Trial Outcomes & Findings for A Study of LY2951742 (Galcanezumab) in Japanese Participants With Episodic Migraine (NCT NCT02959177)
NCT ID: NCT02959177
Last Updated: 2021-04-27
Results Overview
Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Migraine Headache : A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B): A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia; The overall mean is derived from the average of months 1 to 6 from mixed model repeat measures (MMRM) model. Least Square Mean (LSMEAN) was calculated using MMRM models with fixed categorical effects of treatment, month, and treatment-by-month interaction, as well as the continuous, fixed covariates of baseline value and baseline-by-month interaction.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
459 participants
Primary outcome timeframe
Baseline, Month 1 through Month 6
Results posted on
2021-04-27
Participant Flow
Participants were randomized to a Treatment Phase with double-blind treatment arms and then could enter a Follow-up Post Treatment Phase.
Participant milestones
| Measure |
120 mg Galcanezumab
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous (SC)injection.
|
240 mg Galcanezumab
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Placebo
Placebo administered SC once a month for 6 months.
|
|---|---|---|---|
|
Double-Blind Treatment Phase
STARTED
|
115
|
114
|
230
|
|
Double-Blind Treatment Phase
Received at Least 1 Dose of Study Drug
|
115
|
114
|
230
|
|
Double-Blind Treatment Phase
COMPLETED
|
104
|
111
|
225
|
|
Double-Blind Treatment Phase
NOT COMPLETED
|
11
|
3
|
5
|
|
Follow-up Post Treatment Phase
STARTED
|
52
|
52
|
100
|
|
Follow-up Post Treatment Phase
COMPLETED
|
51
|
51
|
98
|
|
Follow-up Post Treatment Phase
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
120 mg Galcanezumab
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous (SC)injection.
|
240 mg Galcanezumab
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Placebo
Placebo administered SC once a month for 6 months.
|
|---|---|---|---|
|
Double-Blind Treatment Phase
Adverse Event
|
5
|
2
|
0
|
|
Double-Blind Treatment Phase
Physician Decision
|
1
|
0
|
0
|
|
Double-Blind Treatment Phase
Protocol Violation
|
0
|
1
|
0
|
|
Double-Blind Treatment Phase
Withdrawal by Subject
|
5
|
0
|
5
|
|
Follow-up Post Treatment Phase
Lost to Follow-up
|
1
|
0
|
0
|
|
Follow-up Post Treatment Phase
Adverse Event
|
0
|
1
|
0
|
|
Follow-up Post Treatment Phase
Withdrawal by Subject
|
0
|
0
|
2
|
Baseline Characteristics
A Study of LY2951742 (Galcanezumab) in Japanese Participants With Episodic Migraine
Baseline characteristics by cohort
| Measure |
120 mg Galcanezumab
n=115 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
240 mg Galcanezumab
n=114 Participants
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Placebo
n=230 Participants
Participants were administered placebo SC once a month for 6 months..
|
Total
n=459 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Less than 20 years old
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Age, Customized
Greater than 20 years old
|
114 Participants
n=99 Participants
|
114 Participants
n=107 Participants
|
229 Participants
n=206 Participants
|
457 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
196 Participants
n=206 Participants
|
387 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
72 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
115 Participants
n=99 Participants
|
114 Participants
n=107 Participants
|
230 Participants
n=206 Participants
|
459 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
115 Participants
n=99 Participants
|
114 Participants
n=107 Participants
|
230 Participants
n=206 Participants
|
459 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Japan
|
115 Participants
n=99 Participants
|
114 Participants
n=107 Participants
|
230 Participants
n=206 Participants
|
459 Participants
n=7 Participants
|
|
Migraine Headache Days (MHD) per month
|
8.6 days per month
STANDARD_DEVIATION 2.8 • n=99 Participants
|
9.0 days per month
STANDARD_DEVIATION 3.0 • n=107 Participants
|
8.6 days per month
STANDARD_DEVIATION 3.0 • n=206 Participants
|
8.8 days per month
STANDARD_DEVIATION 2.9 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 1 through Month 6Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Migraine Headache : A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B): A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia; The overall mean is derived from the average of months 1 to 6 from mixed model repeat measures (MMRM) model. Least Square Mean (LSMEAN) was calculated using MMRM models with fixed categorical effects of treatment, month, and treatment-by-month interaction, as well as the continuous, fixed covariates of baseline value and baseline-by-month interaction.
Outcome measures
| Measure |
120 mg Galcanezumab
n=115 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
240 mg Galcanezumab
n=114 Participants
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Placebo
n=230 Participants
Participants were administered placebo SC once a month for 6 months.
|
|---|---|---|---|
|
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD)
|
-3.60 Days
Interval -4.25 to -2.96
|
-3.36 Days
Interval -4.01 to -2.71
|
-0.59 Days
Interval -1.05 to -0.14
|
SECONDARY outcome
Timeframe: Baseline, Month 1 through Month 6Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. A 50% responder in a particular month is any participant who has a ≥50% reduction from baseline in the monthly number of migraine headache attacks in a 30-day interval. It is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, and baseline MHD category as fixed factors.
Outcome measures
| Measure |
120 mg Galcanezumab
n=115 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
240 mg Galcanezumab
n=114 Participants
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Placebo
n=230 Participants
Participants were administered placebo SC once a month for 6 months.
|
|---|---|---|---|
|
Percentage of Participants With a 50% or Greater Reduction From Baseline in Monthly Migraine Headache Days
|
49.8 percentage of participants
Standard Error 3.4
|
48.2 percentage of participants
Standard Error 3.5
|
20.3 percentage of participants
Standard Error 2.0
|
SECONDARY outcome
Timeframe: Baseline, Month 1 through Month 6Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. A 75% responder in a particular month is any participant who has a ≥75% reduction from baseline in the monthly number of migraine headache attacks in a 30-day interval. It is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, and baseline MHD category as fixed factors.
Outcome measures
| Measure |
120 mg Galcanezumab
n=115 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
240 mg Galcanezumab
n=114 Participants
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Placebo
n=230 Participants
Participants were administered placebo SC once a month for 6 months.
|
|---|---|---|---|
|
Percentage of Participants With a 75% or Greater Reduction From Baseline in Monthly Migraine Headache Days
|
25.5 percentage of participants
Standard Error 2.8
|
25.0 percentage of participants
Standard Error 2.8
|
9.6 percentage of participants
Standard Error 1.3
|
SECONDARY outcome
Timeframe: Baseline, Month 1 through Month 6Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. A 100% responder in a particular month is any participant who has a 100% reduction from baseline in the monthly number of migraine headache attacks in a 30-day interval. It is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, and baseline MHD category as fixed factors.
Outcome measures
| Measure |
120 mg Galcanezumab
n=115 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
240 mg Galcanezumab
n=114 Participants
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Placebo
n=230 Participants
Participants were administered placebo SC once a month for 6 months.
|
|---|---|---|---|
|
Percentage of Participants With a 100% Reduction From Baseline in Monthly Migraine Headache Days
|
9.0 percentage of participants
Standard Error 1.5
|
8.1 percentage of participants
Standard Error 1.5
|
2.8 percentage of participants
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Baseline, Month 4 through Month 6Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
MSQ version 2.1 is a health status instrument consists of 14 items addressing 3 domains:(1)Role Function-Restrictive (items 1-7);(2)Role Function- Preventive (items 8-11);\&(3)Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6), \& are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items in that domain. After total raw score is computed for each domain \& total score, they are transformed to a 0-100 scale with higher scores indicating a better health status \& a positive change in scores reflecting functional improvement. The overall mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, month, treatment by month, baseline by month and baseline MHD category as fixed factors.
Outcome measures
| Measure |
120 mg Galcanezumab
n=112 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
240 mg Galcanezumab
n=112 Participants
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Placebo
n=228 Participants
Participants were administered placebo SC once a month for 6 months.
|
|---|---|---|---|
|
Overall Mean Change From Baseline on the Migraine-Specific Quality (MSQ) of Life Questionnaire
|
17.13 units on a scale
Interval 15.1 to 19.15
|
15.91 units on a scale
Interval 13.89 to 17.93
|
10.12 units on a scale
Interval 8.7 to 11.55
|
SECONDARY outcome
Timeframe: Baseline, Month 1 through Month 6Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
Migraine Headache Day (MHD) with Acute Medication Use: Calendar days on which migraine or probable migraine occurs, requiring acute medication. The overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed effects.
Outcome measures
| Measure |
120 mg Galcanezumab
n=115 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
240 mg Galcanezumab
n=114 Participants
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Placebo
n=230 Participants
Participants were administered placebo SC once a month for 6 months.
|
|---|---|---|---|
|
Overall Mean Change From Baseline in Number of Migraine Headache Days With Acute Medication Use
|
-3.02 MDHs with medication use
Interval -3.6 to -2.43
|
-2.81 MDHs with medication use
Interval -3.4 to -2.23
|
-0.12 MDHs with medication use
Interval -0.53 to 0.3
|
SECONDARY outcome
Timeframe: Baseline, Month 4 through Month 6Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
The PGI-S scale is a patient-rated instrument that measures patients own global impression of their illness severity. The patient was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options were from 1 ("normal, not at all ill") to 7 ("extremely ill"). Mean is derived from the average of months 4 to 6 from MMRM model. Least square mean (LSM) was calculated using an MMRM model with treatment, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed effects.
Outcome measures
| Measure |
120 mg Galcanezumab
n=112 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
240 mg Galcanezumab
n=112 Participants
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Placebo
n=228 Participants
Participants were administered placebo SC once a month for 6 months.
|
|---|---|---|---|
|
Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score
|
-0.25 units on a scale
Interval -0.4 to -0.1
|
-0.41 units on a scale
Interval -0.56 to -0.25
|
-0.15 units on a scale
Interval -0.26 to -0.04
|
SECONDARY outcome
Timeframe: Baseline, Month 1 through Month 6Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
Headache Hours is calculated as the total number of headache hours on which a headache occurred. Overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using the MMRM model with treatment, month, treatment by month, baseline, baseline by month and baseline MHD category.
Outcome measures
| Measure |
120 mg Galcanezumab
n=115 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
240 mg Galcanezumab
n=114 Participants
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Placebo
n=230 Participants
Participants were administered placebo SC once a month for 6 months.
|
|---|---|---|---|
|
Overall Mean Change From Baseline in Headache Hours
|
-14.56 hours per month
Interval -18.1 to -11.01
|
-16.46 hours per month
Interval -20.02 to -12.9
|
-2.73 hours per month
Interval -5.25 to -0.22
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. LSMean was calculated using MMRM model with treatment, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors.
Outcome measures
| Measure |
120 mg Galcanezumab
n=114 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
240 mg Galcanezumab
n=113 Participants
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Placebo
n=229 Participants
Participants were administered placebo SC once a month for 6 months.
|
|---|---|---|---|
|
Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score
|
-7.06 units on a scale
Interval -9.67 to -4.44
|
-5.13 units on a scale
Interval -7.69 to -2.58
|
-2.16 units on a scale
Interval -3.96 to -0.36
|
SECONDARY outcome
Timeframe: Month 6Population: All randomized participants who received at least one dose of study drug and had Month 6 PSMQ-M measurement.
The PSMQ-M is a self-rated scale which measures participants level of satisfaction with study medication.The scale has been modified for use in this study, assessing 3 items related to the clinical trial treatment over the past 4 weeks: satisfaction, preference, and side effects. Satisfaction responses range from "very unsatisfied" to "very satisfied" with the current treatment. Preference compares the current study medication to previous medications, with responses from "much rather prefer my previous medication" to "much rather prefer the medication administered to me during the study"
Outcome measures
| Measure |
120 mg Galcanezumab
n=104 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
240 mg Galcanezumab
n=111 Participants
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Placebo
n=225 Participants
Participants were administered placebo SC once a month for 6 months.
|
|---|---|---|---|
|
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
Satisfaction: Very satisfied
|
35.58 percentage of participants
|
44.14 percentage of participants
|
7.56 percentage of participants
|
|
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
Satisfaction: Somewhat satisfied
|
26.92 percentage of participants
|
23.42 percentage of participants
|
27.11 percentage of participants
|
|
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
Side effects: Much less side effects
|
35.58 percentage of participants
|
28.83 percentage of participants
|
24.89 percentage of participants
|
|
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
Side effects: Less side effects
|
22.12 percentage of participants
|
33.33 percentage of participants
|
25.78 percentage of participants
|
|
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
Preference: Prefer study medication
|
40.38 percentage of participants
|
34.23 percentage of participants
|
28.00 percentage of participants
|
|
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
Preference: Much Prefer study medication
|
22.12 percentage of participants
|
27.03 percentage of participants
|
3.11 percentage of participants
|
SECONDARY outcome
Timeframe: Month 1 through Month 6Population: All randomized participants who received at least one dose of study drug and had at least one post baseline C-SSRS assessment.
C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thoughts occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal ideation (SI): a "yes" answer to any of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent
Outcome measures
| Measure |
120 mg Galcanezumab
n=115 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
240 mg Galcanezumab
n=114 Participants
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Placebo
n=230 Participants
Participants were administered placebo SC once a month for 6 months.
|
|---|---|---|---|
|
Number of Participants With Suicidal Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
Wish to be dead
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
Non-specific active suicidal thoughts
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
Active SI with no intent
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
Active SI with some intent
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
Active SI with specific plan and intent
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 1 through Month 6Population: All randomized participants who received at least one dose of study drug.
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 |
120 mg Galcanezumab
n=115 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
240 mg Galcanezumab
n=114 Participants
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Placebo
n=230 Participants
Participants were administered placebo SC once a month for 6 months.
|
|---|---|---|---|
|
Number of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
Preparatory acts or behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
Aborted attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
Non-fatal suicide attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
Completed suicide
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: All randomized participants who received at least 1 dose of study drug and had evaluable immunogenicity data.
Treatment emergent ADA will be defined as any of the following: * A negative baseline result and a positive post-baseline ADA result with a titer ≥20. This is also called treatment-induced ADA. * A positive baseline result and a positive post-baseline ADA result with a ≥4-fold increase in titers (for example, baseline titer of 10 increasing to ≥40 post-baseline). This is called treatment-boosted ADA.
Outcome measures
| Measure |
120 mg Galcanezumab
n=115 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
240 mg Galcanezumab
n=114 Participants
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Placebo
n=230 Participants
Participants were administered placebo SC once a month for 6 months.
|
|---|---|---|---|
|
Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab
|
9.57 percentage of participants
|
10.53 percentage of participants
|
1.30 percentage of participants
|
SECONDARY outcome
Timeframe: Month 6Population: All randomized participants who received at least one dose of study drug and had measurable serum concentrations.
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Outcome measures
| Measure |
120 mg Galcanezumab
n=104 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
240 mg Galcanezumab
n=111 Participants
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Placebo
Participants were administered placebo SC once a month for 6 months.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
|
20400 nanograms per milliliter
Standard Deviation 7490
|
40600 nanograms per milliliter
Standard Deviation 18400
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: All randomized participants who received at least one dose of study drug and had measurable CGRP concentrations.
Total Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Outcome measures
| Measure |
120 mg Galcanezumab
n=104 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first dosing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
240 mg Galcanezumab
n=110 Participants
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Placebo
n=25 Participants
Participants were administered placebo SC once a month for 6 months.
|
|---|---|---|---|
|
Total Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
|
4.35 nanograms per milliliter
Standard Deviation 1.25
|
5.40 nanograms per milliliter
Standard Deviation 1.53
|
0.634 nanograms per milliliter
Standard Deviation 1.36
|
Adverse Events
Treatment Phase Placebo
Serious events: 0 serious events
Other events: 149 other events
Deaths: 0 deaths
Treatment Phase 120 mg Galcanezumab
Serious events: 3 serious events
Other events: 98 other events
Deaths: 0 deaths
Treatment Phase 240 mg Galcanezumab
Serious events: 1 serious events
Other events: 93 other events
Deaths: 0 deaths
Follow-up Phase Placebo
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Follow-up 120 mg Galcanezumab
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Follow-up Phase 240 mg Galcanezumab
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Phase Placebo
n=230 participants at risk
Participants were administered placebo SC once a month for 6 months.
|
Treatment Phase 120 mg Galcanezumab
n=115 participants at risk
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
Treatment Phase 240 mg Galcanezumab
n=114 participants at risk
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Follow-up Phase Placebo
n=100 participants at risk
Participants did not receive study drug
|
Follow-up 120 mg Galcanezumab
n=52 participants at risk
Participants did not receive study drug
|
Follow-up Phase 240 mg Galcanezumab
n=52 participants at risk
Participants did not receive study drug
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Treatment Phase Placebo
n=230 participants at risk
Participants were administered placebo SC once a month for 6 months.
|
Treatment Phase 120 mg Galcanezumab
n=115 participants at risk
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
Treatment Phase 240 mg Galcanezumab
n=114 participants at risk
Participants received 240 mg galcanezumab administered SC once a month for 6 months.
|
Follow-up Phase Placebo
n=100 participants at risk
Participants did not receive study drug
|
Follow-up 120 mg Galcanezumab
n=52 participants at risk
Participants did not receive study drug
|
Follow-up Phase 240 mg Galcanezumab
n=52 participants at risk
Participants did not receive study drug
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Tachycardia
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Eustachian tube patulous
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Eustachian tube stenosis
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
2/114 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.3%
3/230 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Endocrine disorders
Goitre
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Asthenopia
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Cataract
|
0.87%
2/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Chalazion
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Conjunctivitis allergic
|
0.87%
2/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
2/114 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Corneal disorder
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Dry eye
|
0.87%
2/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Foreign body sensation in eyes
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Glaucoma
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.87%
2/230 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
2/114 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.43%
1/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.5%
8/230 • Number of events 9 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
3/114 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal wall haemorrhage
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Allergic stomatitis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Chapped lips
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Cheilitis granulomatosa
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Radial nerve palsy
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
3/230 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.5%
4/115 • Number of events 4 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dental caries
|
2.2%
5/230 • Number of events 5 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.1%
7/115 • Number of events 8 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.4%
5/114 • Number of events 5 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
7/230 • Number of events 7 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.5%
4/115 • Number of events 6 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
3/114 • Number of events 4 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
1.7%
4/230 • Number of events 5 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
2/114 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastroenteritis eosinophilic
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haematochezia
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.43%
1/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
3/230 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oroantral fistula
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Stomatitis
|
0.87%
2/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Tooth loss
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Toothache
|
1.7%
4/230 • Number of events 5 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
5/115 • Number of events 5 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
0.87%
2/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Asthenia
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chest discomfort
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
0.87%
2/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.7%
2/115 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Hangover
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site bruising
|
1.7%
4/230 • Number of events 4 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.7%
2/115 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site dermatitis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site discolouration
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site discomfort
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site eczema
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site erythema
|
2.2%
5/230 • Number of events 9 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.8%
17/115 • Number of events 46 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
27.2%
31/114 • Number of events 84 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site haemorrhage
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site induration
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
3/115 • Number of events 5 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
3/114 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site inflammation
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
3/115 • Number of events 4 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site mass
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site pain
|
1.3%
3/230 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.1%
7/115 • Number of events 9 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.0%
8/114 • Number of events 14 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site pruritus
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.7%
10/115 • Number of events 24 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.2%
23/114 • Number of events 59 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site rash
|
0.87%
2/230 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
3/114 • Number of events 6 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site reaction
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site swelling
|
1.3%
3/230 • Number of events 4 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.4%
12/115 • Number of events 22 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.5%
12/114 • Number of events 22 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site urticaria
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 4 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site warmth
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.7%
2/115 • Number of events 7 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 4 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Malaise
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Oedema
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Papillitis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Puncture site induration
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
2/114 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
2/100 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bacterial vulvovaginitis
|
0.00%
0/196 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/95 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/84 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/43 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/44 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
3/115 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cystitis
|
0.87%
2/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
3/114 • Number of events 4 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Erysipelas
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
2.2%
5/230 • Number of events 5 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.1%
7/115 • Number of events 7 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
3/114 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
3/52 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Helicobacter infection
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.7%
2/115 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Hordeolum
|
1.3%
3/230 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Infection
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
1.3%
3/230 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.8%
9/115 • Number of events 10 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
2/52 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
33.0%
76/230 • Number of events 103 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
27.0%
31/115 • Number of events 43 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
24.6%
28/114 • Number of events 34 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.0%
4/100 • Number of events 5 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
4/52 • Number of events 5 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
4/52 • Number of events 5 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Oral herpes
|
0.87%
2/230 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.7%
2/115 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
2/52 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Otitis externa
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Otitis media
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pericoronitis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Periodontitis
|
0.87%
2/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis
|
3.9%
9/230 • Number of events 9 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.5%
4/115 • Number of events 4 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
3/114 • Number of events 4 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pyelonephritis
|
0.87%
2/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Rhinitis
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
1.7%
4/230 • Number of events 5 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Tonsillitis
|
0.43%
1/230 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.7%
2/115 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urethritis
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/196 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/95 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/96 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/84 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/43 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/44 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/196 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/95 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/84 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/43 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.3%
1/44 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Chillblains
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.7%
2/115 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.7%
4/230 • Number of events 4 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Dental restoration failure
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
2/114 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fractured ischium
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.7%
2/115 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.3%
3/230 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
2/114 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood bilirubin increased
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Cardiac function test abnormal
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Liver function test increased
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Weight decreased
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
White blood cells urine
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
3/115 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
2/114 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
2/114 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
3/230 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.7%
2/115 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
6/114 • Number of events 6 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
2/52 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.43%
1/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Nodal osteoarthritis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.7%
2/115 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kidney angiomyolipoma
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.87%
2/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
2/114 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dysgeusia
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Facial spasm
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Migraine with aura
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Migraine without aura
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.7%
2/115 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.0%
3/100 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
2/52 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Neuralgia
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Occipital neuralgia
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Poor quality sleep
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Presyncope
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Sciatica
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Somnolence
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Product Issues
Device failure
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
1.3%
3/230 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Neurosis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Haematuria
|
0.43%
1/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Breast mass
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/196 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/95 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/96 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/84 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/43 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/44 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.51%
1/196 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/95 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/96 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/84 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/43 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/44 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/196 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/95 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/84 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/43 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/44 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Premenstrual syndrome
|
0.00%
0/196 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/95 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/84 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/43 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/44 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/196 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/95 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/84 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/43 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/44 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Withdrawal bleed
|
0.51%
1/196 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/95 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/84 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/43 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/44 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.87%
2/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
3/115 • Number of events 4 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
2/114 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.87%
2/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.87%
2/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.7%
4/230 • Number of events 4 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
2/114 • Number of events 5 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.87%
2/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
2/114 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.3%
3/230 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
2/100 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.87%
2/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.87%
2/230 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.87%
2/230 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.8%
2/114 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
3/230 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin hypertrophy
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Solar dermatitis
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.7%
2/115 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.1%
7/114 • Number of events 7 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Social circumstances
Menopause
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/84 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/43 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/44 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Cyst removal
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Maxillary antrum operation
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Meniscus removal
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.87%
1/115 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Nasal septal operation
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.88%
1/114 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Skin cyst excision
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/100 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.7%
2/115 • Number of events 3 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/230 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.7%
2/115 • Number of events 2 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hot flush
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
0.43%
1/230 • Number of events 1 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/115 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/114 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/100 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • 10 months
All randomized participants who received at least 1 dose of study drug during treatment phase and remained in follow-up phase. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60