Trial Outcomes & Findings for Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure (NCT NCT03750552)
NCT ID: NCT03750552
Last Updated: 2022-09-14
Results Overview
OHSA is an assessment of the severity of symptoms from low blood pressure. OHSA is a 6 question symptom assessment scale where each question uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. Question #1 assesses dizziness, lightheadedness, feeling faint, or feeling like you might blackout. A mean negative change from baseline indicates a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
195 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2022-09-14
Participant Flow
195 participants were enrolled across 76 sites in Australia, Austria, Bulgaria, Canada, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Portugal, Spain, Russia, Ukraine, United Kingdom and the United States.
Overall, 194 randomized participants received at least one dose of study drug. Eight participants from one site were excluded from all analysis sets except the Randomized Analysis Set due to data integrity concerns.
Participant milestones
| Measure |
Ampreloxetine
Participants received ampreloxetine at a dose of 10 mg once daily (QD) for 4 weeks.
Ampreloxetine: Oral tablet, QD
|
Placebo
Participants received placebo QD for 4 weeks. Placebo: Oral tablet, QD
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
97
|
|
Overall Study
Safety Analysis Set
|
96
|
90
|
|
Overall Study
Full Analysis Set
|
94
|
90
|
|
Overall Study
COMPLETED
|
90
|
95
|
|
Overall Study
NOT COMPLETED
|
8
|
2
|
Reasons for withdrawal
| Measure |
Ampreloxetine
Participants received ampreloxetine at a dose of 10 mg once daily (QD) for 4 weeks.
Ampreloxetine: Oral tablet, QD
|
Placebo
Participants received placebo QD for 4 weeks. Placebo: Oral tablet, QD
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Other
|
2
|
0
|
Baseline Characteristics
Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
Baseline characteristics by cohort
| Measure |
Ampreloxetine
n=98 Participants
Participants received ampreloxetine at a dose of 10 mg once daily (QD) for 4 weeks.
Ampreloxetine: Oral tablet, QD
|
Placebo
n=97 Participants
Participants received placebo once daily (QD) for 4 weeks. Placebo: Oral tablet, QD
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 65 years
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
70 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
92 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
96 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: Participants included in the Full Analysis Set, defined as all randomized participants who received at least one dose of study medication and had at least 1 post-baseline measurement of Orthostatic Hypotension Symptom Assessment (OHSA) question 1, were included in this analysis.
OHSA is an assessment of the severity of symptoms from low blood pressure. OHSA is a 6 question symptom assessment scale where each question uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. Question #1 assesses dizziness, lightheadedness, feeling faint, or feeling like you might blackout. A mean negative change from baseline indicates a better outcome.
Outcome measures
| Measure |
Ampreloxetine
n=94 Participants
Participants received ampreloxetine at a dose of 10 mg once daily (QD) for 4 weeks.
Ampreloxetine: Oral tablet, QD
|
Placebo
n=90 Participants
Participants received placebo once daily (QD) for 4 weeks. Placebo: Oral tablet, QD
|
|---|---|---|
|
Change From Baseline in Orthostatic Hypotension Symptom Assessment (OHSA) Question #1 Score at Week 4
|
-1.69 score on a scale
Standard Error 0.290
|
-1.45 score on a scale
Standard Error 0.293
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Participants included in the Full Analysis Set, defined as all randomized participants who received at least one dose of study medication and had at least 1 post-baseline measurement of Orthostatic Hypotension Symptom Assessment (OHSA) question 1, with a valid composite OHSA score at Week 4 were included in this analysis.
OHSA is an assessment of the severity of symptoms from low blood pressure. OHSA is a 6 question symptom assessment scale in which the composite score uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. A mean negative change from baseline indicates a better outcome.
Outcome measures
| Measure |
Ampreloxetine
n=90 Participants
Participants received ampreloxetine at a dose of 10 mg once daily (QD) for 4 weeks.
Ampreloxetine: Oral tablet, QD
|
Placebo
n=87 Participants
Participants received placebo once daily (QD) for 4 weeks. Placebo: Oral tablet, QD
|
|---|---|---|
|
Change From Baseline in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score at Week 4
|
-1.32 score on a scale
Standard Error 0.200
|
-1.05 score on a scale
Standard Error 0.202
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Participants included in the Full Analysis Set, defined as all randomized participants who received at least one dose of study medication and had at least 1 post-baseline measurement of Orthostatic Hypotension Symptom Assessment (OHSA) question 1, with a valid composite OHDAS score at Week 4 were included in this analysis.
OHDAS is an assessment of how low blood pressure symptoms affect daily life. OHDAS is a 4 item assessment in which the composite score uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. A mean negative change from baseline indicates a better outcome.
Outcome measures
| Measure |
Ampreloxetine
n=87 Participants
Participants received ampreloxetine at a dose of 10 mg once daily (QD) for 4 weeks.
Ampreloxetine: Oral tablet, QD
|
Placebo
n=85 Participants
Participants received placebo once daily (QD) for 4 weeks. Placebo: Oral tablet, QD
|
|---|---|---|
|
Change From Baseline in Orthostatic Hypotension Daily Activities Scale (OHDAS) Composite Score at Week 4
|
-1.22 score on a scale
Standard Error 0.265
|
-0.95 score on a scale
Standard Error 0.267
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Participants included in the Full Analysis Set, defined as all randomized participants who received at least one dose of study medication and had at least 1 post-baseline measurement of Orthostatic Hypotension Symptom Assessment (OHSA) question 1, who have available data were included in this analysis.
PGI-C was assessed using a 5-point scale where participants were asked to compare their current condition to their condition at baseline from 1 to 5, with 1 indicating the condition is very much improved and 5 indicating the condition is very much worse. These scores were analyzed in 2 categories: better and no change/worse.
Outcome measures
| Measure |
Ampreloxetine
n=91 Participants
Participants received ampreloxetine at a dose of 10 mg once daily (QD) for 4 weeks.
Ampreloxetine: Oral tablet, QD
|
Placebo
n=87 Participants
Participants received placebo once daily (QD) for 4 weeks. Placebo: Oral tablet, QD
|
|---|---|---|
|
Number of Participants Who Experienced an Improvement From Baseline in Patient Global Impression of Change (PGI-C) Score at Week 4
|
49 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Up to Week 4Population: Participants included in the Full Analysis Set, defined as all randomized participants who received at least one dose of study medication and had at least 1 post-baseline measurement of Orthostatic Hypotension Symptom Assessment (OHSA) question 1, who have available data were included in this analysis.
Outcome measures
| Measure |
Ampreloxetine
n=93 Participants
Participants received ampreloxetine at a dose of 10 mg once daily (QD) for 4 weeks.
Ampreloxetine: Oral tablet, QD
|
Placebo
n=90 Participants
Participants received placebo once daily (QD) for 4 weeks. Placebo: Oral tablet, QD
|
|---|---|---|
|
Number of Participants Who Experienced at Least One Fall
|
33 Participants
|
22 Participants
|
Adverse Events
Ampreloxetine
Serious events: 4 serious events
Other events: 42 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ampreloxetine
n=96 participants at risk
Participants received ampreloxetine at a dose of 10 mg once daily (QD) for 4 weeks.
Ampreloxetine: Oral tablet, QD
|
Placebo
n=90 participants at risk
Participants received placebo once daily (QD) for 4 weeks. Placebo: Oral tablet, QD
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
General disorders
Asthenia
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Renal and urinary disorders
Haematuria
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
Other adverse events
| Measure |
Ampreloxetine
n=96 participants at risk
Participants received ampreloxetine at a dose of 10 mg once daily (QD) for 4 weeks.
Ampreloxetine: Oral tablet, QD
|
Placebo
n=90 participants at risk
Participants received placebo once daily (QD) for 4 weeks. Placebo: Oral tablet, QD
|
|---|---|---|
|
Nervous system disorders
Headache
|
5.2%
5/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
3.3%
3/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Infections and infestations
Urinary tract infection
|
3.1%
3/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
4.4%
4/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
General disorders
Fatigue
|
3.1%
3/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Psychiatric disorders
Insomnia
|
3.1%
3/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
2/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
2.2%
2/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Vascular disorders
Supine hypertension
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
3.3%
3/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Psychiatric disorders
Anxiety
|
2.1%
2/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
General disorders
Asthenia
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Nervous system disorders
Dizziness
|
3.1%
3/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Vascular disorders
Hypertension
|
3.1%
3/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.1%
2/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
2.2%
2/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Investigations
Blood creatinine phosphokinase increased
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Gastrointestinal disorders
Constipation
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
2.1%
2/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Nervous system disorders
Somnolence
|
2.1%
2/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
2.2%
2/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Psychiatric disorders
Abnormal dreams
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Nervous system disorders
Amnesia
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Infections and infestations
Bacterial disease carrier
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Renal and urinary disorders
Bladder pain
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Investigations
Blood urea increased
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Investigations
Blood urea nitrogen/creatine ratio increased
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Nervous system disorders
Bulbar palsy
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
General disorders
Catheter site pain
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
General disorders
Chest discomfort
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
General disorders
Chest pain
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Investigations
Crystal urine present
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Infections and infestations
Cystitis
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Nervous system disorders
Depressed level of consciousness
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Nervous system disorders
Dizziness postural
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Nervous system disorders
Dysgeusia
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Vascular disorders
Flushing
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
General disorders
Gait disturbance
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Investigations
Gastric pH decreased
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Gastrointestinal disorders
Gingival bleeding
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Vascular disorders
Hot flush
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Nervous system disorders
Hypoaesthesia
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
General disorders
Illness
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
General disorders
Influenza like illness
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
General disorders
Injection site pain
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Nervous system disorders
Lethargy
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Nervous system disorders
Loss of consciousness
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
General disorders
Malaise
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Investigations
Mean cell haemoglobin increased
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Investigations
Mean cell volume increased
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
General disorders
Oedema peripheral
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Nervous system disorders
Paraesthesia
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Renal and urinary disorders
Pollakiuria
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Investigations
Protein urine
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
General disorders
Pyrexia
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
General disorders
Temperature regulation disorder
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Renal and urinary disorders
Urinary retention
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Renal and urinary disorders
Urinary tract inflammation
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Renal and urinary disorders
Urine flow decreased
|
1.0%
1/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
0.00%
0/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Investigations
Weight increased
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Investigations
White blood cell count increased
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/96 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
1.1%
1/90 • Up to Day 43
Participants in the Safety Analysis set, defined as all randomized subjects who received at least 1 dose of study medication, were included in this analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place