Trial Outcomes & Findings for Reduced Exposure Study in Smokers Using THS 2.2 With 5 Days in a Confinement Setting. (NCT NCT01959932)
NCT ID: NCT01959932
Last Updated: 2020-03-12
Results Overview
Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares (LS) means are provided as descriptive statistics.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
169 participants
Primary outcome timeframe
5 days
Results posted on
2020-03-12
Participant Flow
Study initiated (first subject screened): 29 June 2013 At admission (Day -2), all the subjects performed a product trial of the THS 2.2. During the baseline period, they continued smoking their single preferred brand of CC. Then, on Day 0, subjects were randomized to one of the 3 study arms (THS 2.2, CC or SA) in a 2:1:1 ratio.
Enrolled and randomized population = 160 subjects * 80 subjects in THS 2.2 * 41 subjects in CC * 39 subjects in SA Number of subjects enrolled but NOT randomized (who tried the THS 2.2 at Day -2) = 9
Participant milestones
| Measure |
Tobacco Heating System (THS 2.2)
Ad libitum use of THS 2.2 for 5 days in confinement
|
Conventional Cigarette (CC)
Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
|
Smoking Abstinence (SA)
Abstinence from smoking for 5 days in confinement
|
|---|---|---|---|
|
Overall Study
STARTED
|
80
|
41
|
39
|
|
Overall Study
COMPLETED
|
79
|
41
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Tobacco Heating System (THS 2.2)
Ad libitum use of THS 2.2 for 5 days in confinement
|
Conventional Cigarette (CC)
Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
|
Smoking Abstinence (SA)
Abstinence from smoking for 5 days in confinement
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Reduced Exposure Study in Smokers Using THS 2.2 With 5 Days in a Confinement Setting.
Baseline characteristics by cohort
| Measure |
Tobacco Heating System (THS 2.2)
n=80 Participants
Ad libitum use of THS 2.2 for 5 days in confinement
|
Conventional Cigarette (CC)
n=41 Participants
Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
|
Smoking Abstinence (SA)
n=39 Participants
Abstinence from smoking for 5 days in confinement
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Between 21 and 65 years
|
35.4 years
STANDARD_DEVIATION 9.40 • n=5 Participants
|
32.6 years
STANDARD_DEVIATION 10.06 • n=7 Participants
|
33.6 years
STANDARD_DEVIATION 11.51 • n=5 Participants
|
34.3 years
STANDARD_DEVIATION 10.12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Daily CC consumption at Screening
10 to 19 cig/day
|
41 participants
n=5 Participants
|
21 participants
n=7 Participants
|
19 participants
n=5 Participants
|
81 participants
n=4 Participants
|
|
Daily CC consumption at Screening
> 19 cig/day
|
39 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
79 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 5 daysPopulation: The analysis was performed on the full analysis set (FAS) population. The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid biomarker of exposure (BoExp) measurement (THS 2.2, CC, SA arms).
Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares (LS) means are provided as descriptive statistics.
Outcome measures
| Measure |
Tobacco Heating System (THS 2.2)
n=79 Participants
Ad libitum use of THS 2.2 for 5 days in confinement
|
Conventional Cigarette (CC)
n=41 Participants
Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
|
Smoking Abstinence (SA)
n=39 Participants
Abstinence from smoking for 5 days in confinement
|
|---|---|---|---|
|
Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)
|
194.05 pg/mg creat
Interval 173.23 to 217.38
|
2314.37 pg/mg creat
Interval 1975.39 to 2711.52
|
168.01 pg/mg creat
Interval 142.88 to 197.55
|
PRIMARY outcome
Timeframe: 5 daysPopulation: The analysis was performed on the full analysis set (FAS) population. The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms).
Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
Outcome measures
| Measure |
Tobacco Heating System (THS 2.2)
n=79 Participants
Ad libitum use of THS 2.2 for 5 days in confinement
|
Conventional Cigarette (CC)
n=41 Participants
Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
|
Smoking Abstinence (SA)
n=39 Participants
Abstinence from smoking for 5 days in confinement
|
|---|---|---|---|
|
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
|
398.87 ng/mg creat
Interval 376.74 to 422.3
|
958.03 ng/mg creat
Interval 884.99 to 1037.09
|
242.56 ng/mg creat
Interval 223.64 to 263.09
|
PRIMARY outcome
Timeframe: 5 daysPopulation: The analysis was performed on the full analysis set (FAS) population. The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms).
Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
Outcome measures
| Measure |
Tobacco Heating System (THS 2.2)
n=79 Participants
Ad libitum use of THS 2.2 for 5 days in confinement
|
Conventional Cigarette (CC)
n=41 Participants
Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
|
Smoking Abstinence (SA)
n=39 Participants
Abstinence from smoking for 5 days in confinement
|
|---|---|---|---|
|
Concentration of S-phenylmercapturic Acid (S-PMA)
|
164.51 pg/mg creat
Interval 151.82 to 178.25
|
2748.16 pg/mg creat
Interval 2457.56 to 3073.13
|
153.66 pg/mg creat
Interval 137.03 to 172.31
|
PRIMARY outcome
Timeframe: 5 daysPopulation: The analysis was performed on the full analysis set (FAS) population. The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms).
% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin. Geometric Least Squares means are provided as descriptive statistics.
Outcome measures
| Measure |
Tobacco Heating System (THS 2.2)
n=79 Participants
Ad libitum use of THS 2.2 for 5 days in confinement
|
Conventional Cigarette (CC)
n=41 Participants
Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
|
Smoking Abstinence (SA)
n=39 Participants
Abstinence from smoking for 5 days in confinement
|
|---|---|---|---|
|
Levels of Carboxyhemoglobin (COHb)
|
1.06 % of saturation of hemoglobin
Interval 1.02 to 1.11
|
4.53 % of saturation of hemoglobin
Interval 4.29 to 4.77
|
0.98 % of saturation of hemoglobin
Interval 0.93 to 1.04
|
Adverse Events
Tobacco Heating System (THS 2.2)
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Smoking Abstinence (SA)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Conventional Cigarette (CC)
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Enrolled But Not Randomized
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tobacco Heating System (THS 2.2)
n=80 participants at risk
Ad libitum use of THS 2.2 for 5 days in confinement
|
Smoking Abstinence (SA)
n=39 participants at risk
Abstinence from smoking for 5 days in confinement
|
Conventional Cigarette (CC)
n=41 participants at risk
Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
|
Enrolled But Not Randomized
n=9 participants at risk
Subjects who tried the THS 2.2 at Admission (Day -2) but were not randomized in 1 of the 3 arms as they were back-up subjects
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
30.0%
24/80 • Number of events 30 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
33.3%
13/39 • Number of events 15 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
39.0%
16/41 • Number of events 19 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
33.3%
3/9 • Number of events 3 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
|
Nervous system disorders
Syncope
|
7.5%
6/80 • Number of events 6 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/39 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
9.8%
4/41 • Number of events 4 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/9 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
|
Investigations
Spirometry abnormal
|
5.0%
4/80 • Number of events 4 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
5.1%
2/39 • Number of events 2 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
7.3%
3/41 • Number of events 3 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
33.3%
3/9 • Number of events 3 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
|
Investigations
Lymphocyte count increased
|
1.2%
1/80 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
2.6%
1/39 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/41 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
11.1%
1/9 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
|
Gastrointestinal disorders
Constipation
|
3.8%
3/80 • Number of events 3 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/39 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
4.9%
2/41 • Number of events 2 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
11.1%
1/9 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
|
Gastrointestinal disorders
Toothache
|
1.2%
1/80 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/39 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
2.4%
1/41 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
11.1%
1/9 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/80 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
5.1%
2/39 • Number of events 2 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/41 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/9 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.8%
7/80 • Number of events 7 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/39 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
7.3%
3/41 • Number of events 3 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/9 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
3/80 • Number of events 3 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/39 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/41 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
11.1%
1/9 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
|
Renal and urinary disorders
Polyuria
|
7.5%
6/80 • Number of events 8 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
5.1%
2/39 • Number of events 2 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
9.8%
4/41 • Number of events 6 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/9 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.8%
3/80 • Number of events 3 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
5.1%
2/39 • Number of events 2 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
4.9%
2/41 • Number of events 2 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/9 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/80 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
2.6%
1/39 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/41 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
11.1%
1/9 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.2%
1/80 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/39 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/41 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
11.1%
1/9 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
3/80 • Number of events 3 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
7.7%
3/39 • Number of events 3 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
4.9%
2/41 • Number of events 3 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/9 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
|
Vascular disorders
Hypertension
|
1.2%
1/80 • Number of events 2 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
5.1%
2/39 • Number of events 5 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
2.4%
1/41 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
22.2%
2/9 • Number of events 2 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
|
General disorders
Influenza like illness
|
0.00%
0/80 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
7.7%
3/39 • Number of events 3 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
2.4%
1/41 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/9 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
|
Ear and labyrinth disorders
Vertigo
|
3.8%
3/80 • Number of events 3 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
5.1%
2/39 • Number of events 2 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/41 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/9 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/80 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/39 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/41 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
11.1%
1/9 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/80 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/39 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
0.00%
0/41 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
22.2%
2/9 • Number of events 2 • From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 169 subjects: 160 randomized subjects (80 in THS 2.2, 41 in CC and 39 in SA) and 9 subjects exposed to THS 2.2 from the product trial on Day -2 but not randomized.
|
Additional Information
Christelle HAZIZA, PhD
Philip Morris Products S.A.
Phone: +41 (58) 242 2625
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee We confirm we have the contractual provisions in place which specifies 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 belongs to the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER