Trial Outcomes & Findings for Evaluation of Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 for 26 Weeks (NCT NCT02396381)
NCT ID: NCT02396381
Last Updated: 2023-01-26
Results Overview
Concentrations measured in serum. Geometric Least Squares means are provided as descriptive statistics.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1039 participants
Primary outcome timeframe
26 Weeks
Results posted on
2023-01-26
Participant Flow
Following randomization of 984 subjects, from 1039 enrolled subjects, one clinical site was terminated from this study due to non-GCP compliance. The safety population of 1012 subjects included all enrolled subjects except 27 subjects from the terminated site.
Participant milestones
| Measure |
THS 2.2 Group
Randomized to Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks
|
CC Group
Randomized to Ad libitum use of CC in an ambulatory setting for 26 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
488
|
496
|
|
Overall Study
Full Analysis Set - As Exposed (FAS-EX)
|
414
|
443
|
|
Overall Study
COMPLETED
|
381
|
422
|
|
Overall Study
NOT COMPLETED
|
107
|
74
|
Reasons for withdrawal
| Measure |
THS 2.2 Group
Randomized to Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks
|
CC Group
Randomized to Ad libitum use of CC in an ambulatory setting for 26 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
33
|
24
|
|
Overall Study
Lost to Follow-up
|
49
|
31
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Site terminated by sponsor
|
7
|
8
|
|
Overall Study
Physician Decision
|
5
|
5
|
|
Overall Study
Pregnancy
|
2
|
0
|
|
Overall Study
Non-compliance with study procedures
|
1
|
0
|
|
Overall Study
Moved out of town/state
|
1
|
3
|
|
Overall Study
Could not complete visit
|
1
|
0
|
|
Overall Study
Possible conflict of interest
|
1
|
0
|
|
Overall Study
Randomization/Screening Error
|
3
|
1
|
Baseline Characteristics
Evaluation of Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 for 26 Weeks
Baseline characteristics by cohort
| Measure |
THS 2.2 Use
n=245 Participants
≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \>50% of days in the analysis period.
|
CC Use
n=428 Participants
≥1 THS 2.2 or CC use, and \<1% THS 2.2 use over the entire analysis period and \<1% THS 2.2 use on ≥ 50% of days in the analysis period.
|
Dual Use
n=142 Participants
≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \<70% over the analysis period, or THS 2.2-use and CC-use categories do not apply to 50% of these days.
|
Other Use
n=42 Participants
Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns between consecutive analysis periods.
|
Total
n=857 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 9.64 • n=39 Participants
|
45.2 years
STANDARD_DEVIATION 9.55 • n=41 Participants
|
43.8 years
STANDARD_DEVIATION 9.77 • n=35 Participants
|
44.2 years
STANDARD_DEVIATION 8.14 • n=31 Participants
|
44.6 years
STANDARD_DEVIATION 9.55 • n=146 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=39 Participants
|
182 Participants
n=41 Participants
|
63 Participants
n=35 Participants
|
14 Participants
n=31 Participants
|
353 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
151 Participants
n=39 Participants
|
246 Participants
n=41 Participants
|
79 Participants
n=35 Participants
|
28 Participants
n=31 Participants
|
504 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=39 Participants
|
28 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
53 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
228 Participants
n=39 Participants
|
400 Participants
n=41 Participants
|
135 Participants
n=35 Participants
|
41 Participants
n=31 Participants
|
804 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
6 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
8 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
42 Participants
n=39 Participants
|
74 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
151 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
195 Participants
n=39 Participants
|
341 Participants
n=41 Participants
|
113 Participants
n=35 Participants
|
30 Participants
n=31 Participants
|
679 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
10 Participants
n=146 Participants
|
|
BMI
|
26.9 kg/m2
STANDARD_DEVIATION 3.99 • n=39 Participants
|
27.1 kg/m2
STANDARD_DEVIATION 4.13 • n=41 Participants
|
26.9 kg/m2
STANDARD_DEVIATION 4.35 • n=35 Participants
|
26.9 kg/m2
STANDARD_DEVIATION 5.12 • n=31 Participants
|
27.0 kg/m2
STANDARD_DEVIATION 4.18 • n=146 Participants
|
PRIMARY outcome
Timeframe: 26 WeeksPopulation: Full Analysis Set - As Exposed (FAS-EX)
Concentrations measured in serum. Geometric Least Squares means are provided as descriptive statistics.
Outcome measures
| Measure |
THS 2.2 Use
n=245 Participants
≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \>50% of days in the analysis period.
|
CC Use
n=428 Participants
≥1 THS 2.2 or CC use, and \<1% THS 2.2 use over the entire analysis period and \<1% THS 2.2 use on ≥ 50% of days in the analysis period.
|
Dual Use
n=142 Participants
≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \<70% over the analysis period, or THS 2.2-use and CC-use categories do not apply to 50% of these days.
|
Other Use
n=42 Participants
Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns between consecutive analysis periods.
|
|---|---|---|---|---|
|
Levels of High Density Lipoprotein C (HDL-C).
|
54.1 mg/dL
Interval 51.4 to 56.7
|
50.9 mg/dL
Interval 49.4 to 52.4
|
56.3 mg/dL
Interval 52.7 to 59.9
|
52.8 mg/dL
Interval 47.4 to 58.1
|
PRIMARY outcome
Timeframe: 26 WeeksPopulation: Full Analysis Set - As Exposed (FAS-EX)
Concentrations measured in blood. Geometric Least Squares means are provided as descriptive statistics.
Outcome measures
| Measure |
THS 2.2 Use
n=245 Participants
≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \>50% of days in the analysis period.
|
CC Use
n=428 Participants
≥1 THS 2.2 or CC use, and \<1% THS 2.2 use over the entire analysis period and \<1% THS 2.2 use on ≥ 50% of days in the analysis period.
|
Dual Use
n=142 Participants
≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \<70% over the analysis period, or THS 2.2-use and CC-use categories do not apply to 50% of these days.
|
Other Use
n=42 Participants
Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns between consecutive analysis periods.
|
|---|---|---|---|---|
|
Levels of White Blood Cells (WBC).
|
6.98 GI/L
Interval 6.7 to 7.25
|
7.48 GI/L
Interval 7.28 to 7.69
|
7.41 GI/L
Interval 7.0 to 7.82
|
8.71 GI/L
Interval 7.8 to 9.62
|
PRIMARY outcome
Timeframe: 26 WeeksPopulation: Full Analysis Set - As Exposed (FAS-EX)
FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred). Geometric Least Squares means are provided as descriptive statistics.
Outcome measures
| Measure |
THS 2.2 Use
n=245 Participants
≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \>50% of days in the analysis period.
|
CC Use
n=428 Participants
≥1 THS 2.2 or CC use, and \<1% THS 2.2 use over the entire analysis period and \<1% THS 2.2 use on ≥ 50% of days in the analysis period.
|
Dual Use
n=142 Participants
≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \<70% over the analysis period, or THS 2.2-use and CC-use categories do not apply to 50% of these days.
|
Other Use
n=42 Participants
Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns between consecutive analysis periods.
|
|---|---|---|---|---|
|
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1).
|
95.4 Percent of predicted FEV1
Interval 93.7 to 97.1
|
93.4 Percent of predicted FEV1
Interval 92.0 to 94.8
|
93.7 Percent of predicted FEV1
Interval 91.3 to 96.0
|
94.3 Percent of predicted FEV1
Interval 89.3 to 99.4
|
PRIMARY outcome
Timeframe: 26 WeeksPopulation: Full Analysis Set - As Exposed (FAS-EX)
Concentrations measured in serum. Geometric Least Squares means are provided as descriptive statistics.
Outcome measures
| Measure |
THS 2.2 Use
n=245 Participants
≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \>50% of days in the analysis period.
|
CC Use
n=428 Participants
≥1 THS 2.2 or CC use, and \<1% THS 2.2 use over the entire analysis period and \<1% THS 2.2 use on ≥ 50% of days in the analysis period.
|
Dual Use
n=142 Participants
≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \<70% over the analysis period, or THS 2.2-use and CC-use categories do not apply to 50% of these days.
|
Other Use
n=42 Participants
Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns between consecutive analysis periods.
|
|---|---|---|---|---|
|
Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1).
|
252 ng/mL
Interval 239.0 to 266.0
|
266 ng/mL
Interval 253.0 to 279.0
|
270 ng/mL
Interval 253.0 to 288.0
|
273 ng/mL
Interval 234.0 to 317.0
|
PRIMARY outcome
Timeframe: 26 WeeksPopulation: Full Analysis Set - As Exposed (FAS-EX)
Concentrations measured in urine and expressed as concentration adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
Outcome measures
| Measure |
THS 2.2 Use
n=245 Participants
≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \>50% of days in the analysis period.
|
CC Use
n=428 Participants
≥1 THS 2.2 or CC use, and \<1% THS 2.2 use over the entire analysis period and \<1% THS 2.2 use on ≥ 50% of days in the analysis period.
|
Dual Use
n=142 Participants
≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \<70% over the analysis period, or THS 2.2-use and CC-use categories do not apply to 50% of these days.
|
Other Use
n=42 Participants
Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns between consecutive analysis periods.
|
|---|---|---|---|---|
|
Concentrations of 11-dehydrothromboxane B2 (11-DTXB2).
|
496 pg/mg creat
Interval 446.0 to 551.0
|
523 pg/mg creat
Interval 482.0 to 568.0
|
532 pg/mg creat
Interval 464.0 to 610.0
|
626 pg/mg creat
Interval 504.0 to 777.0
|
PRIMARY outcome
Timeframe: 26 WeeksPopulation: Full Analysis Set - As Exposed (FAS-EX)
Concentrations measured in urine and expressed as concentration adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
Outcome measures
| Measure |
THS 2.2 Use
n=245 Participants
≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \>50% of days in the analysis period.
|
CC Use
n=428 Participants
≥1 THS 2.2 or CC use, and \<1% THS 2.2 use over the entire analysis period and \<1% THS 2.2 use on ≥ 50% of days in the analysis period.
|
Dual Use
n=142 Participants
≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \<70% over the analysis period, or THS 2.2-use and CC-use categories do not apply to 50% of these days.
|
Other Use
n=42 Participants
Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns between consecutive analysis periods.
|
|---|---|---|---|---|
|
Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α).
|
321 pg/mg creat
Interval 299.0 to 344.0
|
351 pg/mg creat
Interval 334.0 to 369.0
|
347 pg/mg creat
Interval 318.0 to 377.0
|
335 pg/mg creat
Interval 281.0 to 400.0
|
PRIMARY outcome
Timeframe: 26 WeeksPopulation: Full Analysis Set - As Exposed (FAS-EX)
Concentrations measured in urine and expressed as concentration adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
Outcome measures
| Measure |
THS 2.2 Use
n=245 Participants
≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \>50% of days in the analysis period.
|
CC Use
n=428 Participants
≥1 THS 2.2 or CC use, and \<1% THS 2.2 use over the entire analysis period and \<1% THS 2.2 use on ≥ 50% of days in the analysis period.
|
Dual Use
n=142 Participants
≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \<70% over the analysis period, or THS 2.2-use and CC-use categories do not apply to 50% of these days.
|
Other Use
n=42 Participants
Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns between consecutive analysis periods.
|
|---|---|---|---|---|
|
Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).
|
144 pg/mg creat
Interval 118.0 to 175.0
|
282 pg/mg creat
Interval 254.0 to 314.0
|
286 pg/mg creat
Interval 244.0 to 334.0
|
342 pg/mg creat
Interval 254.0 to 460.0
|
PRIMARY outcome
Timeframe: 26 WeeksPopulation: Full Analysis Set - As Exposed (FAS-EX)
Carboxyhemoglobin (COHb) is assayed from whole blood. Geometric Least Squares means are provided as descriptive statistics. Expressed as % of saturation of hemoglobin.
Outcome measures
| Measure |
THS 2.2 Use
n=245 Participants
≥1 THS 2.2 or CC, and ≥70% THS 2.2 use over the analysis period, and ≥70% THS 2.2 use on \>50% of days in the analysis period.
|
CC Use
n=428 Participants
≥1 THS 2.2 or CC use, and \<1% THS 2.2 use over the entire analysis period and \<1% THS 2.2 use on ≥ 50% of days in the analysis period.
|
Dual Use
n=142 Participants
≥ 1 THS 2.2 or CC and, 1% ≤THS 2.2 \<70% over the analysis period, or THS 2.2-use and CC-use categories do not apply to 50% of these days.
|
Other Use
n=42 Participants
Subjects with missing product use data, subjects using e-cigarettes or other tobacco products, quitters, or subjects who switched across different use patterns between consecutive analysis periods.
|
|---|---|---|---|---|
|
Percent Change From Baseline of Carboxyhemoglobin (COHb)
|
2.84 percentage change from baseline
Interval 2.51 to 3.2
|
4.38 percentage change from baseline
Interval 4.16 to 4.61
|
4.23 percentage change from baseline
Interval 3.8 to 4.7
|
5.59 percentage change from baseline
Interval 4.87 to 6.41
|
Adverse Events
THS 2.2 Group
Serious events: 6 serious events
Other events: 23 other events
Deaths: 2 deaths
CC Group
Serious events: 7 serious events
Other events: 29 other events
Deaths: 0 deaths
Product Test
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
THS 2.2 Group
n=477 participants at risk
Randomized to Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks
|
CC Group
n=483 participants at risk
Randomized to Ad libitum use of CC in an ambulatory setting for 26 weeks
|
Product Test
n=52 participants at risk
Enrolled subjects who participated in a product test, but were not randomized.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.21%
1/477 • Number of events 1 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/483 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/52 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/477 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.21%
1/483 • Number of events 1 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/52 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
|
Infections and infestations
Pyelonephritis acute, with Urosepsis and Nephrolithiasis
|
0.00%
0/477 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.21%
1/483 • Number of events 3 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/52 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/477 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.21%
1/483 • Number of events 1 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/52 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
|
Injury, poisoning and procedural complications
Head injury with seizure
|
0.21%
1/477 • Number of events 2 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/483 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/52 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.21%
1/477 • Number of events 1 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/483 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/52 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/477 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.21%
1/483 • Number of events 1 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/52 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
|
Psychiatric disorders
Completed suicide
|
0.21%
1/477 • Number of events 1 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/483 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/52 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/477 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.21%
1/483 • Number of events 1 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/52 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
|
Psychiatric disorders
Alcohol abuse
|
0.21%
1/477 • Number of events 1 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/483 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/52 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood and bereavement
|
0.00%
0/477 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.21%
1/483 • Number of events 2 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/52 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to small intestine with anaemia
|
0.21%
1/477 • Number of events 2 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/483 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/52 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Vertebral osteophyte with Cervical myelopathy
|
0.00%
0/477 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.21%
1/483 • Number of events 2 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/52 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
Other adverse events
| Measure |
THS 2.2 Group
n=477 participants at risk
Randomized to Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks
|
CC Group
n=483 participants at risk
Randomized to Ad libitum use of CC in an ambulatory setting for 26 weeks
|
Product Test
n=52 participants at risk
Enrolled subjects who participated in a product test, but were not randomized.
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
23/477 • Number of events 26 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
6.0%
29/483 • Number of events 33 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
0.00%
0/52 • The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee We confirm we have the contractual provisions in place which specify that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements. The Intellectual Property rights and research results from the present study belong to the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER