Trial Outcomes & Findings for Inositol in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia (NCT NCT00783705)
NCT ID: NCT00783705
Last Updated: 2017-12-05
Results Overview
The definitions of responses are: Complete response: regression of all dysplastic lesion (DL) found at baseline to lesions that were no worse than hyperplasia and no new DL that were mild dysplasia or worse; Partial response: regression of some but not all of the DL with no new lesions that are mild dysplasia or worse; Progressive disease: progression of one or more sites by two or more grades or new DL that were mild dysplasia or worse; Stable disease: no complete response, partial response or progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
85 participants
Primary outcome timeframe
From baseline up to 6 months
Results posted on
2017-12-05
Participant Flow
448 subjects were pre-registered through 3 Cancer Prevention Network (CPN) member organizations from 2008 to 2013.
363 subjects were excluded from pre-assignment: 342 ineligible via bronchoscopy, 3 participant decision, 13 lab values out of range, 1 screening time line issue and 4 suspicious of cancer.
Participant milestones
| Measure |
Arm A (Myo-inositol)
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
41
|
|
Overall Study
COMPLETED
|
38
|
36
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Arm A (Myo-inositol)
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
Inositol in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia
Baseline characteristics by cohort
| Measure |
Arm A (Myo-inositol)
n=44 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=41 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
n=5 Participants
|
58.0 years
n=7 Participants
|
58.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
36 participants
n=5 Participants
|
33 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Body Mass Index, kg/m^2
|
27.2 kg/m^2
n=5 Participants
|
26.0 kg/m^2
n=7 Participants
|
26.5 kg/m^2
n=5 Participants
|
|
Smoking Status
Current
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Smoking Status
Former
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Prior NSAID (nonsteroidal anti-inflammatory drugs) Use
No
|
28 participants
n=5 Participants
|
29 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Prior NSAID (nonsteroidal anti-inflammatory drugs) Use
Yes
|
16 participants
n=5 Participants
|
12 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Alcohol Intake
1 or fewer drinks per day
|
27 participants
n=5 Participants
|
11 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Alcohol Intake
2-3 drinks per day
|
7 participants
n=5 Participants
|
13 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Alcohol Intake
4 or more drinks per day
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Alcohol Intake
None
|
9 participants
n=5 Participants
|
13 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Dysplastic Lesions Identified
1 Dysplastic lesion
|
22 participants
n=5 Participants
|
19 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Dysplastic Lesions Identified
>1 Dysplastic lesions
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Mucosal Biopsies Obtained
|
6.0 biopsies
n=5 Participants
|
7.0 biopsies
n=7 Participants
|
7.0 biopsies
n=5 Participants
|
|
Most Advanced Histology
Mild dysplasia
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Most Advanced Histology
Moderate dysplasia
|
28 participants
n=5 Participants
|
22 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Most Advanced Histology
Severe dysplasia
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline up to 6 monthsPopulation: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy.
The definitions of responses are: Complete response: regression of all dysplastic lesion (DL) found at baseline to lesions that were no worse than hyperplasia and no new DL that were mild dysplasia or worse; Partial response: regression of some but not all of the DL with no new lesions that are mild dysplasia or worse; Progressive disease: progression of one or more sites by two or more grades or new DL that were mild dysplasia or worse; Stable disease: no complete response, partial response or progression.
Outcome measures
| Measure |
Arm A (Myo-inositol)
n=38 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=36 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis.
Complete response
|
26.3 percentage of participants
|
13.9 percentage of participants
|
|
Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis.
Partial response
|
10.5 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis.
Stable disease
|
15.8 percentage of participants
|
36.1 percentage of participants
|
|
Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis.
Progressive disease
|
47.4 percentage of participants
|
33.3 percentage of participants
|
PRIMARY outcome
Timeframe: From baseline up to 6 monthsPopulation: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy.
The definitions of responses are: Complete response: the regression of a dysplastic lesion (DL) of any grade to one classified as being hyperplastic/normal; Progressive disease: appearance of lesions that were classified as mild dysplasia or worse; Stable disease: lesions that are not classified as complete response or progressive disease
Outcome measures
| Measure |
Arm A (Myo-inositol)
n=38 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=36 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis.
Complete response
|
10.2 percentage of participants
|
7.4 percentage of participants
|
|
Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis.
Stable disease
|
15.9 percentage of participants
|
22.6 percentage of participants
|
|
Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis.
Progressive disease
|
12.5 percentage of participants
|
10.3 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline up to 6 monthsPopulation: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with lesions biopsied.
The change in the number of bronchial dysplastic lesions is defined as disappearance or appearance of lesions.
Outcome measures
| Measure |
Arm A (Myo-inositol)
n=38 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=36 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment
|
-53.5 percentage change in number of lesions
Standard Deviation 116.1
|
-50.0 percentage change in number of lesions
Standard Deviation 115.8
|
SECONDARY outcome
Timeframe: From baseline up to 6 monthsPopulation: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with lesions biopsied.
Outcome measures
| Measure |
Arm A (Myo-inositol)
n=33 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=32 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia
|
-22.8 percentage of Ki67 expression level
Standard Deviation 105.3
|
-6.2 percentage of Ki67 expression level
Standard Deviation 98.7
|
SECONDARY outcome
Timeframe: From baseline up to 6 monthsPopulation: Data were not collected due to a study team decision not to analyze this endpoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline up to 6 monthsPopulation: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Outcome measures
| Measure |
Arm A (Myo-inositol)
n=38 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=36 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
|
-66.96 ng/mL
Interval -127.56 to 52.26
|
-54.32 ng/mL
Interval -144.65 to 140.84
|
SECONDARY outcome
Timeframe: From baseline up to 6 monthsPopulation: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Outcome measures
| Measure |
Arm A (Myo-inositol)
n=38 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=36 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
|
-0.68 pg/mL
Interval -2.78 to 0.34
|
-0.27 pg/mL
Interval -1.54 to 1.89
|
SECONDARY outcome
Timeframe: From baseline up to 6 monthsPopulation: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Outcome measures
| Measure |
Arm A (Myo-inositol)
n=38 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=36 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
|
-9.25 pg/mL
Interval -44.32 to 8.62
|
9.41 pg/mL
Interval -52.58 to 54.6
|
SECONDARY outcome
Timeframe: From baseline up to 6 monthsPopulation: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Outcome measures
| Measure |
Arm A (Myo-inositol)
n=38 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=36 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
|
-3.46 ng/mL
Interval -8.17 to 2.77
|
-1.15 ng/mL
Interval -8.43 to 1.21
|
SECONDARY outcome
Timeframe: From baseline up to 6 monthsPopulation: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Outcome measures
| Measure |
Arm A (Myo-inositol)
n=38 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=36 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
|
-121.47 ng/mL
Interval -1234.7 to 1122.9
|
10.70 ng/mL
Interval -684.95 to 683.25
|
SECONDARY outcome
Timeframe: From baseline up to 6 monthsPopulation: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Outcome measures
| Measure |
Arm A (Myo-inositol)
n=38 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=36 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
|
-12.39 ng/mL
Interval -47.12 to 5.72
|
7.21 ng/mL
Interval -7.62 to 23.79
|
SECONDARY outcome
Timeframe: From baseline up to 6 monthsPopulation: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Outcome measures
| Measure |
Arm A (Myo-inositol)
n=38 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=36 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
|
-0.25 umol/L
Interval -1.98 to 0.48
|
-0.56 umol/L
Interval -1.13 to 0.33
|
SECONDARY outcome
Timeframe: From baseline up to 6 monthsPopulation: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Outcome measures
| Measure |
Arm A (Myo-inositol)
n=38 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=36 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA
|
-0.08 ng/mL
Interval -0.82 to 0.92
|
-0.58 ng/mL
Interval -1.71 to 0.19
|
SECONDARY outcome
Timeframe: From baseline up to 6 monthsPopulation: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Outcome measures
| Measure |
Arm A (Myo-inositol)
n=38 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=36 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA
|
161.18 ng/mL
Interval -248.55 to 744.31
|
-74.11 ng/mL
Interval -752.24 to 412.33
|
SECONDARY outcome
Timeframe: From baseline up to 6 monthsPopulation: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Outcome measures
| Measure |
Arm A (Myo-inositol)
n=38 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=36 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA
|
0.06 pg/mL
Interval -0.74 to 0.46
|
0.01 pg/mL
Interval -0.55 to 0.73
|
SECONDARY outcome
Timeframe: From baseline up to 6 monthsPopulation: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Outcome measures
| Measure |
Arm A (Myo-inositol)
n=38 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=36 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA
|
2.19 pg/mL
Interval -35.08 to 29.56
|
9.08 pg/mL
Interval -5.53 to 44.08
|
SECONDARY outcome
Timeframe: From baseline up to 6 monthsPopulation: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Outcome measures
| Measure |
Arm A (Myo-inositol)
n=38 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=36 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA
|
0.20 ng/mL
Interval -2.05 to 2.17
|
0.09 ng/mL
Interval -1.57 to 4.42
|
SECONDARY outcome
Timeframe: From baseline up to 6 monthsPopulation: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Outcome measures
| Measure |
Arm A (Myo-inositol)
n=38 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=36 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA
|
0.77 mmol/L
Interval -2.84 to 4.68
|
0.88 mmol/L
Interval -1.7 to 4.0
|
SECONDARY outcome
Timeframe: From baseline up to 6 monthsPopulation: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Outcome measures
| Measure |
Arm A (Myo-inositol)
n=38 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=36 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA
|
1.50 ng/mL
Interval -0.6 to 3.19
|
-0.16 ng/mL
Interval -2.42 to 0.88
|
SECONDARY outcome
Timeframe: From baseline up to 6 monthsPopulation: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R\&D Systems), interleukin-6 (IL-6, R\&D Systems), and CCL-2 (R\&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R\&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R\&D Systems) and CC18 (R\&D Systems).
Outcome measures
| Measure |
Arm A (Myo-inositol)
n=38 Participants
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=36 Participants
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA
|
-0.28 ng/mL
Interval -0.93 to 1.51
|
-0.22 ng/mL
Interval -1.26 to 2.22
|
Adverse Events
Arm A (Myo-inositol)
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Arm B (Placebo)
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Myo-inositol)
n=44 participants at risk
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=41 participants at risk
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Cardiac disorders
Cardiac disorder
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
Other adverse events
| Measure |
Arm A (Myo-inositol)
n=44 participants at risk
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
Arm B (Placebo)
n=41 participants at risk
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
4.9%
2/41 • Number of events 3
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
4.9%
2/41 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Eye disorders
Cataract
|
2.3%
1/44 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.8%
3/44 • Number of events 5
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.8%
3/44 • Number of events 5
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
4.9%
2/41 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
40.9%
18/44 • Number of events 26
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
22.0%
9/41 • Number of events 14
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Gastrointestinal disorders
Flatulence
|
29.5%
13/44 • Number of events 16
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
7.3%
3/41 • Number of events 5
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
9.1%
4/44 • Number of events 5
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
4.9%
2/41 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Gastrointestinal disorders
Nausea
|
15.9%
7/44 • Number of events 7
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
7.3%
3/41 • Number of events 3
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
4.9%
2/41 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Gastrointestinal disorders
Tooth disorder
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
4/44 • Number of events 6
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
4.9%
2/41 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
General disorders
Chest pain
|
11.4%
5/44 • Number of events 5
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
General disorders
Chills
|
11.4%
5/44 • Number of events 5
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
4.9%
2/41 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
General disorders
Fatigue
|
13.6%
6/44 • Number of events 6
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
17.1%
7/41 • Number of events 10
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
General disorders
Fever
|
9.1%
4/44 • Number of events 4
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
17.1%
7/41 • Number of events 8
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
General disorders
General symptom
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
General disorders
Injection site reaction
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
General disorders
Localized edema
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
General disorders
Pain
|
6.8%
3/44 • Number of events 3
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
4.9%
2/41 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Infections and infestations
Bladder infection
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
4.9%
2/41 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Infections and infestations
Peripheral nerve infection
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Infections and infestations
Skin infection
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Injury, poisoning and procedural complications
Bruising
|
4.5%
2/44 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Investigations
Laboratory test abnormal
|
4.5%
2/44 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Investigations
Platelet count decreased
|
4.5%
2/44 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Investigations
Weight gain
|
4.5%
2/44 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Investigations
Weight loss
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
2.3%
1/44 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
4.5%
2/44 • Number of events 7
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
9.8%
4/41 • Number of events 5
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased cervical spine
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
2/44 • Number of events 5
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
4.9%
2/41 • Number of events 3
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Nervous system disorders
Dizziness
|
9.1%
4/44 • Number of events 4
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
4.9%
2/41 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Nervous system disorders
Headache
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
14.6%
6/41 • Number of events 6
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Nervous system disorders
Syncope
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Psychiatric disorders
Agitation
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Psychiatric disorders
Depression
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
4.9%
2/41 • Number of events 3
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Psychiatric disorders
Insomnia
|
4.5%
2/44 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
4.9%
2/41 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Renal and urinary disorders
Hemoglobin urine positive
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Renal and urinary disorders
Urinary frequency
|
4.5%
2/44 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Renal and urinary disorders
Urogenital disorder
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Reproductive system and breast disorders
Penile pain
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Reproductive system and breast disorders
Prostatic pain
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Reproductive system and breast disorders
Reproductive tract disorder
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Reproductive system and breast disorders
Testicular pain
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
11.4%
5/44 • Number of events 6
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
7.3%
3/41 • Number of events 3
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
4.5%
2/44 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
4.9%
2/41 • Number of events 3
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.5%
13/44 • Number of events 17
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
31.7%
13/41 • Number of events 16
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.8%
3/44 • Number of events 4
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
4.9%
2/41 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.5%
2/44 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
12.2%
5/41 • Number of events 8
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
15.9%
7/44 • Number of events 7
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
17.1%
7/41 • Number of events 8
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
4.5%
2/44 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
14.6%
6/41 • Number of events 9
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
4.9%
2/41 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
7.3%
3/41 • Number of events 3
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
7.3%
3/41 • Number of events 3
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
4.5%
2/44 • Number of events 3
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
4.9%
2/41 • Number of events 2
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Vascular disorders
Hematoma
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
0.00%
0/41
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/44
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Vascular disorders
Hot flashes
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
|
Vascular disorders
Hypertension
|
2.3%
1/44 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
2.4%
1/41 • Number of events 1
Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60