Trial Outcomes & Findings for Facilitating Smoking Cessation With Reduced Nicotine Cigarettes (NCT NCT02796391)
NCT ID: NCT02796391
Last Updated: 2022-11-14
Results Overview
Pilot: Complete formative research based on 15 participants to prepare for Study 2.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
163 participants
Primary outcome timeframe
Up to 2 Weeks
Results posted on
2022-11-14
Participant Flow
1 participant did not meet inclusion criteria in study 1 before being assigned to an arm.
Participant milestones
| Measure |
Study 1: Immediate Reduction
Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
|
Study 1: Gradual Reduction
Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
|
Study 2: Targeted/Immediate Reduction
Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counselling.
|
Study 2: Targeted/Gradual Reduction
Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counseling.
|
Study 2: Generic/Immediate Reduction
Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling.
|
Study 2: Generic/Gradual Reduction
Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
41
|
32
|
34
|
40
|
|
Overall Study
COMPLETED
|
4
|
5
|
16
|
14
|
14
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
25
|
18
|
20
|
20
|
Reasons for withdrawal
| Measure |
Study 1: Immediate Reduction
Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
|
Study 1: Gradual Reduction
Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
|
Study 2: Targeted/Immediate Reduction
Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counselling.
|
Study 2: Targeted/Gradual Reduction
Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counseling.
|
Study 2: Generic/Immediate Reduction
Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling.
|
Study 2: Generic/Gradual Reduction
Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
13
|
8
|
14
|
13
|
|
Overall Study
COVID
|
0
|
0
|
5
|
5
|
2
|
4
|
|
Overall Study
Participant did not like study cigarettes
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
4
|
3
|
4
|
3
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Facilitating Smoking Cessation With Reduced Nicotine Cigarettes
Baseline characteristics by cohort
| Measure |
Study 1: Immediate Reduction
n=7 Participants
Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
|
Study 1: Gradual Reduction
n=8 Participants
Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
|
Study 2: Targeted/Immediate Reduction
n=41 Participants
Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counselling.
|
Study 2: Targeted/Gradual Reduction
n=32 Participants
Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counseling.
|
Study 2: Generic/Immediate Reduction
n=34 Participants
Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling.
|
Study 2: Generic/Gradual Reduction
n=40 Participants
Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
137 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
90 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
72 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
35 Participants
n=10 Participants
|
142 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
136 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
41 participants
n=5 Participants
|
32 participants
n=4 Participants
|
34 participants
n=21 Participants
|
40 participants
n=10 Participants
|
162 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Up to 2 WeeksPilot: Complete formative research based on 15 participants to prepare for Study 2.
Outcome measures
| Measure |
Study 1: Immediate Reduction
n=7 Participants
This group will receive the lowest nicotine dose (.03 mb nicotine yield) very low nicotine content (VLNC) cigarettes, each of four pre-quit weeks (immediate reduction.
Study 1: Participants will be randomly assigned to 1 of 2 groups (Immediate or gradual nicotine reduction). They will all receive a targeted intervention workbook ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with brief one-on-one counseling.
Very Low Nicotine Content (VLNC) Cigarettes: Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week.
Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks.
Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm.
One on One Counseling: All participants will receive One on One Counseling.
|
Study 1: Gradual Reduction
n=8 Participants
This group will receive VLNC cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4 (gradual reduction).
Study 1: Participants will be randomly assigned to 1 of 2 groups (Immediate or gradual nicotine reduction). They will all receive a targeted intervention workbook ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with brief one-on-one counseling.
Very Low Nicotine Content (VLNC) Cigarettes: Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week.
Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks.
Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm.
One on One Counseling: All participants will receive One on One Counseling.
|
Study 2: Generic/Immediate Reduction
This group will receive the lowest nicotine dose (.03 mg nicotine yield) very low nicotine content (VLNC) cigarettes, each of four pre-quit weeks (immediate reduction).
Study 2: Participants will be randomly assigned to 1 of 4 groups (Immediate or gradual nicotine reduction/ Generic or targeted intervention). They will receive either targeted ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") or generic ("Clearing the Air") materials, and will receive one-on-one counseling.
Very Low Nicotine Content (VLNC) Cigarettes: Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week.
Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks.
Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm.
One on One Counseling: All participants will receive One on One Counseling.
|
Study 2: Generic/Gradual Reduction
This group will receive VLNC cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4 (gradual reduction).
Study 2: Participants will be randomly assigned to 1 of 4 groups (Immediate or gradual nicotine reduction/ Generic or targeted intervention). They will receive either targeted ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") or generic ("Clearing the Air") materials, and will receive one-on-one counseling.
Very Low Nicotine Content (VLNC) Cigarettes: Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week.
Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks.
Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm.
One on One Counseling: All participants will receive One on One Counseling.
|
|---|---|---|---|---|
|
Study 1 - Rate of Participant Completion of Pilot
|
4 Participants
|
5 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At 2 MonthsParticipants reporting 7-day point prevalence abstinence at 2 months RCT: The purpose of Study 2 is to test effects of the targeted intervention developed in Study 1 on smoking cessation. Comparison of abstinence success per treatment arm, utilizing 7-day point prevalence abstinence at each follow-up assessment.
Outcome measures
| Measure |
Study 1: Immediate Reduction
n=41 Participants
This group will receive the lowest nicotine dose (.03 mb nicotine yield) very low nicotine content (VLNC) cigarettes, each of four pre-quit weeks (immediate reduction.
Study 1: Participants will be randomly assigned to 1 of 2 groups (Immediate or gradual nicotine reduction). They will all receive a targeted intervention workbook ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with brief one-on-one counseling.
Very Low Nicotine Content (VLNC) Cigarettes: Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week.
Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks.
Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm.
One on One Counseling: All participants will receive One on One Counseling.
|
Study 1: Gradual Reduction
n=32 Participants
This group will receive VLNC cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4 (gradual reduction).
Study 1: Participants will be randomly assigned to 1 of 2 groups (Immediate or gradual nicotine reduction). They will all receive a targeted intervention workbook ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with brief one-on-one counseling.
Very Low Nicotine Content (VLNC) Cigarettes: Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week.
Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks.
Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm.
One on One Counseling: All participants will receive One on One Counseling.
|
Study 2: Generic/Immediate Reduction
n=34 Participants
This group will receive the lowest nicotine dose (.03 mg nicotine yield) very low nicotine content (VLNC) cigarettes, each of four pre-quit weeks (immediate reduction).
Study 2: Participants will be randomly assigned to 1 of 4 groups (Immediate or gradual nicotine reduction/ Generic or targeted intervention). They will receive either targeted ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") or generic ("Clearing the Air") materials, and will receive one-on-one counseling.
Very Low Nicotine Content (VLNC) Cigarettes: Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week.
Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks.
Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm.
One on One Counseling: All participants will receive One on One Counseling.
|
Study 2: Generic/Gradual Reduction
n=40 Participants
This group will receive VLNC cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4 (gradual reduction).
Study 2: Participants will be randomly assigned to 1 of 4 groups (Immediate or gradual nicotine reduction/ Generic or targeted intervention). They will receive either targeted ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") or generic ("Clearing the Air") materials, and will receive one-on-one counseling.
Very Low Nicotine Content (VLNC) Cigarettes: Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week.
Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks.
Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm.
One on One Counseling: All participants will receive One on One Counseling.
|
|---|---|---|---|---|
|
Study 2 - Participant Abstinence Success at 2 Months
|
12 participants
|
8 participants
|
10 participants
|
13 participants
|
PRIMARY outcome
Timeframe: At 6 MonthsParticipants reporting 7-day point prevalence abstinence at 6 months RCT: The purpose of Study 2 is to test effects of the targeted intervention developed in Study 1 on smoking cessation. Comparison of abstinence success per treatment arm, utilizing 7-day point prevalence abstinence at each follow-up assessment.
Outcome measures
| Measure |
Study 1: Immediate Reduction
n=41 Participants
This group will receive the lowest nicotine dose (.03 mb nicotine yield) very low nicotine content (VLNC) cigarettes, each of four pre-quit weeks (immediate reduction.
Study 1: Participants will be randomly assigned to 1 of 2 groups (Immediate or gradual nicotine reduction). They will all receive a targeted intervention workbook ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with brief one-on-one counseling.
Very Low Nicotine Content (VLNC) Cigarettes: Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week.
Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks.
Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm.
One on One Counseling: All participants will receive One on One Counseling.
|
Study 1: Gradual Reduction
n=32 Participants
This group will receive VLNC cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4 (gradual reduction).
Study 1: Participants will be randomly assigned to 1 of 2 groups (Immediate or gradual nicotine reduction). They will all receive a targeted intervention workbook ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with brief one-on-one counseling.
Very Low Nicotine Content (VLNC) Cigarettes: Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week.
Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks.
Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm.
One on One Counseling: All participants will receive One on One Counseling.
|
Study 2: Generic/Immediate Reduction
n=34 Participants
This group will receive the lowest nicotine dose (.03 mg nicotine yield) very low nicotine content (VLNC) cigarettes, each of four pre-quit weeks (immediate reduction).
Study 2: Participants will be randomly assigned to 1 of 4 groups (Immediate or gradual nicotine reduction/ Generic or targeted intervention). They will receive either targeted ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") or generic ("Clearing the Air") materials, and will receive one-on-one counseling.
Very Low Nicotine Content (VLNC) Cigarettes: Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week.
Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks.
Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm.
One on One Counseling: All participants will receive One on One Counseling.
|
Study 2: Generic/Gradual Reduction
n=40 Participants
This group will receive VLNC cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4 (gradual reduction).
Study 2: Participants will be randomly assigned to 1 of 4 groups (Immediate or gradual nicotine reduction/ Generic or targeted intervention). They will receive either targeted ("Countdown: Preparing to Quit Smoking with Low-Nicotine Cigarettes") or generic ("Clearing the Air") materials, and will receive one-on-one counseling.
Very Low Nicotine Content (VLNC) Cigarettes: Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week.
Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks.
Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm.
One on One Counseling: All participants will receive One on One Counseling.
|
|---|---|---|---|---|
|
Study 2 - Participant Abstinence Success at 6 Months
|
10 participants
|
7 participants
|
6 participants
|
10 participants
|
Adverse Events
Study 1: Immediate Reduction
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Study 1: Gradual Reduction
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Study 2: Targeted/Immediate Reduction
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Study 2: Targeted/Gradual Reduction
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Study 2: Generic/Immediate Reduction
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Study 2: Generic/Gradual Reduction
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study 1: Immediate Reduction
n=7 participants at risk
Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
|
Study 1: Gradual Reduction
n=8 participants at risk
Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
|
Study 2: Targeted/Immediate Reduction
n=41 participants at risk
Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counselling.
|
Study 2: Targeted/Gradual Reduction
n=32 participants at risk
Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counseling.
|
Study 2: Generic/Immediate Reduction
n=34 participants at risk
Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling.
|
Study 2: Generic/Gradual Reduction
n=40 participants at risk
Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
General disorders
Pain
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
Other adverse events
| Measure |
Study 1: Immediate Reduction
n=7 participants at risk
Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
|
Study 1: Gradual Reduction
n=8 participants at risk
Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
|
Study 2: Targeted/Immediate Reduction
n=41 participants at risk
Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counselling.
|
Study 2: Targeted/Gradual Reduction
n=32 participants at risk
Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counseling.
|
Study 2: Generic/Immediate Reduction
n=34 participants at risk
Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling.
|
Study 2: Generic/Gradual Reduction
n=40 participants at risk
Participants will receive very low nicotine cigarettes containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
5.0%
2/40 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Eye disorders
Blurred vision
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Eye disorders
Watering eyes
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
6.2%
2/32 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
4.9%
2/41 • Number of events 3 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
25.0%
2/8 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
5.0%
2/40 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
4.9%
2/41 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
6.2%
2/32 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
14.7%
5/34 • Number of events 6 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
9.4%
3/32 • Number of events 5 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Tooth discoloration
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
5.9%
2/34 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
5.0%
2/40 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
General disorders
Chills
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
General disorders
Fatigue
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
4.9%
2/41 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
5.0%
2/40 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
General disorders
Fever
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
12.5%
4/32 • Number of events 4 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
General disorders
Flu like symptoms
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
General disorders
Irritability
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
9.8%
4/41 • Number of events 4 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
8.8%
3/34 • Number of events 3 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
7.5%
3/40 • Number of events 3 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
7.5%
3/40 • Number of events 4 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
General disorders
Pain
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
5.9%
2/34 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Infections and infestations
Eye infection
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Infections and infestations
Otitis media
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Infections and infestations
Skin infection
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Investigations
Cholesterol high
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Investigations
Weight gain
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
12.2%
5/41 • Number of events 5 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
9.4%
3/32 • Number of events 3 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
12.5%
5/40 • Number of events 5 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
5.0%
2/40 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
4.9%
2/41 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
6.2%
2/32 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
5.9%
2/34 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
4.9%
2/41 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
4.9%
2/41 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Nervous system disorders
Dysesthesia
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
5.9%
2/34 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
5.0%
2/40 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
6.2%
2/32 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
11.8%
4/34 • Number of events 4 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
15.0%
6/40 • Number of events 8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
6.2%
2/32 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
4.9%
2/41 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
5.0%
2/40 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
7.3%
3/41 • Number of events 3 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
9.4%
3/32 • Number of events 4 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
8.8%
3/34 • Number of events 4 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
15.0%
6/40 • Number of events 7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Psychiatric disorders
Confusion
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
7.5%
3/40 • Number of events 3 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Renal and urinary disorders
Suicidal ideation
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Renal and urinary disorders
Bladder perforation
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
5.9%
2/34 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
7.5%
3/40 • Number of events 3 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
9.8%
4/41 • Number of events 6 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
25.0%
8/32 • Number of events 9 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
14.7%
5/34 • Number of events 5 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
17.5%
7/40 • Number of events 9 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
5.9%
2/34 • Number of events 3 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
12.5%
1/8 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
6.2%
2/32 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
5.9%
2/34 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
9.8%
4/41 • Number of events 5 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
9.4%
3/32 • Number of events 4 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
14.7%
5/34 • Number of events 6 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
5.0%
2/40 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Reproductive system and breast disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
17.6%
6/34 • Number of events 6 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
4.9%
2/41 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
9.8%
4/41 • Number of events 4 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
28.1%
9/32 • Number of events 11 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
14.7%
5/34 • Number of events 5 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
12.5%
5/40 • Number of events 8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
6.2%
2/32 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Urticaria
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
8.8%
3/34 • Number of events 3 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 2 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Infections and infestations
Tooth Infection
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Skin and subcutaneous tissue disorders
Squamous cell spot
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.4%
1/41 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Chest congestion
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/40 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
|
Musculoskeletal and connective tissue disorders
Cramping
|
0.00%
0/7 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/8 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/41 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/32 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
0.00%
0/34 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected from date of on study to when participant has last study visit, approximately 6 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place