Trial Outcomes & Findings for Early Signs of Efficacy Study With Riociguat in Adult Homozygous Delta F508 Cystic Fibrosis Patients (NCT NCT02170025)
NCT ID: NCT02170025
Last Updated: 2023-11-07
Results Overview
Sweat chloride samples were obtained by using a Macroduct induction and collection device according to standard procedures.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Baseline, at day 14 and day 28 in study part 1
Results posted on
2023-11-07
Participant Flow
The study was conducted at multiple centers in 7 countries worldwide between 30-Sep-2014 (first subject first visit) and 31-Jan-2017 (last subject last visit).
Of 31 participants who were screened, 10 failed screening, 21 were randomized.
Participant milestones
| Measure |
Riociguat (Adempas, BAY63-2521)
Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient.
|
Placebo
Participants received matching placebo tid
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
7
|
|
Overall Study
COMPLETED
|
12
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Riociguat (Adempas, BAY63-2521)
Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient.
|
Placebo
Participants received matching placebo tid
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Pharmacodynamic analysis set (N=16) included patients who received the medication and who had valid sweat chloride data for efficacy analysis.
Baseline characteristics by cohort
| Measure |
Riociguat (Adempas, BAY63-2521)
n=14 Participants
Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient.
|
Placebo
n=7 Participants
Participants received matching placebo tid
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.1 Years
STANDARD_DEVIATION 6.9 • n=14 Participants
|
29.1 Years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
27.8 Years
STANDARD_DEVIATION 6.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=14 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=14 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=21 Participants
|
|
Sweat chloride content
|
96.33 mmol/L
STANDARD_DEVIATION 17.28 • n=9 Participants • Pharmacodynamic analysis set (N=16) included patients who received the medication and who had valid sweat chloride data for efficacy analysis.
|
94.50 mmol/L
STANDARD_DEVIATION 12.82 • n=7 Participants • Pharmacodynamic analysis set (N=16) included patients who received the medication and who had valid sweat chloride data for efficacy analysis.
|
95.53 mmol/L
STANDARD_DEVIATION 15.03 • n=16 Participants • Pharmacodynamic analysis set (N=16) included patients who received the medication and who had valid sweat chloride data for efficacy analysis.
|
PRIMARY outcome
Timeframe: Baseline, at day 14 and day 28 in study part 1Population: Pharmacodynamic analysis set (N=16) included patients who received the medication and who had valid sweat chloride data for efficacy analysis.
Sweat chloride samples were obtained by using a Macroduct induction and collection device according to standard procedures.
Outcome measures
| Measure |
Riociguat (Adempas, BAY63-2521)
n=9 Participants
Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient.
|
Placebo
n=7 Participants
Participants received matching placebo tid
|
|---|---|---|
|
Change of Sweat Chloride Content From Baseline
Change at day 14 in part 1
|
7.06 mmol/L
Standard Deviation 10.26
|
8.71 mmol/L
Standard Deviation 8.20
|
|
Change of Sweat Chloride Content From Baseline
Change at day 28 in part 1
|
3.44 mmol/L
Standard Deviation 11.04
|
9.00 mmol/L
Standard Deviation 12.71
|
SECONDARY outcome
Timeframe: From Baseline to Day 14, Day 28 and Follow-upPopulation: Pharmacodynamic analysis set (N=16) included patients who received the medication and who had valid sweat chloride data for efficacy analysis.
Spirometry was performed according to the American Thoracic Society Guidelines 1995 at the time points screening/ baseline, treatment period and follow up.
Outcome measures
| Measure |
Riociguat (Adempas, BAY63-2521)
n=9 Participants
Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient.
|
Placebo
n=7 Participants
Participants received matching placebo tid
|
|---|---|---|
|
Change of FEV1 From Baseline
Change at day 14
|
0.86 % predicted value
Standard Deviation 4.59
|
2.00 % predicted value
Standard Deviation 7.28
|
|
Change of FEV1 From Baseline
Change at day 28
|
-0.79 % predicted value
Standard Deviation 6.04
|
2.43 % predicted value
Standard Deviation 9.55
|
|
Change of FEV1 From Baseline
Change at follow-up visit
|
-0.46 % predicted value
Standard Deviation 5.51
|
2.63 % predicted value
Standard Deviation 9.50
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Riociguat (Adempas, BAY63-2521)
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=7 participants at risk
Participants received matching placebo tid
|
Riociguat (Adempas, BAY63-2521)
n=14 participants at risk
Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient.
|
|---|---|---|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
14.3%
1/7 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
0.00%
0/14 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
Other adverse events
| Measure |
Placebo
n=7 participants at risk
Participants received matching placebo tid
|
Riociguat (Adempas, BAY63-2521)
n=14 participants at risk
Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient.
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Eye disorders
Eye allergy
|
14.3%
1/7 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
0.00%
0/14 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 4 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
21.4%
3/14 • Number of events 3 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 3 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
14.3%
2/14 • Number of events 2 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 2 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
14.3%
2/14 • Number of events 2 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • Number of events 2 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
0.00%
0/14 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
14.3%
2/14 • Number of events 2 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Gastrointestinal disorders
Faecal volume decreased
|
14.3%
1/7 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
0.00%
0/14 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
General disorders
Fatigue
|
14.3%
1/7 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
14.3%
2/14 • Number of events 2 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
General disorders
Pain
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
General disorders
Pyrexia
|
14.3%
1/7 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 3 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Immune system disorders
Jarisch-Herxheimer reaction
|
14.3%
1/7 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
0.00%
0/14 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Infections and infestations
Nasopharyngitis
|
28.6%
2/7 • Number of events 2 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
14.3%
2/14 • Number of events 2 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
28.6%
2/7 • Number of events 2 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
14.3%
2/14 • Number of events 2 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Investigations
C-reactive protein increased
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Investigations
Pseudomonas test positive
|
14.3%
1/7 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
0.00%
0/14 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
0.00%
0/14 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
14.3%
1/7 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
0.00%
0/14 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • Number of events 4 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
21.4%
3/14 • Number of events 4 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Nervous system disorders
Paraesthesia
|
14.3%
1/7 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
0.00%
0/14 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Nervous system disorders
Orthostatic intolerance
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
21.4%
3/14 • Number of events 3 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
14.3%
1/7 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
14.3%
2/14 • Number of events 3 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
14.3%
1/7 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 2 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
|
28.6%
2/7 • Number of events 2 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
0.00%
0/14 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
7.1%
1/14 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Vascular disorders
Flushing
|
14.3%
1/7 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
0.00%
0/14 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
|
Product Issues
Device occlusion
|
14.3%
1/7 • Number of events 1 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
0.00%
0/14 • AE events were collected from first treatment until follow up visit 14 days after last treatment
Treatment emergent AEs based on Safety analysis set (N=21)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI(s) shall provide to Bayer any proposed publication or oral presentation relating to the Study or the Study Drug or the Results at least sixty (60) days prior to the intended submission or presentation of the Publication in order to allow Bayer to review it.
- Publication restrictions are in place
Restriction type: OTHER