Trial Outcomes & Findings for Pilot Trial of Inhaled Molgramostim in Non-tuberculous Mycobacterial (NTM) Infection (NCT NCT03421743)

NCT ID: NCT03421743

Last Updated: 2024-07-03

Results Overview

Sputum culture conversion is defined as at least 3 consecutive sputum samples without growth of NTM during the treatment period.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 32 participants
• Primary outcome timeframe: 48 weeks
• Results posted on: 2024-07-03

Participant Flow

This was a multicenter study conducted in a total of 5 sites in Australia and the UK. First participant was enrolled on 1 March 2018 and last participant completed the study on 13 January 2020.

Adults with chronic pulmonary NTM infection and a positive sputum culture at Screening were recruited into 2 groups: 1. On multidrug NTM guideline-based antimycobacterial regimen ongoing for ≥6 months prior to Baseline. 2. Had stopped multidrug NTM regimen ≥28 days prior to Screening (lack of response/intolerance)/never started such treatment.

Participant milestones

Measure	Inhaled Molgramostim/Antimycobacterials Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation	Inhaled Molgramostim Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Overall Study STARTED	14	18
Overall Study COMPLETED	11	16
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Inhaled Molgramostim/Antimycobacterials Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation	Inhaled Molgramostim Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Overall Study Lack of Efficacy	1	0
Overall Study Adverse Event	2	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Pilot Trial of Inhaled Molgramostim in Non-tuberculous Mycobacterial (NTM) Infection

Baseline characteristics by cohort

Measure	Inhaled Molgramostim/Antimycobacterials n=14 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation	Inhaled Molgramostim n=18 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Age, Continuous	67.4 years STANDARD_DEVIATION 9.9 • n=5 Participants	66.0 years STANDARD_DEVIATION 9.0 • n=7 Participants	66.6 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	8 Participants n=7 Participants	10 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	0 Participants n=5 Participants	2 Participants n=7 Participants	2 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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
Region of Enrollment United Kingdom	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Australia	12 participants n=5 Participants	18 participants n=7 Participants	30 participants n=5 Participants
NTM type Mycobacterium avium complex	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
NTM type Mycobacterium abscessus	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Age at NTM diagnosis	60.9 years STANDARD_DEVIATION 9.7 • n=5 Participants	60.1 years STANDARD_DEVIATION 11.7 • n=7 Participants	60.4 years STANDARD_DEVIATION 10.7 • n=5 Participants
Smoking status Never	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Smoking status Previous	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Smoking status Current	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Baseline Lower Respiratory Tract Infections - Visual Analogue Scale (LRTI-VAS) Scores	19.71 score on a scale STANDARD_DEVIATION 9.74 • n=5 Participants	14.87 score on a scale STANDARD_DEVIATION 9.29 • n=7 Participants	16.99 score on a scale STANDARD_DEVIATION 9.65 • n=5 Participants
Baseline Quality of Life Questionnaire - Bronchiectasis (QOL-B) scale scores Emotional functioning	83.97 score on a scale STANDARD_DEVIATION 15.76 • n=5 Participants	80.09 score on a scale STANDARD_DEVIATION 13.14 • n=7 Participants	81.72 score on a scale STANDARD_DEVIATION 14.18 • n=5 Participants
Baseline Quality of Life Questionnaire - Bronchiectasis (QOL-B) scale scores Health perceptions	42.31 score on a scale STANDARD_DEVIATION 24.41 • n=5 Participants	52.31 score on a scale STANDARD_DEVIATION 20.17 • n=7 Participants	48.12 score on a scale STANDARD_DEVIATION 22.23 • n=5 Participants
Baseline Quality of Life Questionnaire - Bronchiectasis (QOL-B) scale scores Physical functioning	58.46 score on a scale STANDARD_DEVIATION 29.71 • n=5 Participants	61.11 score on a scale STANDARD_DEVIATION 28.21 • n=7 Participants	60.00 score on a scale STANDARD_DEVIATION 28.39 • n=5 Participants
Baseline Quality of Life Questionnaire - Bronchiectasis (QOL-B) scale scores Respiratory symptoms	60.01 score on a scale STANDARD_DEVIATION 21.70 • n=5 Participants	66.41 score on a scale STANDARD_DEVIATION 12.75 • n=7 Participants	63.72 score on a scale STANDARD_DEVIATION 17.05 • n=5 Participants
Baseline Quality of Life Questionnaire - Bronchiectasis (QOL-B) scale scores Role functioning	62.05 score on a scale STANDARD_DEVIATION 32.93 • n=5 Participants	74.07 score on a scale STANDARD_DEVIATION 23.97 • n=7 Participants	69.03 score on a scale STANDARD_DEVIATION 28.21 • n=5 Participants
Baseline Quality of Life Questionnaire - Bronchiectasis (QOL-B) scale scores Social functioning	59.83 score on a scale STANDARD_DEVIATION 27.49 • n=5 Participants	56.94 score on a scale STANDARD_DEVIATION 26.97 • n=7 Participants	58.15 score on a scale STANDARD_DEVIATION 26.77 • n=5 Participants
Baseline Quality of Life Questionnaire - Bronchiectasis (QOL-B) scale scores Treatment burden	65.28 score on a scale STANDARD_DEVIATION 17.25 • n=5 Participants	73.61 score on a scale STANDARD_DEVIATION 20.52 • n=7 Participants	69.44 score on a scale STANDARD_DEVIATION 18.81 • n=5 Participants
Baseline Quality of Life Questionnaire - Bronchiectasis (QOL-B) scale scores Vitality	41.03 score on a scale STANDARD_DEVIATION 23.30 • n=5 Participants	55.56 score on a scale STANDARD_DEVIATION 19.80 • n=7 Participants	49.46 score on a scale STANDARD_DEVIATION 22.19 • n=5 Participants
Baseline Global Rating of Health (GRH) scores	2.64 score on a scale STANDARD_DEVIATION 0.84 • n=5 Participants	2.78 score on a scale STANDARD_DEVIATION 0.65 • n=7 Participants	2.72 score on a scale STANDARD_DEVIATION 0.73 • n=5 Participants
Body weight	52.24 kilogram STANDARD_DEVIATION 8.84 • n=5 Participants	66.50 kilogram STANDARD_DEVIATION 14.40 • n=7 Participants	60.26 kilogram STANDARD_DEVIATION 14.07 • n=5 Participants
Baseline 6-Minute Walking Distance (6MWD)	431.0 meters STANDARD_DEVIATION 89.6 • n=5 Participants	440.8 meters STANDARD_DEVIATION 107.1 • n=7 Participants	436.5 meters STANDARD_DEVIATION 98.4 • n=5 Participants
Baseline dyspnea scores	2.08 score on a scale STANDARD_DEVIATION 2.48 • n=5 Participants	2.47 score on a scale STANDARD_DEVIATION 2.06 • n=7 Participants	2.30 score on a scale STANDARD_DEVIATION 2.22 • n=5 Participants
Baseline Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)	71.005 percent predicted STANDARD_DEVIATION 23.076 • n=5 Participants	73.166 percent predicted STANDARD_DEVIATION 17.338 • n=7 Participants	72.221 percent predicted STANDARD_DEVIATION 19.926 • n=5 Participants
Baseline Forced Expiratory Volume in 1 Second (FEV1)	72.2231 percent predicted STANDARD_DEVIATION 19.1010 • n=5 Participants	69.7239 percent predicted STANDARD_DEVIATION 24.2097 • n=7 Participants	70.8173 percent predicted STANDARD_DEVIATION 21.8175 • n=5 Participants
Baseline Forced Vital Capacity (FVC)	77.1785 percent predicted STANDARD_DEVIATION 18.6934 • n=5 Participants	82.7931 percent predicted STANDARD_DEVIATION 22.0540 • n=7 Participants	80.3367 percent predicted STANDARD_DEVIATION 20.5249 • n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

Sputum culture conversion is defined as at least 3 consecutive sputum samples without growth of NTM during the treatment period.

Outcome measures

Measure	Inhaled Molgramostim/Antimycobacterials n=14 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation Antimycobacterial regimen: Multidrug NTM-guideline based antimycobacterial regimen	Inhaled Molgramostim n=18 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Number of Participants With Sputum Culture Conversion to Negative	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Only participants who were smear positive at Baseline are included in the analysis.

Sputum smear conversion is defined as at least three consecutive negative acid-fast bacilli (AFB) stained sputum smears on microscopy during the treatment period among participants who were smear positive at Baseline.

Outcome measures

Measure	Inhaled Molgramostim/Antimycobacterials n=13 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation Antimycobacterial regimen: Multidrug NTM-guideline based antimycobacterial regimen	Inhaled Molgramostim n=16 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Number of Participants With Sputum Smear Conversion to Negative	5 Participants	6 Participants

SECONDARY outcome

Timeframe: 60 weeks

Durability is defined as sputum culture conversion at or before Week 24 and culture still negative for growth of NTM at 12-weeks follow-up.

Outcome measures

Measure	Inhaled Molgramostim/Antimycobacterials n=14 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation Antimycobacterial regimen: Multidrug NTM-guideline based antimycobacterial regimen	Inhaled Molgramostim n=18 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Number of Participants With Durable Sputum Culture Conversion	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 60 weeks

Durability is defined as sputum smear conversion at or before Week 48 and AFB stained smear still negative for NTM at 12-weeks follow-up among participants who were smear positive at Baseline.

Outcome measures

Measure	Inhaled Molgramostim/Antimycobacterials n=14 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation Antimycobacterial regimen: Multidrug NTM-guideline based antimycobacterial regimen	Inhaled Molgramostim n=18 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Number of Participants With Durable Sputum Smear Conversion	5 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Evaluable participants at Week 48 included in the analysis.

For each of the clinical symptoms of Lower Respiratory Tract Infections (dyspnea, fatigue, cough, pain, and sputum), the participant assessed the severity using a 10 cm visual analogue scale (VAS) ranging from 0 = no symptoms to 10 = worst possible symptoms. A total LRTI score was calculated by summing up the score of each symptom (i.e., total LRTI score ranged from 0 to 50).

Outcome measures

Measure	Inhaled Molgramostim/Antimycobacterials n=9 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation Antimycobacterial regimen: Multidrug NTM-guideline based antimycobacterial regimen	Inhaled Molgramostim n=16 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Change From Baseline in Symptom Scores (Assessed Using Lower Respiratory Tract Infections - Visual Analogue Scale) Total score	2.48 score on a scale Standard Deviation 9.13	4.32 score on a scale Standard Deviation 13.32
Change From Baseline in Symptom Scores (Assessed Using Lower Respiratory Tract Infections - Visual Analogue Scale) Dyspnoea	1.74 score on a scale Standard Deviation 2.50	0.91 score on a scale Standard Deviation 3.64
Change From Baseline in Symptom Scores (Assessed Using Lower Respiratory Tract Infections - Visual Analogue Scale) Cough	5.28 score on a scale Standard Deviation 3.08	3.35 score on a scale Standard Deviation 2.08
Change From Baseline in Symptom Scores (Assessed Using Lower Respiratory Tract Infections - Visual Analogue Scale) Color of phlegm	-1.88 score on a scale Standard Deviation 3.54	0.28 score on a scale Standard Deviation 2.24
Change From Baseline in Symptom Scores (Assessed Using Lower Respiratory Tract Infections - Visual Analogue Scale) Pain	1.22 score on a scale Standard Deviation 2.76	0.58 score on a scale Standard Deviation 2.82
Change From Baseline in Symptom Scores (Assessed Using Lower Respiratory Tract Infections - Visual Analogue Scale) Tiredness	1.29 score on a scale Standard Deviation 3.63	1.08 score on a scale Standard Deviation 3.96

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Evaluable participants at Week 48 included in the analysis.

