Trial Outcomes & Findings for Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium. (NCT NCT03460704)
NCT ID: NCT03460704
Last Updated: 2023-12-29
Results Overview
The primary efficacy assessment for an individual subject was the frequency of pulmonary exacerbations (exacerbation rate). A pulmonary exacerbation was defined as the presence concurrently of at least three of the following eight symptoms/signs for at least 24 hours: * increased cough; * increased sputum volume and/or consistency; * increased sputum purulence; * new or increased haemoptysis; * increased wheezing; * increased dyspnoea; * increased fatigue/malaise and * episodes of fever (temperature ≥38°C). AND It was clinically determined that the subject required and was prescribed systemic antibiotic therapy. AND The episode of exacerbation lasted for at least 24 hours. The overall episode of exacerbation needs to last at least 24 hours, but individual symptoms/signs can last less than 24 hours (e.g, a temperature)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
287 participants
Primary outcome timeframe
12 months
Results posted on
2023-12-29
Participant Flow
Recruitment was halted with 287 subjects randomised.
Participant milestones
| Measure |
CMS (Colistimethate Sodium)
Inhaled colistimethate sodium twice daily. The active pharmaceutical ingredient consisting of pure CMS one million international units (MIU) / 80 mg of CMS / 33 mg colistin base activity (CBA) was provided as a powder for nebuliser solution in 10R Internation Organization for Standardization (ISO) glass vials.
CMS: 1 MIU equivalent to 80 mg colistimethate sodium diluted in 1 mL saline solution 0.45%. Investigational Medicinal Product (IMP) glass vials were shrink wrapped in opaque white plastic and provided in boxes of 30 vials (two weeks of b.i.d. dosing).
The 1 MIU/ml CMS/0.45% saline solution was transferred from the glass vial into a specific nebuliser system fitted with a 0.3 mL medication chamber, for administration by inhalation. This delivered a nominal dose of 0.3 MIU/24 mg CMS (11 mg CBA) from the device.
The first dose of the IMP was administered at the site under the supervision of the site staff and subjects were instructed how to prepare and self-administer the IMP at home via a specific nebuliser system, b.i.d. (morning and evening) over aperiod of 12 month.
At least 10 minutes (min) before each administration, an inhaled short-acting bronchodilator (e.g. salbutamol/albuterol), supplied by the Sponsor, could be taken to improve tolerability.
|
Placebo
Saline solution inhaled twice daily, provided and administered at the same way of the IMP.
Placebo: 1 mL saline solution 0.45%. The placebo was made up of identical empty glass vials to which the same saline solution diluent was added in exactly the same way as the reconstitution of the active treatment by injecting the diluent through the rubber stopper. The glass vials were shrink wrapped with opaque white plastic to mantain the blind.
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
135
|
|
Overall Study
Modified Intention to Treat Population - (mITT)
|
152
|
135
|
|
Overall Study
Safety Population - (SAF)
|
152
|
135
|
|
Overall Study
Per-Protocol Population - (PP)
|
112
|
98
|
|
Overall Study
COMPLETED
|
94
|
89
|
|
Overall Study
NOT COMPLETED
|
58
|
46
|
Reasons for withdrawal
| Measure |
CMS (Colistimethate Sodium)
Inhaled colistimethate sodium twice daily. The active pharmaceutical ingredient consisting of pure CMS one million international units (MIU) / 80 mg of CMS / 33 mg colistin base activity (CBA) was provided as a powder for nebuliser solution in 10R Internation Organization for Standardization (ISO) glass vials.
CMS: 1 MIU equivalent to 80 mg colistimethate sodium diluted in 1 mL saline solution 0.45%. Investigational Medicinal Product (IMP) glass vials were shrink wrapped in opaque white plastic and provided in boxes of 30 vials (two weeks of b.i.d. dosing).
The 1 MIU/ml CMS/0.45% saline solution was transferred from the glass vial into a specific nebuliser system fitted with a 0.3 mL medication chamber, for administration by inhalation. This delivered a nominal dose of 0.3 MIU/24 mg CMS (11 mg CBA) from the device.
The first dose of the IMP was administered at the site under the supervision of the site staff and subjects were instructed how to prepare and self-administer the IMP at home via a specific nebuliser system, b.i.d. (morning and evening) over aperiod of 12 month.
At least 10 minutes (min) before each administration, an inhaled short-acting bronchodilator (e.g. salbutamol/albuterol), supplied by the Sponsor, could be taken to improve tolerability.
|
Placebo
Saline solution inhaled twice daily, provided and administered at the same way of the IMP.
Placebo: 1 mL saline solution 0.45%. The placebo was made up of identical empty glass vials to which the same saline solution diluent was added in exactly the same way as the reconstitution of the active treatment by injecting the diluent through the rubber stopper. The glass vials were shrink wrapped with opaque white plastic to mantain the blind.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
14
|
|
Overall Study
Study terminated by the Sponsor
|
29
|
19
|
|
Overall Study
Adverse Event
|
10
|
5
|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Non-Compliance with Study Drug
|
3
|
0
|
|
Overall Study
Protocol-Specified Withdrawal Criterion Met
|
0
|
5
|
|
Overall Study
Other
|
2
|
1
|
Baseline Characteristics
Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium.
Baseline characteristics by cohort
| Measure |
CMS (Colistimethate Sodium)
n=152 Participants
Inhaled colistimethate sodium twice daily. The active pharmaceutical ingredient consisting of pure CMS one million international units (MIU) / 80 mg of CMS / 33 mg colistin base activity (CBA) was provided as a powder for nebuliser solution in 10R Internation Organization for Standardization (ISO) glass vials.
CMS: 1 MIU equivalent to 80 mg colistimethate sodium diluted in 1 mL saline solution 0.45%. Investigational Medicinal Product (IMP) glass vials were shrink wrapped in opaque white plastic and provided in boxes of 30 vials (two weeks of b.i.d. dosing).
The 1 MIU/ml CMS/0.45% saline solution was transferred from the glass vial into a specific nebuliser system fitted with a 0.3 mL medication chamber, for administration by inhalation. This delivered a nominal dose of 0.3 MIU/24 mg CMS (11 mg CBA) from the device.
The first dose of the IMP was administered at the site under the supervision of the site staff and subjects were instructed how to prepare and self-administer the IMP at home via a specific nebuliser system, b.i.d. (morning and evening) over aperiod of 12 month.
At least 10 minutes (min) before each administration, an inhaled short-acting bronchodilator (e.g. salbutamol/albuterol), supplied by the Sponsor, could be taken to improve tolerability.
|
Placebo
n=135 Participants
Saline solution inhaled twice daily, provided and administered at the same way of the IMP.
Placebo: 1 mL saline solution 0.45%. The placebo was made up of identical empty glass vials to which the same saline solution diluent was added in exactly the same way as the reconstitution of the active treatment by injecting the diluent through the rubber stopper. The glass vials were shrink wrapped with opaque white plastic to mantain the blind.
|
Total
n=287 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
85 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
158 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
67 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 15.19 • n=99 Participants
|
59.6 years
STANDARD_DEVIATION 14.73 • n=107 Participants
|
59.7 years
STANDARD_DEVIATION 14.95 • n=206 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=99 Participants
|
94 Participants
n=107 Participants
|
198 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
146 Participants
n=99 Participants
|
130 Participants
n=107 Participants
|
276 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
Greece
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
New Zealand
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
9 participants
n=99 Participants
|
10 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Region of Enrollment
Argentina
|
56 participants
n=99 Participants
|
52 participants
n=107 Participants
|
108 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
20 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
22 participants
n=99 Participants
|
26 participants
n=107 Participants
|
48 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Region of Enrollment
France
|
18 participants
n=99 Participants
|
12 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Region of Enrollment
Portugal
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The modified Intention-To-Treat (mITT) Population is the Full Analysis Set and comprised all subjects who provided informed consent, were randomised and received at least 1 dose or partial dose of the IMP.
The primary efficacy assessment for an individual subject was the frequency of pulmonary exacerbations (exacerbation rate). A pulmonary exacerbation was defined as the presence concurrently of at least three of the following eight symptoms/signs for at least 24 hours: * increased cough; * increased sputum volume and/or consistency; * increased sputum purulence; * new or increased haemoptysis; * increased wheezing; * increased dyspnoea; * increased fatigue/malaise and * episodes of fever (temperature ≥38°C). AND It was clinically determined that the subject required and was prescribed systemic antibiotic therapy. AND The episode of exacerbation lasted for at least 24 hours. The overall episode of exacerbation needs to last at least 24 hours, but individual symptoms/signs can last less than 24 hours (e.g, a temperature)
Outcome measures
| Measure |
CMS (Colistimethate Sodium)
n=152 Participants
Inhaled colistimethate sodium twice daily. The active pharmaceutical ingredient consisting of pure CMS one million international units (MIU) / 80 mg of CMS / 33 mg colistin base activity (CBA) was provided as a powder for nebuliser solution in 10R Internation Organization for Standardization (ISO) glass vials.
CMS: 1 MIU equivalent to 80 mg colistimethate sodium diluted in 1 mL saline solution 0.45%. Investigational Medicinal Product (IMP) glass vials were shrink wrapped in opaque white plastic and provided in boxes of 30 vials (two weeks of b.i.d. dosing).
The 1 MIU/ml CMS/0.45% saline solution was transferred from the glass vial into a specific nebuliser system fitted with a 0.3 mL medication chamber, for administration by inhalation. This delivered a nominal dose of 0.3 MIU/24 mg CMS (11 mg CBA) from the device.
The first dose of the IMP was administered at the site under the supervision of the site staff and subjects were instructed how to prepare and self-administer the IMP at home via a specific nebuliser system, b.i.d. (morning and evening) over aperiod of 12 month.
At least 10 minutes (min) before each administration, an inhaled short-acting bronchodilator (e.g. salbutamol/albuterol), supplied by the Sponsor, could be taken to improve tolerability.
|
Placebo
n=135 Participants
Saline solution inhaled twice daily, provided and administered at the same way of the IMP.
Placebo: 1 mL saline solution 0.45%. The placebo was made up of identical empty glass vials to which the same saline solution diluent was added in exactly the same way as the reconstitution of the active treatment by injecting the diluent through the rubber stopper. The glass vials were shrink wrapped with opaque white plastic to mantain the blind.
|
|---|---|---|
|
Mean Annual Non-cystic Fibrosis Bronchiectasis (NCFB) Pulmonary Exacerbation Rate
|
0.889 Number of Pulmonary Exacerbations
Interval 0.722 to 1.093
|
0.885 Number of Pulmonary Exacerbations
Interval 0.71 to 1.103
|
Adverse Events
CMS (Colistimethate Sodium) (SAF)
Serious events: 27 serious events
Other events: 123 other events
Deaths: 3 deaths
Placebo (SAF)
Serious events: 17 serious events
Other events: 104 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
CMS (Colistimethate Sodium) (SAF)
n=152 participants at risk
Inhaled colistimethate sodium twice daily. The active pharmaceutical ingredient consisting of pure CMS one million international units (MIU) / 80 mg of CMS / 33 mg colistin base activity (CBA) was provided as a powder for nebuliser solution in 10R Internation Organization for Standardization (ISO) glass vials.
CMS: 1 MIU equivalent to 80 mg colistimethate sodium diluted in 1 mL saline solution 0.45%. Investigational Medicinal Product (IMP) glass vials were shrink wrapped in opaque white plastic and provided in boxes of 30 vials (two weeks of b.i.d. dosing).
The 1 MIU/ml CMS/0.45% saline solution was transferred from the glass vial into a specific nebuliser system fitted with a 0.3 mL medication chamber, for administration by inhalation. This delivered a nominal dose of 0.3 MIU/24 mg CMS (11 mg CBA) from the device.
The first dose of the IMP was administered at the site under the supervision of the site staff and subjects were instructed how to prepare and self-administer the IMP at home via a specific nebuliser system, b.i.d. (morning and evening) over aperiod of 12 month.
At least 10 minutes (min) before each administration, an inhaled short-acting bronchodilator (e.g. salbutamol/albuterol), supplied by the Sponsor, could be taken to improve tolerability.
|
Placebo (SAF)
n=135 participants at risk
Saline solution inhaled twice daily, provided and administered at the same way of the IMP.
Placebo: 1 mL saline solution 0.45%. The placebo was made up of identical empty glass vials to which the same saline solution diluent was added in exactly the same way as the reconstitution of the active treatment by injecting the diluent through the rubber stopper. The glass vials were shrink wrapped with opaque white plastic to mantain the blind.
|
|---|---|---|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
7.9%
12/152 • Number of events 12 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
7.4%
10/135 • Number of events 11 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
COVID-19
|
2.0%
3/152 • Number of events 3 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
Brain abscess
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
Pneumonia
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.74%
1/135 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/152 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.74%
1/135 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.3%
2/152 • Number of events 2 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.3%
2/152 • Number of events 2 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/152 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.74%
1/135 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/152 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.74%
1/135 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/152 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.74%
1/135 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/152 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.74%
1/135 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Cardiac disorders
Adams-Stokes syndrome
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/152 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.74%
1/135 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Cardiac disorders
Sinus arrest
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Gastrointestinal disorders
Constipation
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.74%
1/135 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/152 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.74%
1/135 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/152 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.74%
1/135 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
General disorders
Death
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/152 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.74%
1/135 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal neoplasm
|
0.00%
0/152 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.74%
1/135 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
Other adverse events
| Measure |
CMS (Colistimethate Sodium) (SAF)
n=152 participants at risk
Inhaled colistimethate sodium twice daily. The active pharmaceutical ingredient consisting of pure CMS one million international units (MIU) / 80 mg of CMS / 33 mg colistin base activity (CBA) was provided as a powder for nebuliser solution in 10R Internation Organization for Standardization (ISO) glass vials.
CMS: 1 MIU equivalent to 80 mg colistimethate sodium diluted in 1 mL saline solution 0.45%. Investigational Medicinal Product (IMP) glass vials were shrink wrapped in opaque white plastic and provided in boxes of 30 vials (two weeks of b.i.d. dosing).
The 1 MIU/ml CMS/0.45% saline solution was transferred from the glass vial into a specific nebuliser system fitted with a 0.3 mL medication chamber, for administration by inhalation. This delivered a nominal dose of 0.3 MIU/24 mg CMS (11 mg CBA) from the device.
The first dose of the IMP was administered at the site under the supervision of the site staff and subjects were instructed how to prepare and self-administer the IMP at home via a specific nebuliser system, b.i.d. (morning and evening) over aperiod of 12 month.
At least 10 minutes (min) before each administration, an inhaled short-acting bronchodilator (e.g. salbutamol/albuterol), supplied by the Sponsor, could be taken to improve tolerability.
|
Placebo (SAF)
n=135 participants at risk
Saline solution inhaled twice daily, provided and administered at the same way of the IMP.
Placebo: 1 mL saline solution 0.45%. The placebo was made up of identical empty glass vials to which the same saline solution diluent was added in exactly the same way as the reconstitution of the active treatment by injecting the diluent through the rubber stopper. The glass vials were shrink wrapped with opaque white plastic to mantain the blind.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.3%
5/152 • Number of events 5 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
2.0%
3/152 • Number of events 3 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
1.5%
2/135 • Number of events 3 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Gastrointestinal disorders
Constipation
|
2.6%
4/152 • Number of events 5 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.74%
1/135 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
2/152 • Number of events 4 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
2.2%
3/135 • Number of events 4 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Musculoskeletal and connective tissue disorders
Muscoskeletal chest pain
|
2.0%
3/152 • Number of events 3 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
1.5%
2/135 • Number of events 2 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
2.2%
3/135 • Number of events 3 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
3/152 • Number of events 4 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.74%
1/135 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
3/152 • Number of events 3 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.74%
1/135 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
3/152 • Number of events 3 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.74%
1/135 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
3/152 • Number of events 3 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.74%
1/135 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
General disorders
Non-cardiac chest pain
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
2.2%
3/135 • Number of events 3 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
General disorders
Pyrexia
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
2.2%
3/135 • Number of events 3 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.66%
1/152 • Number of events 1 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
2.2%
3/135 • Number of events 3 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Nervous system disorders
Syncope
|
2.0%
3/152 • Number of events 3 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Injury, poisoning and procedural complications
Exposure to contaminated device
|
0.00%
0/152 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
2.2%
3/135 • Number of events 3 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Investigations
Weight decreased
|
0.00%
0/152 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
2.2%
3/135 • Number of events 3 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
Chronic sinusitis
|
2.0%
3/152 • Number of events 6 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/135 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
45.4%
69/152 • Number of events 111 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
49.6%
67/135 • Number of events 103 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.2%
11/152 • Number of events 15 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
6.7%
9/135 • Number of events 10 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Nervous system disorders
Headache
|
4.6%
7/152 • Number of events 7 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
5.9%
8/135 • Number of events 8 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.9%
9/152 • Number of events 15 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
3.7%
5/135 • Number of events 8 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.6%
7/152 • Number of events 10 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
4.4%
6/135 • Number of events 7 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
COVID-19
|
5.3%
8/152 • Number of events 8 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
3.0%
4/135 • Number of events 4 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
Sinusitis
|
3.9%
6/152 • Number of events 7 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
4.4%
6/135 • Number of events 10 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
5/152 • Number of events 8 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
4.4%
6/135 • Number of events 7 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
4.6%
7/152 • Number of events 8 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
2.2%
3/135 • Number of events 7 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
2/152 • Number of events 2 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
4.4%
6/135 • Number of events 6 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
General disorders
Fatigue
|
3.9%
6/152 • Number of events 7 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
1.5%
2/135 • Number of events 2 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Vascular disorders
Hypertension
|
2.0%
3/152 • Number of events 3 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
3.0%
4/135 • Number of events 4 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.0%
3/152 • Number of events 3 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
2.2%
3/135 • Number of events 3 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
Influenza
|
2.6%
4/152 • Number of events 4 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
1.5%
2/135 • Number of events 2 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.0%
3/152 • Number of events 4 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
2.2%
3/135 • Number of events 3 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
2/152 • Number of events 2 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
3.0%
4/135 • Number of events 6 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
2/152 • Number of events 4 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
3.0%
4/135 • Number of events 5 • All AEs occurring from Visit 2 (day 0 = first IMP administration) until the follow-up phone call (2 weeks +/- 3 days after the end of treatment = totally up to 54 weeks +/- 3 days from the study Day 0.
An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place