Trial Outcomes & Findings for Changes in Biomarker of Exposure in Adults Who Smoke Cigarettes Switching From Cigarettes to Heated Tobacco Products (NCT NCT06179290)
NCT ID: NCT06179290
Last Updated: 2026-05-27
Results Overview
1-aminonaphthalene (1-AN) in urine adjusted for urine creatinine (pg/mg creatinine)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
921 participants
Primary outcome timeframe
Baseline through Day 5
Results posted on
2026-05-27
Participant Flow
A total of 921 subjects consented to study participation; 611 subjects failed screening testing: 4 subjects met eligibility criteria but were not needed; 306 participants enrolled in the Product Trial period and 10 participants discontinued study participation either due to failure to meet randomization criteria or withdrawal by subject prior to study randomization on Day -1, resulting in 296 participants randomized into study.
Participant milestones
| Measure |
Study Product A: Ploom HTP Menthol HTS
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Menthol HTS: Menthol heated tobacco product
|
Study Product B: Continue Smoking (Menthol)
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product C: Smoking Abstinence (Menthol)
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator
|
Study Product D: Ploom HTP Tobacco HTS
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Tobacco HTS: Non-menthol heated tobacco product
|
Study Product E: Continue Smoking (Non-menthol)
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product F: Smoking Abstinence (Non-menthol)
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
59
|
60
|
30
|
61
|
57
|
29
|
|
Overall Study
COMPLETED
|
43
|
51
|
16
|
48
|
52
|
17
|
|
Overall Study
NOT COMPLETED
|
16
|
9
|
14
|
13
|
5
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Changes in Biomarker of Exposure in Adults Who Smoke Cigarettes Switching From Cigarettes to Heated Tobacco Products
Baseline characteristics by cohort
| Measure |
Study Product D: Ploom HTP Tobacco HTS
n=57 Participants
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Tobacco HTS: Non-menthol heated tobacco product
|
Study Product A: Ploom HTP Menthol HTS
n=55 Participants
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Menthol HTS: Menthol heated tobacco product
|
Study Product B: Continue Smoking (Menthol)
n=55 Participants
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product C: Smoking Abstinence (Menthol)
n=25 Participants
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator
|
Study Product E: Continue Smoking (Non-menthol)
n=54 Participants
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product F: Smoking Abstinence (Non-menthol)
n=21 Participants
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
|
Total
n=267 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.1 years
STANDARD_DEVIATION 10.63 • n=24 Participants
|
37.1 years
STANDARD_DEVIATION 9.03 • n=51 Participants
|
36.8 years
STANDARD_DEVIATION 8.05 • n=14 Participants
|
38.6 years
STANDARD_DEVIATION 8.37 • n=65 Participants
|
40.6 years
STANDARD_DEVIATION 9.61 • n=107 Participants
|
41.5 years
STANDARD_DEVIATION 9.90 • n=1000 Participants
|
38.2 years
STANDARD_DEVIATION 9.41
|
|
Sex: Female, Male
Female
|
23 Participants
n=24 Participants
|
22 Participants
n=51 Participants
|
22 Participants
n=14 Participants
|
11 Participants
n=65 Participants
|
22 Participants
n=107 Participants
|
9 Participants
n=1000 Participants
|
109 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=24 Participants
|
33 Participants
n=51 Participants
|
33 Participants
n=14 Participants
|
14 Participants
n=65 Participants
|
32 Participants
n=107 Participants
|
12 Participants
n=1000 Participants
|
158 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=24 Participants
|
2 Participants
n=51 Participants
|
2 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=24 Participants
|
53 Participants
n=51 Participants
|
53 Participants
n=14 Participants
|
23 Participants
n=65 Participants
|
54 Participants
n=107 Participants
|
21 Participants
n=1000 Participants
|
259 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
0 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=24 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=24 Participants
|
34 Participants
n=51 Participants
|
36 Participants
n=14 Participants
|
18 Participants
n=65 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=1000 Participants
|
105 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=24 Participants
|
20 Participants
n=51 Participants
|
17 Participants
n=14 Participants
|
7 Participants
n=65 Participants
|
47 Participants
n=107 Participants
|
17 Participants
n=1000 Participants
|
153 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=24 Participants
|
1 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
0 Participants
|
|
Weight (kg)
|
88.86 kg
STANDARD_DEVIATION 20.257 • n=24 Participants
|
82.55 kg
STANDARD_DEVIATION 15.685 • n=51 Participants
|
84.85 kg
STANDARD_DEVIATION 19.842 • n=14 Participants
|
90.00 kg
STANDARD_DEVIATION 15.407 • n=65 Participants
|
86.48 kg
STANDARD_DEVIATION 20.196 • n=107 Participants
|
85.97 kg
STANDARD_DEVIATION 20.370 • n=1000 Participants
|
86.13 kg
STANDARD_DEVIATION 18.872
|
|
Height (cm)
|
172.35 cm
STANDARD_DEVIATION 8.486 • n=24 Participants
|
170.96 cm
STANDARD_DEVIATION 9.166 • n=51 Participants
|
173.91 cm
STANDARD_DEVIATION 10.484 • n=14 Participants
|
172.40 cm
STANDARD_DEVIATION 8.730 • n=65 Participants
|
172.67 cm
STANDARD_DEVIATION 9.949 • n=107 Participants
|
171.50 cm
STANDARD_DEVIATION 10.954 • n=1000 Participants
|
172.39 cm
STANDARD_DEVIATION 9.546
|
|
BMI (kg/m^2)
|
29.748 kg/m^2
STANDARD_DEVIATION 5.5458 • n=24 Participants
|
28.284 kg/m^2
STANDARD_DEVIATION 5.0665 • n=51 Participants
|
28.039 kg/m^2
STANDARD_DEVIATION 5.8573 • n=14 Participants
|
30.419 kg/m^2
STANDARD_DEVIATION 5.6031 • n=65 Participants
|
28.908 kg/m^2
STANDARD_DEVIATION 5.7549 • n=107 Participants
|
29.032 kg/m^2
STANDARD_DEVIATION 5.3861 • n=1000 Participants
|
28.931 kg/m^2
STANDARD_DEVIATION 5.5558
|
PRIMARY outcome
Timeframe: Baseline through Day 5Population: MITT Population
Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in urine adjusted for urine creatinine (pg/mg creatinine)
Outcome measures
| Measure |
Study Product A: Ploom HTP Menthol HTS
n=55 Participants
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Menthol HTS: Menthol heated tobacco product
|
Study Product B: Continue Smoking (Menthol)
n=55 Participants
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product C: Smoking Abstinence (Menthol)
n=25 Participants
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
|
Study Product D: Ploom HTP Tobacco HTS
n=57 Participants
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Tobacco HTS: Non-menthol heated tobacco product.
|
Study Product E: Continue Smoking (Non-menthol)
n=54 Participants
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product F: Smoking Abstinence (Non-menthol)
n=21 Participants
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
|
|---|---|---|---|---|---|---|
|
Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)
Day -1
|
170.800 pg/mg creatinine
Standard Deviation 124.8543
|
174.464 pg/mg creatinine
Standard Deviation 185.1288
|
194.995 pg/mg creatinine
Standard Deviation 141.7563
|
228.143 pg/mg creatinine
Standard Deviation 156.7392
|
285.008 pg/mg creatinine
Standard Deviation 217.2566
|
507.570 pg/mg creatinine
Standard Deviation 1318.2533
|
|
Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)
Day 5
|
79.880 pg/mg creatinine
Standard Deviation 54.6184
|
162.521 pg/mg creatinine
Standard Deviation 144.7708
|
74.502 pg/mg creatinine
Standard Deviation 65.1357
|
89.738 pg/mg creatinine
Standard Deviation 61.4953
|
329.839 pg/mg creatinine
Standard Deviation 443.4196
|
229.269 pg/mg creatinine
Standard Deviation 703.8425
|
PRIMARY outcome
Timeframe: Baseline through Day 5Population: MITT Population
Total N-nitrosonornicotine (NNN) in urine adjusted for urine creatinine (pg/mg creatinine)
Outcome measures
| Measure |
Study Product A: Ploom HTP Menthol HTS
n=55 Participants
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Menthol HTS: Menthol heated tobacco product
|
Study Product B: Continue Smoking (Menthol)
n=55 Participants
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product C: Smoking Abstinence (Menthol)
n=25 Participants
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
|
Study Product D: Ploom HTP Tobacco HTS
n=57 Participants
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Tobacco HTS: Non-menthol heated tobacco product.
|
Study Product E: Continue Smoking (Non-menthol)
n=54 Participants
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product F: Smoking Abstinence (Non-menthol)
n=21 Participants
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
|
|---|---|---|---|---|---|---|
|
Total N-nitrosonornicotine (NNN)
Day 5
|
1.375 pg/mg creatinine
Standard Deviation 1.3337
|
4.859 pg/mg creatinine
Standard Deviation 4.0353
|
0.180 pg/mg creatinine
Standard Deviation 0.2838
|
12.443 pg/mg creatinine
Standard Deviation 63.4717
|
13.252 pg/mg creatinine
Standard Deviation 19.7708
|
0.573 pg/mg creatinine
Standard Deviation 1.5771
|
|
Total N-nitrosonornicotine (NNN)
Day -1
|
12.040 pg/mg creatinine
Standard Deviation 53.3206
|
8.775 pg/mg creatinine
Standard Deviation 32.5520
|
5.444 pg/mg creatinine
Standard Deviation 5.3881
|
26.947 pg/mg creatinine
Standard Deviation 104.5354
|
8.572 pg/mg creatinine
Standard Deviation 6.8520
|
11.192 pg/mg creatinine
Standard Deviation 13.8495
|
PRIMARY outcome
Timeframe: Baseline through Day 5Population: MITT Population
2-hydroxybutenylmercapturic acid (2-MHBMA) in urine adjusted for urine creatinine (ng/mg creatinine)
Outcome measures
| Measure |
Study Product A: Ploom HTP Menthol HTS
n=55 Participants
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Menthol HTS: Menthol heated tobacco product
|
Study Product B: Continue Smoking (Menthol)
n=55 Participants
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product C: Smoking Abstinence (Menthol)
n=25 Participants
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
|
Study Product D: Ploom HTP Tobacco HTS
n=57 Participants
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Tobacco HTS: Non-menthol heated tobacco product.
|
Study Product E: Continue Smoking (Non-menthol)
n=54 Participants
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product F: Smoking Abstinence (Non-menthol)
n=21 Participants
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
|
|---|---|---|---|---|---|---|
|
2-hydroxybutenylmercapturic Acid (2-MHBMA)
Day -1
|
2.137 ng/mg creatinine
Standard Deviation 1.6120
|
1.847 ng/mg creatinine
Standard Deviation 1.4816
|
2.162 ng/mg creatinine
Standard Deviation 1.6899
|
2.210 ng/mg creatinine
Standard Deviation 1.5263
|
3.033 ng/mg creatinine
Standard Deviation 2.1493
|
2.949 ng/mg creatinine
Standard Deviation 2.1748
|
|
2-hydroxybutenylmercapturic Acid (2-MHBMA)
Day 5
|
0.111 ng/mg creatinine
Standard Deviation 0.0564
|
1.908 ng/mg creatinine
Standard Deviation 1.6431
|
0.125 ng/mg creatinine
Standard Deviation 0.0794
|
0.136 ng/mg creatinine
Standard Deviation 0.1015
|
3.053 ng/mg creatinine
Standard Deviation 2.2841
|
0.145 ng/mg creatinine
Standard Deviation 0.1013
|
PRIMARY outcome
Timeframe: Baseline through Day 5Population: MITT Population
3-hydroxypropylmercapturic acid (3-HPMA) in urine adjusted for urine creatinine (ng/mg creatinine)
Outcome measures
| Measure |
Study Product A: Ploom HTP Menthol HTS
n=55 Participants
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Menthol HTS: Menthol heated tobacco product
|
Study Product B: Continue Smoking (Menthol)
n=55 Participants
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product C: Smoking Abstinence (Menthol)
n=25 Participants
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
|
Study Product D: Ploom HTP Tobacco HTS
n=57 Participants
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Tobacco HTS: Non-menthol heated tobacco product.
|
Study Product E: Continue Smoking (Non-menthol)
n=54 Participants
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product F: Smoking Abstinence (Non-menthol)
n=21 Participants
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
|
|---|---|---|---|---|---|---|
|
3-hydroxypropylmercapturic Acid (3-HPMA)
Day -1
|
829.767 ng/mg creatinine
Standard Deviation 367.8057
|
834.225 ng/mg creatinine
Standard Deviation 484.5765
|
850.262 ng/mg creatinine
Standard Deviation 428.0811
|
948.776 ng/mg creatinine
Standard Deviation 413.4578
|
1042.730 ng/mg creatinine
Standard Deviation 456.3864
|
1004.666 ng/mg creatinine
Standard Deviation 528.2803
|
|
3-hydroxypropylmercapturic Acid (3-HPMA)
Day 5
|
253.882 ng/mg creatinine
Standard Deviation 95.9616
|
833.978 ng/mg creatinine
Standard Deviation 454.5715
|
227.284 ng/mg creatinine
Standard Deviation 71.2002
|
245.143 ng/mg creatinine
Standard Deviation 85.8623
|
1047.168 ng/mg creatinine
Standard Deviation 511.1119
|
190.162 ng/mg creatinine
Standard Deviation 66.1290
|
PRIMARY outcome
Timeframe: Baseline through Day 5Population: MITT Population
S-phenyl mercapturic acid (SPMA) in urine adjusted for urine creatinine (pg/mg creatinine)
Outcome measures
| Measure |
Study Product A: Ploom HTP Menthol HTS
n=55 Participants
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Menthol HTS: Menthol heated tobacco product
|
Study Product B: Continue Smoking (Menthol)
n=55 Participants
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product C: Smoking Abstinence (Menthol)
n=25 Participants
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
|
Study Product D: Ploom HTP Tobacco HTS
n=57 Participants
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Tobacco HTS: Non-menthol heated tobacco product.
|
Study Product E: Continue Smoking (Non-menthol)
n=54 Participants
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product F: Smoking Abstinence (Non-menthol)
n=21 Participants
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
|
|---|---|---|---|---|---|---|
|
S-phenyl Mercapturic Acid (SPMA)
Day 5
|
254.116 pg/mg creatinine
Standard Deviation 202.1143
|
3070.205 pg/mg creatinine
Standard Deviation 2628.8427
|
360.856 pg/mg creatinine
Standard Deviation 354.5053
|
204.307 pg/mg creatinine
Standard Deviation 135.8059
|
4949.420 pg/mg creatinine
Standard Deviation 3507.5785
|
230.747 pg/mg creatinine
Standard Deviation 135.9124
|
|
S-phenyl Mercapturic Acid (SPMA)
Day -1
|
3510.177 pg/mg creatinine
Standard Deviation 2547.2148
|
3112.358 pg/mg creatinine
Standard Deviation 2587.9965
|
3716.221 pg/mg creatinine
Standard Deviation 3118.0196
|
3323.300 pg/mg creatinine
Standard Deviation 2249.6061
|
4789.832 pg/mg creatinine
Standard Deviation 3281.2831
|
4477.719 pg/mg creatinine
Standard Deviation 3215.3437
|
PRIMARY outcome
Timeframe: Baseline through Day 5Population: MITT Population
2-Hydroxyethyl mercapturic acid (HEMA) in urine adjusted for urine creatinine (ng/mg creatinine)
Outcome measures
| Measure |
Study Product A: Ploom HTP Menthol HTS
n=55 Participants
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Menthol HTS: Menthol heated tobacco product
|
Study Product B: Continue Smoking (Menthol)
n=55 Participants
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product C: Smoking Abstinence (Menthol)
n=25 Participants
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
|
Study Product D: Ploom HTP Tobacco HTS
n=57 Participants
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Tobacco HTS: Non-menthol heated tobacco product.
|
Study Product E: Continue Smoking (Non-menthol)
n=54 Participants
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product F: Smoking Abstinence (Non-menthol)
n=21 Participants
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
|
|---|---|---|---|---|---|---|
|
2-Hydroxyethyl Mercapturic Acid (HEMA)
Day -1
|
3.868 ng/mg creatinine
Standard Deviation 4.0284
|
3.604 ng/mg creatinine
Standard Deviation 3.5749
|
3.863 ng/mg creatinine
Standard Deviation 3.0593
|
4.127 ng/mg creatinine
Standard Deviation 3.4968
|
4.908 ng/mg creatinine
Standard Deviation 4.4893
|
4.436 ng/mg creatinine
Standard Deviation 5.6017
|
|
2-Hydroxyethyl Mercapturic Acid (HEMA)
Day 5
|
1.207 ng/mg creatinine
Standard Deviation 1.0405
|
3.362 ng/mg creatinine
Standard Deviation 2.8263
|
0.983 ng/mg creatinine
Standard Deviation 0.5246
|
1.090 ng/mg creatinine
Standard Deviation 0.9835
|
3.870 ng/mg creatinine
Standard Deviation 2.4352
|
1.395 ng/mg creatinine
Standard Deviation 1.1951
|
PRIMARY outcome
Timeframe: Baseline through Day 5Population: MITT Population
1-aminonaphthalene (1-AN) in urine adjusted for urine creatinine (pg/mg creatinine)
Outcome measures
| Measure |
Study Product A: Ploom HTP Menthol HTS
n=55 Participants
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Menthol HTS: Menthol heated tobacco product
|
Study Product B: Continue Smoking (Menthol)
n=55 Participants
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product C: Smoking Abstinence (Menthol)
n=25 Participants
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
|
Study Product D: Ploom HTP Tobacco HTS
n=57 Participants
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Tobacco HTS: Non-menthol heated tobacco product.
|
Study Product E: Continue Smoking (Non-menthol)
n=54 Participants
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product F: Smoking Abstinence (Non-menthol)
n=21 Participants
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
|
|---|---|---|---|---|---|---|
|
1-aminonaphthalene (1-AN)
Day -1
|
78.519 pg/mg creatinine
Standard Deviation 36.3020
|
71.920 pg/mg creatinine
Standard Deviation 41.9082
|
77.334 pg/mg creatinine
Standard Deviation 43.0510
|
99.217 pg/mg creatinine
Standard Deviation 54.1058
|
105.310 pg/mg creatinine
Standard Deviation 43.1709
|
101.899 pg/mg creatinine
Standard Deviation 48.4057
|
|
1-aminonaphthalene (1-AN)
Day 5
|
4.901 pg/mg creatinine
Standard Deviation 9.5656
|
71.968 pg/mg creatinine
Standard Deviation 46.0026
|
4.186 pg/mg creatinine
Standard Deviation 3.2778
|
6.475 pg/mg creatinine
Standard Deviation 18.1943
|
104.005 pg/mg creatinine
Standard Deviation 56.2063
|
4.040 pg/mg creatinine
Standard Deviation 2.5923
|
PRIMARY outcome
Timeframe: Baseline through Day 5Population: MITT Population
2-aminonaphthalene (2-AN) in urine adjusted for urine creatinine (pg/mg creatinine)
Outcome measures
| Measure |
Study Product A: Ploom HTP Menthol HTS
n=55 Participants
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Menthol HTS: Menthol heated tobacco product
|
Study Product B: Continue Smoking (Menthol)
n=55 Participants
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product C: Smoking Abstinence (Menthol)
n=25 Participants
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
|
Study Product D: Ploom HTP Tobacco HTS
n=57 Participants
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Tobacco HTS: Non-menthol heated tobacco product.
|
Study Product E: Continue Smoking (Non-menthol)
n=54 Participants
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product F: Smoking Abstinence (Non-menthol)
n=21 Participants
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
|
|---|---|---|---|---|---|---|
|
2-aminonaphthalene (2-AN)
Day -1
|
24.369 pg/mg creatinine
Standard Deviation 11.3051
|
21.931 pg/mg creatinine
Standard Deviation 12.1576
|
24.919 pg/mg creatinine
Standard Deviation 13.9308
|
29.671 pg/mg creatinine
Standard Deviation 14.5973
|
32.192 pg/mg creatinine
Standard Deviation 13.6806
|
32.803 pg/mg creatinine
Standard Deviation 17.9562
|
|
2-aminonaphthalene (2-AN)
Day 5
|
2.919 pg/mg creatinine
Standard Deviation 1.5628
|
21.818 pg/mg creatinine
Standard Deviation 12.9678
|
2.969 pg/mg creatinine
Standard Deviation 1.8499
|
3.161 pg/mg creatinine
Standard Deviation 1.8523
|
31.944 pg/mg creatinine
Standard Deviation 15.1259
|
3.008 pg/mg creatinine
Standard Deviation 0.9895
|
PRIMARY outcome
Timeframe: Baseline to Day 5Population: MITT Population
2-cyanoethyl-mercapturic acid (CEMA) in urine adjusted for urine creatinine (ng/mg creatinine)
Outcome measures
| Measure |
Study Product A: Ploom HTP Menthol HTS
n=55 Participants
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Menthol HTS: Menthol heated tobacco product
|
Study Product B: Continue Smoking (Menthol)
n=55 Participants
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product C: Smoking Abstinence (Menthol)
n=25 Participants
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
|
Study Product D: Ploom HTP Tobacco HTS
n=57 Participants
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Tobacco HTS: Non-menthol heated tobacco product.
|
Study Product E: Continue Smoking (Non-menthol)
n=54 Participants
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product F: Smoking Abstinence (Non-menthol)
n=21 Participants
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
|
|---|---|---|---|---|---|---|
|
2-cyanoethyl-mercapturic Acid (CEMA)
Day -1
|
104.903 ng/mg creatinine
Standard Deviation 44.7835
|
95.215 ng/mg creatinine
Standard Deviation 51.4508
|
111.016 ng/mg creatinine
Standard Deviation 57.2097
|
119.283 ng/mg creatinine
Standard Deviation 51.9319
|
122.633 ng/mg creatinine
Standard Deviation 46.2446
|
130.474 ng/mg creatinine
Standard Deviation 64.7667
|
|
2-cyanoethyl-mercapturic Acid (CEMA)
Day 5
|
18.250 ng/mg creatinine
Standard Deviation 12.9136
|
93.373 ng/mg creatinine
Standard Deviation 50.0179
|
16.838 ng/mg creatinine
Standard Deviation 13.4913
|
15.059 ng/mg creatinine
Standard Deviation 8.7471
|
123.809 ng/mg creatinine
Standard Deviation 54.0271
|
17.101 ng/mg creatinine
Standard Deviation 14.6475
|
PRIMARY outcome
Timeframe: Baseline through Day 5Population: MITT Population
3-hydroxybenzo\[a\]pyrene (3-OH-B\[a\]P) in urine adjusted for urine creatinine (fg/mg creatinine)
Outcome measures
| Measure |
Study Product A: Ploom HTP Menthol HTS
n=55 Participants
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Menthol HTS: Menthol heated tobacco product
|
Study Product B: Continue Smoking (Menthol)
n=55 Participants
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product C: Smoking Abstinence (Menthol)
n=25 Participants
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
|
Study Product D: Ploom HTP Tobacco HTS
n=57 Participants
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Tobacco HTS: Non-menthol heated tobacco product.
|
Study Product E: Continue Smoking (Non-menthol)
n=54 Participants
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product F: Smoking Abstinence (Non-menthol)
n=21 Participants
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
|
|---|---|---|---|---|---|---|
|
3-hydroxybenzo[a]Pyrene (3-OH-B[a]P)
Day -1
|
164.805 fg/mg creatinine
Standard Deviation 102.9737
|
193.878 fg/mg creatinine
Standard Deviation 171.4818
|
162.947 fg/mg creatinine
Standard Deviation 110.8604
|
206.696 fg/mg creatinine
Standard Deviation 107.578
|
230.243 fg/mg creatinine
Standard Deviation 145.2773
|
251.885 fg/mg creatinine
Standard Deviation 199.3621
|
|
3-hydroxybenzo[a]Pyrene (3-OH-B[a]P)
Day 5
|
29.136 fg/mg creatinine
Standard Deviation 22.9703
|
170.848 fg/mg creatinine
Standard Deviation 126.0485
|
30.050 fg/mg creatinine
Standard Deviation 24.1808
|
46.063 fg/mg creatinine
Standard Deviation 43.2626
|
217.985 fg/mg creatinine
Standard Deviation 142.1780
|
39.932 fg/mg creatinine
Standard Deviation 35.6003
|
PRIMARY outcome
Timeframe: Baseline through Day 5Population: MITT Population
3-hydroxy-1-methylpropylmercapturic acid (HMPMA) in urine adjusted for urine creatinine (ng/mg creatinine)
Outcome measures
| Measure |
Study Product A: Ploom HTP Menthol HTS
n=55 Participants
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Menthol HTS: Menthol heated tobacco product
|
Study Product B: Continue Smoking (Menthol)
n=55 Participants
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product C: Smoking Abstinence (Menthol)
n=25 Participants
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
|
Study Product D: Ploom HTP Tobacco HTS
n=57 Participants
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Tobacco HTS: Non-menthol heated tobacco product.
|
Study Product E: Continue Smoking (Non-menthol)
n=54 Participants
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product F: Smoking Abstinence (Non-menthol)
n=21 Participants
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
|
|---|---|---|---|---|---|---|
|
3-hydroxy-1-methylpropylmercapturic Acid (HMPMA)
Day -1
|
254.165 ng/mg creatinine
Standard Deviation 114.4959
|
235.118 ng/mg creatinine
Standard Deviation 125.9136
|
242.750 ng/mg creatinine
Standard Deviation 120.5295
|
305.876 ng/mg creatinine
Standard Deviation 140.5156
|
304.849 ng/mg creatinine
Standard Deviation 104.1312
|
352.194 ng/mg creatinine
Standard Deviation 162.5002
|
|
3-hydroxy-1-methylpropylmercapturic Acid (HMPMA)
Day 5
|
55.055 ng/mg creatinine
Standard Deviation 16.1886
|
232.767 ng/mg creatinine
Standard Deviation 112.4148
|
52.376 ng/mg creatinine
Standard Deviation 23.2316
|
55.382 ng/mg creatinine
Standard Deviation 17.1225
|
307.258 ng/mg creatinine
Standard Deviation 115.2398
|
51.587 ng/mg creatinine
Standard Deviation 14.7478
|
PRIMARY outcome
Timeframe: Baseline through Day 5Population: MITT Population
4-Aminobiphenyl (4-ABP) in urine adjusted for urine creatinine (pg/mg creatinine)
Outcome measures
| Measure |
Study Product A: Ploom HTP Menthol HTS
n=55 Participants
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Menthol HTS: Menthol heated tobacco product
|
Study Product B: Continue Smoking (Menthol)
n=55 Participants
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product C: Smoking Abstinence (Menthol)
n=25 Participants
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
|
Study Product D: Ploom HTP Tobacco HTS
n=57 Participants
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Tobacco HTS: Non-menthol heated tobacco product.
|
Study Product E: Continue Smoking (Non-menthol)
n=54 Participants
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product F: Smoking Abstinence (Non-menthol)
n=21 Participants
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
|
|---|---|---|---|---|---|---|
|
4-Aminobiphenyl (4-ABP)
Day -1
|
11.961 pg/mg creatinine
Standard Deviation 5.5104
|
11.140 pg/mg creatinine
Standard Deviation 6.3710
|
12.082 pg/mg creatinine
Standard Deviation 7.0283
|
14.608 pg/mg creatinine
Standard Deviation 6.7839
|
16.568 pg/mg creatinine
Standard Deviation 7.0169
|
15.952 pg/mg creatinine
Standard Deviation 9.8441
|
|
4-Aminobiphenyl (4-ABP)
Day 5
|
2.155 pg/mg creatinine
Standard Deviation 1.2191
|
10.811 pg/mg creatinine
Standard Deviation 6.1092
|
2.413 pg/mg creatinine
Standard Deviation 1.6717
|
2.439 pg/mg creatinine
Standard Deviation 1.3135
|
15.864 pg/mg creatinine
Standard Deviation 7.5081
|
2.214 pg/mg creatinine
Standard Deviation 1.1909
|
PRIMARY outcome
Timeframe: Baseline through Day 5Population: MITT Population
S-benzyl mercapturic acid (SBMA) in urine adjusted for urine creatinine (pg/mg creatinine)
Outcome measures
| Measure |
Study Product A: Ploom HTP Menthol HTS
n=55 Participants
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Menthol HTS: Menthol heated tobacco product
|
Study Product B: Continue Smoking (Menthol)
n=55 Participants
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product C: Smoking Abstinence (Menthol)
n=25 Participants
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
|
Study Product D: Ploom HTP Tobacco HTS
n=57 Participants
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Tobacco HTS: Non-menthol heated tobacco product.
|
Study Product E: Continue Smoking (Non-menthol)
n=54 Participants
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product F: Smoking Abstinence (Non-menthol)
n=21 Participants
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
|
|---|---|---|---|---|---|---|
|
S-benzyl Mercapturic Acid (SBMA)
Day -1
|
6048.160 pg/mg creatinine
Standard Deviation 3652.4749
|
9317.557 pg/mg creatinine
Standard Deviation 17338.4643
|
5701.074 pg/mg creatinine
Standard Deviation 2971.8769
|
5258.557 pg/mg creatinine
Standard Deviation 3226.6231
|
6679.521 pg/mg creatinine
Standard Deviation 13955.4008
|
5314.347 pg/mg creatinine
Standard Deviation 3407.1637
|
|
S-benzyl Mercapturic Acid (SBMA)
Day 5
|
5137.334 pg/mg creatinine
Standard Deviation 3038.4035
|
8912.017 pg/mg creatinine
Standard Deviation 15988.9106
|
5275.686 pg/mg creatinine
Standard Deviation 2260.4106
|
4637.925 pg/mg creatinine
Standard Deviation 2890.3838
|
6433.838 pg/mg creatinine
Standard Deviation 14084.8797
|
5075.996 pg/mg creatinine
Standard Deviation 2769.5354
|
PRIMARY outcome
Timeframe: Baseline to Day 5Population: MITT Population
COHb, or carboxyhemoglobin, is the percent of hemoglobin that is bound to carbon monoxide instead of oxygen
Outcome measures
| Measure |
Study Product A: Ploom HTP Menthol HTS
n=55 Participants
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Menthol HTS: Menthol heated tobacco product
|
Study Product B: Continue Smoking (Menthol)
n=55 Participants
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product C: Smoking Abstinence (Menthol)
n=25 Participants
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
|
Study Product D: Ploom HTP Tobacco HTS
n=57 Participants
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Tobacco HTS: Non-menthol heated tobacco product.
|
Study Product E: Continue Smoking (Non-menthol)
n=54 Participants
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product F: Smoking Abstinence (Non-menthol)
n=21 Participants
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
|
|---|---|---|---|---|---|---|
|
Carboxyhemoglobin (COHb)
Day -1
|
4.81 COHb (%)
Standard Deviation 1.870
|
4.85 COHb (%)
Standard Deviation 2.039
|
4.86 COHb (%)
Standard Deviation 1.512
|
5.62 COHb (%)
Standard Deviation 1.908
|
5.96 COHb (%)
Standard Deviation 1.979
|
5.39 COHb (%)
Standard Deviation 2.629
|
|
Carboxyhemoglobin (COHb)
Day 5
|
0.95 COHb (%)
Standard Deviation 0.462
|
4.53 COHb (%)
Standard Deviation 2.080
|
1.04 COHb (%)
Standard Deviation 0.507
|
1.21 COHb (%)
Standard Deviation 0.467
|
5.91 COHb (%)
Standard Deviation 2.017
|
1.05 COHb (%)
Standard Deviation 0.481
|
Adverse Events
Product Trial Period
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Study Product A: Ploom HTP Menthol HTS
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Study Product B: Continue Smoking (Menthol)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Study Product C: Smoking Abstinence (Menthol)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Study Product D: Ploom HTP Tobacco HTS
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Study Product E: Continue Smoking (Non-menthol)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Study Product F: Smoking Abstinence (Non-menthol)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Product Trial Period
n=306 participants at risk
Product trial include the adverse events occurred during the product trial and baseline period.
|
Study Product A: Ploom HTP Menthol HTS
n=59 participants at risk
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Menthol HTS: Menthol heated tobacco product
|
Study Product B: Continue Smoking (Menthol)
n=60 participants at risk
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product C: Smoking Abstinence (Menthol)
n=30 participants at risk
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
|
Study Product D: Ploom HTP Tobacco HTS
n=61 participants at risk
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Tobacco HTS: Non-menthol heated tobacco product.
|
Study Product E: Continue Smoking (Non-menthol)
n=57 participants at risk
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product F: Smoking Abstinence (Non-menthol)
n=29 participants at risk
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
|
|---|---|---|---|---|---|---|---|
|
General disorders
DEATH (DEATH BY NATURAL CAUSES)
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
3.3%
1/30 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS (SPONTANEOUS ABORTION)
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/60 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
Other adverse events
| Measure |
Product Trial Period
n=306 participants at risk
Product trial include the adverse events occurred during the product trial and baseline period.
|
Study Product A: Ploom HTP Menthol HTS
n=59 participants at risk
Subjects in A arm (Group 1 Menthol) will be required to use Ploom HTP Menthol HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Menthol HTS: Menthol heated tobacco product
|
Study Product B: Continue Smoking (Menthol)
n=60 participants at risk
Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product C: Smoking Abstinence (Menthol)
n=30 participants at risk
Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases.
Smoking Abstinence (menthol): No smoking or other tobacco product use for duration of the study, menthol group comparator.
|
Study Product D: Ploom HTP Tobacco HTS
n=61 participants at risk
Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS study product at least 5 times per day ad libitum from Day 1 through Day 60.
Ploom HTP Tobacco HTS: Non-menthol heated tobacco product.
|
Study Product E: Continue Smoking (Non-menthol)
n=57 participants at risk
Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from Day 1 through Day 60.
|
Study Product F: Smoking Abstinence (Non-menthol)
n=29 participants at risk
Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study from Day 1 through Day 60.
Smoking Abstinence (non-menthol): No smoking or other tobacco product use for duration of the study, non-menthol group comparator.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
3.5%
2/57 • Number of events 2 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
3.3%
2/61 • Number of events 2 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
3.4%
1/29 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/60 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/59 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.33%
1/306 • Number of events 2 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
3.4%
2/59 • Number of events 3 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.6%
1/61 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
3.5%
2/57 • Number of events 2 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
3.4%
1/29 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/59 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/59 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Gastrointestinal disorders
Nausea
|
0.65%
2/306 • Number of events 2 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/60 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.6%
1/61 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
3.4%
2/59 • Number of events 2 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.6%
1/61 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.8%
1/57 • Number of events 2 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
6.9%
2/29 • Number of events 2 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Gastrointestinal disorders
Vomiting
|
0.65%
2/306 • Number of events 2 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
General disorders
Pyrexia
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/60 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.8%
1/57 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.8%
1/57 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Infections and infestations
COVID-19
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/59 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
3.3%
1/30 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.6%
1/61 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Infections and infestations
Ear infection
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.8%
1/57 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Infections and infestations
Influenza
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/60 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.6%
1/61 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/60 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.6%
1/61 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/59 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
3.3%
1/30 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.6%
1/61 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.6%
1/61 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.8%
1/57 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
3.4%
1/29 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Infections and infestations
Viral infection
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/60 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.6%
1/61 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.6%
1/61 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.6%
1/61 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
3.4%
1/29 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Injury, poisoning and procedural complications
Piercing associated complication
|
0.33%
1/306 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.8%
1/57 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.8%
1/57 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Investigations
Blood pressure increased
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/59 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Investigations
White blood cell count increased
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/59 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/60 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.65%
2/306 • Number of events 2 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.33%
1/306 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/59 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/60 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
6.9%
2/29 • Number of events 2 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.33%
1/306 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.33%
1/306 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.33%
1/306 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
3.4%
1/29 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.33%
1/306 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Nervous system disorders
Dizziness
|
0.33%
1/306 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Nervous system disorders
Headache
|
6.9%
21/306 • Number of events 21 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
8.5%
5/59 • Number of events 5 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
10.0%
6/60 • Number of events 6 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
3.3%
1/30 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
6.6%
4/61 • Number of events 4 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
8.8%
5/57 • Number of events 5 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
10.3%
3/29 • Number of events 3 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.8%
1/57 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Nervous system disorders
Presyncope
|
0.33%
1/306 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.6%
1/61 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.6%
1/61 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.33%
1/306 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/60 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/59 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
3.3%
2/60 • Number of events 2 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
4.9%
3/61 • Number of events 3 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/59 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.33%
1/306 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.6%
1/61 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
3.3%
2/61 • Number of events 2 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.33%
1/306 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
3.4%
1/29 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/59 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/59 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.7%
1/59 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.6%
1/61 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/306 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
1.6%
1/61 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
|
Vascular disorders
Pallor
|
0.33%
1/306 • Number of events 1 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/59 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/60 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/30 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/61 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/57 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
0.00%
0/29 • From Product Trial (Day -2), Baseline (Day -1) and study period (from Day 1 through 60) for a total of 62 days for monitoring of adverse experiences.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place