Trial Outcomes & Findings for A Study of Cytisinicline for Smoking Cessation in Adult Smokers (NCT NCT04576949)
NCT ID: NCT04576949
Last Updated: 2026-01-15
Results Overview
Smoking abstinence as verified by weekly expired carbon monoxide (CO) measurements ≤10 parts per million (ppm).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
810 participants
Primary outcome timeframe
Weeks 3 to 6
Results posted on
2026-01-15
Participant Flow
Participant milestones
| Measure |
Placebo + Behavioral Support
one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
|
6 Week Cytisinicline + 6 Week Placebo + Behavioral Support
one cytisinicline tablet PO TID plus behavioral support for 6 weeks followed by one placebo tablet PO TID plus behavioral support for 6 weeks
|
12 Week Cytisinicline + Behavioral Support
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
271
|
269
|
270
|
|
Overall Study
COMPLETED
|
194
|
199
|
225
|
|
Overall Study
NOT COMPLETED
|
77
|
70
|
45
|
Reasons for withdrawal
| Measure |
Placebo + Behavioral Support
one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
|
6 Week Cytisinicline + 6 Week Placebo + Behavioral Support
one cytisinicline tablet PO TID plus behavioral support for 6 weeks followed by one placebo tablet PO TID plus behavioral support for 6 weeks
|
12 Week Cytisinicline + Behavioral Support
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
41
|
26
|
18
|
|
Overall Study
Physician Decision
|
3
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
29
|
37
|
24
|
|
Overall Study
Other, Not Specified
|
2
|
3
|
1
|
|
Overall Study
Other
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Cytisinicline for Smoking Cessation in Adult Smokers
Baseline characteristics by cohort
| Measure |
Placebo + Behavioral Support
n=271 Participants
one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
|
6 Week Cytisinicline + 6 Week Placebo + Behavioral Support
n=269 Participants
one cytisinicline tablet PO TID plus behavioral support for 6 weeks followed by one placebo tablet PO TID plus behavioral support for 6 weeks
|
12 Week Cytisinicline + Behavioral Support
n=270 Participants
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
|
Total
n=810 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 11.96 • n=9 Participants
|
52.2 years
STANDARD_DEVIATION 11.15 • n=6 Participants
|
53.3 years
STANDARD_DEVIATION 11.55 • n=9 Participants
|
52.5 years
STANDARD_DEVIATION 11.56 • n=205 Participants
|
|
Sex: Female, Male
Female
|
159 Participants
n=9 Participants
|
148 Participants
n=6 Participants
|
135 Participants
n=9 Participants
|
442 Participants
n=205 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=9 Participants
|
121 Participants
n=6 Participants
|
135 Participants
n=9 Participants
|
368 Participants
n=205 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=9 Participants
|
26 Participants
n=6 Participants
|
23 Participants
n=9 Participants
|
68 Participants
n=205 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
252 Participants
n=9 Participants
|
243 Participants
n=6 Participants
|
247 Participants
n=9 Participants
|
742 Participants
n=205 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
3 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Black or African American
|
42 Participants
n=9 Participants
|
40 Participants
n=6 Participants
|
48 Participants
n=9 Participants
|
130 Participants
n=205 Participants
|
|
Race (NIH/OMB)
White
|
221 Participants
n=9 Participants
|
222 Participants
n=6 Participants
|
216 Participants
n=9 Participants
|
659 Participants
n=205 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
10 Participants
n=205 Participants
|
PRIMARY outcome
Timeframe: Weeks 3 to 6Population: All Randomized Set: all randomized participants. Placebo and 6-week treatment arms only.
Smoking abstinence as verified by weekly expired carbon monoxide (CO) measurements ≤10 parts per million (ppm).
Outcome measures
| Measure |
Placebo + Behavioral Support
n=271 Participants
one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
|
6 Week Cytisinicline + 6 Week Placebo + Behavioral Support
n=269 Participants
one cytisinicline tablet PO TID plus behavioral support for 6 weeks followed by one placebo tablet PO TID plus behavioral support for 6 weeks
|
|---|---|---|
|
Percentage of Participants With Smoking Abstinence From Weeks 3 to Week 6
|
4.4 percentage of participants
|
25.3 percentage of participants
|
PRIMARY outcome
Timeframe: Weeks 9 to 12Population: All Randomized Set: all randomized participants. Placebo and 12-week treatment arms only.
Smoking abstinence as verified by weekly expired CO measurements ≤10 ppm.
Outcome measures
| Measure |
Placebo + Behavioral Support
n=271 Participants
one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
|
6 Week Cytisinicline + 6 Week Placebo + Behavioral Support
n=270 Participants
one cytisinicline tablet PO TID plus behavioral support for 6 weeks followed by one placebo tablet PO TID plus behavioral support for 6 weeks
|
|---|---|---|
|
Percentage of Participants With Smoking Abstinence From Weeks 9 to Week 12
|
7.0 percentage of participants
|
32.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6 to Week 24Population: All Randomized Set: all randomized participants. Placebo and 6-week treatment arms only.
Smoking abstinence as verified by expired CO measurements ≤10 ppm. Measurements were weekly from Week 6 to Week 12 and monthly from Week 12 to Week 16.
Outcome measures
| Measure |
Placebo + Behavioral Support
n=271 Participants
one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
|
6 Week Cytisinicline + 6 Week Placebo + Behavioral Support
n=269 Participants
one cytisinicline tablet PO TID plus behavioral support for 6 weeks followed by one placebo tablet PO TID plus behavioral support for 6 weeks
|
|---|---|---|
|
Percentage of Participants With Continuous Smoking Abstinence From Week 6 to Week 24
|
2.6 percentage of participants
|
8.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12 to Week 24Population: All Randomized Set: all randomized participants. Placebo and 12-week treatment arms only.
Smoking abstinence as verified by expired CO measurements ≤10 ppm. Measurements were monthly from Week 12 to Week 24.
Outcome measures
| Measure |
Placebo + Behavioral Support
n=271 Participants
one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
|
6 Week Cytisinicline + 6 Week Placebo + Behavioral Support
n=270 Participants
one cytisinicline tablet PO TID plus behavioral support for 6 weeks followed by one placebo tablet PO TID plus behavioral support for 6 weeks
|
|---|---|---|
|
Percentage of Participants With Continuous Smoking Abstinence From Week 12 to Week 24
|
4.8 percentage of participants
|
21.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: All Randomized Set: all randomized participants. Participants in the cytisinicline arms.
Relapse is defined as participant reported resuming smoking or an expired CO measure ≥ 10ppm. Relapse is defined as a participant having met one of the following: not being abstinent from Weeks 3 to 6; not being abstinent at the Week 12 visit; not abstinent or not self-reported abstinent during the Week 16 to Week 24 follow-up period. (During the follow-up period (Weeks 16 - 24) up to a total of 5 cigarettes could have been smoked.)
Outcome measures
| Measure |
Placebo + Behavioral Support
n=269 Participants
one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
|
6 Week Cytisinicline + 6 Week Placebo + Behavioral Support
n=270 Participants
one cytisinicline tablet PO TID plus behavioral support for 6 weeks followed by one placebo tablet PO TID plus behavioral support for 6 weeks
|
|---|---|---|
|
Percentage of Participants Taking Cytisinicline Who Were Relapse-Free at Week 24
|
10.4 percentage of participants
|
13.3 percentage of participants
|
Adverse Events
Placebo + Behavioral Support
Serious events: 3 serious events
Other events: 98 other events
Deaths: 0 deaths
6 Week Cytisinicline + 6 Week Placebo + Behavioral Support
Serious events: 10 serious events
Other events: 114 other events
Deaths: 1 deaths
12 Week Cytisinicline + Behavioral Support
Serious events: 8 serious events
Other events: 118 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + Behavioral Support
n=270 participants at risk
one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
|
6 Week Cytisinicline + 6 Week Placebo + Behavioral Support
n=269 participants at risk
one cytisinicline tablet PO TID plus behavioral support for 6 weeks followed by one placebo tablet PO TID plus behavioral support for 6 weeks
|
12 Week Cytisinicline + Behavioral Support
n=270 participants at risk
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Cardiac disorders
Coronary artery dissection
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.37%
1/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Gastrointestinal disorders
Superior mesenteric artery syndrome
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
General disorders
Chest pain
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.37%
1/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Infections and infestations
Pneumonia
|
0.37%
1/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Metabolism and nutrition disorders
Hyponatraemic syndrome
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.74%
2/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.00%
0/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.37%
1/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
Other adverse events
| Measure |
Placebo + Behavioral Support
n=270 participants at risk
one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
|
6 Week Cytisinicline + 6 Week Placebo + Behavioral Support
n=269 participants at risk
one cytisinicline tablet PO TID plus behavioral support for 6 weeks followed by one placebo tablet PO TID plus behavioral support for 6 weeks
|
12 Week Cytisinicline + Behavioral Support
n=270 participants at risk
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.1%
3/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
5.9%
16/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
4.8%
13/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
15/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
3.7%
10/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
4.4%
12/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Gastrointestinal disorders
Dry mouth
|
1.1%
3/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
3.7%
10/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
2.2%
6/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Gastrointestinal disorders
Nausea
|
7.4%
20/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
5.9%
16/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
5.6%
15/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
3/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
1.1%
3/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
2.2%
6/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
General disorders
Fatigue
|
1.5%
4/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
3.3%
9/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
3.3%
9/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Infections and infestations
COVID-19
|
2.2%
6/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
2.2%
6/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
3.3%
9/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Infections and infestations
Sinusitis
|
2.6%
7/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
1.5%
4/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
1.1%
3/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
3/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
0.74%
2/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
3.0%
8/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Investigations
Weight increased
|
1.1%
3/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
2.2%
6/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
3.3%
9/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
4/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
2.6%
7/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
3.0%
8/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Nervous system disorders
Dizziness
|
1.9%
5/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
4.5%
12/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
2.2%
6/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Nervous system disorders
Headache
|
8.1%
22/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
6.7%
18/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
7.8%
21/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Psychiatric disorders
Abnormal dreams
|
3.0%
8/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
8.2%
22/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
7.8%
21/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Psychiatric disorders
Anxiety
|
1.9%
5/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
2.6%
7/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
5.6%
15/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Psychiatric disorders
Depression
|
1.1%
3/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
2.2%
6/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
1.1%
3/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Psychiatric disorders
Insomnia
|
4.8%
13/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
8.6%
23/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
9.6%
26/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Psychiatric disorders
Irritability
|
1.9%
5/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
3.0%
8/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
3.0%
8/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Psychiatric disorders
Sleep disorder
|
1.1%
3/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
2.2%
6/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
1.5%
4/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
|
Vascular disorders
Hypertension
|
1.5%
4/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
2.6%
7/269 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
2.2%
6/270 • From randomization (all-cause mortality) or first dose of study drug (adverse events) through Week 24.
Safety Set: all randomized participants who take at least one dose of study drug. Treatment emergent adverse events: events that appear during treatment or are present before treatment and subsequently worsen.
|
Additional Information
Daniel Cain, Vice President, Clinical Research
Achieve Life Sciences
Phone: 425.686.1546
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are bound by requirements outlined in their individual clinical trial agreements with regard to publication of trial results.
- Publication restrictions are in place
Restriction type: OTHER