Trial Outcomes & Findings for Safety and Efficacy Study of LHW090 in Resistant Hypertension Patients (NCT NCT02515331)
NCT ID: NCT02515331
Last Updated: 2021-01-05
Results Overview
Number of participants with AEs, SAEs and deaths were assessed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
6 months
Results posted on
2021-01-05
Participant Flow
Participants were randomized in a 1:1:2 ratio to LHW090 100 mg, LHW090 200 mg and placebo, respectively.
Participant milestones
| Measure |
LHW090 100 mg
LHW090 100 mg once daily for 28 days
|
LHW090 200 mg
LHW090 200 mg once daily for 28 days
|
Placebo
Matching placebo to LHW090 oral dose for 28 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
15
|
32
|
|
Overall Study
Primary Pharmacodynamic Analysis Set
|
15
|
14
|
29
|
|
Overall Study
Pharmacokinetic (PK) Analysis Set
|
17
|
15
|
0
|
|
Overall Study
COMPLETED
|
15
|
15
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
4
|
Reasons for withdrawal
| Measure |
LHW090 100 mg
LHW090 100 mg once daily for 28 days
|
LHW090 200 mg
LHW090 200 mg once daily for 28 days
|
Placebo
Matching placebo to LHW090 oral dose for 28 days
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Protocol deviation
|
0
|
0
|
3
|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy Study of LHW090 in Resistant Hypertension Patients
Baseline characteristics by cohort
| Measure |
LHW090 100 mg
n=17 Participants
LHW090 100 mg once daily for 28 days
|
LHW090 200 mg
n=15 Participants
LHW090 200 mg once daily for 28 days
|
Placebo
n=32 Participants
Matching placebo to LHW090 oral dose for 28 days
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.2 Years
STANDARD_DEVIATION 8.42 • n=5 Participants
|
61.8 Years
STANDARD_DEVIATION 5.16 • n=7 Participants
|
64.4 Years
STANDARD_DEVIATION 9.56 • n=5 Participants
|
63.8 Years
STANDARD_DEVIATION 8.38 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Safety analysis set: included all participants who were randomized.
Number of participants with AEs, SAEs and deaths were assessed.
Outcome measures
| Measure |
LHW090 100 mg
n=17 Participants
LHW090 100 mg once daily for 28 days
|
LHW090 200 mg
n=15 Participants
LHW090 200 mg once daily for 28 days
|
Placebo
n=32 Participants
Matching placebo to LHW090 oral dose for 28 days
|
|---|---|---|---|
|
Number of Participants With Reported Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths
AEs
|
12 Participants
|
3 Participants
|
14 Participants
|
|
Number of Participants With Reported Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Reported Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, day 27Population: The primary pharmacodynamics (PD) analysis set, which included patients that received study drug with any available PD data, was considered for the analysis. Only patients with values on both baseline and day 27 were analyzed.
Change in the 12 hour average of systolic blood pressure (SBP) measured by ambulatory blood pressure was defined as the 12 hour daytime average SBP on Day 28 minus the 12 hour daytime average SBP on Day -1. monitoring (ABPM). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
LHW090 100 mg
n=15 Participants
LHW090 100 mg once daily for 28 days
|
LHW090 200 mg
n=13 Participants
LHW090 200 mg once daily for 28 days
|
Placebo
n=28 Participants
Matching placebo to LHW090 oral dose for 28 days
|
|---|---|---|---|
|
Change From Baseline in Mean Daytime Blood Pressure
|
-9.41 mmHg
Standard Deviation 8.379
|
-16.84 mmHg
Standard Deviation 7.678
|
-0.79 mmHg
Standard Deviation 10.555
|
SECONDARY outcome
Timeframe: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28Population: The PK analysis set, which included participants with at least one valid PK concentration measurement and no major protocol deviations affecting PK data, was considered. Only participants with available PK data were analyzed.
Blood samples were collected to assess Cmax.
