Trial Outcomes & Findings for A Study of Fluoxetine in Major Depressive Disorder (MDD) Long-Term Dosing (NCT NCT01808651)
NCT ID: NCT01808651
Last Updated: 2015-11-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
200 participants
Primary outcome timeframe
Baseline through Week 52.
Results posted on
2015-11-26
Participant Flow
This study consisted of 2 study periods for Japanese participants who completed acute treatment in Study B1Y-JE-HCLV(NCT#: NCT01808612): Study period I was a 52-week open-label treatment period with fluoxetine 20 to 40 milligrams (mg), administered once daily, and Study period II was a 2-wk observation phase following discontinuation of fluoxetine.
Participant milestones
| Measure |
PLA/FLX
Period 1: Participants (Pts) randomized to placebo in Study B1Y-JE-HCLV transitioned to fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.
Period 2: 2-week observation phase following discontinuation (DC'd) of fluoxetine.
|
FLX20/FLX
Period 1: Participants randomized to fluoxetine 20 mg /day in Study B1Y-JE-HCLV and continued on fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.
Period 2: 2-week observation phase following discontinuation of fluoxetine.
|
FLX40/FLX
Period 1: Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.
Period 2: 2-week observation phase following discontinuation of fluoxetine.
|
|---|---|---|---|
|
Study Period 1
STARTED
|
99
|
65
|
36
|
|
Study Period 1
Received at Least One Dose of Study Drug
|
98
|
65
|
36
|
|
Study Period 1
COMPLETED
|
73
|
48
|
31
|
|
Study Period 1
NOT COMPLETED
|
26
|
17
|
5
|
|
Study Period 2
STARTED
|
77
|
52
|
33
|
|
Study Period 2
COMPLETED
|
77
|
52
|
33
|
|
Study Period 2
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
PLA/FLX
Period 1: Participants (Pts) randomized to placebo in Study B1Y-JE-HCLV transitioned to fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.
Period 2: 2-week observation phase following discontinuation (DC'd) of fluoxetine.
|
FLX20/FLX
Period 1: Participants randomized to fluoxetine 20 mg /day in Study B1Y-JE-HCLV and continued on fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.
Period 2: 2-week observation phase following discontinuation of fluoxetine.
|
FLX40/FLX
Period 1: Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.
Period 2: 2-week observation phase following discontinuation of fluoxetine.
|
|---|---|---|---|
|
Study Period 1
Lost to Follow-up
|
1
|
3
|
0
|
|
Study Period 1
Protocol Violation
|
1
|
0
|
1
|
|
Study Period 1
Physician Decision
|
3
|
2
|
0
|
|
Study Period 1
Lack of Efficacy
|
2
|
1
|
0
|
|
Study Period 1
Adverse Event
|
10
|
4
|
1
|
|
Study Period 1
Participant Decision
|
9
|
7
|
3
|
Baseline Characteristics
A Study of Fluoxetine in Major Depressive Disorder (MDD) Long-Term Dosing
Baseline characteristics by cohort
| Measure |
PLA/FLX (Placebo/Fluoxetine)
n=98 Participants
Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
FLX20/FLX
n=65 Participants
Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
FLX40/FLX
n=36 Participants
Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.60 years
STANDARD_DEVIATION 12.95 • n=5 Participants
|
39.72 years
STANDARD_DEVIATION 10.91 • n=7 Participants
|
41.20 years
STANDARD_DEVIATION 10.51 • n=5 Participants
|
39.44 years
STANDARD_DEVIATION 11.88 • n=4 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
98 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
199 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
98 participants
n=5 Participants
|
65 participants
n=7 Participants
|
36 participants
n=5 Participants
|
199 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 52.Population: Participants who received at least 1 dose of the study drug were evaluated for AEs and SAEs. SAE reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 1.
Outcome measures
| Measure |
PLA/FLX
n=98 Participants
Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
FLX20/FLX
n=65 Participants
Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
FLX40/FLX
n=36 Participants
Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs)
Participants with >=1 AEs
|
75 participants
|
46 participants
|
29 participants
|
|
Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs)
Participants with >=1 SAE
|
2 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline through Week 52Population: Participants who received at least 1 dose of study drug with at least 1 post-baseline C-SSRS score during Study Period 1.
C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.
Outcome measures
| Measure |
PLA/FLX
n=98 Participants
Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
FLX20/FLX
n=65 Participants
Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
FLX40/FLX
n=36 Participants
Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
|---|---|---|---|
|
Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
|
8 participants
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during Study Period 1.
HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.
Outcome measures
| Measure |
PLA/FLX
n=98 Participants
Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
FLX20/FLX
n=64 Participants
Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
FLX40/FLX
n=36 Participants
Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
|---|---|---|---|
|
Mean Change From Baseline to Week 52 on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score
|
-10.04 units on a scale
Standard Error 0.73
|
-11.25 units on a scale
Standard Error 0.90
|
-11.70 units on a scale
Standard Error 1.16
|
SECONDARY outcome
Timeframe: Baseline, up to Week 52Population: Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.
The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100.
Outcome measures
| Measure |
PLA/FLX
n=98 Participants
Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
FLX20/FLX
n=65 Participants
Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
FLX40/FLX
n=36 Participants
Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
|---|---|---|---|
|
Percentage of Participants Achieving a Response at Week 52
|
68 Percentage of participants
|
65 Percentage of participants
|
83 Percentage of participants
|
SECONDARY outcome
Timeframe: up to Week 52Population: Participants who received at least 1 dose of study drug with a baseline (which had not achieved remission threshold criteria) and had at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.
The percentage of participants achieving a remission (defined as a HAMD21 total score ≤7) was calculated by dividing the number of participants achieving a remission at last observation by the total number of participants at risk, multiplied by 100.
Outcome measures
| Measure |
PLA/FLX
n=86 Participants
Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
FLX20/FLX
n=60 Participants
Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
FLX40/FLX
n=33 Participants
Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
|---|---|---|---|
|
Percentage of Participants Achieving a Remission at Week 52
|
64 percentage of participants
|
57 percentage of participants
|
76 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline CGI-S score during the Treatment Period.
CGI-S measures severity of illness at the time of assessment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline CGI-S score.
Outcome measures
| Measure |
PLA/FLX
n=98 Participants
Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
FLX20/FLX
n=64 Participants
Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
FLX40/FLX
n=36 Participants
Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
|---|---|---|---|
|
Mean Change From Baseline to Week 52 on the Clinical Global Impression of Severity (CGI-S) Scale
|
-1.41 units on a scale
Standard Error 0.10
|
-1.45 units on a scale
Standard Error 0.13
|
-1.64 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 subscale score. LSM (least square mean) and SE (standard error) are from visit 16.
HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score.
Outcome measures
| Measure |
PLA/FLX
n=98 Participants
Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
FLX20/FLX
n=64 Participants
Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
FLX40/FLX
n=36 Participants
Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
|---|---|---|---|
|
Mean Change From Baseline to Week 52 on the HAMD21 Subscale Scores
HAMD17 total scale
|
-9.06 units on a scale
Standard Error 0.67
|
-10.20 units on a scale
Standard Error 0.83
|
-10.51 units on a scale
Standard Error 1.07
|
|
Mean Change From Baseline to Week 52 on the HAMD21 Subscale Scores
Maier subscale score
|
-4.73 units on a scale
Standard Error 0.37
|
-5.55 units on a scale
Standard Error 0.46
|
-5.02 units on a scale
Standard Error 0.60
|
|
Mean Change From Baseline to Week 52 on the HAMD21 Subscale Scores
Anxiety/Somatization subscale score
|
-3.08 units on a scale
Standard Error 0.25
|
-3.16 units on a scale
Standard Error 0.31
|
-3.61 units on a scale
Standard Error 0.39
|
|
Mean Change From Baseline to Week 52 on the HAMD21 Subscale Scores
Retardation/Somatization subscale score
|
-3.45 units on a scale
Standard Error 0.26
|
-3.98 units on a scale
Standard Error 0.32
|
-3.55 units on a scale
Standard Error 0.42
|
|
Mean Change From Baseline to Week 52 on the HAMD21 Subscale Scores
Sleep subscale score
|
-1.49 units on a scale
Standard Error 0.15
|
-1.34 units on a scale
Standard Error 0.18
|
-1.95 units on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Baseline up to 52 weeksPopulation: Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline SDS score. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.
SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/school (Item 1), social life/leisure activities (Item 2), and family life/home responsibilities (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, pooled investigative site, and baseline SDS score.
Outcome measures
| Measure |
PLA/FLX
n=98 Participants
Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
FLX20/FLX
n=64 Participants
Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
FLX40/FLX
n=36 Participants
Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
|---|---|---|---|
|
Change From Baseline to Week 52 in Sheehan Disability Scale (SDS) Total Score and Subscale Scores
SDS Total Score
|
-6.53 units on a scale
Standard Error 0.78
|
-6.17 units on a scale
Standard Error 0.97
|
-6.14 units on a scale
Standard Error 1.28
|
|
Change From Baseline to Week 52 in Sheehan Disability Scale (SDS) Total Score and Subscale Scores
Work/School subscale (N:85, 60, 28)
|
-2.46 units on a scale
Standard Error 0.32
|
-2.62 units on a scale
Standard Error 0.38
|
-2.24 units on a scale
Standard Error 0.56
|
|
Change From Baseline to Week 52 in Sheehan Disability Scale (SDS) Total Score and Subscale Scores
Social/Leisure subscale (N:98, 64, 36)
|
-2.11 units on a scale
Standard Error 0.28
|
-2.11 units on a scale
Standard Error 0.35
|
-2.06 units on a scale
Standard Error 0.47
|
|
Change From Baseline to Week 52 in Sheehan Disability Scale (SDS) Total Score and Subscale Scores
Family/Home subscale (N:98,64,36)
|
-1.93 units on a scale
Standard Error 0.25
|
-1.55 units on a scale
Standard Error 0.31
|
-2.01 units on a scale
Standard Error 0.41
|
Adverse Events
Study Period 1 PLA/FLX
Serious events: 2 serious events
Other events: 74 other events
Deaths: 0 deaths
Study Period 1 FLX20/FLX
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
Study Period 1 FLX40/FLX
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Study Period 2 Discontinued From PLA/FLX
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Study Period 2 Discontinued From FLX20/FLX
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Study Period 2 Discontinued From FLX40/FLX
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Period 1 PLA/FLX
n=98 participants at risk
Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
Study Period 1 FLX20/FLX
n=65 participants at risk
Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
Study Period 1 FLX40/FLX
n=36 participants at risk
Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
Study Period 2 Discontinued From PLA/FLX
n=77 participants at risk
Participants in the PLA/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2,
|
Study Period 2 Discontinued From FLX20/FLX
n=52 participants at risk
Participants in the FLX20/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2.
|
Study Period 2 Discontinued From FLX40/FLX
n=33 participants at risk
Participants in the FLX40/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2.
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Intentional self-injury
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Psychiatric disorders
Major depression
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.9%
1/52 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
Other adverse events
| Measure |
Study Period 1 PLA/FLX
n=98 participants at risk
Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
Study Period 1 FLX20/FLX
n=65 participants at risk
Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
Study Period 1 FLX40/FLX
n=36 participants at risk
Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
|
Study Period 2 Discontinued From PLA/FLX
n=77 participants at risk
Participants in the PLA/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2,
|
Study Period 2 Discontinued From FLX20/FLX
n=52 participants at risk
Participants in the FLX20/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2.
|
Study Period 2 Discontinued From FLX40/FLX
n=33 participants at risk
Participants in the FLX40/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Cardiac disorders
Atrioventricular block first degree
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Cardiac disorders
Bradycardia
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Cardiac disorders
Palpitations
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
3.1%
2/65 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Cardiac disorders
Tachycardia
|
1.0%
1/98 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Ear and labyrinth disorders
Vertigo
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
3.1%
2/65 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Eye disorders
Asthenopia
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Eye disorders
Conjunctivitis allergic
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
5.6%
2/36 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.1%
5/98 • Number of events 6
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
3.1%
2/65 • Number of events 4
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.3%
1/77 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
2/98 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.3%
1/77 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Gastrointestinal disorders
Dental caries
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
3/98 • Number of events 3
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
6.2%
4/65 • Number of events 4
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
5.6%
2/36 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
3.0%
1/33 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Gastrointestinal disorders
Enterocolitis
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Gastrointestinal disorders
Gastritis
|
3.1%
3/98 • Number of events 3
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Gastrointestinal disorders
Glossodynia
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Gastrointestinal disorders
Nausea
|
8.2%
8/98 • Number of events 10
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
4.6%
3/65 • Number of events 3
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
11.1%
4/36 • Number of events 5
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Gastrointestinal disorders
Periodontal disease
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
3.1%
2/65 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
General disorders
Chest discomfort
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
General disorders
Chest pain
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.9%
1/52 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
General disorders
Fatigue
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
General disorders
Feeling abnormal
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
General disorders
Malaise
|
2.0%
2/98 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
General disorders
Pyrexia
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
5.6%
2/36 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
General disorders
Thirst
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Infections and infestations
Bronchitis
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Infections and infestations
Conjunctivitis
|
2.0%
2/98 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Infections and infestations
Cystitis
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Infections and infestations
Enterocolitis viral
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Infections and infestations
Gastroenteritis
|
2.0%
2/98 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Infections and infestations
Herpes zoster
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Infections and infestations
Influenza
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Infections and infestations
Nasopharyngitis
|
32.7%
32/98 • Number of events 43
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
30.8%
20/65 • Number of events 27
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
41.7%
15/36 • Number of events 26
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.3%
1/77 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.9%
1/52 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Infections and infestations
Pharyngitis
|
3.1%
3/98 • Number of events 3
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
3.1%
2/65 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/47
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
3.0%
1/33 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/19
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/47
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
3.0%
1/33 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/19
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
2.0%
2/98 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
3.1%
2/65 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.0%
2/98 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
8.3%
3/36 • Number of events 3
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Injury, poisoning and procedural complications
Wound
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Investigations
Alanine aminotransferase increased
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Investigations
Aspartate aminotransferase increased
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Investigations
Blood bilirubin increased
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
4.6%
3/65 • Number of events 3
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Investigations
Blood pressure increased
|
2.0%
2/98 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.9%
1/52 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Investigations
Blood triglycerides increased
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Investigations
Blood urine present
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Investigations
Electrocardiogram abnormal
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Investigations
Electrocardiogram qt prolonged
|
2.0%
2/98 • Number of events 3
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Investigations
Liver function test abnormal
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Investigations
Qrs axis abnormal
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Investigations
Weight decreased
|
2.0%
2/98 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Investigations
Weight increased
|
4.1%
4/98 • Number of events 4
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Investigations
White blood cell count decreased
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.1%
3/98 • Number of events 3
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
2.0%
2/98 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Metabolism and nutrition disorders
Increased appetite
|
2.0%
2/98 • Number of events 3
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.1%
4/98 • Number of events 4
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
2/98 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
3.1%
2/65 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.9%
1/52 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Nervous system disorders
Dizziness
|
5.1%
5/98 • Number of events 6
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.9%
1/52 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
3.0%
1/33 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Nervous system disorders
Headache
|
7.1%
7/98 • Number of events 8
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
9.2%
6/65 • Number of events 9
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
13.9%
5/36 • Number of events 5
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.9%
1/52 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Nervous system disorders
Intercostal neuralgia
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Nervous system disorders
Loss of consciousness
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.3%
1/77 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Nervous system disorders
Somnolence
|
7.1%
7/98 • Number of events 7
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
7.7%
5/65 • Number of events 5
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
13.9%
5/36 • Number of events 6
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Psychiatric disorders
Activation syndrome
|
2.0%
2/98 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Psychiatric disorders
Anxiety
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Psychiatric disorders
Delirium
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Psychiatric disorders
Insomnia
|
4.1%
4/98 • Number of events 4
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
3.1%
2/65 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Psychiatric disorders
Irritability
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Psychiatric disorders
Major depression
|
2.0%
2/98 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Psychiatric disorders
Nightmare
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
3.1%
2/65 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Psychiatric disorders
Panic reaction
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Psychiatric disorders
Sleep disorder
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Psychiatric disorders
Terminal insomnia
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Psychiatric disorders
Trichotillomania
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.3%
1/77 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Renal and urinary disorders
Pollakiuria
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Renal and urinary disorders
Renal glycosuria
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.1%
1/47 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
3.0%
1/33 • Number of events 7
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
5.3%
1/19 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
2.1%
1/47 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/19
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
5.6%
2/36 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.0%
2/98 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
2.0%
2/98 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
2/98 • Number of events 2
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.9%
1/52 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
1.5%
1/65 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.1%
3/98 • Number of events 3
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/98
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
2.8%
1/36 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
|
Vascular disorders
Hypertension
|
1.0%
1/98 • Number of events 1
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/65
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/36
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/77
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/52
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
0.00%
0/33
SAE "Asthma" reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 2; however, SAE "Asthma" was reported in both Study Period 1 and Study Period 2 for this participant.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60