The QOL-B questionnaire including 37 items on 8 scales (emotional functioning, health perceptions, physical functioning, respiratory symptoms, role functioning, social functioning, treatment burden, vitality) was used to assess participant's quality of life (QoL). Each of the 37 items is scored from 1 to 4, and each of the 8 scale scores is standardised on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and QoL. Scales contain between 3 and 9 items, thus changing 1 answer category will correspond to a change of 11.1 to 3.7 points.

Outcome measures

Measure	Inhaled Molgramostim/Antimycobacterials n=9 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation Antimycobacterial regimen: Multidrug NTM-guideline based antimycobacterial regimen	Inhaled Molgramostim n=16 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Change From Baseline in Symptom Scores (Assessed Using Quality of Life Questionnaire - Bronchiectasis (QOL-B)) Social functioning	-16.36 score on a scale Standard Deviation 15.43	-7.81 score on a scale Standard Deviation 20.16
Change From Baseline in Symptom Scores (Assessed Using Quality of Life Questionnaire - Bronchiectasis (QOL-B)) Emotional functioning	0.00 score on a scale Standard Deviation 8.33	3.12 score on a scale Standard Deviation 12.12
Change From Baseline in Symptom Scores (Assessed Using Quality of Life Questionnaire - Bronchiectasis (QOL-B)) Health perceptions	-12.96 score on a scale Standard Deviation 13.25	-6.77 score on a scale Standard Deviation 21.99
Change From Baseline in Symptom Scores (Assessed Using Quality of Life Questionnaire - Bronchiectasis (QOL-B)) Physical functioning	-17.78 score on a scale Standard Deviation 21.34	-7.50 score on a scale Standard Deviation 28.38
Change From Baseline in Symptom Scores (Assessed Using Quality of Life Questionnaire - Bronchiectasis (QOL-B)) Respiratory symptoms	-6.84 score on a scale Standard Deviation 8.24	-4.34 score on a scale Standard Deviation 16.36
Change From Baseline in Symptom Scores (Assessed Using Quality of Life Questionnaire - Bronchiectasis (QOL-B)) Role functioning	-13.33 score on a scale Standard Deviation 14.91	-10.42 score on a scale Standard Deviation 22.96
Change From Baseline in Symptom Scores (Assessed Using Quality of Life Questionnaire - Bronchiectasis (QOL-B)) Treatment burden	-3.70 score on a scale Standard Deviation 12.83	4.44 score on a scale Standard Deviation 21.66
Change From Baseline in Symptom Scores (Assessed Using Quality of Life Questionnaire - Bronchiectasis (QOL-B)) Vitality	-9.88 score on a scale Standard Deviation 12.96	-7.64 score on a scale Standard Deviation 26.83

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Evaluable participants at Week 48 included in the analysis.

GRH was assessed as an interviewer questionnaire, which assesses global health as "excellent, good, fair or poor". For analysis, these were scored as 1 (poor) to 4 (excellent).

Outcome measures

Measure	Inhaled Molgramostim/Antimycobacterials n=9 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation Antimycobacterial regimen: Multidrug NTM-guideline based antimycobacterial regimen	Inhaled Molgramostim n=16 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Change From Baseline in Global Rating of Health (GRH)	-0.78 score on a scale Standard Deviation 0.67	-0.38 score on a scale Standard Deviation 0.81

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Evaluable participants at Week 48 included in the analysis.

Outcome measures

Measure	Inhaled Molgramostim/Antimycobacterials n=9 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation Antimycobacterial regimen: Multidrug NTM-guideline based antimycobacterial regimen	Inhaled Molgramostim n=15 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Change From Baseline in Body Weight	-1.77 kilogram Standard Deviation 2.51	-1.44 kilogram Standard Deviation 3.09

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Evaluable participants at Week 48 included in the analysis.

The 6-minute walk test (6MWT) was performed in accordance with the European Respiratory Society/American Thoracic Society (ERS/ATS) guideline by technicians with documented training and experience. The 6MWT was performed twice at each visit.

Outcome measures

Measure	Inhaled Molgramostim/Antimycobacterials n=9 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation Antimycobacterial regimen: Multidrug NTM-guideline based antimycobacterial regimen	Inhaled Molgramostim n=15 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Change From Baseline in 6-Minute Walking Distance (6MWD)	-17.1 meter Standard Deviation 62.5	12.5 meter Standard Deviation 56.2

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Evaluable participants at Week 48 included in the analysis.

Outcome measures

Measure	Inhaled Molgramostim/Antimycobacterials n=9 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation Antimycobacterial regimen: Multidrug NTM-guideline based antimycobacterial regimen	Inhaled Molgramostim n=15 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Change From Baseline in Dyspnea Scores During a 6MWT	0.79 score on a scale Standard Deviation 0.92	1.43 score on a scale Standard Deviation 3.01

SECONDARY outcome

Timeframe: 60 weeks

All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.

Outcome measures

Measure	Inhaled Molgramostim/Antimycobacterials n=14 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation Antimycobacterial regimen: Multidrug NTM-guideline based antimycobacterial regimen	Inhaled Molgramostim n=18 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Number of Adverse Events (AEs) During the Trial Period	199 events	223 events

SECONDARY outcome

Timeframe: 60 weeks

SAEs were defined as any untoward medicinal occurrence or effect that at any dose:

• Results in death
• Is life-threatening
• Requires hospitalisation or prolongation of existing hospitalisation
• Results in persistent or significant disability or incapacity
• Is a congenital abnormality or birth defect
• May jeopardise the participant or may require medical intervention to prevent one or more of the outcomes listed above (Important Medical Events).

Outcome measures

Measure	Inhaled Molgramostim/Antimycobacterials n=14 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation Antimycobacterial regimen: Multidrug NTM-guideline based antimycobacterial regimen	Inhaled Molgramostim n=18 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Number of Serious AEs (SAEs) During the Trial Period	14 events	17 events

SECONDARY outcome

Timeframe: 60 weeks

All AEs were assessed by the investigator for causality (unlikely, possible, probable, not applicable) according to current regulatory standards. AEs which had a 'possible' or 'probable' causality were classified as ADRs.

Outcome measures

Measure	Inhaled Molgramostim/Antimycobacterials n=14 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation Antimycobacterial regimen: Multidrug NTM-guideline based antimycobacterial regimen	Inhaled Molgramostim n=18 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Number of Adverse Drug Reactions (ADRs) During the Trial Period	67 events	81 events

SECONDARY outcome

Timeframe: 60 weeks

All AEs were assessed by the investigator for severity (mild, moderate, severe) according to current regulatory standards.

Outcome measures

Measure	Inhaled Molgramostim/Antimycobacterials n=14 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation Antimycobacterial regimen: Multidrug NTM-guideline based antimycobacterial regimen	Inhaled Molgramostim n=18 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Number of Severe AEs During the Trial Period	5 events	6 events

SECONDARY outcome

Timeframe: 60 weeks

Outcome measures

Measure	Inhaled Molgramostim/Antimycobacterials n=14 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation Antimycobacterial regimen: Multidrug NTM-guideline based antimycobacterial regimen	Inhaled Molgramostim n=18 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Number of Participants Withdrawn From Treatment Due to an AE During the Trial Period	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Evaluable participants at Week 48 included in the analysis.

Outcome measures

Measure	Inhaled Molgramostim/Antimycobacterials n=9 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation Antimycobacterial regimen: Multidrug NTM-guideline based antimycobacterial regimen	Inhaled Molgramostim n=16 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Change From Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)	-4.565 percent predicted Standard Deviation 8.198	-3.079 percent predicted Standard Deviation 7.766

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Evaluable participants at Week 48 included in the analysis.