Outcome measures
| Measure |
LHW090 100 mg
n=17 Participants
LHW090 100 mg once daily for 28 days
|
LHW090 200 mg
n=15 Participants
LHW090 200 mg once daily for 28 days
|
Placebo
Matching placebo to LHW090 oral dose for 28 days
|
|---|---|---|---|
|
Pharmacokinetics of LHW090/LHV527 in Plasma: Observe Maximum Plasma Concentration Following LHW090 at Steady State in Patients (Cmax)
LHW090, day 1
|
3620 ng/mL
Standard Deviation 1220
|
6340 ng/mL
Standard Deviation 3440
|
—
|
|
Pharmacokinetics of LHW090/LHV527 in Plasma: Observe Maximum Plasma Concentration Following LHW090 at Steady State in Patients (Cmax)
LHW090, day 28
|
4190 ng/mL
Standard Deviation 1740
|
7340 ng/mL
Standard Deviation 4300
|
—
|
|
Pharmacokinetics of LHW090/LHV527 in Plasma: Observe Maximum Plasma Concentration Following LHW090 at Steady State in Patients (Cmax)
LHV527, day 1
|
5040 ng/mL
Standard Deviation 1770
|
6330 ng/mL
Standard Deviation 3700
|
—
|
|
Pharmacokinetics of LHW090/LHV527 in Plasma: Observe Maximum Plasma Concentration Following LHW090 at Steady State in Patients (Cmax)
LHV527, day 28
|
5240 ng/mL
Standard Deviation 1960
|
9870 ng/mL
Standard Deviation 1810
|
—
|
SECONDARY outcome
Timeframe: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28Population: The PK analysis set, which included participants with at least one valid PK concentration measurement and no major protocol deviations affecting PK data, was considered. Only participants with available PK data were analyzed.
Blood samples were collected to assess Tmax.
Outcome measures
| Measure |
LHW090 100 mg
n=17 Participants
LHW090 100 mg once daily for 28 days
|
LHW090 200 mg
n=15 Participants
LHW090 200 mg once daily for 28 days
|
Placebo
Matching placebo to LHW090 oral dose for 28 days
|
|---|---|---|---|
|
Pharmacokinetics of LHW090/LHV527 in Plasma: Time to Reach the Maximum Concentration After Administration of LHW090 (Tmax)
LHW090, day 1
|
2.08 hour
Interval 1.0 to 7.95
|
3.00 hour
Interval 2.0 to 8.08
|
—
|
|
Pharmacokinetics of LHW090/LHV527 in Plasma: Time to Reach the Maximum Concentration After Administration of LHW090 (Tmax)
LHW090, day 28
|
2.00 hour
Interval 1.0 to 3.0
|
2.92 hour
Interval 0.383 to 8.08
|
—
|
|
Pharmacokinetics of LHW090/LHV527 in Plasma: Time to Reach the Maximum Concentration After Administration of LHW090 (Tmax)
LHV527, day 1
|
3.07 hour
Interval 2.08 to 8.03
|
4.08 hour
Interval 1.0 to 8.5
|
—
|
|
Pharmacokinetics of LHW090/LHV527 in Plasma: Time to Reach the Maximum Concentration After Administration of LHW090 (Tmax)
LHV527, day 28
|
3.92 hour
Interval 1.17 to 8.0
|
4.00 hour
Interval 2.38 to 8.08
|
—
|
SECONDARY outcome
Timeframe: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28Population: The PK analysis set, which included participants with at least one valid PK concentration measurement and no major protocol deviations affecting PK data, was considered. Only participants with available PK data were analyzed.
Blood samples were collected to assess AUClast.
Outcome measures
| Measure |
LHW090 100 mg
n=17 Participants
LHW090 100 mg once daily for 28 days
|
LHW090 200 mg
n=15 Participants
LHW090 200 mg once daily for 28 days
|
Placebo
Matching placebo to LHW090 oral dose for 28 days
|
|---|---|---|---|
|
Pharmacokinetics of LHW090/LHV527 in Plasma: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
LHW090, day 1
|
12300 Hr*ng/mL
Standard Deviation 3870
|
24500 Hr*ng/mL
Standard Deviation 16000
|
—
|
|
Pharmacokinetics of LHW090/LHV527 in Plasma: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
LHW090, day 28
|
13700 Hr*ng/mL
Standard Deviation 4370
|
24400 Hr*ng/mL
Standard Deviation 11400
|
—
|
|
Pharmacokinetics of LHW090/LHV527 in Plasma: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
LHV527, day 1
|
25300 Hr*ng/mL
Standard Deviation 11800
|
28700 Hr*ng/mL
Standard Deviation 17900
|
—
|
|
Pharmacokinetics of LHW090/LHV527 in Plasma: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
LHV527, day 28
|
27700 Hr*ng/mL
Standard Deviation 11600
|
52300 Hr*ng/mL
Standard Deviation 14400
|
—
|
SECONDARY outcome
Timeframe: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28Population: The PK analysis set, which included participants with at least one valid PK concentration measurement and no major protocol deviations affecting PK data, was considered. Only participants with available PK data were analyzed.
Blood samples were collected to assess Clast.
Outcome measures
| Measure |
LHW090 100 mg
n=17 Participants
LHW090 100 mg once daily for 28 days
|
LHW090 200 mg
n=15 Participants
LHW090 200 mg once daily for 28 days
|
Placebo
Matching placebo to LHW090 oral dose for 28 days
|
|---|---|---|---|
|
Pharmacokinetics of LHW090/LHV527 in Plasma: Last Measurable Plasma Concentration (Clast)
LHW090, day 1
|
404 ng/mL
Standard Deviation 358
|
1710 ng/mL
Standard Deviation 1600
|
—
|
|
Pharmacokinetics of LHW090/LHV527 in Plasma: Last Measurable Plasma Concentration (Clast)
LHW090, day 28
|
682 ng/mL
Standard Deviation 752
|
1790 ng/mL
Standard Deviation 1740
|
—
|
|
Pharmacokinetics of LHW090/LHV527 in Plasma: Last Measurable Plasma Concentration (Clast)
LHV527, day 1
|
3490 ng/mL
Standard Deviation 1700
|
4670 ng/mL
Standard Deviation 3050
|
—
|
|
Pharmacokinetics of LHW090/LHV527 in Plasma: Last Measurable Plasma Concentration (Clast)
LHV527, day 28
|
3430 ng/mL
Standard Deviation 1340
|
7840 ng/mL
Standard Deviation 3130
|
—
|
SECONDARY outcome
Timeframe: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28Population: The PK analysis set, which included participants with at least one valid PK concentration measurement and no major protocol deviations affecting PK data, was considered. Only participants with available PK data were analyzed.
Blood samples were collected to assess Tlast.
Outcome measures
| Measure |
LHW090 100 mg
n=17 Participants
LHW090 100 mg once daily for 28 days
|
LHW090 200 mg
n=15 Participants
LHW090 200 mg once daily for 28 days
|
Placebo
Matching placebo to LHW090 oral dose for 28 days
|
|---|---|---|---|
|
Pharmacokinetics of LHW090/LHV527 in Plasma:Tlast
LHW090, day 1
|
8.00 hour
Interval 7.07 to 8.08
|
8.00 hour
Interval 7.83 to 8.5
|
—
|
|
Pharmacokinetics of LHW090/LHV527 in Plasma:Tlast
LHW090, day 28
|
8.00 hour
Interval 4.0 to 8.5
|
8.00 hour
Interval 7.83 to 8.5
|
—
|
|
Pharmacokinetics of LHW090/LHV527 in Plasma:Tlast
LHV527, day 1
|
8.00 hour
Interval 7.07 to 8.08
|
8.00 hour
Interval 7.83 to 8.5
|
—
|
|
Pharmacokinetics of LHW090/LHV527 in Plasma:Tlast
LHV527, day 28
|
8.00 hour
Interval 4.0 to 8.5
|
8.00 hour
Interval 7.38 to 8.08
|
—
|
Adverse Events
LHW090 100mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
LHW090 200mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LHW090 100mg
n=17 participants at risk
LHW090 100 mg once daily for 28 days
|
LHW090 200mg
n=15 participants at risk
LHW090 200 mg once daily for 28 days
|
Placebo
n=32 participants at risk
Matching placebo to LHW090 oral dose for 28 days
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/17 • up to 28 days
|
6.7%
1/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
Eye disorders
Eyelid oedema
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
Eye disorders
Photopsia
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • up to 28 days
|
6.7%
1/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
General disorders
Asthenia
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
General disorders
Feeling hot
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/17 • up to 28 days
|
6.7%
1/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
General disorders
Oedema peripheral
|
11.8%
2/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
9.4%
3/32 • up to 28 days
|
|
Immune system disorders
Hypersensitivity
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
Infections and infestations
Eye infection
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
6.2%
2/32 • up to 28 days
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Investigations
Blood cholesterol increased
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
Investigations
Blood potassium increased
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Investigations
Cardiac murmur
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Investigations
Haematocrit increased
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
Investigations
Haemoglobin increased
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
Investigations
Weight increased
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
6.2%
2/32 • up to 28 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
6.2%
2/32 • up to 28 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/17 • up to 28 days
|
6.7%
1/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Renal and urinary disorders
Pollakiuria
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
Renal and urinary disorders
Renal failure
|
5.9%
1/17 • up to 28 days
|
6.7%
1/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Renal and urinary disorders
Urethral pain
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
Reproductive system and breast disorders
Breast discomfort
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/17 • up to 28 days
|
6.7%
1/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.6%
3/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
3.1%
1/32 • up to 28 days
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
5.9%
1/17 • up to 28 days
|
0.00%
0/15 • up to 28 days
|
0.00%
0/32 • up to 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER