Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications (NCT NCT03381196)
NCT ID: NCT03381196
Last Updated: 2025-02-04
Results Overview
The Flu-iiQ is a PRO that measures influenza symptom intensity (none, mild, moderate, or severe) on a 4 point Likert response rating scale ranging from 0 to 3, where "0" represents the absence of symptom and "3" represents the severe symptom. The resolution of influenza-related symptoms is defined as the beginning of the 24-hour period that 7 influenza symptoms (cough, sore throat, headache, nasal congestion, feeling feverish, body aches and pains, fatigue) are at most mild or at least back to previous level of symptom severity in case the participant reported the symptom as pre-existing.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
553 participants
Primary outcome timeframe
Up to Day 28
Results posted on
2025-02-04
Participant Flow
Participant milestones
| Measure |
Pimodivir + SOC
Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment.
|
Placebo + SOC
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
276
|
277
|
|
Overall Study
Treated
|
273
|
271
|
|
Overall Study
COMPLETED
|
260
|
258
|
|
Overall Study
NOT COMPLETED
|
16
|
19
|
Reasons for withdrawal
| Measure |
Pimodivir + SOC
Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment.
|
Placebo + SOC
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
7
|
|
Overall Study
Other
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Randomized, not treated
|
3
|
6
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications
Baseline characteristics by cohort
| Measure |
Pimodivir + SOC
n=273 Participants
Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment.
|
Placebo + SOC
n=271 Participants
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment.
|
Total
n=544 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.1 years
STANDARD_DEVIATION 16.6 • n=5 Participants
|
50.3 years
STANDARD_DEVIATION 17.35 • n=7 Participants
|
50.7 years
STANDARD_DEVIATION 16.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
152 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
293 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
83 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
185 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
363 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
27 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
206 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
407 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
ARGENTINA
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
AUSTRALIA
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
BELGIUM
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
BRAZIL
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
BULGARIA
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
CANADA
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
ESTONIA
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
FRANCE
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
GERMANY
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
HUNGARY
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
INDIA
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
ITALY
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
LATVIA
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
LITHUANIA
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
MALAYSIA
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
MEXICO
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
POLAND
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
SOUTH AFRICA
|
25 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Region of Enrollment
SOUTH KOREA
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
SPAIN
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
SWEDEN
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
TAIWAN
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
THAILAND
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
TURKEY
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
UKRAINE
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
UNITED STATES
|
178 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
355 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28Population: The Intent-To-Treat infected (ITT-i) Set included all randomized participants who received at least 1 dose of study drug and who had confirmed infection with influenza A and analyzed by planned treatment.
The Flu-iiQ is a PRO that measures influenza symptom intensity (none, mild, moderate, or severe) on a 4 point Likert response rating scale ranging from 0 to 3, where "0" represents the absence of symptom and "3" represents the severe symptom. The resolution of influenza-related symptoms is defined as the beginning of the 24-hour period that 7 influenza symptoms (cough, sore throat, headache, nasal congestion, feeling feverish, body aches and pains, fatigue) are at most mild or at least back to previous level of symptom severity in case the participant reported the symptom as pre-existing.
Outcome measures
| Measure |
Pimodivir + SOC
n=223 Participants
Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment.
|
Placebo + SOC
n=223 Participants
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment.
|
|---|---|---|
|
Time to Resolution of 7 Primary Influenza-related Symptoms as Assessed by the Patient-Reported Outcome (PRO) Measure Flu-Intensity and Impact Questionnaire (Flu-iiQ)
|
92.62 hours
Interval 77.6 to 104.2
|
105.13 hours
Interval 92.73 to 128.63
|
SECONDARY outcome
Timeframe: Up to Day 28Population: The Intent-To-Treat infected (ITT-i) Set included all randomized participants who received at least 1 dose of study drug and who had confirmed infection with influenza A and analyzed by planned treatment.
The number of participants hospitalized after treatment initiation were reported.
Outcome measures
| Measure |
Pimodivir + SOC
n=223 Participants
Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment.
|
Placebo + SOC
n=223 Participants
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment.
|
|---|---|---|
|
Number of Participants Hospitalized After Treatment Initiation
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 3, 6, 10, 14Population: The Intent-To-Treat infected (ITT-i) Set included all randomized participants who received at least 1 dose of study drug and who had confirmed infection with influenza A and analyzed by planned treatment. Here N (number of participants analyzed) are participants evaluable for this outcome measure and "n (number analyzed)" signifies number of participants analyzed for specified categories.
Viral load over time was measured by quantitative real time polymerase chain reaction (qRT-PCR) and viral culture in the mid-turbinate (MT) nasal swabs and endotracheal samples.
Outcome measures
| Measure |
Pimodivir + SOC
n=221 Participants
Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment.
|
Placebo + SOC
n=216 Participants
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment.
|
|---|---|---|
|
Viral Load Over Time
Baseline
|
5.891 log 10 viral particles per milliliter
Standard Deviation 1.5745
|
5.914 log 10 viral particles per milliliter
Standard Deviation 1.4947
|
|
Viral Load Over Time
Day 3
|
3.558 log 10 viral particles per milliliter
Standard Deviation 1.1918
|
4.244 log 10 viral particles per milliliter
Standard Deviation 1.3535
|
|
Viral Load Over Time
Day 6
|
2.644 log 10 viral particles per milliliter
Standard Deviation 0.9159
|
2.833 log 10 viral particles per milliliter
Standard Deviation 1.0432
|
|
Viral Load Over Time
Day 10
|
2.234 log 10 viral particles per milliliter
Standard Deviation 0.4586
|
2.289 log 10 viral particles per milliliter
Standard Deviation 0.6279
|
|
Viral Load Over Time
Day 14
|
2.153 log 10 viral particles per milliliter
Standard Deviation 0.3904
|
2.162 log 10 viral particles per milliliter
Standard Deviation 0.4355
|
SECONDARY outcome
Timeframe: Up to Day 28Population: Population included participants from ITT-i set with both baseline and post-baseline sequencing data.
Emergence of viral resistance to pimodivir was detected by genotyping and/or phenotyping. Nasal MT swabs and endotracheal samples were used for sequence analysis of the polymerase basic protein (PB)2 region of the influenza polymerase gene, and of neuraminidase (NA) genes for participants using an NA inhibitor (NAI) as part of their Standard of Care (SOC).
Outcome measures
| Measure |
Pimodivir + SOC
n=71 Participants
Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment.
|
Placebo + SOC
n=108 Participants
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment.
|
|---|---|---|
|
Number of Participants With Emergence of Viral Resistance to Pimodivir
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 3, 6, 7Population: The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated. Here, N (number of participants analyzed) signifies participants evaluable for this outcome measure and "n (number analyzed)" signifies number of participants analyzed for specified categories.
Plasma concentration of Pimodivir was reported.
Outcome measures
| Measure |
Pimodivir + SOC
n=200 Participants
Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment.
|
Placebo + SOC
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment.
|
|---|---|---|
|
Plasma Concentration of Pimodivir
Day 3
|
1233.0 nanograms per milliliter (ng/mL)
Standard Deviation 1912.6
|
—
|
|
Plasma Concentration of Pimodivir
Day 6
|
933.8 nanograms per milliliter (ng/mL)
Standard Deviation 2131.4
|
—
|
|
Plasma Concentration of Pimodivir
Day 7
|
276.7 nanograms per milliliter (ng/mL)
Standard Deviation 308.6
|
—
|
SECONDARY outcome
Timeframe: Up to Day 28Population: The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Outcome measures
| Measure |
Pimodivir + SOC
n=273 Participants
Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment.
|
Placebo + SOC
n=271 Participants
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment.
|
|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
|
123 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Number of participants with clinically significant changes in laboratory tests were reported. Blood samples for hematology, serum chemistry, and urinalysis was collected at predefined time points for clinical laboratory testing.
Outcome measures
| Measure |
Pimodivir + SOC
n=273 Participants
Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment.
|
Placebo + SOC
n=271 Participants
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Laboratory Tests
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Number of participants with clinically significant changes in Electrocardiogram (ECG) were reported.
Outcome measures
| Measure |
Pimodivir + SOC
n=273 Participants
Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment.
|
Placebo + SOC
n=271 Participants
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Number of participants with clinically significant changes in vital signs (temperature, pulse rate, respiratory rate and blood pressure) were reported.
Outcome measures
| Measure |
Pimodivir + SOC
n=273 Participants
Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment.
|
Placebo + SOC
n=271 Participants
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs
|
0 Participants
|
0 Participants
|
Adverse Events
Pimodivir + SOC
Serious events: 3 serious events
Other events: 122 other events
Deaths: 0 deaths
Placebo + SOC
Serious events: 4 serious events
Other events: 99 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Pimodivir + SOC
n=273 participants at risk
Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment.
|
Placebo + SOC
n=271 participants at risk
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment.
|
|---|---|---|
|
Infections and infestations
Bacteraemia
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Pneumonia Pneumococcal
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Streptococcal Sepsis
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
Other adverse events
| Measure |
Pimodivir + SOC
n=273 participants at risk
Participants received 600 milligrams (mg) pimodivir twice daily (bid) on Day 1 through Day 5 along with standard of care (SOC) treatment.
|
Placebo + SOC
n=271 participants at risk
Participants received matching placebo bid on Day 1 through Day 5 along with SOC treatment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
1.1%
3/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
2.6%
7/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Cardiac disorders
Palpitations
|
0.73%
2/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Cardiac disorders
Tachycardia
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Ear and labyrinth disorders
Tympanic Membrane Disorder
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.74%
2/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
3/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Eye disorders
Dry Eye
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.74%
2/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.74%
2/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Gastrointestinal disorders
Constipation
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Gastrointestinal disorders
Diarrhoea
|
19.8%
54/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
6.6%
18/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Gastrointestinal disorders
Faeces Soft
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Gastrointestinal disorders
Gastritis
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Gastrointestinal disorders
Infrequent Bowel Movements
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Gastrointestinal disorders
Lip Disorder
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Gastrointestinal disorders
Nausea
|
3.3%
9/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
3.7%
10/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Gastrointestinal disorders
Pancreatic Atrophy
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
5/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
3.3%
9/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
General disorders
Fatigue
|
1.1%
3/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
General disorders
Feeling Jittery
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
General disorders
Impaired Healing
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
General disorders
Malaise
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
General disorders
Peripheral Swelling
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
General disorders
Pyrexia
|
0.73%
2/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
1.5%
4/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
General disorders
Vessel Puncture Site Bruise
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.74%
2/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.74%
2/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Abscess
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Adenoviral Upper Respiratory Infection
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Bronchitis
|
2.6%
7/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
3.3%
9/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Bronchitis Bacterial
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.74%
2/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Candida Infection
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Ear Infection
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Gastroenteritis
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Gastroenteritis Rotavirus
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Influenza
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Kidney Infection
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Laryngitis
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.73%
2/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Oral Candidiasis
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Otitis Media Acute
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Pharyngitis
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.74%
2/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Pneumonia
|
0.73%
2/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.74%
2/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.74%
2/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Sinusitis
|
2.6%
7/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
1.5%
4/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Skin Candida
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Tonsillitis
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Infections and infestations
Urinary Tract Infection
|
4.0%
11/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.74%
2/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
1.5%
4/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
Amylase Abnormal
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
Amylase Increased
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.73%
2/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
1.1%
3/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
Blood Bilirubin
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
1.1%
3/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
1.1%
3/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
Blood Glucose Increased
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
Blood Potassium Increased
|
1.1%
3/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
Blood Pressure Decreased
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
Glomerular Filtration Rate Decreased
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
Hepatic Enzyme Increased
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
International Normalised Ratio Increased
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
Liver Function Test Increased
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
Neutrophil Count Decreased
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
Pancreatic Enzymes Increased
|
0.73%
2/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
Transaminases Increased
|
0.73%
2/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.73%
2/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.74%
2/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
2.2%
6/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.73%
2/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Nervous system disorders
Dizziness
|
1.1%
3/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
1.1%
3/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Nervous system disorders
Headache
|
0.73%
2/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Nervous system disorders
Hyperaesthesia
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Nervous system disorders
Intercostal Neuralgia
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Nervous system disorders
Loss of Consciousness
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Nervous system disorders
Presyncope
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Psychiatric disorders
Depression
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Psychiatric disorders
Insomnia
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Renal and urinary disorders
Glycosuria
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Renal and urinary disorders
Haematuria
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Renal and urinary disorders
Proteinuria
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Renal and urinary disorders
Renal Pain
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Reproductive system and breast disorders
Testicular Pain
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.8%
5/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
1.8%
5/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.74%
2/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
4/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.74%
2/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.74%
2/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.73%
2/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Mucosal Disorder
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Erythema
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.5%
4/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Cold Sweat
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.73%
2/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.73%
2/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.37%
1/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Vascular disorders
Haematoma
|
0.00%
0/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.74%
2/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Vascular disorders
Hot Flush
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Vascular disorders
Hypertension
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Vascular disorders
Ischaemia
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
|
Vascular disorders
Thrombosis
|
0.37%
1/273 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
0.00%
0/271 • Up to Day 28
The Safety Set (or all participants treated) included all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
|
Additional Information
Senior Director Medical Leader
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER