Trial Outcomes & Findings for Study to Evaluate Adverse Events and Change in Disease Activity With Oral Capsules of Galicaftor/Navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 Combination Therapies in Adult Participants With Cystic Fibrosis (NCT NCT04853368)
NCT ID: NCT04853368
Last Updated: 2024-07-16
Results Overview
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. Mixed-effect model with repeated measures (MMRM) was used for the analyses.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Day 1 (Baseline) through Day 29
Results posted on
2024-07-16
Participant Flow
In this 2-part study, Cystic Fibrosis (CF) participants either homozygous or heterozygous for F508del mutation were placed in cohorts based on genotype and treatment status of ETI therapy. In Part 1, Cohort 1(Day -29 to -1) (C1) completed Galicaftor + Navocaftor (G+N) dual combination therapy for 28 days (d) and automatically started Part 2. In Part 2, C1(d1 - 29) and C2(d1 - 29) received G+N+ABBV-119 triple combination, and C3(d1 -29) received G+N+ABBV-576 triple combination for 28d
Participant milestones
| Measure |
C1(d-29 to -1) Dual Combo G + N
F508del Homozygous cystic fibrosis (CF) participants received Galicaftor/ Navocaftor dual combination (Day -29 to -1).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
|
C1(d1 - 29) Triple Combo G + N + ABBV-119
F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received G + N dual combination therapy
followed by
Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
C2(d1 - 29) Triple Combo G + N + ABBV-119
F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
C2(d1 - 29) Placebo
F508del Heterozygous CF participants received placebo (Day 1 - 29).
Placebo: Oral capsules
|
C3 (d1 - 29) Triple Combo G + N + ABBV-576 for F508del Homo
F508del Homozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
C3 (d1 - 29) Triple Combo G + N + ABBV-576 for F508del Hetero
F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
|---|---|---|---|---|---|---|
|
Part 1 (Day -29 to -1)
STARTED
|
24
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 (Day -29 to -1)
COMPLETED
|
24
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 (Day -29 to -1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 (Day 1-29)
STARTED
|
0
|
24
|
9
|
4
|
9
|
2
|
|
Part 2 (Day 1-29)
COMPLETED
|
0
|
22
|
9
|
4
|
8
|
2
|
|
Part 2 (Day 1-29)
NOT COMPLETED
|
0
|
2
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The number of participants analyzed for each Cohort varied from Overall analyzed as follows: Cohort 1 (N=24); Cohort 2 (N=13); Cohort 3 (N=11).
Baseline characteristics by cohort
| Measure |
Cohort 2 (d1 - 29) Triple Combo: G + N + ABBV-119 for F508del Heterozygous
n=9 Participants
F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy(Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2 (d1 - 29) Placebo for F508del Heterozygous
n=4 Participants
F508del Heterozygous CF participants received placebo (Day 1 - 29).
Placebo: Oral capsules
|
C1 (d -29 to -1) Dual Combo: G + N, and C1 (d1 - 29) Triple Combo: G + N + ABBV-119 for F508del Homo
n=24 Participants
Cohort 1 (Day -29 to -1):
F508del Homozygous cystic fibrosis (CF) participants received Galicaftor/Navocaftor dual combination therapy:
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
Cohort 1 (Day 1 to 29):
F508del Homozygous cystic fibrosis CF participants from Cohort 1 (Day -29 to -2) dual combination who received Galicaftor/Navocaftor dual combination followed by Galicaftor/Navocaftor/ABBV-119 triple combination therapy:
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 3 (d1 - 29) Triple Combo: G + N + ABBV-576 for F508del Homozygous
n=9 Participants
F508del Homozygous CF participants receive Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
Cohort 3 (d1 - 29) Triple Combo: G + N + ABBV-576 for F508del Heterozygous
n=2 Participants
F508del Heterozygous CF participants received Galicaftor/nNavocaftor/ABBV-576 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=48 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=9 Participants
|
4 Participants
n=4 Participants
|
24 Participants
n=24 Participants
|
9 Participants
n=9 Participants
|
2 Participants
n=2 Participants
|
48 Participants
n=48 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=48 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=24 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=2 Participants
|
17 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=9 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=24 Participants
|
7 Participants
n=9 Participants
|
0 Participants
n=2 Participants
|
31 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=9 Participants
|
4 Participants
n=4 Participants
|
24 Participants
n=24 Participants
|
9 Participants
n=9 Participants
|
1 Participants
n=2 Participants
|
47 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=9 Participants
|
4 Participants
n=4 Participants
|
24 Participants
n=24 Participants
|
9 Participants
n=9 Participants
|
2 Participants
n=2 Participants
|
47 Participants
n=48 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=48 Participants
|
|
Region of Enrollment
Australia
|
5 participants
n=9 Participants
|
2 participants
n=4 Participants
|
8 participants
n=24 Participants
|
1 participants
n=9 Participants
|
0 participants
n=2 Participants
|
16 participants
n=48 Participants
|
|
Region of Enrollment
Hungary
|
1 participants
n=9 Participants
|
0 participants
n=4 Participants
|
6 participants
n=24 Participants
|
0 participants
n=9 Participants
|
0 participants
n=2 Participants
|
7 participants
n=48 Participants
|
|
Region of Enrollment
Netherlands
|
1 participants
n=9 Participants
|
1 participants
n=4 Participants
|
1 participants
n=24 Participants
|
0 participants
n=9 Participants
|
0 participants
n=2 Participants
|
3 participants
n=48 Participants
|
|
Region of Enrollment
New Zealand
|
2 participants
n=9 Participants
|
1 participants
n=4 Participants
|
5 participants
n=24 Participants
|
0 participants
n=9 Participants
|
0 participants
n=2 Participants
|
8 participants
n=48 Participants
|
|
Region of Enrollment
Slovakia
|
0 participants
n=9 Participants
|
0 participants
n=4 Participants
|
4 participants
n=24 Participants
|
0 participants
n=9 Participants
|
0 participants
n=2 Participants
|
4 participants
n=48 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=9 Participants
|
0 participants
n=4 Participants
|
0 participants
n=24 Participants
|
8 participants
n=9 Participants
|
2 participants
n=2 Participants
|
10 participants
n=48 Participants
|
|
Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (%) at Baseline (Day 1)
Cohort 1 (Day 1 - 29)
|
—
|
—
|
57.0 percent predicted FEV1 (%)
STANDARD_DEVIATION 14.63 • n=24 Participants • The number of participants analyzed for each Cohort varied from Overall analyzed as follows: Cohort 1 (N=24); Cohort 2 (N=13); Cohort 3 (N=11).
|
—
|
—
|
57.0 percent predicted FEV1 (%)
STANDARD_DEVIATION 14.63 • n=24 Participants • The number of participants analyzed for each Cohort varied from Overall analyzed as follows: Cohort 1 (N=24); Cohort 2 (N=13); Cohort 3 (N=11).
|
|
Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (%) at Baseline (Day 1)
Cohort 2 (Day 1 - 29)
|
62.9 percent predicted FEV1 (%)
STANDARD_DEVIATION 18.27 • n=9 Participants • The number of participants analyzed for each Cohort varied from Overall analyzed as follows: Cohort 1 (N=24); Cohort 2 (N=13); Cohort 3 (N=11).
|
67.3 percent predicted FEV1 (%)
STANDARD_DEVIATION 19.97 • n=4 Participants • The number of participants analyzed for each Cohort varied from Overall analyzed as follows: Cohort 1 (N=24); Cohort 2 (N=13); Cohort 3 (N=11).
|
—
|
—
|
—
|
64.2 percent predicted FEV1 (%)
STANDARD_DEVIATION 18.07 • n=13 Participants • The number of participants analyzed for each Cohort varied from Overall analyzed as follows: Cohort 1 (N=24); Cohort 2 (N=13); Cohort 3 (N=11).
|
|
Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (%) at Baseline (Day 1)
Cohort 3 (Day 1 - 29)
|
—
|
—
|
—
|
57.0 percent predicted FEV1 (%)
STANDARD_DEVIATION 19.77 • n=9 Participants • The number of participants analyzed for each Cohort varied from Overall analyzed as follows: Cohort 1 (N=24); Cohort 2 (N=13); Cohort 3 (N=11).
|
51.0 percent predicted FEV1 (%)
STANDARD_DEVIATION 5.66 • n=2 Participants • The number of participants analyzed for each Cohort varied from Overall analyzed as follows: Cohort 1 (N=24); Cohort 2 (N=13); Cohort 3 (N=11).
|
55.9 percent predicted FEV1 (%)
STANDARD_DEVIATION 17.94 • n=11 Participants • The number of participants analyzed for each Cohort varied from Overall analyzed as follows: Cohort 1 (N=24); Cohort 2 (N=13); Cohort 3 (N=11).
|
|
Sweat Chloride (SwCl) in mmol/L at Baseline (Day 1) Cohort 3
Cohort 3 (Day 1 - 29)
|
—
|
—
|
—
|
42.94 mmol/L
STANDARD_DEVIATION 10.333 • n=9 Participants • The number of participants analyzed for each Cohort varied from Overall analyzed as follows: Cohort 1 (N=24); Cohort 2 (N=13); Cohort 3 (N=11).
|
26.50 mmol/L
STANDARD_DEVIATION 4.950 • n=2 Participants • The number of participants analyzed for each Cohort varied from Overall analyzed as follows: Cohort 1 (N=24); Cohort 2 (N=13); Cohort 3 (N=11).
|
39.95 mmol/L
STANDARD_DEVIATION 11.494 • n=11 Participants • The number of participants analyzed for each Cohort varied from Overall analyzed as follows: Cohort 1 (N=24); Cohort 2 (N=13); Cohort 3 (N=11).
|
|
Sweat Chloride (SwCl) in mmol/L at Baseline (Day 1) Cohort 3
Cohort 1 (Day 1 - 29)
|
—
|
—
|
76.71 mmol/L
STANDARD_DEVIATION 13.127 • n=24 Participants • The number of participants analyzed for each Cohort varied from Overall analyzed as follows: Cohort 1 (N=24); Cohort 2 (N=13); Cohort 3 (N=11).
|
—
|
—
|
76.71 mmol/L
STANDARD_DEVIATION 13.127 • n=24 Participants • The number of participants analyzed for each Cohort varied from Overall analyzed as follows: Cohort 1 (N=24); Cohort 2 (N=13); Cohort 3 (N=11).
|
|
Sweat Chloride (SwCl) in mmol/L at Baseline (Day 1) Cohort 3
Cohort 2 (Day1 - 29)
|
93.61 mmol/L
STANDARD_DEVIATION 12.437 • n=9 Participants • The number of participants analyzed for each Cohort varied from Overall analyzed as follows: Cohort 1 (N=24); Cohort 2 (N=13); Cohort 3 (N=11).
|
98.38 mmol/L
STANDARD_DEVIATION 9.978 • n=4 Participants • The number of participants analyzed for each Cohort varied from Overall analyzed as follows: Cohort 1 (N=24); Cohort 2 (N=13); Cohort 3 (N=11).
|
—
|
—
|
—
|
95.08 mmol/L
STANDARD_DEVIATION 11.543 • n=13 Participants • The number of participants analyzed for each Cohort varied from Overall analyzed as follows: Cohort 1 (N=24); Cohort 2 (N=13); Cohort 3 (N=11).
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) through Day 29Population: The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. Mixed-effect model with repeated measures (MMRM) was used for the analyses.
Outcome measures
| Measure |
Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous
n=20 Participants
F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/Navocaftor dual combination therapy
followed by
Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous
n=7 Participants
F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2 (Day 1 - 29) Placebo for F508del Heterozygous
n=4 Participants
F508del Heterozygous CF participants received placebo (Day 1 - 29).
Placebo: Oral capsules
|
Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous
F508del Homozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day
1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous
F508del Heterozygous CF participants received Galicaftor/nNavocaftor/ABBV-576 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
|---|---|---|---|---|---|
|
Cohorts 1 and 2: Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
|
2.2 percent predicted FEV1 (%ppFEV1)
Standard Deviation 3.68
|
2.6 percent predicted FEV1 (%ppFEV1)
Standard Deviation 5.62
|
-2.0 percent predicted FEV1 (%ppFEV1)
Standard Deviation 6.63
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) through Day 29Population: The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.
Sweat collection was performed to evaluate sweat chloride concentration. SwCl is a biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) activity. Persons with CF have higher levels of chloride in their sweat. MMRM was used for the analysis.
Outcome measures
| Measure |
Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous
n=1 Participants
F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/Navocaftor dual combination therapy
followed by
Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous
n=1 Participants
F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2 (Day 1 - 29) Placebo for F508del Heterozygous
F508del Heterozygous CF participants received placebo (Day 1 - 29).
Placebo: Oral capsules
|
Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous
F508del Homozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day
1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous
F508del Heterozygous CF participants received Galicaftor/nNavocaftor/ABBV-576 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
|---|---|---|---|---|---|
|
Cohort 3: Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl) in mmol/L
|
24 Milli-mole/Liter (mmol/L)
Interval 24.0 to 24.0
|
40 Milli-mole/Liter (mmol/L)
Interval 40.0 to 40.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) through Day 29Population: The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.
Sweat collection was performed to evaluate sweat chloride concentration. SwCl is a biomarker of CFTR activity. Persons with CF have higher levels of chloride in their sweat. MMRM was used for the analysis.
Outcome measures
| Measure |
Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous
n=20 Participants
F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/Navocaftor dual combination therapy
followed by
Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous
n=7 Participants
F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2 (Day 1 - 29) Placebo for F508del Heterozygous
n=4 Participants
F508del Heterozygous CF participants received placebo (Day 1 - 29).
Placebo: Oral capsules
|
Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous
F508del Homozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day
1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous
F508del Heterozygous CF participants received Galicaftor/nNavocaftor/ABBV-576 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
|---|---|---|---|---|---|
|
Cohorts 1 and 2: Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl) in mmol/L
|
5.7 mmol/L
Standard Deviation 10.78
|
-11.5 mmol/L
Standard Deviation 16.61
|
2.5 mmol/L
Standard Deviation 4.56
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) through Day 29Population: The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.
FVC is the total amount of air exhaled during forced expiratory volume (FEV) test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.
Outcome measures
| Measure |
Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous
n=20 Participants
F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/Navocaftor dual combination therapy
followed by
Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous
n=7 Participants
F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2 (Day 1 - 29) Placebo for F508del Heterozygous
n=4 Participants
F508del Heterozygous CF participants received placebo (Day 1 - 29).
Placebo: Oral capsules
|
Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous
n=3 Participants
F508del Homozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day
1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous
n=1 Participants
F508del Heterozygous CF participants received Galicaftor/nNavocaftor/ABBV-576 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
|
0.10 Liters (L)
Standard Deviation 0.256
|
0.05 Liters (L)
Standard Deviation 0.269
|
-0.07 Liters (L)
Standard Deviation 0.297
|
-0.22 Liters (L)
Standard Deviation 0.318
|
-0.28 Liters (L)
Standard Deviation NA
Not applicable; value could not be estimated due to n=1
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) through Day 29Population: The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.
FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.
Outcome measures
| Measure |
Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous
n=20 Participants
F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/Navocaftor dual combination therapy
followed by
Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous
n=7 Participants
F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2 (Day 1 - 29) Placebo for F508del Heterozygous
n=4 Participants
F508del Heterozygous CF participants received placebo (Day 1 - 29).
Placebo: Oral capsules
|
Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous
n=3 Participants
F508del Homozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day
1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous
n=1 Participants
F508del Heterozygous CF participants received Galicaftor/nNavocaftor/ABBV-576 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-Lung Capacity (FEF25-75)
|
0.067 Liters/second (L/sec)
Standard Deviation 0.2038
|
0.134 Liters/second (L/sec)
Standard Deviation 0.2506
|
-0.082 Liters/second (L/sec)
Standard Deviation 0.1947
|
-0.329 Liters/second (L/sec)
Standard Deviation 0.378
|
-0.263 Liters/second (L/sec)
Standard Deviation NA
Not applicable; value could not be estimated due to n=1
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) through Day 29Population: The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. MMRM was used for the analyses. Note: The primary analysis of ppFEV1 using MMRM excludes data that are inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.
Outcome measures
| Measure |
Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous
n=20 Participants
F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/Navocaftor dual combination therapy
followed by
Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous
n=7 Participants
F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2 (Day 1 - 29) Placebo for F508del Heterozygous
n=4 Participants
F508del Heterozygous CF participants received placebo (Day 1 - 29).
Placebo: Oral capsules
|
Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous
n=3 Participants
F508del Homozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day
1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous
n=1 Participants
F508del Heterozygous CF participants received Galicaftor/nNavocaftor/ABBV-576 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
|---|---|---|---|---|---|
|
Relative Changes From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
|
3.8 % ppFEV1
Standard Deviation 6.07
|
3.3 % ppFEV1
Standard Deviation 8.15
|
-4.9 % ppFEV1
Standard Deviation 12.25
|
-9.1 % ppFEV1
Standard Deviation 5.12
|
-19.1 % ppFEV1
Standard Deviation NA
value could not be estimated due to n=1
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) through Day 29Population: The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.
FVC is the total amount of air exhaled during FEV test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.
Outcome measures
| Measure |
Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous
n=20 Participants
F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/Navocaftor dual combination therapy
followed by
Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous
n=7 Participants
F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2 (Day 1 - 29) Placebo for F508del Heterozygous
n=4 Participants
F508del Heterozygous CF participants received placebo (Day 1 - 29).
Placebo: Oral capsules
|
Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous
n=3 Participants
F508del Homozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day
1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous
n=1 Participants
F508del Heterozygous CF participants received Galicaftor/nNavocaftor/ABBV-576 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
|---|---|---|---|---|---|
|
Relative Changes From Baseline Through Day 29 in Forced Vital Capacity (FVC)
|
3.75 Liters (L)
Standard Deviation 7.006
|
1.07 Liters (L)
Standard Deviation 6.524
|
-2.06 Liters (L)
Standard Deviation 8.004
|
-6.01 Liters (L)
Standard Deviation 8.782
|
-16.91 Liters (L)
Standard Deviation NA
value could not be estimated due to n=1
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) through Day 29Population: The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.
FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.
Outcome measures
| Measure |
Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous
n=20 Participants
F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/Navocaftor dual combination therapy
followed by
Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous
n=7 Participants
F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2 (Day 1 - 29) Placebo for F508del Heterozygous
n=4 Participants
F508del Heterozygous CF participants received placebo (Day 1 - 29).
Placebo: Oral capsules
|
Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous
n=3 Participants
F508del Homozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day
1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous
n=1 Participants
F508del Heterozygous CF participants received Galicaftor/nNavocaftor/ABBV-576 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
|---|---|---|---|---|---|
|
Relative Changes From Baseline Through Day 29 in Forced Expiratory Flow at Mid-Lung Capacity (FEF25-75)
|
4.553 Liters/second (L/sec)
Standard Deviation 13.2453
|
8.701 Liters/second (L/sec)
Standard Deviation 12.9781
|
-6.449 Liters/second (L/sec)
Standard Deviation 25.1954
|
-8.288 Liters/second (L/sec)
Standard Deviation 24.409
|
-25.784 Liters/second (L/sec)
Standard Deviation NA
value could not be estimated due to n=1
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) through Day 29Population: The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.
The CF Questionnaire-Revised (CFQ-R) Respiratory Domain Score is designed for use in participants with a diagnosis of cystic fibrosis and is designed to measure impact on overall health, daily life, perceived well-being, and symptoms. CFQ-R has a total of 50 questions. Questions 40, 41, 42, 44, 45, 46, scored 1, 2, 3, or 4, from worst to best, were used to calculate the respiratory domain score. The scaled score for the domain is calculated as 100 × (mean scores of all non-missing questions - 1) / 3, ranging from 0 to 100. If more than 3 questions in the domain have missing scores, the scaled score was set as missing. Note: The LS mean is estimated using the linear regression on the change in CFQ-R from baseline to day 29. The higher CFQ-R respiratory score indicates better health. A positive change in CFQ-R respiratory score since baseline indicates improved health quality, while a negative change indicates a decreased health quality.
Outcome measures
| Measure |
Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous
n=19 Participants
F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/Navocaftor dual combination therapy
followed by
Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous
n=7 Participants
F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2 (Day 1 - 29) Placebo for F508del Heterozygous
n=4 Participants
F508del Heterozygous CF participants received placebo (Day 1 - 29).
Placebo: Oral capsules
|
Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous
n=3 Participants
F508del Homozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day
1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous
n=1 Participants
F508del Heterozygous CF participants received Galicaftor/nNavocaftor/ABBV-576 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
|---|---|---|---|---|---|
|
Absolute Change in CF Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline.
|
5.56 score on a scale
Standard Deviation 15.930
|
10.32 score on a scale
Standard Deviation 19.092
|
-5.56 score on a scale
Standard Deviation 21.754
|
-9.26 score on a scale
Standard Deviation 22.453
|
-22.22 score on a scale
Standard Deviation NA
value could not be estimated due to n=1
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) through Day 29Population: The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. MMRM was used for the analyses. Note: The primary analysis of ppFEV1 using MMRM excludes data that are inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.
Outcome measures
| Measure |
Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous
n=3 Participants
F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/Navocaftor dual combination therapy
followed by
Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous
n=1 Participants
F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2 (Day 1 - 29) Placebo for F508del Heterozygous
F508del Heterozygous CF participants received placebo (Day 1 - 29).
Placebo: Oral capsules
|
Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous
F508del Homozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day
1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous
F508del Heterozygous CF participants received Galicaftor/nNavocaftor/ABBV-576 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
|---|---|---|---|---|---|
|
Cohort 3: Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
|
-5.7 % ppFEV1
Interval -9.0 to -3.0
|
-9.0 % ppFEV1
Interval -9.0 to -9.0
|
—
|
—
|
—
|
Adverse Events
Cohort 1 (Day -29 to -1) Dual Combination Galicaftor + Navocaftor for F508del Homozygous
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2 (Day 1 - 29) Placebo F508del Heterozygous
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (Day -29 to -1) Dual Combination Galicaftor + Navocaftor for F508del Homozygous
n=24 participants at risk
F508del Homozygous cystic fibrosis (CF) participants received Galicaftor/Navocaftor dual combination (Day
-29 to -1).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
|
Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous
n=24 participants at risk
F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/ Navocaftor dual combination therapy.
followed by
Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous
n=9 participants at risk
F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2 (Day 1 - 29) Placebo F508del Heterozygous
n=4 participants at risk
F508del Heterozygous CF participants received placebo (Day 1 - 29).
Placebo: Oral capsules
|
Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous
n=9 participants at risk
F508del Homozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous
n=2 participants at risk
F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
|---|---|---|---|---|---|---|
|
Congenital, familial and genetic disorders
CYSTIC FIBROSIS
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
4.2%
1/24 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Infections and infestations
INFECTIVE EXACERBATION OF BRONCHIECTASIS
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
Other adverse events
| Measure |
Cohort 1 (Day -29 to -1) Dual Combination Galicaftor + Navocaftor for F508del Homozygous
n=24 participants at risk
F508del Homozygous cystic fibrosis (CF) participants received Galicaftor/Navocaftor dual combination (Day
-29 to -1).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
|
Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous
n=24 participants at risk
F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/ Navocaftor dual combination therapy.
followed by
Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous
n=9 participants at risk
F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-119: 210 mg BID, Oral capsules
|
Cohort 2 (Day 1 - 29) Placebo F508del Heterozygous
n=4 participants at risk
F508del Heterozygous CF participants received placebo (Day 1 - 29).
Placebo: Oral capsules
|
Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous
n=9 participants at risk
F508del Homozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous
n=2 participants at risk
F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).
Galicaftor: 300 mg QD, Oral capsules
Navocaftor: 50 mg QD, Oral capsules
ABBV-576: 5 mg QD, Oral capsules
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
8.3%
2/24 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
4.2%
1/24 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
8.3%
2/24 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
DISTAL INTESTINAL OBSTRUCTION SYNDROME
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
8.3%
2/24 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
4.2%
1/24 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
4.2%
1/24 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
8.3%
2/24 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
25.0%
1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
50.0%
1/2 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
STEATORRHOEA
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
25.0%
1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
General disorders
CHEST DISCOMFORT
|
4.2%
1/24 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
50.0%
1/2 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
General disorders
FATIGUE
|
4.2%
1/24 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
8.3%
2/24 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
25.0%
1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
General disorders
PAIN
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
16.7%
4/24 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Infections and infestations
INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
25.0%
1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.2%
1/24 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
NASAL INJURY
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Investigations
FORCED EXPIRATORY VOLUME DECREASED
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
25.0%
1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Investigations
FORCED VITAL CAPACITY DECREASED
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
25.0%
1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Investigations
SPIROMETRY ABNORMAL
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
25.0%
1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
4.2%
1/24 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
50.0%
1/2 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
4.2%
1/24 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Nervous system disorders
HEADACHE
|
4.2%
1/24 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
8.3%
2/24 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Nervous system disorders
POST-TRAUMATIC HEADACHE
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
CATARRH
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
4.2%
1/24 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
50.0%
2/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
44.4%
4/9 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
100.0%
2/2 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
33.3%
3/9 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
100.0%
2/2 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT CONGESTION
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
50.0%
1/2 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
SPUTUM INCREASED
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
8.3%
2/24 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
22.2%
2/9 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
50.0%
1/2 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
50.0%
1/2 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/24 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
8.3%
2/24 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
11.1%
1/9 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/4 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/9 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
0.00%
0/2 • All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.
For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER