Trial Outcomes & Findings for Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting Followed by 86 Days in an Ambulatory Setting (NCT NCT01989156)
NCT ID: NCT01989156
Last Updated: 2020-03-24
Results Overview
Concentrations measured in urine, adjusted for creatinine, at Day 5 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
5 days
Results posted on
2020-03-24
Participant Flow
Study initiated (first subject screened): 17 December 2013 At admission (Day -2), all the subjects performed a product trial of THS 2.2 Menthol. During the baseline period, they continued to smoke their single preferred brand of mCC. Then, on Day 0, they were randomized to one of the 3 study arms (mTHS 2.2, mCC or SA) in a 2:1:1 ratio.
Enrolled and randomized population = 160 subjects * 80 subjects in mTHS 2.2 * 41 subjects in mCC * 39 subjects in SA Number of subjects exposed to the product test = 165 * Number of subjects enrolled but NOT randomized = 4 * Number of subjects failed screening = 1
Participant milestones
| Measure |
THS 2.2 Menthol (mTHS 2.2)
Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
Menthol Conventional Cigarette (mCC)
Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
Smoking Abstinence (SA)
Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
|---|---|---|---|
|
Confinement Period (Population at Day 5)
STARTED
|
80
|
41
|
39
|
|
Confinement Period (Population at Day 5)
COMPLETED
|
80
|
40
|
34
|
|
Confinement Period (Population at Day 5)
NOT COMPLETED
|
0
|
1
|
5
|
|
End of Study (Population at Day 90)
STARTED
|
80
|
40
|
34
|
|
End of Study (Population at Day 90)
COMPLETED
|
73
|
35
|
31
|
|
End of Study (Population at Day 90)
NOT COMPLETED
|
7
|
5
|
3
|
Reasons for withdrawal
| Measure |
THS 2.2 Menthol (mTHS 2.2)
Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
Menthol Conventional Cigarette (mCC)
Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
Smoking Abstinence (SA)
Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
|---|---|---|---|
|
Confinement Period (Population at Day 5)
Withdrawal by Subject
|
0
|
1
|
3
|
|
Confinement Period (Population at Day 5)
Patient Anxiety
|
0
|
0
|
1
|
|
Confinement Period (Population at Day 5)
Adverse Event
|
0
|
0
|
1
|
|
End of Study (Population at Day 90)
Withdrawal by Subject
|
2
|
2
|
2
|
|
End of Study (Population at Day 90)
Lost to Follow-up
|
3
|
2
|
0
|
|
End of Study (Population at Day 90)
Physician Decision
|
1
|
0
|
1
|
|
End of Study (Population at Day 90)
Moved out of state
|
1
|
0
|
0
|
|
End of Study (Population at Day 90)
Employment Conflict
|
0
|
1
|
0
|
Baseline Characteristics
Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting Followed by 86 Days in an Ambulatory Setting
Baseline characteristics by cohort
| Measure |
THS 2.2 Menthol (mTHS 2.2)
n=80 Participants
Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
Menthol Conventional Cigarette (mCC)
n=41 Participants
Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
Smoking Abstinence (SA)
n=39 Participants
Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 11.72 • n=5 Participants
|
33.7 years
STANDARD_DEVIATION 10.17 • n=7 Participants
|
38.8 years
STANDARD_DEVIATION 11.42 • n=5 Participants
|
37.7 years
STANDARD_DEVIATION 11.45 • n=4 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Daily mCC consumption at screening
10 to 19 cig/day
|
43 participants
n=5 Participants
|
21 participants
n=7 Participants
|
18 participants
n=5 Participants
|
82 participants
n=4 Participants
|
|
Daily mCC consumption at screening
> 19 cig/day
|
36 participants
n=5 Participants
|
20 participants
n=7 Participants
|
21 participants
n=5 Participants
|
77 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 5 daysPopulation: The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.
Concentrations measured in urine, adjusted for creatinine, at Day 5 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.
Outcome measures
| Measure |
THS 2.2 Menthol (mTHS 2.2)
n=65 Participants
Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
Menthol Conventional Cigarette (mCC)
n=30 Participants
Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
Smoking Abstinence (SA)
n=21 Participants
Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
|---|---|---|---|
|
Concentration of Monohydroxybutenylmercapturic Acid (MHBMA)
|
110.96 pg/mg creat
Interval 93.49 to 131.68
|
882.25 pg/mg creat
Interval 687.25 to 1132.57
|
94.97 pg/mg creat
Interval 70.67 to 127.61
|
PRIMARY outcome
Timeframe: 5 daysPopulation: The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.
Concentrations measured in urine, adjusted for creatinine, at Day 5 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.
Outcome measures
| Measure |
THS 2.2 Menthol (mTHS 2.2)
n=67 Participants
Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
Menthol Conventional Cigarette (mCC)
n=30 Participants
Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
Smoking Abstinence (SA)
n=21 Participants
Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
|---|---|---|---|
|
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
|
278.13 ng/mg creat
Interval 254.95 to 303.43
|
607.68 ng/mg creat
Interval 534.34 to 691.09
|
152.05 ng/mg creat
Interval 130.47 to 177.19
|
PRIMARY outcome
Timeframe: 5 daysPopulation: The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.
Concentrations measured in urine, adjusted for creatinine, at Day 5 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.
Outcome measures
| Measure |
THS 2.2 Menthol (mTHS 2.2)
n=65 Participants
Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
Menthol Conventional Cigarette (mCC)
n=30 Participants
Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
Smoking Abstinence (SA)
n=21 Participants
Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
|---|---|---|---|
|
Concentration of S-phenylmercapturic Acid (S-PMA)
|
134.11 pg/mg creat
Interval 114.63 to 156.9
|
1065.91 pg/mg creat
Interval 848.45 to 1339.09
|
131.05 pg/mg creat
Interval 99.78 to 172.13
|
PRIMARY outcome
Timeframe: 90 daysPopulation: The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.
Concentrations measured in urine, adjusted for creatinine, at Day 90 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.
Outcome measures
| Measure |
THS 2.2 Menthol (mTHS 2.2)
n=43 Participants
Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
Menthol Conventional Cigarette (mCC)
n=29 Participants
Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
Smoking Abstinence (SA)
n=9 Participants
Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
|---|---|---|---|
|
Levels of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol (Total NNAL)
|
41.05 pg/mg creat
Interval 31.28 to 53.86
|
155.45 pg/mg creat
Interval 112.46 to 214.88
|
54.03 pg/mg creat
Interval 30.0 to 97.28
|
PRIMARY outcome
Timeframe: 5 daysPopulation: The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.
Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Blood measurements performed in the evening of Day 5, for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.
Outcome measures
| Measure |
THS 2.2 Menthol (mTHS 2.2)
n=74 Participants
Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
Menthol Conventional Cigarette (mCC)
n=34 Participants
Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
Smoking Abstinence (SA)
n=23 Participants
Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
|---|---|---|---|
|
Levels of Carboxyhemoglobin (COHb)
|
2.33 % of saturation of hemoglobin
Interval 2.19 to 2.48
|
6.11 % of saturation of hemoglobin
Interval 5.58 to 6.68
|
2.39 % of saturation of hemoglobin
Interval 2.14 to 2.67
|
Adverse Events
THS 2.2 Menthol (mTHS 2.2)
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Menthol Conventional Cigarette (mCC)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Smoking Abstinence (SA)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
THS 2.2 Menthol (mTHS 2.2)
n=80 participants at risk
Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
Menthol Conventional Cigarette (mCC)
n=41 participants at risk
Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
Smoking Abstinence (SA)
n=39 participants at risk
Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
3/80 • Number of events 3 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
9.8%
4/41 • Number of events 4 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
2.6%
1/39 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/80 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
0.00%
0/41 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
5.1%
2/39 • Number of events 2 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
|
Investigations
Blood triglycerides increased
|
2.5%
2/80 • Number of events 2 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
4.9%
2/41 • Number of events 3 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
5.1%
2/39 • Number of events 2 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
|
Investigations
Haemoglobin decreased
|
13.8%
11/80 • Number of events 14 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
9.8%
4/41 • Number of events 5 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
15.4%
6/39 • Number of events 8 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
|
Investigations
Lymphocyte count increased
|
7.5%
6/80 • Number of events 7 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
4.9%
2/41 • Number of events 2 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
2.6%
1/39 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
|
Nervous system disorders
Dizziness
|
1.2%
1/80 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
0.00%
0/41 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
5.1%
2/39 • Number of events 2 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
|
Nervous system disorders
Headache
|
5.0%
4/80 • Number of events 4 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
2.4%
1/41 • Number of events 1 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
7.7%
3/39 • Number of events 4 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
|
Investigations
Neutrophil count decreased
|
5.0%
4/80 • Number of events 5 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
0.00%
0/41 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
0.00%
0/39 • From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 150 days (including a screening period of up to 28 days, an 8-day confinement period followed by an 85-day ambulatory setting, and by a 28-day safety follow-up period (28 days after discharge of the subject or early discontinuation)).
The adverse events and serious adverse events reported are for the post-randomization period. The safety was assessed in the safety population, consisting of 165 subjects: 160 randomized subjects (80 in mTHS 2.2, 41 in mCC and 39 in SA) and 5 subjects exposed to mTHS 2.2 from the product trial on Day -2 but not randomized. After randomization, the Safety Population consisted of 160 subjects with one valid post-randomization safety assessment.
|
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 belong to the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER