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Reduced Exposure Study Using the CHTP 1.2 With 5 Days in a Confinement Setting Followed by 85 Days in an Ambulatory Setting.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02641587
Recruitment Status : Completed
First Posted : December 29, 2015
Results First Posted : March 6, 2019
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Smoking
Interventions Other: CHTP 1.2
Other: CC
Enrollment 121
Recruitment Details  
Pre-assignment Details

Following enrollment of 121 subjects, each subject received a product test of CHTP 1.2 prior to randomization.

One subject was not randomized due to the physician's decision. This subject is included in the "Exposed Not Randomized" reporting group of the Baseline Characteristics.

Consequently, 120 subjects were randomized.

Arm/Group Title CHTP 1.2 Cigarettes (CC)
Hide Arm/Group Description

Ad libitum use of the CHTP 1.2

CHTP 1.2: Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting.

Ad libitum use of subject's own preferred non-menthol brand of CC

CC: Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting.

Period Title: Confinement Period
Started 80 40
Completed 77 39
Not Completed 3 1
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             2             1
Period Title: Ambulatory Period
Started 77 39
Completed 76 39
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title CHTP 1.2 Cigarettes (CC) Exposed Not Randomized Total
Hide Arm/Group Description

Ad libitum use of the CHTP 1.2

CHTP 1.2: Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting.

Ad libitum use of subject's own preferred non-menthol brand of CC

CC: Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting.

"Exposed not randomized" refers to all subjects exposed to CHTP 1.2 but not randomized. Total of all reporting groups
Overall Number of Baseline Participants 80 40 1 121
Hide Baseline Analysis Population Description
Overall safety population refers to all subjects who were exposed and randomized or exposed and not randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 40 participants 1 participants 121 participants
38.9  (8.9) 39.0  (8.0) 28 38.8  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 40 participants 1 participants 121 participants
Female
36
  45.0%
20
  50.0%
1
 100.0%
57
  47.1%
Male
44
  55.0%
20
  50.0%
0
   0.0%
64
  52.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 40 participants 1 participants 121 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
80
 100.0%
40
 100.0%
0
   0.0%
120
  99.2%
More than one race
0
   0.0%
0
   0.0%
1
 100.0%
1
   0.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 80 participants 40 participants 1 participants 121 participants
25.74  (3.51) 25.70  (2.96) 21.7 25.69  (3.33)
1.Primary Outcome
Title Concentrations of Monohydroxybutenylmercapturic Acid (MHBMA)
Hide Description

Concentrations measured at Day 5 in urine, adjusted for creatinine.

Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.

Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population
Arm/Group Title CHTP 1.2 Cigarettes (CC)
Hide Arm/Group Description:

Ad libitum use of the CHTP 1.2

CHTP 1.2: Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting.

Ad libitum use of subject's own preferred non-menthol brand of CC

CC: Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting.

Overall Number of Participants Analyzed 74 34
Geometric Least Squares Mean (95% Confidence Interval)
Unit of Measure: pg/mg creat
285.5
(258.0 to 315.8)
1904
(1641 to 2209)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CHTP 1.2, Cigarettes (CC)
Comments Analysis will be conducted on the natural log scale. The Day 5 levels of MHBMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of MHBMA.
Type of Statistical Test Other
Comments

The analysis will test if the geometric LS mean level of MHBMA for CHTP is lower than for CC. The following hypothesis will be evaluated:

H0: XCHTP - XCC ≤ 0.0

HA: XCHTP - XCC > 0.0

where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test).

Statistical Test of Hypothesis P-Value <0.001
Comments The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.
Method Generalized linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Reduction
Estimated Value 85.01
Confidence Interval (2-Sided) 95%
82.06 to 87.47
Estimation Comments Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC [%]), and their 95% CI.
2.Primary Outcome
Title Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
Hide Description

Concentrations measured at Day 5 in urine, adjusted for creatinine.

Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.

Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population
Arm/Group Title CHTP 1.2 Cigarettes (CC)
Hide Arm/Group Description:

Ad libitum use of the CHTP 1.2

CHTP 1.2: Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting.

Ad libitum use of subject's own preferred non-menthol brand of CC

CC: Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting.

Overall Number of Participants Analyzed 74 34
Geometric Least Squares Mean (95% Confidence Interval)
Unit of Measure: ng/mg creat
616.8
(565.6 to 672.8)
1031
(907.9 to 1172)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CHTP 1.2, Cigarettes (CC)
Comments Analysis will be conducted on the natural log scale. The Day 5 levels of 3-HPMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of 3-HPMA.
Type of Statistical Test Other
Comments

The analysis will test if the geometric LS mean level of 3-HPMA for CHTP is lower than for CC. The following hypothesis will be evaluated:

H0: XCHTP - XCC ≤ 0.0

HA: XCHTP - XCC > 0.0

where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test).

Statistical Test of Hypothesis P-Value <0.001
Comments The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.
Method Generalized linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Reduction
Estimated Value 40.20
Confidence Interval (2-Sided) 95%
30.25 to 48.73
Estimation Comments Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC [%]), and their 95% CI.
3.Primary Outcome
Title Concentration of S-phenylmercapturic Acid (S-PMA)
Hide Description

Concentrations measured at Day 5 in urine, adjusted for creatinine.

Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.

Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population
Arm/Group Title CHTP 1.2 Cigarettes (CC)
Hide Arm/Group Description:

Ad libitum use of the CHTP 1.2

CHTP 1.2: Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting.

Ad libitum use of subject's own preferred non-menthol brand of CC

CC: Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting.

Overall Number of Participants Analyzed 74 34
Geometric Least Squares Mean (95% Confidence Interval)
Unit of Measure: pg/mg creat
386.6
(358.7 to 416.7)
2401
(2151 to 2681)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CHTP 1.2, Cigarettes (CC)
Comments Analysis will be conducted on the natural log scale. The Day 5 levels of S-PMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of S-PMA.
Type of Statistical Test Other
Comments

The analysis will test if the geometric LS mean level of S-PMA for CHTP is lower than for CC. The following hypothesis will be evaluated:

H0: XCHTP - XCC ≤ 0.0

HA: XCHTP - XCC > 0.0

where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test).

Statistical Test of Hypothesis P-Value <0.001
Comments The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.
Method Generalized linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Reduction
Estimated Value 83.90
Confidence Interval (2-Sided) 95%
81.61 to 85.90
Estimation Comments Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC [%]), and their 95% CI.
4.Primary Outcome
Title Levels of Carboxyhemoglobin (COHb)
Hide Description

% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.

Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.

Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population
Arm/Group Title CHTP 1.2 Cigarettes (CC)
Hide Arm/Group Description:

Ad libitum use of the CHTP 1.2

CHTP 1.2: Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting.

Ad libitum use of subject's own preferred non-menthol brand of CC

CC: Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting.

Overall Number of Participants Analyzed 58 22
Geometric Least Squares Mean (95% Confidence Interval)
Unit of Measure: % of saturation of hemoglobin
2.01
(1.86 to 2.16)
4.53
(4.01 to 5.11)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CHTP 1.2, Cigarettes (CC)
Comments Analysis will be conducted on the natural log scale. The Day 5 levels of COHb will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of COHb.
Type of Statistical Test Other
Comments

The analysis will test if the geometric LS mean level of COHb for CHTP is lower than for CC. The following hypothesis will be evaluated:

H0: XCHTP - XCC ≤ 0.0

HA: XCHTP - XCC > 0.0

where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test).

Statistical Test of Hypothesis P-Value <0.001
Comments The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.
Method Generalized linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Reduction
Estimated Value 55.74
Confidence Interval (2-Sided) 95%
49.03 to 61.56
Estimation Comments Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC [%]), and their 95% CI.
5.Primary Outcome
Title Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
Hide Description

Concentrations measured at Day 90 in urine, adjusted for creatinine.

Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 90 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.

Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population
Arm/Group Title CHTP 1.2 Cigarettes (CC)
Hide Arm/Group Description:

Ad libitum use of the CHTP 1.2

CHTP 1.2: Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting.

Ad libitum use of subject's own preferred non-menthol brand of CC

CC: Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting.

Overall Number of Participants Analyzed 57 35
Geometric Least Squares Mean (95% Confidence Interval)
Unit of Measure: pg/mg creat
37.26
(31.39 to 44.24)
180.6
(144.8 to 225.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CHTP 1.2, Cigarettes (CC)
Comments Analysis will be conducted on the natural log scale. The Day 5 levels of Total NNAL will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of Total NNAL.
Type of Statistical Test Other
Comments

The analysis will test if the geometric LS mean level of Total NNAL for CHTP is lower than for CC. The following hypothesis will be evaluated:

H0: XCHTP - XCC ≤ 0.0

HA: XCHTP - XCC > 0.0

where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test).

Statistical Test of Hypothesis P-Value <0.001
Comments The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.
Method Generalized linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Reduction
Estimated Value 79.36
Confidence Interval (2-Sided) 95%
72.73 to 84.39
Estimation Comments Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC [%]), and their 95% CI.
Time Frame Adverse events were collected from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period, which covered a period of between 128 to 169 days for each subject.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Product Test CHTP 1.2 Confinement CC Confinement CHTP 1.2 Ambulatory CC Ambulatory CHTP 1.2 Safety FU CC Safety FU CHTP 1.2 Post-Randomization CC Post-Randomization
Hide Arm/Group Description After all inclusion/exclusion criteria were checked, all eligible subjects were enrolled and performed a product test using up to five CHTP 1.2 Ad libitum use of the CHTP 1.2 for 5 days in confinement. Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement. Ad libitum use of the CHTP 1.2 for 85 days in an ambulatory setting. Ad libitum use of subject's own preferred non-menthol brand of CC for 85 days in an ambulatory setting. CHTP 1.2 Safety Follow-Up period of 28 days CC Safety Follow-Up period of 28 days CHTP 1.2 Post-Randomization period CC Post-Randomization period
All-Cause Mortality
Product Test CHTP 1.2 Confinement CC Confinement CHTP 1.2 Ambulatory CC Ambulatory CHTP 1.2 Safety FU CC Safety FU CHTP 1.2 Post-Randomization CC Post-Randomization
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/121 (0.00%)      0/80 (0.00%)      0/40 (0.00%)      0/77 (0.00%)      0/39 (0.00%)      0/80 (0.00%)      0/40 (0.00%)      0/80 (0.00%)      0/40 (0.00%)    
Hide Serious Adverse Events
Product Test CHTP 1.2 Confinement CC Confinement CHTP 1.2 Ambulatory CC Ambulatory CHTP 1.2 Safety FU CC Safety FU CHTP 1.2 Post-Randomization CC Post-Randomization
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/121 (0.00%)      1/80 (1.25%)      0/40 (0.00%)      1/77 (1.30%)      1/39 (2.56%)      0/80 (0.00%)      0/40 (0.00%)      2/80 (2.50%)      1/40 (2.50%)    
Infections and infestations                   
Appendicitis  0/121 (0.00%)  0 0/80 (0.00%)  0 0/40 (0.00%)  0 1/77 (1.30%)  1 0/39 (0.00%)  0 0/80 (0.00%)  0 0/40 (0.00%)  0 1/80 (1.25%)  1 0/40 (0.00%)  0
Peritonsillar Abscess  0/121 (0.00%)  0 1/80 (1.25%)  1 0/40 (0.00%)  0 0/77 (0.00%)  0 0/39 (0.00%)  0 0/80 (0.00%)  0 0/40 (0.00%)  0 1/80 (1.25%)  1 0/40 (0.00%)  0
Injury, poisoning and procedural complications                   
Joint Dislocation  0/121 (0.00%)  0 0/80 (0.00%)  0 0/40 (0.00%)  0 0/77 (0.00%)  0 1/39 (2.56%)  1 0/80 (0.00%)  0 0/40 (0.00%)  0 0/80 (0.00%)  0 1/40 (2.50%)  1
1
Term from vocabulary, MedDRA version 18.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Product Test CHTP 1.2 Confinement CC Confinement CHTP 1.2 Ambulatory CC Ambulatory CHTP 1.2 Safety FU CC Safety FU CHTP 1.2 Post-Randomization CC Post-Randomization
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   62/121 (51.24%)      37/80 (46.25%)      12/40 (30.00%)      50/77 (64.94%)      26/39 (66.67%)      1/80 (1.25%)      1/40 (2.50%)      64/80 (80.00%)      31/40 (77.50%)    
Gastrointestinal disorders                   
  2/121 (1.65%)  2 9/80 (11.25%)  9 2/40 (5.00%)  2 6/77 (7.79%)  6 2/39 (5.13%)  2 0/80 (0.00%)  0 1/40 (2.50%)  3 12/80 (15.00%)  15 5/40 (12.50%)  7
General disorders                   
Vessel Puncture Site Bruise  6/121 (4.96%)  6 5/80 (6.25%)  5 1/40 (2.50%)  1 0/77 (0.00%)  0 0/39 (0.00%)  0 0/80 (0.00%)  0 0/40 (0.00%)  0 5/80 (6.25%)  5 1/40 (2.50%)  1
General disorders  1  6/121 (4.96%)  6 6/80 (7.50%)  6 3/40 (7.50%)  3 1/77 (1.30%)  1 1/39 (2.56%)  1 0/80 (0.00%)  0 0/40 (0.00%)  0 7/80 (8.75%)  7 4/40 (10.00%)  4
Infections and infestations                   
Nasopharyngitis  3/121 (2.48%)  3 6/80 (7.50%)  6 2/40 (5.00%)  2 9/77 (11.69%)  9 1/39 (2.56%)  1 0/80 (0.00%)  0 0/40 (0.00%)  0 14/80 (17.50%)  15 3/40 (7.50%)  3
Injury, poisoning and procedural complications                   
  0/121 (0.00%)  0 0/80 (0.00%)  0 0/40 (0.00%)  0 0/77 (0.00%)  0 2/39 (5.13%)  2 1/80 (1.25%)  1 0/40 (0.00%)  0 1/80 (1.25%)  1 2/40 (5.00%)  2
Investigations                   
Alanine Aminotransferase Increased  1/121 (0.83%)  1 3/80 (3.75%)  3 0/40 (0.00%)  0 3/77 (3.90%)  3 1/39 (2.56%)  1 0/80 (0.00%)  0 0/40 (0.00%)  0 6/80 (7.50%)  6 1/40 (2.50%)  1
Blood Triglycerides Increased  1/121 (0.83%)  1 0/80 (0.00%)  0 0/40 (0.00%)  0 1/77 (1.30%)  1 2/39 (5.13%)  2 0/80 (0.00%)  0 0/40 (0.00%)  0 1/80 (1.25%)  1 2/40 (5.00%)  2
Metabolism and nutrition disorders                   
Hyperglycaemia  4/121 (3.31%)  4 2/80 (2.50%)  2 0/40 (0.00%)  0 14/77 (18.18%)  15 4/39 (10.26%)  4 0/80 (0.00%)  0 0/40 (0.00%)  0 15/80 (18.75%)  17 4/40 (10.00%)  4
Hypertriglyceridaemia  8/121 (6.61%)  8 0/80 (0.00%)  0 0/40 (0.00%)  0 3/77 (3.90%)  3 1/39 (2.56%)  1 0/80 (0.00%)  0 0/40 (0.00%)  0 3/80 (3.75%)  3 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorders                   
  1/121 (0.83%)  1 4/80 (5.00%)  4 0/40 (0.00%)  0 1/77 (1.30%)  1 0/39 (0.00%)  0 0/80 (0.00%)  0 0/40 (0.00%)  0 5/80 (6.25%)  5 0/40 (0.00%)  0
Nervous system disorders                   
Headache  42/121 (34.71%)  54 9/80 (11.25%)  10 4/40 (10.00%)  7 14/77 (18.18%)  15 8/39 (20.51%)  9 0/80 (0.00%)  0 0/40 (0.00%)  0 20/80 (25.00%)  25 11/40 (27.50%)  16
Respiratory, thoracic and mediastinal disorders                   
Oropharyngeal Pain  1/121 (0.83%)  1 2/80 (2.50%)  2 2/40 (5.00%)  2 3/77 (3.90%)  3 2/39 (5.13%)  2 0/80 (0.00%)  0 0/40 (0.00%)  0 5/80 (6.25%)  5 4/40 (10.00%)  4
Cough  0/121 (0.00%)  0 4/80 (5.00%)  4 0/40 (0.00%)  0 2/77 (2.60%)  2 2/39 (5.13%)  2 0/80 (0.00%)  0 1/40 (2.50%)  1 6/80 (7.50%)  6 3/40 (7.50%)  3
Skin and subcutaneous tissue disorders                   
Rash  0/121 (0.00%)  0 5/80 (6.25%)  5 0/40 (0.00%)  0 1/77 (1.30%)  1 0/39 (0.00%)  0 0/80 (0.00%)  0 0/40 (0.00%)  0 6/80 (7.50%)  6 0/40 (0.00%)  0
1
Term from vocabulary, MedDRA version 18.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christelle Haziza
Organization: Philip Morris Products S.A.
Phone: +41 58 242 11 11
EMail: christelle.haziza@pmi.com
Layout table for additonal information
Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT02641587    
Other Study ID Numbers: P2R-REXA-07-EU
First Submitted: December 23, 2015
First Posted: December 29, 2015
Results First Submitted: October 2, 2018
Results First Posted: March 6, 2019
Last Update Posted: March 27, 2020