Trial Outcomes & Findings for Study of the Effect of Serelaxin on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure (NCT NCT02625922)
NCT ID: NCT02625922
Last Updated: 2018-09-21
Results Overview
This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15+/- 1)
Results posted on
2018-09-21
Participant Flow
There were total 11 centers from 3 countries. (Germany-6, Switzerland-1, and the United Kingdom-4).
Participant milestones
| Measure |
Serelaxin-Placebo
Subjects received serelaxin in Treatment Period 1 and placebo in Treatment Period 2.
Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion.
|
Placebo-Serelaxin
Subjects received placebo in Treatment Period 1 and serelaxin in Treatment Period 2.
Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
|
Overall Study
Completed Treatment Period 1
|
12
|
10
|
|
Overall Study
Completed Treatment Period 2
|
11
|
8
|
|
Overall Study
COMPLETED
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Serelaxin-Placebo
Subjects received serelaxin in Treatment Period 1 and placebo in Treatment Period 2.
Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion.
|
Placebo-Serelaxin
Subjects received placebo in Treatment Period 1 and serelaxin in Treatment Period 2.
Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion.
|
|---|---|---|
|
Overall Study
Non-availability of IMP
|
1
|
1
|
|
Overall Study
Systolic blood pressure < 125 mmHg
|
1
|
1
|
Baseline Characteristics
Study of the Effect of Serelaxin on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure
Baseline characteristics by cohort
| Measure |
Serelaxin-Placebo
n=14 Participants
Subjects received serelaxin in Treatment Period 1 and placebo in Treatment Period 2.
Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion.
|
Placebo-Serelaxin
n=12 Participants
Subjects received placebo in Treatment Period 1 and serelaxin in Treatment Period 2.
Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.7 years
STANDARD_DEVIATION 7.62 • n=99 Participants
|
66.5 years
STANDARD_DEVIATION 13.89 • n=107 Participants
|
70.9 years
STANDARD_DEVIATION 11.51 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Weight (kg)
|
84.5 kilogram (kg)
STANDARD_DEVIATION 14.19 • n=99 Participants
|
83.9 kilogram (kg)
STANDARD_DEVIATION 17.85 • n=107 Participants
|
84.2 kilogram (kg)
STANDARD_DEVIATION 15.65 • n=206 Participants
|
|
Childbearing status
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15+/- 1)Population: The primary analysis of mixed model repeated measures was not performed because the validation of the primary endpoint variable hs-cTnI assay (Singulex Erenna®) was not completed because of the early termination of the study and, therefore, hs-cTnI was not analyzed.
This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 and 5 hours after exercise testing sessionPopulation: The objective was not analyzed because the validation of the hs-cTnI Singulex Erenna® assay was not completed because of the early termination of the study.
This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1)Population: The full analysis set (FAS) consisted of all randomized patients.
This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.
Outcome measures
| Measure |
Serelaxin-Placebo
n=26 Participants
Subjects received serelaxin in Treatment Period 1 and placebo in Treatment Period 2.
Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion.
|
Placebo-Serelaxin
n=26 Participants
Subjects received placebo in Treatment Period 1 and serelaxin in Treatment Period 2.
Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion.
|
|---|---|---|
|
Log-transformed Concentration of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations Compared to Placebo
Baseline
|
13.5026 pg/mL
Standard Deviation 0.64893
|
13.6217 pg/mL
Standard Deviation 0.60192
|
|
Log-transformed Concentration of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations Compared to Placebo
132 minutes
|
13.5729 pg/mL
Standard Deviation 0.62057
|
13.7076 pg/mL
Standard Deviation 0.61612
|
|
Log-transformed Concentration of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations Compared to Placebo
180 minutes
|
13.5302 pg/mL
Standard Deviation 0.62107
|
13.6777 pg/mL
Standard Deviation 0.61118
|
|
Log-transformed Concentration of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations Compared to Placebo
240 minutes
|
13.5673 pg/mL
Standard Deviation 0.68419
|
13.7011 pg/mL
Standard Deviation 0.58471
|
|
Log-transformed Concentration of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations Compared to Placebo
300 minutes
|
13.6103 pg/mL
Standard Deviation 0.63614
|
13.7129 pg/mL
Standard Deviation 0.57832
|
|
Log-transformed Concentration of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations Compared to Placebo
360 minutes
|
13.6687 pg/mL
Standard Deviation 0.65735
|
13.7213 pg/mL
Standard Deviation 0.57366
|
|
Log-transformed Concentration of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations Compared to Placebo
420 minutes
|
13.6533 pg/mL
Standard Deviation 0.64776
|
13.7399 pg/mL
Standard Deviation 0.57361
|
SECONDARY outcome
Timeframe: Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1)Population: The full analysis set (FAS) consisted of all randomized patients. Patients were analyzed according to the treatment they had been assigned to at randomization.
This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.
Outcome measures
| Measure |
Serelaxin-Placebo
n=26 Participants
Subjects received serelaxin in Treatment Period 1 and placebo in Treatment Period 2.
Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion.
|
Placebo-Serelaxin
n=26 Participants
Subjects received placebo in Treatment Period 1 and serelaxin in Treatment Period 2.
Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion.
|
|---|---|---|
|
Log-transformed Concentration Values of Heart-type Fatty Acid-binding Protein (H-FABP) Concentrations Compared to Placebo
Baseline
|
8.8256 ng/mL
Standard Deviation 0.67027
|
8.8810 ng/mL
Standard Deviation 0.64372
|
|
Log-transformed Concentration Values of Heart-type Fatty Acid-binding Protein (H-FABP) Concentrations Compared to Placebo
132 minutes
|
8.8644 ng/mL
Standard Deviation 0.63646
|
8.8409 ng/mL
Standard Deviation 0.67261
|
|
Log-transformed Concentration Values of Heart-type Fatty Acid-binding Protein (H-FABP) Concentrations Compared to Placebo
180 minutes
|
8.7897 ng/mL
Standard Deviation 0.62835
|
8.7955 ng/mL
Standard Deviation 0.62729
|
|
Log-transformed Concentration Values of Heart-type Fatty Acid-binding Protein (H-FABP) Concentrations Compared to Placebo
240 minutes
|
8.7718 ng/mL
Standard Deviation 0.63971
|
8.8662 ng/mL
Standard Deviation 0.58565
|
|
Log-transformed Concentration Values of Heart-type Fatty Acid-binding Protein (H-FABP) Concentrations Compared to Placebo
300 minutes
|
8.7309 ng/mL
Standard Deviation 0.62177
|
8.7202 ng/mL
Standard Deviation 0.65890
|
|
Log-transformed Concentration Values of Heart-type Fatty Acid-binding Protein (H-FABP) Concentrations Compared to Placebo
360 minutes
|
8.7692 ng/mL
Standard Deviation 0.64920
|
8.8088 ng/mL
Standard Deviation 0.59672
|
|
Log-transformed Concentration Values of Heart-type Fatty Acid-binding Protein (H-FABP) Concentrations Compared to Placebo
420 minutes
|
8.7669 ng/mL
Standard Deviation 0.65793
|
8.7329 ng/mL
Standard Deviation 0.63139
|
Adverse Events
Serelaxin
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Total
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Serelaxin
n=20 participants at risk
Participants receiving serelaxin in Treatment Period 1 and in Treatment Period 2.
Each participant received each of the treatments in randomized order in 2 treatment periods separated by a 15 +/- 1-day washout.
Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen.
|
Placebo
n=20 participants at risk
Participants receiving placebo in Treatment Period 1 and in Treatment Period 2. Each participant received each of the treatments in randomized order in 2 treatment periods separated by a 15 +/- 1-day washout.
Placebo was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen.
|
Total
n=22 participants at risk
Total
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
5.0%
1/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
4.5%
1/22 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
Other adverse events
| Measure |
Serelaxin
n=20 participants at risk
Participants receiving serelaxin in Treatment Period 1 and in Treatment Period 2.
Each participant received each of the treatments in randomized order in 2 treatment periods separated by a 15 +/- 1-day washout.
Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen.
|
Placebo
n=20 participants at risk
Participants receiving placebo in Treatment Period 1 and in Treatment Period 2. Each participant received each of the treatments in randomized order in 2 treatment periods separated by a 15 +/- 1-day washout.
Placebo was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen.
|
Total
n=22 participants at risk
Total
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
0.00%
0/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
4.5%
1/22 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
5.0%
1/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
4.5%
1/22 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
|
General disorders
Fatigue
|
5.0%
1/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
0.00%
0/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
4.5%
1/22 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
5.0%
1/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
4.5%
1/22 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
5.0%
1/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
4.5%
1/22 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.0%
1/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
0.00%
0/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
4.5%
1/22 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
5.0%
1/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
0.00%
0/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
4.5%
1/22 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
0.00%
0/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
4.5%
1/22 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
0.00%
0/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
4.5%
1/22 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
5.0%
1/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
4.5%
1/22 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
5.0%
1/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
4.5%
1/22 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
5.0%
1/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
4.5%
1/22 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
0.00%
0/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
4.5%
1/22 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
0.00%
0/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
4.5%
1/22 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
5.0%
1/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
4.5%
1/22 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
|
Vascular disorders
Hypotension
|
10.0%
2/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
0.00%
0/20 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
9.1%
2/22 • Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
|
Additional Information
Clinical Disclosure Office
Novartis Pharmaceuticals
Phone: 862-778-8300
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 publication of the pooled data (i.e.,data from all sites)in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER