Trial Outcomes & Findings for Study to Evaluate Relacorilant (CORT125134) in Combination With Nab-paclitaxel in Participants With Solid Tumors (NCT NCT02762981)
NCT ID: NCT02762981
Last Updated: 2022-12-06
Results Overview
The Maximum Tolerated Dose and the development regimen of relacorilant with nab-paclitaxel was determined by the number of participants with dose-limiting toxicities as defined in the protocol.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
85 participants
Primary outcome timeframe
Up to completion of Cycle 1 (up to 28 days)
Results posted on
2022-12-06
Participant Flow
The starting population included all study participants.
Participant milestones
| Measure |
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen
Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen
Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
40
|
7
|
16
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
17
|
40
|
7
|
16
|
5
|
Reasons for withdrawal
| Measure |
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen
Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen
Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
1
|
1
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Disease progression
|
11
|
23
|
4
|
10
|
1
|
|
Overall Study
Enrolled not treated
|
1
|
5
|
0
|
2
|
0
|
|
Overall Study
Other
|
2
|
3
|
1
|
0
|
0
|
|
Overall Study
Missing
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
1
|
3
|
0
|
Baseline Characteristics
Study to Evaluate Relacorilant (CORT125134) in Combination With Nab-paclitaxel in Participants With Solid Tumors
Baseline characteristics by cohort
| Measure |
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen
n=14 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=34 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=6 Participants
Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen
n=14 Participants
Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen
n=5 Participants
Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
65 Participants
n=8 Participants
|
|
Age, Continuous
|
57.0 years
STANDARD_DEVIATION 10.60 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 12.81 • n=7 Participants
|
56.8 years
STANDARD_DEVIATION 18.51 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 12.02 • n=4 Participants
|
64.8 years
STANDARD_DEVIATION 10.21 • n=21 Participants
|
59.7 years
STANDARD_DEVIATION 12.47 • n=8 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
50 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
58 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
34 participants
n=7 Participants
|
6 participants
n=5 Participants
|
14 participants
n=4 Participants
|
5 participants
n=21 Participants
|
73 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to completion of Cycle 1 (up to 28 days)Population: The dose-limiting toxicity evaluable population was participants who completed 1 cycle of treatment and assessment or received at least 1 dose of relacorilant and discontinued treatment before completing Cycle 1 due to toxicity.
The Maximum Tolerated Dose and the development regimen of relacorilant with nab-paclitaxel was determined by the number of participants with dose-limiting toxicities as defined in the protocol.
Outcome measures
| Measure |
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen
n=10 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=23 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=4 Participants
Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen
n=11 Participants
Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen
n=3 Participants
Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicity
|
0 Participants
|
8 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)Population: The safety population was all enrolled participants who received at least 1 dose of relacorilant.
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Outcome measures
| Measure |
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen
n=14 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=34 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=6 Participants
Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen
n=14 Participants
Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen
n=5 Participants
Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|
|
Number of Participants With One or More Adverse Events Related to Treatment With Relacorilant
|
13 Participants
|
24 Participants
|
5 Participants
|
13 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 512 daysPopulation: All enrolled participants who received at least 1 dose of relacorilant. The Statistical Plan specified summarization of Objective Response Rate results by Segment I and Segment II.
Objective response rate is defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as best response of complete response (CR) or partial response (PR) from the start of relacorilant or nab-paclitaxel, whichever is earliest, across all time points during study observation period (including both confirmed and unconfirmed responses).
Outcome measures
| Measure |
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen
n=54 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=19 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen
Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen
Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|
|
Objective Response Rate
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 512 daysPopulation: All enrolled participants who received at least 1 dose of relacorilant. The Statistical Plan specified summarization of Clinical Benefit Rate results by Segment I and Segment II.
Clinical benefit rate is defined as the participants who have achieved CR or PR (including both confirmed and unconfirmed responses), or stable disease for 16 weeks or greater.
Outcome measures
| Measure |
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen
n=54 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=19 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen
Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen
Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|
|
Clinical Benefit Rate
|
13 Participants
|
6 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the time of response up to the last disease assessment (up to 512 days)Population: All enrolled participants who received at least 1 dose of relacorilant. This outcome measure assessed participants with confirmed responses to treatment. The Statistical Plan specified summarization of Duration of Response results by Segment I and Segment II.
Duration of response (DOR) is defined as the date that criteria are met for CR or PR until the first date that progressive disease or death is objectively documented, whichever occurs first. Participants with no documentation of disease progression or death on-study are censored at the date of last available tumor assessment
Outcome measures
| Measure |
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen
n=7 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=2 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen
Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen
Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|
|
Duration of Response
|
9.7 months
Interval 5.4 to 10.7
|
NA months
Interval 0.95 to
Median and upper limit of 95% confidence interval was not estimable due to low number of participants with events.
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 512 daysPopulation: All enrolled participants who received at least 1 dose of relacorilant. The Statistical Plan specified summarization of Progression-free Survival results by Segment I and Segment II.
Progression-free survival is defined as the time from date of first dose of relacorilant or nab-paclitaxel, whichever is earliest, to the date of documented disease progression per RECIST v1.1 or death for any cause, whichever occurs first. Participants with no documentation of disease progression or death on-study are censored at the date of last available tumor assessment.
Outcome measures
| Measure |
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen
n=54 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=19 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen
Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen
Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|
|
Progression-free Survival
|
2.8 Months
Interval 2.1 to 4.0
|
3.7 Months
Interval 2.9 to 16.2
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 512 daysPopulation: All enrolled participants who received at least 1 dose of relacorilant. The Statistical Plan specified summarization of Overall Survival results by Segment I and Segment II.
Overall survival is defined as the time from date of the first dose of relacorilant or nab paclitaxel, whichever is earliest, to the date of death for any cause. Participants with no documentation of death on-study are censored at the date at which they are last known to be alive.
Outcome measures
| Measure |
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen
n=54 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=19 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen
Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen
Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|
|
Overall Survival
|
8.3 Months
Interval 5.2 to 10.9
|
16.5 Months
Interval 8.5 to
Upper limit of 95% confidence interval was not estimable due to low number of participants with event.
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 512 daysPopulation: The population was all enrolled participants who received at least 1 dose of relacorilant and had tumor biopsy tissue assessed for GR. These data were planned to be summarized by GR H-score category: above or below the overall median value.
Best response is defined by RECIST v1.1 as the best response recorded from the date of the first dose of relacorilant or nab-paclitaxel, whichever is earliest, across all time points during study observation period (including both confirmed and unconfirmed responses).
Outcome measures
| Measure |
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen
n=16 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=16 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen
Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen
Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|
|
Best Response Rate in Participants With Tumor Glucocorticoid Receptor (GR) Above or Below the Median Overall Level
Complete response
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Best Response Rate in Participants With Tumor Glucocorticoid Receptor (GR) Above or Below the Median Overall Level
Partial response
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Best Response Rate in Participants With Tumor Glucocorticoid Receptor (GR) Above or Below the Median Overall Level
Stable disease
|
7 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Best Response Rate in Participants With Tumor Glucocorticoid Receptor (GR) Above or Below the Median Overall Level
Progressive disease
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Best Response Rate in Participants With Tumor Glucocorticoid Receptor (GR) Above or Below the Median Overall Level
Missing or not evaluable
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1Population: The population analyzed was participants in the Safety Population with adequate pharmacokinetic data. One participant in the Segment II: relacorilant 150 mg + nab-paclitaxel 80 mg/m\^2 intermittent dosing group had insufficient data to evaluate AUC0-24 for relacorilant.
Outcome measures
| Measure |
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen
n=10 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=27 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=4 Participants
Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen
n=14 Participants
Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen
n=4 Participants
Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration-time Curve From Zero to 24 Hours (AUC0-24) of Plasma Relacorilant
|
3380 ng*h/mL
Geometric Coefficient of Variation 139
|
3780 ng*h/mL
Geometric Coefficient of Variation 110
|
7480 ng*h/mL
Geometric Coefficient of Variation 50.0
|
3300 ng*h/mL
Geometric Coefficient of Variation 104
|
7440 ng*h/mL
Geometric Coefficient of Variation 146
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1Population: The population analyzed was participants in the Safety Population with adequate pharmacokinetic data.
Outcome measures
| Measure |
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen
n=10 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=27 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=4 Participants
Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen
n=15 Participants
Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen
n=4 Participants
Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|
|
Pharmacokinetics: AUC0-24 of Plasma Nab-Paclitaxel
|
2290 ng*h/mL
Geometric Coefficient of Variation 48.5
|
3580 ng*h/mL
Geometric Coefficient of Variation 67.5
|
3380 ng*h/mL
Geometric Coefficient of Variation 12.7
|
3440 ng*h/mL
Geometric Coefficient of Variation 62.8
|
5910 ng*h/mL
Geometric Coefficient of Variation 73.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1Population: The population analyzed was participants in the Safety Population with adequate pharmacokinetic data.
Outcome measures
| Measure |
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen
n=10 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=27 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=4 Participants
Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen
n=15 Participants
Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen
n=4 Participants
Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of Plasma Relacorilant
|
363 ng/mL
Geometric Coefficient of Variation 100
|
423 ng/mL
Geometric Coefficient of Variation 88.8
|
767 ng/mL
Geometric Coefficient of Variation 47.4
|
546 ng/mL
Geometric Coefficient of Variation 89.4
|
897 ng/mL
Geometric Coefficient of Variation 55.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Segment I: before dosing and up to 24 hours after dosing on Cycle 1 Day 8; Segment II: before dosing and up to 24 hours after dosing on Cycle 1 Day 1Population: The population analyzed was participants in the Safety Population with adequate pharmacokinetic data.
Outcome measures
| Measure |
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen
n=10 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=27 Participants
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=4 Participants
Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen
n=15 Participants
Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen
n=4 Participants
Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Cmax of Plasma Nab-Paclitaxel
|
1810 ng/mL
Geometric Coefficient of Variation 71.0
|
2660 ng/mL
Geometric Coefficient of Variation 69.9
|
1560 ng/mL
Geometric Coefficient of Variation 79.3
|
2600 ng/mL
Geometric Coefficient of Variation 70.0
|
3070 ng/mL
Geometric Coefficient of Variation 41.5
|
Adverse Events
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen
Serious events: 6 serious events
Other events: 13 other events
Deaths: 12 deaths
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
Serious events: 18 serious events
Other events: 31 other events
Deaths: 19 deaths
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
Serious events: 5 serious events
Other events: 6 other events
Deaths: 5 deaths
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen
Serious events: 8 serious events
Other events: 14 other events
Deaths: 4 deaths
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen
Serious events: 3 serious events
Other events: 5 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen
n=14 participants at risk
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=34 participants at risk
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=6 participants at risk
Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen
n=14 participants at risk
Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen
n=5 participants at risk
Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
5.9%
2/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
8.8%
3/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
8.8%
3/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Obstruction gastric
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Infections and infestations
Corneal infection
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Infections and infestations
Device related infection
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Infections and infestations
Empyema
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Infections and infestations
Retroperitoneal abscess
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Infections and infestations
Sepsis
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Infections and infestations
Urosepsis
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
5.9%
2/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
8.8%
3/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Cardiac disorders
Atrial fibrillation
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
General disorders
Chest pain
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
General disorders
Pyrexia
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Injury, poisoning and procedural complications
Transfusion-related acute lung injury
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Vascular disorders
Cerebral artery stenosis
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
Other adverse events
| Measure |
Segment I: Relacorilant 100 mg + Nab-paclitaxel 60 mg/m^2 Continuous Dosing Regimen
n=14 participants at risk
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 60 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 100 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=34 participants at risk
Following lead-in, participants received relacorilant 100 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment I: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Continuous Dosing Regimen
n=6 participants at risk
Following lead-in, participants received relacorilant 150 mg, administered orally once daily, in combination with nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 150 mg + Nab-paclitaxel 80 mg/m^2 Intermittent Dosing Regimen
n=14 participants at risk
Following lead-in, participants received relacorilant 150 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 80 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
Segment II: Relacorilant 200 mg + Nab-paclitaxel 100 mg/m^2 Intermittent Dosing Regimen
n=5 participants at risk
Following lead-in, participants received relacorilant 200 mg, administered orally the day before, the day of, and the day after nab-paclitaxel 100 mg/m\^2 infusions on Days 1, 8, and 15 of each 28-day cycle.
|
|---|---|---|---|---|---|
|
Investigations
Blood potassium increased
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Investigations
Lipase increased
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Injury, poisoning and procedural complications
Blister
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
8.8%
3/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
40.0%
2/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
8.8%
3/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
66.7%
4/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
35.7%
5/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
11.8%
4/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
66.7%
4/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
28.6%
4/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
33.3%
2/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
5.9%
2/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
5.9%
2/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
33.3%
2/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
35.3%
12/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
42.9%
6/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
60.0%
3/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
26.5%
9/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
35.7%
5/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
80.0%
4/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
8.8%
3/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
23.5%
8/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
5.9%
2/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
33.3%
2/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Infections and infestations
Candida infection
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
8.8%
3/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Infections and infestations
Influenza
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Infections and infestations
Ear infection
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Infections and infestations
Laryngitis
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Psychiatric disorders
Depression
|
21.4%
3/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
5.9%
2/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Psychiatric disorders
Disturbance in attention
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
5.9%
2/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Investigations
Aspartate aminotransferase increased
|
21.4%
3/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Investigations
Blood bilirubin increased
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
5.9%
2/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Investigations
Blood creatinine increased
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Cardiac disorders
Tachycardia
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
8.8%
3/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Cardiac disorders
Oedema peripheral
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Vascular disorders
Hypotension
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
40.0%
2/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Vascular disorders
Hypertension
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Eye disorders
Lacrimation increased
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Eye disorders
Dry eye
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
33.3%
2/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Eye disorders
Vision blurred
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Eye disorders
Eye disorder
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Renal and urinary disorders
Nocturia
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Nausea
|
50.0%
7/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
38.2%
13/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
50.0%
3/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
71.4%
10/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
40.0%
2/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
6/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
38.2%
13/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
50.0%
3/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
57.1%
8/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
60.0%
3/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
42.9%
6/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
35.3%
12/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
33.3%
2/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
64.3%
9/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
60.0%
3/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
21.4%
3/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
14.7%
5/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
42.9%
6/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Constipation
|
28.6%
4/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.6%
7/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
28.6%
4/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
40.0%
2/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Stomatitis
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
11.8%
4/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
66.7%
4/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
28.6%
4/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
17.6%
6/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
11.8%
4/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Flatulence
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
5.9%
2/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
8.8%
3/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Dysgeusia
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Throat irritation
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Gastrointestinal stoma complication
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
General disorders
Fatigue
|
35.7%
5/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
47.1%
16/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
100.0%
6/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
57.1%
8/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
80.0%
4/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
General disorders
Pyrexia
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
17.6%
6/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
33.3%
2/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
General disorders
Mucosal inflammation
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
11.8%
4/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
21.4%
3/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
40.0%
2/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
General disorders
Oedema peripheral
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
11.8%
4/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
General disorders
Chills
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
General disorders
Early satiety
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
General disorders
Pain
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
General disorders
Chest pain
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
General disorders
Oedema
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
11.8%
4/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
33.3%
2/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
General disorders
Peripheral swelling
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
General disorders
Face oedema
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
General disorders
Hot flush
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
35.7%
5/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
23.5%
8/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
33.3%
2/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.6%
7/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
66.7%
4/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
17.6%
6/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
21.4%
3/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
40.0%
2/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
11.8%
4/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
21.4%
3/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
40.0%
2/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
8.8%
3/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
33.3%
2/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Metabolism and nutrition disorders
Oedema pheripheral
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
11.8%
4/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
5.9%
2/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
35.7%
5/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.6%
7/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
50.0%
3/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
42.9%
6/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
40.0%
2/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.6%
4/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
26.5%
9/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
50.0%
3/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
28.6%
4/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
11.8%
4/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
66.7%
4/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
50.0%
7/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
40.0%
2/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
14.7%
5/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
66.7%
4/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
50.0%
7/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
40.0%
2/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
50.0%
3/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
5.9%
2/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
50.0%
3/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
5.9%
2/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
40.0%
2/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Skin and subcutaneous tissue disorders
Nail bed disorder
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
28.6%
4/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
26.5%
9/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
50.0%
3/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
21.4%
3/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
8.8%
3/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
33.3%
2/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.4%
3/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
5.9%
2/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
11.8%
4/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
5.9%
2/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Nervous system disorders
Neuropathy peripheral
|
21.4%
3/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.6%
7/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
83.3%
5/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
21.4%
3/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
60.0%
3/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.6%
7/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Nervous system disorders
Dysgeusia
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
21.4%
3/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Nervous system disorders
Tremor
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
2.9%
1/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Nervous system disorders
Insomnia
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Nervous system disorders
Urinary incontinence
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
20.0%
1/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Vascular disorders
Orthostatic hypotension
|
14.3%
2/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
16.7%
1/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
|
Vascular disorders
Bloody discharge
|
0.00%
0/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/34 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/6 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
7.1%
1/14 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
0.00%
0/5 • Up to 28 days after the last dose of study drug (Segment I: up to approximately 2.5 years, Segment II: up to approximately 1.5 years)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Corcept Therapeutics as the Sponsor, has a proprietary interest in this study. Authorship and manuscript composition will reflect joint cooperation between multiple Investigators and sites and Corcept personnel. Authorship will be established before the writing of the manuscript. As this study involves multiple centers, no individual publications will be allowed before completion of the final report of the multicenter study except as agreed with Corcept.
- Publication restrictions are in place
Restriction type: OTHER