Outcome measures

Measure	Inhaled Molgramostim/Antimycobacterials n=8 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation Antimycobacterial regimen: Multidrug NTM-guideline based antimycobacterial regimen	Inhaled Molgramostim n=16 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) (% Predicted)	-1.7986 percent predicted Standard Deviation 10.2133	-3.4011 percent predicted Standard Deviation 6.9830

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Evaluable participants at Week 48 included in the analysis.

Outcome measures

Measure	Inhaled Molgramostim/Antimycobacterials n=8 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation Antimycobacterial regimen: Multidrug NTM-guideline based antimycobacterial regimen	Inhaled Molgramostim n=16 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Change From Baseline in Forced Vital Capacity (FVC) (% Predicted)	-2.4575 percent predicted Standard Deviation 6.6511	-2.6135 percent predicted Standard Deviation 7.7040

SECONDARY outcome

Timeframe: 60 weeks

Analyses for anti-GM-CSF antibodies were performed at a central laboratory.

Outcome measures

Measure	Inhaled Molgramostim/Antimycobacterials n=14 Participants Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation Antimycobacterial regimen: Multidrug NTM-guideline based antimycobacterial regimen	Inhaled Molgramostim n=18 Participants Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Number of Subjects With Development of Anti-GM-CSF Antibodies in Serum	5 Participants	10 Participants

Adverse Events

Inhaled Molgramostim/Antimycobacterials

Serious events: 8 serious events

Other events: 14 other events

Deaths: 2 deaths

Inhaled Molgramostim

Serious events: 6 serious events

Other events: 18 other events

Deaths: 1 deaths

Serious adverse events

Measure	Inhaled Molgramostim/Antimycobacterials n=14 participants at risk Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation	Inhaled Molgramostim n=18 participants at risk Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Vascular disorders Hypotension	0.00% 0/14 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Cardiac disorders Right ventricular failure	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	0.00% 0/18 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Ear and labyrinth disorders Vertigo	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	0.00% 0/18 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Gastrointestinal disorders Diarrhoea	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	0.00% 0/18 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
General disorders Chest pain	0.00% 0/14 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Infections and infestations Infective exacerbation of bronchiectasis	28.6% 4/14 • Number of events 5 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	16.7% 3/18 • Number of events 4 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/14 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Infections and infestations Lung infection pseudomonal	0.00% 0/14 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Infections and infestations Mycobacterium avium complex infection	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Infections and infestations Pneumonia	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	0.00% 0/18 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Infections and infestations Sepsis	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	0.00% 0/18 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Injury, poisoning and procedural complications Fall	0.00% 0/14 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Injury, poisoning and procedural complications Overdose	0.00% 0/14 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Investigations Weight decreased	0.00% 0/14 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Psychiatric disorders Anxiety	0.00% 0/14 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/14 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	21.4% 3/14 • Number of events 3 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	0.00% 0/18 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/14 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	11.1% 2/18 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/14 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.

Other adverse events

Measure	Inhaled Molgramostim/Antimycobacterials n=14 participants at risk Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM-guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation	Inhaled Molgramostim n=18 participants at risk Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM-guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment Inhaled molgramostim: 300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Vascular disorders Hypotension	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	11.1% 2/18 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
General disorders Fatigue	28.6% 4/14 • Number of events 4 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	22.2% 4/18 • Number of events 7 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
General disorders Pyrexia	14.3% 2/14 • Number of events 4 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	22.2% 4/18 • Number of events 5 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
General disorders Chest pain	14.3% 2/14 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	11.1% 2/18 • Number of events 3 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
General disorders Chest discomfort	14.3% 2/14 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	11.1% 2/18 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
General disorders Malaise	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	11.1% 2/18 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Injury, poisoning and procedural complications Wrist fracture	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Investigations Eosinophil count increased	28.6% 4/14 • Number of events 4 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	33.3% 6/18 • Number of events 8 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Investigations C-reactive protein increased	42.9% 6/14 • Number of events 6 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	16.7% 3/18 • Number of events 3 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Investigations Weight decreased	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	16.7% 3/18 • Number of events 3 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Investigations Blood creatinine increased	7.1% 1/14 • Number of events 3 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	11.1% 2/18 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Investigations Blood urine present	14.3% 2/14 • Number of events 3 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	0.00% 0/18 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Investigations Haemoglobin decreased	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Respiratory, thoracic and mediastinal disorders Cough	64.3% 9/14 • Number of events 15 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	72.2% 13/18 • Number of events 24 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Respiratory, thoracic and mediastinal disorders Dyspnoea	64.3% 9/14 • Number of events 9 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	50.0% 9/18 • Number of events 10 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Respiratory, thoracic and mediastinal disorders Haemoptysis	35.7% 5/14 • Number of events 12 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	16.7% 3/18 • Number of events 8 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Respiratory, thoracic and mediastinal disorders Sputum increased	14.3% 2/14 • Number of events 3 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	22.2% 4/18 • Number of events 4 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	28.6% 4/14 • Number of events 5 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	11.1% 2/18 • Number of events 3 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	14.3% 2/14 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/14 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	11.1% 2/18 • Number of events 4 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Respiratory, thoracic and mediastinal disorders Wheezing	7.1% 1/14 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Respiratory, thoracic and mediastinal disorders Dysphonia	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Blood and lymphatic system disorders Eosinophilia	21.4% 3/14 • Number of events 3 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	11.1% 2/18 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Nervous system disorders Headache	14.3% 2/14 • Number of events 3 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	22.2% 4/18 • Number of events 6 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Nervous system disorders Dizziness	0.00% 0/14 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	11.1% 2/18 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Ear and labyrinth disorders Vertigo	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	16.7% 3/18 • Number of events 3 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Ear and labyrinth disorders Tinnitus	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Gastrointestinal disorders Nausea	35.7% 5/14 • Number of events 9 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	38.9% 7/18 • Number of events 13 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Gastrointestinal disorders Diarrhoea	28.6% 4/14 • Number of events 5 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	27.8% 5/18 • Number of events 7 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Gastrointestinal disorders Abdominal pain upper	14.3% 2/14 • Number of events 9 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	16.7% 3/18 • Number of events 4 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Gastrointestinal disorders Constipation	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	11.1% 2/18 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Gastrointestinal disorders Vomiting	14.3% 2/14 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Renal and urinary disorders Leukocyturia	14.3% 2/14 • Number of events 3 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Skin and subcutaneous tissue disorders Urticaria	7.1% 1/14 • Number of events 3 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Skin and subcutaneous tissue disorders Pruritus	14.3% 2/14 • Number of events 3 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	0.00% 0/18 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Skin and subcutaneous tissue disorders Rash	0.00% 0/14 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	11.1% 2/18 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	14.3% 2/14 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	16.7% 3/18 • Number of events 5 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Musculoskeletal and connective tissue disorders Arthralgia	21.4% 3/14 • Number of events 5 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Musculoskeletal and connective tissue disorders Muscle spasms	14.3% 2/14 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	11.1% 2/18 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Musculoskeletal and connective tissue disorders Myalgia	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	11.1% 2/18 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/14 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	11.1% 2/18 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Infections and infestations Infective exacerbation of bronchiectasis	28.6% 4/14 • Number of events 5 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	27.8% 5/18 • Number of events 9 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Infections and infestations Upper respiratory tract infection	21.4% 3/14 • Number of events 5 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	11.1% 2/18 • Number of events 2 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Infections and infestations Gastroenteritis	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Infections and infestations Mycobacterium avium complex infection	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Infections and infestations Pneumonia	7.1% 1/14 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.	5.6% 1/18 • Number of events 1 • Baseline to 12-week follow-up (60 weeks in total). All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.

Additional Information

Paymond D Pratt, Chief Medical Officer

Savara Inc

Phone: +1 512 784 8757

Email: ray.pratt@savarapharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place