Vortioxetine: Medication currently approved for major depression.	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	39.0 years STANDARD_DEVIATION 12.9 • n=5 Participants	41.4 years STANDARD_DEVIATION 13.8 • n=7 Participants	40.2 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	36 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	24 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Placebo n=28 Participants 10 milligrams per day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Placebo	Vortioxetine n=29 Participants 10 milligrams per day day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Vortioxetine: Medication currently approved for major depression.
Change in Number of Binge Eating Episodes	.93 binge eating episodes Standard Deviation 1.49	.76 binge eating episodes Standard Deviation 1.33

SECONDARY outcome

Timeframe: 12 weeks

Assessment of change in patient body mass index over the course of the study (from baseline to the final visit at Week 12).

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants 10 milligrams per day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Placebo	Vortioxetine n=34 Participants 10 milligrams per day day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Vortioxetine: Medication currently approved for major depression.
BMI Pre-Treatment	36.19 kg/m^2 Standard Deviation 8.47	38.39 kg/m^2 Standard Deviation 9.30
BMI Post-Treatment	36.29 kg/m^2 Standard Deviation 8.52	38.73 kg/m^2 Standard Deviation 9.66

SECONDARY outcome

Timeframe: 4 weeks

Subjects will be assessed at 4 weeks to determine cessation of binge eating status.

Outcome measures

Outcome measures
Measure	Placebo n=37 Participants 10 milligrams per day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Placebo	Vortioxetine n=39 Participants 10 milligrams per day day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Vortioxetine: Medication currently approved for major depression.
Number of Participants With 4-week Cessation From Binge Eating No 4-Week Cessation	27 Participants	26 Participants
Number of Participants With 4-week Cessation From Binge Eating 4-Week Cessation	10 Participants	13 Participants

SECONDARY outcome

Timeframe: Week 12 (final) visit

Patient global improvement relative to baseline, with scores ranging from 1-7. Higher scores indicate the patient is doing severely worse than they were at the beginning of treatment.

Outcome measures

Outcome measures
Measure	Placebo n=33 Participants 10 milligrams per day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Placebo	Vortioxetine n=33 Participants 10 milligrams per day day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Vortioxetine: Medication currently approved for major depression.
Clinical Global Impression Improvement Scale (CGI) Pre-Treatment	4.18 units on a scale Standard Deviation .64	4.25 units on a scale Standard Deviation .71
Clinical Global Impression Improvement Scale (CGI) Post-Treatment	2.79 units on a scale Standard Deviation 1.29	2.70 units on a scale Standard Deviation 1.33

SECONDARY outcome

Timeframe: 12 weeks

A self-reported measure of binge eating behavior that will be collected at all 9 study visits with scores ranging from 0-51, with higher scores indicating more compulsive eating habits.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants 10 milligrams per day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Placebo	Vortioxetine n=33 Participants 10 milligrams per day day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Vortioxetine: Medication currently approved for major depression.
Three-Factor Eating Questionnaire Pre-Treatment	7.71 units on a scale Standard Deviation 3.97	6.92 units on a scale Standard Deviation 4.53
Three-Factor Eating Questionnaire Post-Treatment	9.85 units on a scale Standard Deviation 5.12	9.48 units on a scale Standard Deviation 6.00

SECONDARY outcome

Timeframe: 12 weeks

A clinician-administered scale assessing binge eating severity that will be assessed at all 9 study visits. Scores range from 0-40 with higher scores indicating more severe OCD symptoms.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants 10 milligrams per day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Placebo	Vortioxetine n=33 Participants 10 milligrams per day day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Vortioxetine: Medication currently approved for major depression.
Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating Pre-Treatment	20.10 units on a scale Standard Deviation 4.03	20.55 units on a scale Standard Deviation 3.88
Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating Post-Treatment	10.44 units on a scale Standard Deviation 7.09	9.94 units on a scale Standard Deviation 8.10

SECONDARY outcome

Timeframe: 12 weeks

A self-report assessment of patient perceived quality of life that will be assessed at baseline and final visit. The scale provides a discrete score ranging from -192 to 192, with higher numbers indicating higher subjective quality of life.

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants 10 milligrams per day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Placebo	Vortioxetine n=21 Participants 10 milligrams per day day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Vortioxetine: Medication currently approved for major depression.
Quality of Life Inventory Pre-Treatment	39.13 units on a scale Standard Deviation 29.00	35.00 units on a scale Standard Deviation 14.72
Quality of Life Inventory Post-Treatment	46.22 units on a scale Standard Deviation 15.38	44.00 units on a scale Standard Deviation 16.69

SECONDARY outcome

Timeframe: 12 weeks

A clinician-administered assessment of depression that will be assessed at all 8 study visits after the baseline visit. The scale provides a discrete score that ranges from 0-52, with higher scores indicating more severe depressive symptoms.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants 10 milligrams per day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Placebo	Vortioxetine n=34 Participants 10 milligrams per day day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Vortioxetine: Medication currently approved for major depression.
Hamilton Depression Rating Scale Pre-Treatment	4.55 units on a scale Standard Deviation 4.32	4.32 units on a scale Standard Deviation 4.38
Hamilton Depression Rating Scale Post-Treatment	2.06 units on a scale Standard Deviation 2.57	3.66 units on a scale Standard Deviation 4.38

SECONDARY outcome

Timeframe: 12 weeks

A clinician-administered assessment of anxiety that will be assessed at all 9 study visits. The scale provides a discrete score that ranges from 0-56, with higher scores indicating more severe anxiety symptoms.

Outcome measures

Outcome measures
Measure	Placebo n=33 Participants 10 milligrams per day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Placebo	Vortioxetine n=32 Participants 10 milligrams per day day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Vortioxetine: Medication currently approved for major depression.
Hamilton Anxiety Rating Scale Pre-Treatment	4.13 units on a scale Standard Deviation 4.26	3.68 units on a scale Standard Deviation 3.51
Hamilton Anxiety Rating Scale Post-Treatment	1.79 units on a scale Standard Deviation 1.95	2.72 units on a scale Standard Deviation 4.18

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Vortioxetine

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Jon E. Grant

University of Chicago

Phone: 773-834-1325

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo n=40 participants at risk 10 milligrams per day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Placebo	Vortioxetine n=40 participants at risk 10 milligrams per day day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods. Vortioxetine: Medication currently approved for major depression.
Skin and subcutaneous tissue disorders Itching	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	5.0% 2/40 • Number of events 2 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Gastrointestinal disorders Nausea	15.0% 6/40 • Number of events 9 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	25.0% 10/40 • Number of events 20 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Nervous system disorders Headache	10.0% 4/40 • Number of events 5 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	10.0% 4/40 • Number of events 4 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Nervous system disorders Dizziness	7.5% 3/40 • Number of events 5 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	10.0% 4/40 • Number of events 4 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Gastrointestinal disorders Dry Mouth	5.0% 2/40 • Number of events 5 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	10.0% 4/40 • Number of events 5 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Nervous system disorders Insomnia	5.0% 2/40 • Number of events 2 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	7.5% 3/40 • Number of events 7 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Gastrointestinal disorders Constipation	7.5% 3/40 • Number of events 3 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Gastrointestinal disorders Vomiting	5.0% 2/40 • Number of events 2 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	7.5% 3/40 • Number of events 4 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Gastrointestinal disorders Bloating	5.0% 2/40 • Number of events 3 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	7.5% 3/40 • Number of events 4 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Gastrointestinal disorders Flatulence	7.5% 3/40 • Number of events 3 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Nervous system disorders Tingling/Numbness	5.0% 2/40 • Number of events 2 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	2.5% 1/40 • Number of events 2 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Psychiatric disorders Irritability	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Nervous system disorders Temperature Fluctuations	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	0.00% 0/40 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Psychiatric disorders Anxiety	0.00% 0/40 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	2.5% 1/40 • Number of events 4 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Musculoskeletal and connective tissue disorders Tooth Sensitivity	0.00% 0/40 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Psychiatric disorders Panic symptoms	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	0.00% 0/40 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Eye disorders Blurry vision	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Nervous system disorders Drowsiness	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	0.00% 0/40 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Nervous system disorders Fatigue	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Reproductive system and breast disorders Loss of Libido	0.00% 0/40 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Gastrointestinal disorders Stomach Pain	0.00% 0/40 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	5.0% 2/40 • Number of events 2 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Nervous system disorders Increased heart rate	0.00% 0/40 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Gastrointestinal disorders Difficulty swallowing	0.00% 0/40 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Nervous system disorders Restlessness	0.00% 0/40 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Psychiatric disorders Depressed Mood	0.00% 0/40 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Nervous system disorders Somnolence	0.00% 0/40 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).
Respiratory, thoracic and mediastinal disorders Shortness of breath	0.00% 0/40 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).	2.5% 1/40 • Number of events 1 • Adverse event data were collected for the 12 weeks of participation at every visit after the baseline visit (at each of the 8 follow-up visits -- each one or two weeks apart from each other, depending on the part of the study).